final Report
                                                Study No. 5221,08
                          TcoaciTY OF
                     IN
                     MBA Chemical No.;  25
        Sponsor;
      Sponsor
         Triangle Institute
P.O. BOX 12194
         Triangle
Korth Carolina  27709
                     Or. Derails Diets
Testing facility;    Microbiological            Inc* (MBA)
                     5221 River Bead
                               MD
 Initiation                  03,

        Ion Date;    January 04,
    L.  Thomas
    Study

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 REPORT DOCUMENTATION
         PACE
                         1, REPORT NO,
EPA/530-SW-88-025
1. Recipient's Accession No.
 PB88-195292
 4. Title and Subtitle
      Subchronic Toxicity of  Para-Cresol  in Sprague Dawley Rats
                                                  *. Report Date
                                                    April 4,  1988
      Dr.  Dennis Dietz and  Dr. L,  Thomas  Mulligan
 9. Performing Organization Name and Address
                                                                            8. Performing Organization Repi- No
      Microbiological Associates,  Inc.
      5221 Kiver Road
      Bethesda,  MD  20816
                                                                             10. Preiect/Taik/Work tin II Na.
                                                  11. ContracHC) or Grant (G! No.
                                                  to 68-01-7075

                                                  (G)
 12. Sponsoring Organization Nam and
       U.S.  Environmental Protection Agency
       Office  of Solid  Waste
       401 M  Street,  SW
       Washington,  DC 20460
                                                  II. Type of Report & Period Covered

                                                    Final Report
                                                  14.
 IS. Sypptemfifttary Notes
       Study  conducted for  Research Triangle  Park under EPA Contract No.  68-01-7075
 IS. Abstract (Limit: 200 words)
   This  study was conducted  to assess the tcxicity of  para-cresol  (p-cresol) in rats
   when  administered  for 13  weeks  by gavage.
 17. Document Analytic a. Detcrlpton
   b. Identlfiers/Qpen-Ended Terms
   C. CO SAT I Fulc/Grouc
16- Availability Statement

        RELEASE UNLIMITED
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See ANSI-Z39 16}
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                                                           OPTIONAL FORM 272 C4-77)
                                                            (Formally NTIS-35)
                                                           Oept rtmenl of Commerce

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                                                       Final Report
                                                       Study No. 5221.08


                              TABLE OF CONTENTS


                                                                      Page
   I.  SUMMARY...	    1

  II.  UfTSDDUCnON	,	    1

 III.  MATERIALS AND METHODS	    1

       A.  Test Article.,	    1
       B.  Animals..	    l
       c.  Experimental  Design	    2
       D.  Statistical Analyses...	    6

  IV.  RESUUrS	    6

       A.  Analyses and  stability of Dosage Form Preparations	    6
       B.  Mortality/Clinical Observations	    6
       C.  Body Weight.	    7
       D.  Food Consumption	    8
       E.  Clinical Pathology	    8
       F.  Ophthalmology	    9
       G.  Organ Weights	    9
       H.  Pathology...			   lo

   V.  DISCUSSION	   11

  VI.  PERSONNEL....	.		   12

 VII.  ARCHIVES	   12

VIII.  PROTOCOL	   46


                                 APPENDICES

       APPENDIX A - 1WD-WEEK RANCS-FIbroiNG/EXPlJDRATORY STUDY
                    OF META-CRESOL IN SPRAGUE DAWL1Y RATS	  A-l

       APPENDIX B - ANALYTICAL CHEMISTRY METHODOLOGY....		  B-l

       APPENDIX C - CLINICAL PATHOLOGY METHODOLOGY	  C-l

       APPENDIX D - INDIVIDUAL ANIMAL DATA	  D-l

       APPENDIX E - OPHTHALMOLOGY REPORT.	  E-l

       APPENDIX F - PATHOLOGY REPORT.	  F-l

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 ATTENTION


PORTIONS OP THIS REPORT ARE NOT

FULLY LEGIBLE.  DUE TO THE IMPORTANCE

OF THE MATERIAL IT IS MADE AVAILABLE

TO THE PUBLIC.  HOWEVER, IT IS THE BEST

REPRODUCTION AVAILABLE PROM THE COPY SENT

TO MIS.

DOCUMENT COMPLETE AS PAGINATED PER SOURCE.


DIRECT QUESTIONS RESULTING PROM ILLEGIBILITY

TO:  U.S. EPA
     OSWER - HSCD

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                                                       Final Report
                                                       Study No. 5221.08
 I. '\SUMMARY;
      This''study examined the oral toxicity of para-cresol  (p-cresol) in
      Sprague  Dawley rats during 13 weeks of oral gavage administration.
      Dose levels studied were 0, 50,  175 and 600 mg/kg/day.  Three females
      treated  with the high dose of p-Cresol died during the first three
      days of  the study.  Signs of central nervous system  (CNS) depression
      were apparent  in high-dose males and females.  Reductions in bcdy
      weight gain were seen for males  and females treated at the high dose
      level and  to a lesser extent in  the mid dose males.  Para-cresol was
      hepatotoxic, nephrotoxic,  and induced a mild anemic state.  Based on
      the results of the present investigation, 50 mg/kg/day appears to be
      the level  at which no toxic effects were observed under the conditions
      of the present study. ^,:
 II.  INTRODUCnON:

      This study was conducted to assess the toxicity of para-cresol (p-
      cresol) in rats when administered for 13 weeks by gavage.  All methods
      and procedures were conducted in accordance with the appropriate
      Quality Assurance Programs (Microbiological Associates Inc.; MEA or
      Pathology Associates, Inc.; PAI) designed to conform with FDA and EPA
      Good laboratory Practices Regulations.
III.

      A.  Test Article

          Para-cresol, 4 kg, was received on 29 July 1985 and was assigned
          MBA chemical number 25.  The source was Eastman Kodak Company,
          Rochester, NY, 14650, and was Lot No. A13A.  The test article was
          described as a colorless liquid and was 99.9% pure according to
          information provided by the supplier.  The test article was stored
          in its original container, a translucent plastic bottle, at room
          temperature and ambient humidity.

      B.  Animals

          One-hundred and fifty-eight male, and 157 female Sprague Dawley
          rats were obtained from Charles River Breeding Laboratores,  Inc.,
          Newfield, NY on 2 October, 1985.  The animals were approximately
          five weeks old upon arrival at the Microbiological Associates
          animal facility.  The animals were in quarantine/pretest for
          approximately two weeks prior to the initiation of treatment.
          Housing was by groups during quarantine/pretest and individual
          during the treatment period.  The animals were housed on Beta-Chip

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                                                       Final Report
                                                       Study No. 5221.08
           hartJwood bedding  in polycarbonate cages which conformed to the
           upper weight range  :recanmended  in the Guide f or_the Care and Use
           of Laboratory Animals. CHEW,  (NIH) No. 78.23.  All test animals
           received Purina Laboratory Chow No. 5001 in block form and water
            (Washington Surburban Sanitary  Commission, Potomac Plant) ad
           libitum  except during an approximate 16-18 hour fast prior to
           necropsy.

           During the study  period, animals were housed in a temperature-
           controlled room with a 12-hour  light/dark illumination cycle.
           Animal room temperature and relative humidity were recorded once
           daily and were noted to be outside the protocol-specified ranges
           on several occasions during the study.  Monthly environmental data
           are summarized below:
Month/Year

  10/85
  11/85
  12/85
   1/86
Number of
Readings

  16
  30
  31
  17
Temperature ( *}
   70.3  3.5
   74.3  2.3
   70.8  5.4
   73.2  2.2
64-76
70-82
48-80
69-78
Number (%) of Readings
Within_ Required_Bange

       10 (63)
       22 (73)
       19 (61)
       15 (88)

Month/Year
10/85
11/85
12/85
1/86
Number of
Readings
16
30
31
17
Relative
Humidity (%)a>(
46.3  12.9
39.4  9.8
22.6  9.1
26.5  6.1

2 Bange
24-63
24-64
11-50
16-38
Number (%) of Readings
Within, Required _Range
12 (75)
20 (67)
4 (13)
1 (6) -
a Protocol-required range = 69-75 F
k Protocol-required range *= 35-65%
c Values presented as mean  standard deviation.
       C.  Experimental Design

           During the second week of guarantine, animals were examined by the
           staff veterinarian and were found to be acceptable for use on
           study.  One hundred and twenty animals of each sex were selected
           on the basis of body weight and were assigned permanent cage
           numbers (1-120) for each sex.  These numbers were then randomized
           into four groups of 30 animals/sex/group.   Ten male and ten
           female rats were also chosen for baseline hematology and clinical
           chemistry determinations.  Baseline clinical pathology animals

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                                                       Final Report
                                                       Study No. 5221.08


           ware chosen from animals not previously assigned to test groups
           using a table of random numbers.

           The following dose levels were selected by the Sponsor on the
           basis of preliminary studies which included a two-week range-
           finding exploratory test (Appendix A), and were administered once
           daily by gavage for at least 13 consecutive weeks.

Treatment        Dose lsvel         Number of Animals     Dosage Fonraalation
  Group          (mcr/kg/day)        Male       Percale     	frag/ml)	

    1                 0              30          30                0
    2                50              30          30               10
    3               175              30          30               35
    4               600              30          30              120
    5  [Baseline Clinical Pathology] 10          10


           Hie test chemical was diluted in corn oil to achieve the above
           concentrations which allowed for a dosing volume of 5 ml/kg.
           Dosage formulations were prepared fresh weekly throughout the
           study and were stored protected from light at room temperature.
           American Biogenics Corporation, Decatur, IL, tested the stability
           of p-cresol dosage formulations following a 14-day holding period.
           Additionally, the concentration of p~cresol in corn oil was
           analyzed from formulations used during Test Weeks 1, 2, 4, 8, and
           13 by ENSECD, Inc., Cambridge, MA.

           All rats in the study received a unique test animal number which
           appeared as an ear tag.  A cage card WES displayed on the front of
           each cage and contained the following information:  study number,
           animal number, test article name, treatment group name or number,
           room number, dose level, strain, sex, receipt date, and start
           date.  The cage cards were color-coded as a function of treatment
           group and sex.

           The test article or vehicle (corn oil)  was orally administered
           once daily for at least 13 consecutive weeks commencing on
           16 October 1985.   Animals were dosed up to the day prior to
           routine necropsy at either Test Week 7 (interim kill)  or 14
           (terminal kill).   The gavage proocedure was accomplished by the
           use of a rigid oral feeding needle.

           Non-fasted body weights were recorded on Test Day 1 and weekly
           thereafter.   Individual food consumption data were collected on a
           weekly basis.  Moribundity/inortality checks were routinely
           performed twice daily (once in the morning and once in the
           afternoon),  and moribund animals were killed and necropsied.  The
                                                                       6

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                                             Final Report
                                             Study No.  5221,08


 test animals were given complete physical  examinations on a weekly
 basis.

 Ophthalmology examinations were performed  during the quarantine
 period  and In Test Week 13 by Dr.  Nancy Bromberg,  Diplcmate,
 American College of Veterinary Ophthalmologists.   This procedure
 was done by indirect cphthalrooscopy,  and only animals  which were
 free of visable lesions,  or had congenital or incidental lesions
 which were not considered to  interfere with  the study, were
 considered for test animal selection.

 Blood samples were collected  from 10  rats/sex designated for
 baseline clinical pathology determinations,  10  rats/sej^/dose
 sacrificed during Test Week 7,  and 10 rats/se^/dose  sacrificed at
 study termination (Test Week  14).   Blood was obtained  via orbital
 sinus puncture while under 003  anesthesia.   Animals  were fasted
 for approximately 16-18 hours prior to blood collection.

 The following hematology and  clinical chemistry tests  were
 performed;

 Hematology
 Hemoglobin                     Erythrocyte count
 Hematocrit                     Reticulocyte  count
 Prothrombin time (PT)
 Total and differential leukocyte count
 Activated partial tbromboplastin time (APTT)

 Clinical Chemistry
 Sodium                          C02
 Chloride                       SGFT
 Potassium                      SCOT
 Calcium                        Glucose
 Phosphorus                     BUN
 Direct  and total  bilirubin     Globulin (calculated)
Alkaline Efiosphatase           Total protein
Total Cholesterol              Creatinine
Albumin                        A/G  ratio (calculated)

Urine specimens were obtained from  10 rats/se^dose sacrificed
during Test Week  7 and  from 10  rats/sex/dose which were sacrificed
at study termination.  The urine specimens were collected from
metabolism pans into gauze-filtered urinalysis cups during the
overnight fasting period.  The  following parameters were assessed:

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                                             Final Report
                                             Study No.  5221.08


 Uripalysis
 Appearance                     Glucose
 Volume                         Ketones
 Color                          Bilirubin
 Specific gravity               Urobilinogen
 pH                             Hemoglobin
 Protein                        Microscopic examination

 Clinical pathology methodology is contained in Appendix  C.

 Complete gross necropsy examinations were performed on rats found
 dead during the  study and those killed at the  interim  and terminal
 sacrifice intervals.  Eats assigned to the interim sacrifice
 (identified at study  onset) were  killed  in random order  over  a
 two-day consecutive period  (02-03 December 1985).  At  the terminal
 sacrifice,  all surviving rats  were killed in random order over a
 three-day consecutive period  (15-17 January 1986).  All  rats  were
 anesthetized with OQ2 and exsanguinated  by bleeding from the
 posterior vena cava.  Animals  were fasted overnight prior to
 necropsy.

 The  necropsy procedure  included a thorough and systematic
 examination and  dissection of  the animal viscera and carcass, and
 collection of the following tissues/organs in  10% neutral buffered
 formalin:                                          ."

 All  gross lesions                  Ovaries
 Brain (3 levels)                    Corpus and cervix  uteri
 Spleen                             Eye
 Bone (with marrow)                  pituitary   .
 Skeletal inuscle                     Lymph node
 Salivary gland                      Spinal cord
 Mammary gland                       Heart
 Thymus                             Aorta
 Thyroid (with parathyroid)          Sciatic nerve
 Lungs (with roainstem bronchi)       Pancreas
 Trachea                            Esophagus
 Liver                              Kidneys
 Urinary bladder                     Small  and  large intestine
 Testes                             Adrenals
 Prostate              -              Stomach

All of the  above tissues for all control and high dose animals
 sacrificed  at study termination as well as  those that died during
the study were submitted for histopathologic evaluation.
 During terminal sacrifice, in addition to terminal body weight,
the heart,  liver, spleen,  brain, kidneys  (individually),  gonads
 (individually),  adrenals,  and toyroid/parathyroid were weighed.

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                                                     Final Report
                                                     Study No. 5221,08
     D.  Statistical Analyses:
         Body weight, food consumption, clinical chemistry, hematology,  and
         organ weight data were analyzed by sex by one-way Analysis of
         Variance tests with Burnett's t-test employed if a significant F
         ratio was found (p < 0.05}.   Individual animal data can be found
         in Appendix D.
IV.  RESUUTS
     A.  Analyses and Stability of Dosage Form Preparations

         Para-cresol in corn oil was found to be stable for at least 14
         days at the concentrations tested.   Additionally,  the analyses  of
         the dosage form preparations used during Test Weeks 1,  2,  4,  8  and
         13 indicated that target concentrations were generally within an
         acceptable range at the 10 and 35 Jng/ml dose levels.   Seven of
         these ten preparations were within 10% of the intended
         concentration.   Of the remaining three,  two were for the 35 mg/ml
         dose level (mid dose), and were approximately 11%  more than
         target.   The renaining sample (10 mg/rol dose level) was 17% over
         the intended concentration. At the 120 rag/ml dose  level, the
         assayed values  for all five samples were greater than 10%  over
         target.   They ranged from 10.6% to  17.6% (mean = 15.6%)  above the
         intended concentration (Tables la and Ib).   Purity confirmation
         analyses performed by ENSEQO,  Inc.  indicated that  the bulk
         chemical was 99.6-99.7% pure.

     B.   Mortality/Clinical Observations

         Three high dose females died-within the first three days of-
         dosing.   Animal no.  3899  demonstrated tremors and  convulsions, and
         was comatose prior to  death.   Another female (animal  no. 3883) was
         comatose and demonstrated tremors prior to her demise, whereas the
         third female (animal no,  3910)  was  found dead without any clinical
         signs observed.

         Lethargy,  excessive salivation,  tremors,  and occasional
         convulsions and comas  were observed for roost of the surviving
         males and females  at the  high dose  level.  These clinical signs
         were not seen at the lower dose levels.  All high  dose males
         and/or females  exhibited  lethargy after dosing on  days 2 and  3.
         Treatment-related  clinical signs of tcxicity were  also observed  in
         the high dose rats at  the weekly physical examination intervals.
         The incidences  of  relevant clinical signs are summarized below:

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                                                       Final Report
                                                       Study No. 5221.08
              Incidence of Relevant Clinical Signs In High Dose Ratsa

Week

1
2
3
4
5
6
7
8
9
10
11
12
13

Lethargy
M F
30/30 25/30
3/30 5/27
4/30 4/27
12/30 10/27
10/30 12/27
13/30 10/27
13/20 11/18
7/20 6/18
7/20 4/18
12/20 9/18
9/20 8/18
7/20 4/18
9/20 7/18

Tremors
M F
6/30 4/30
- 2/27
2/30 2/27
3/30 6/27
5/30 5/27
4/30 2/27
7/20 3/18
2/20 2/18
4/20 2/18
5/20 5/18
4/20 2/18
5/20 2/18
2/20 3/18


Convulsions
M
-
-

-

1/30
2/20
-


-
-
"
I
1/30


-



-


-
-
"
Excess
Comatose Salivation
J F MF
2/30 - -
_ _ _ _
11/30 8/27
4/30 3/27
_ _ 2/27
1/30 - 2/30 3/27
2/20 4/18
3/20 1/18
- - 3/18
2/20 3/18
- - 1/18
C /"^ O
 D/J.O
- - - 4/18
a Number of animals exhibiting sign/number alive at beginning of week.
           No other treatment-related clinical signs of toxicity were
           apparent for p-eresol treated rats.  Diarrhea was an infrequent
           observation in the high dose animals.  This finding was noted in
           one high dose female during week 2 and one high dose wale during
           weeks 3 and 4.  Diarrhea was also noted in two control males
           during week 3, one control male during week 6, one control female
           during Week 4, and one low dose male during Week 6.

       C.  Body Weight

           Dose-related reductions in body weight gains were apparent for '
           p-cresol-treated males.  Decreases for the high and mid dose males
           were approximately 25% and 7%, respectively, throughout the
           treatment period. Statistically significant (p < 0.05)  reductions
           in weight gain were evident for the high dose males during Weeks
           1-13 and for the mid-dose males during Weeks 1-3.

           Weekly body weights recorded for the high dose males showed
           statistically significant reductions for all weeks throughout the
           course of the study but week 1,  as compared to the controls.   Mid
           dose males had significantly (p < 0.05) lower body weights than
           controls at weeks 2-4.

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                                                Final Report
                                                Study No. 5221.08
    The mean weight gains of the high dose females were noted to be
    significantly  (p < 0.05) lower than the control during weeks 1-7,
    10, and 13  (approximately a 15% decrease).  Slight but
    statistically  significant decreases in weight gain were noted for
    the mid and low dose females during the first few weeks of
    treatment  (Tables 2-5).

    High dose females had significantly (p <  0.05) reduced body
    weights at weeks 2-9, and 14.  The average body weight of the low
    dose females was noted to be significantly (p < 0.05) lower than
    the controls at weeks 1-5, and 7.  Therefore, the apparent
    reductions  in mean body weight gain for the low dose females
    during the early weeks of the study way be a reflection of the
    lower initial body weights.

D.  Food Consumption

    Food consultation was generally decreased  for high dose males
    throughout most of the treatment period.  The food consumption
    values of the high dose males were significantly (p < 0.05) lower
    than control during Weeks 1-7, and 9.  This reduction was seen on
    fewer occasions for high dose females, and was statistically
    significant at Weeks 1,  2, and 6.  Sporadic decreases were seen
    for the other two dose levels which did not generally appear to be
    related to treatment.  Exceptions to this include statistically
    significant reductions in food intake for mid-dose males during
    the first and fifth test weeks.   During Test Weeks 5 and 9, low
    dose males showed slight,  but statistically significant reductions
    in food consumption.

E.  Clinical Pathology

    At study termination, dose-related reductions in red blood cell
    count,  hemoglobin concentration, and hematocrit were seen for
    female but not male rats administered p-cresol at doses of
    175 mg/kg/day or greater.   Statistically significant reductions in
    the oxygen transport parameters were evident in the mid and high
    dose females;  values for the low dose females were numerically
    lower but not statistically significantly lower than that of the
    controls.   The effect was mild and physiological compensatory
    responses to the anemic state, i.e.,  reticulocytes,  macrocytosis,
    and elevated numbers of RBCs,  were not in evidence.

    Statistically significant elevations in mean SGPT levels were
    observed for high dose females at the interim sacrifice.   At study
    termination, high dose females showed significant elevations in
    both SGPT and SCOT levels.  The individual animal results showed
    that the increased transaminase levels at study termination were

                                 8

                                                          li

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                                                Final Report
                                                Study No. 5221.08


     attributable to unusually high values in  four high dose females
     (animals 3892,  3893,  3894,  and 3895); the remaining six animals In
     this group had  levels that  were generally comparable to those of
     the controls.   Two of the high dose females with elevated enzyme
     values  (animals 3893  and  3895) had chronic hepatic inflammation,
     which could  explain the elevations in transaminase levels.  No
     correlating  histopathologic findings were evident in the other two
     high dose females  (3892 and 3894).

     No  treatnnent-related  effects on SGPT or SCOT levels were noted for
     the high dose males.  Although one high dose male (animal 3761)
     showed  elevated transaminase levels at study termination, the
     values  for all  other  animals in this group were generally similar
     to  the  control  values.

     Significantly (p < 0.05)  increased serum cholesterol levels were
     observed for the high dose  females at study termination but not at
     the interim  period.   This parameter also appeared elevated for
     mid-dose females and  mid and high dose males at termination
     although these  changes were not statistically significant.

     At  termination, total protein was statistically significantly
     increased for male but not  female rats at the mid and high dose
     levels  in a  dose-related  fashion.  This appeared to be primarily
     due to  the elevated globulin levels.  Sporadic increases and
     decreases for other clinical pathology parameters were seen, and'
    were not considered related to p-cresol treatment (Tables 8-15).

F.  Ophthalmology

    The Ophthalmology Seport  is  contained in Appendix E.
    Treatment-related ophthalmic lesions were not seen for rats
    receiving para-cresol.

G.  Organ Weights

    Significantly (p < 0.05)  elevated relative renal weights were seen
    for male rats administered 175 ing/jag/day or greater.   Relative
    renal weights for the 50 mg/kg/day males were also numerically
    elevated, although statistical significance was not noted.   In the
    females, increased relative kidney weights were noted at the high
    dose? the mean relative right kidney weight was significantly (p <
    0.05)  elevated,  whereas that of the left kidney was only
    numerically higher than control.

    A treatment-related effect on relative liver weight was also
    evident in male rats administered 175 mg/kg/day or greater.   The
    mean relative liver weight of the 600 mg/kg/day males was


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                                                Final Eeport
                                                Study No. 5221.08


    175 rog/>ag/day group was numerically higher but not statistically
    increased.  Other statistically significant increases in relative
    organ weights were noted for the heart, testes, and brain (high
    dose males), and for the spleen (low dose females).

    Alterations in absolute organ weights, as compared to controls,
    were limited to the high dose group animals.  Slight but
    statistically significant decreases in absolute brain weights were
    apparent for high dose animals of both sexes; however, the
    significant increase in relative brain weight for the high dose
    male reflects that group's reduction in body weight gain.
    Similarly, the slight (but statistically significant) increase in-
    relative but not absolute testes weights for high dose males
    probably reflects their depressed body weight gains (Tables 16-
    19).  In addition, significantly (p < 0.05) lower absolute liver
    and spleen weights were noted for the high dose males, and
    significantly lower absolute right ovary weights were noted for
    the high dose females.

H.  Pathology

    The Pathology Report is contained in Appendix F.  Gross necropsy
    examinations did not detect treatment-related lesions.
    Histologically, a slight increase in the incidence of chronic
  ...  nephropathy was noted in all dosed male rat groups when compared
    to the male controls.   The increased incidence was significantly
    (p < 0.05)  greater at the low and high dose but not the middle
    dose.  The proportion of male rats with minimal and mild
    nephropathy was generally similar for all male rats including the
    controls.       ,  

    Epithelial metaplasia of the trachea was observed to a
    significantly (p < 0.05)  greater extent for high dose animals than
    for respective controls.   The incidence of this lesion was similar
    for low dose,  mid dose,  and control animals.   This lesion was
    characterized by multifccal to diffuse replacement of goblet and
    secretory granular cells by squamous epithelial cells which were
    flattened,  had nuclei  parallel to the basement membrane,  and were
    occasionally stratified.

    No other histemorphologic lesions appeared to be related to p-
    cresol treatment.
                                10

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                                                    Final Report
                                                    Study No. 5221.08
V.  DISCUSSION
    This study evaluated the oral toxicity of para-cresol in Sprague
    Dawley rats when administered for 13 weeks by gavage.  Three high dose
    females died within the first three days of the study.  Tremors and/or
    convulsions were seen for two of these animals prior to their demise.
    Surviving high dose males and females generally exhibited these
    clinical signs throughout the trea'taient period in addition to lethargy
    and excessive salivation. Additionally, statistically significant
    (p < 0.05) reductions in body weight gain were seen for male and
    female rats at the high dose level and to a lesser extent for mid dose
    males.

    Para-cresol appeared to be hepatotoxic on the basis of clinical
    pathologic indices and organ weights.  Histologic lesions of the
    liver, however, were not in evidence.  Serum transaminase levels were
    significantly (p < 0.05) elevated for high dose females and
    hypercholesterolemia was observed for this sex and possibly for males
    at the high and possibly mid doses.  Additionally, total protein and
    relative liver weights were significantly (p < 0.05)  increased at the
    high dose for males at study termination.

    Renal injury was suggested from both organ weight and light
    microscopic changes.  Slight increases in the incidence of chronic
    nephropathy were noted in all dosed raale rat groups and were
    significantly (p < 0.05) increased at the low and high dose levels.
    Significantly (p < 0.05) elevated kidney weights occurred for this sex
    at the mid dose or greater.  High dose females also demonstrated
    increased renal weights.  Clinical pathologic indices of kidney
    function neither clearly support nor contradict these observations.

    A dose-related anemic state was seen for female but not male rats was
    seen at the mid and high dose levels.  This effect was slight and
    compensatory physiologic mechanisms, i.e., elevated nucleated KBCs,
    retulocytosis, macrocytosis, etc.,  were not in evidence.  Bone marrow
    also appeared normal.   This anemic state was probably not hemolytic as
    neither congestion of the spleen nor hemosiderosis of this organ or
    the liver (Kupffer cells)  was seen.

    Ophthalmology examinations did not identify any occular lesions
    attributable to p-cresol.

    In summary,  three females treated with the high dose of p-cresol died
    during the first three days of study? lethargy,  tremors, and/or coma
    were observed in these animals prior to death.   Lethargy,  tremors,
    excessive salivation,  and occasional convulsions and comas were
    observed in surviving high dose rats throughout the study.
    Statistically significant reductions in body weight gain were observed

                                    11

-------
                                                       Final Report
                                                       Study No. 5221.08
       in males ana females at the high dose and, to a lesser extent, mid
       dose males.  Para-cresol was hepatotoxic, nephrotoxic, and induced a
       mild anemic state.  Based on the results of the present investigation,
       50 ing/kg/day appears to be the level at which no toxic effects were
       observed under the conditions of the present study.
  VI.  PERSONNEL

       L. Tom Mulligan, Ph.D, served as Study Director, and was responsible
       for the overall conduct of the study.  Barry S. Levine, D.Sc.,
       Diplomate, American Board of Toxicology, was Study lexicologist and
       was responsible for the in-life portion of the study.  Dr. Levine was
       also reponsible for clinical pathology evaluations.  Diana Copeland,
       DVM, Diplomats, American College of Veterinary Pathologists, was
       responsible for gross necropsies and histopathologic evaluations.
       John Miller, DVM, was responsible for laboratory animal care.  Harry
       J. Paulin, M.S. served as Study Chemist, and provided dosage
       formulations and analytical chemistry services.  Nona S. Karten, M.A.,
       was responsible for the Quality Assurance Program.  Mike Schulz, B.A.,
       and Brian Makle, B.S., were responsible for the collection of in-life
       test animal data.
VII.   ARCHIVES;'

       The raw data and final report are archived at Microbiological
       Associates Inc., 5221 River Road, Bethesda, MD 20816 with the
       following exceptions.  Pathology specimens including wet tissues,
       blocks and slides and original necropsy fonts are temporarily archived
       at Pathology Associates, Inc., 10075 Tyler Place, Hyatt Park II,
       Ijamsville, MD 21754 and will be transferred to the MBA Archives upon
       Sponsor approval of the final report.
VIII.  PROGDOOOL:

       The study protocol, complete with all amendments, is included
       following the study tables.
                                       12                           * c;
                                                                    1 O

-------
                                                                 Study 5221,08
                                   TABLE la


            SUECHRONIC TOXieiTY OF PARA-CRESOL IN SERAGUE BAWIZY BATS
                    ODNCENIRATION OF PARA-CRESOL IN CORN OIL (rag/ml)



                             STABILITY ANALYSES3
Sairple
NurriDer
C02S7A85
C0289A85
Date
Mixed
10/15/85
10/15/35
Target
Cone. (mcr/ittL)
10
120
Concentration fiw/rnl)
Zero Day
10.42b
138.6
14-Day
11.23b
143.6
Percent
Difference*
4-7.8
+3.6
*Percent Difference = 14-Day Value minus Zero Day Value   x 100
                                Zero Day Value

aAnalyses performed in duplicate by American Biogenics Corporation unless
noted otherwise.

^Analyses performed in triplicate.

-------
                                                                            Study 5221.08
                                              TABLE lb

                     SUBCHRQNIC TOXieiTY OF PARA-CRESOL IN SPRAGUE DAWLEY RATS
                          CONCENTRATION OF PARA-CRESOL IN CORN OIL (rag/ml)

Target
Concentration
fmcr/ml} 1
0 ND
10 9.9
35 36.8
120 140.1
FORMULATION ANALYSES3
Test Week
24 8 33
ND ND ND ND
9.2 11.7 10.3 9.6
35.1 36.1 38.8 39.0
132.7 141.1 140.1 139.2
aAnalyses performed by ENSECO Inc.  (formerly ERGO),  Cambridge, MA unless otherwise noted.

ND = Not detected above the minimum reporting limit of 1.0 mg/ml.

-------

                                                                    Study Mo. 5221.03
                                      TABLE 2
              SUBCHROMIC  TOXICm OF PARA-CRESOL IN SPRAGUE DAULIY RATS
                             MALE BODY WEIGHT DATA (g)
TEST
WEEK
a
i
2
3
4
5
6
7
8
9
10
11
12
13
14
0 ng/kg/day
233 
296 i
345 i
391 t
424 
452 t
460 t
501 t
525 t
547 t
555 
568 
533 i
592 
u<
18(
23<
25 {
2B(
32<
33 (
39 (
45<
46C
46C
46<
51(
53C
3D)
30)
30)
30)
30)
30)
30)
20)
20)
20)
20)
20}
20)
202
50 mg/ki/day
230 
289 i
338 i
385 i
419 i
447 t
475 t
496 t
516 i
531 
537 
549 i
562 
572 
17( 30)
21( 30)
25( 30)
28C 30)
32( 30)
33 ( 30)
36C 30)
37C 20)
4U 20)
4SC 20)
47C 20)
48( 20)
54< 20)
53( 20)
175 mg/kg/diy
227 i
282 
329 i
372 i
407 
434 i
461 
476 i
493 
516 i
526 i
535 i
550 
559 i
15C
21 (
24 C
29(
31 C
32C
34(
34C
35<
37(
37(
4H
4U
4H
30)
30)*
30)*
30)*
30)
30)
30)
20}
20)
20)
20)
20)
20)
20)
600 mg/kg/day
225 
256 t
297 
335 i
367 i
389 *
407 i
430 
447 i
463 i
469 *
483 i
495 i
507 t
17<
24(
27C
30C
34(
36(
39C
42(
47(
49(
50(
53 
57{
59C
30)
305*
30)*
30)*
30)*
30)*
30)*
205*
20)*
20)*
20)*
20)*
20)*
20)*
Weights taken on Test Day 1 prior to dosing.

Statistically significant differtncs frem control  group
using ANOVA and Ounnett's T-Test (P<=0.05).

Results presented as mean  standard deviation CM)
                                                                               IS

-------
                                                                    Study Mo. 5221.08
                                      TABLE 3
              SUSCKRONIC  TQXIC1TY OF PARA-CRESQt  IN SPRAGUE QAWLEY RATS
                          KALE BODY WEIGHT GAIN  DATA (i)
TEST
WEES
\
2
3
4
5 "
6
7
8
9
10
11
12
13
0 mg/kg/day
63 
112 t
158 t
191 4
219 
247 i
269 t
294 t
316 
324 i
337 *
352 n
360 t
7<
12C
15(
18C
22 {
24 (
30(
36(
37C
SBC
33C
43 (
45 C
30)
303
30)
30}
30)
303
20)
20)
20)
20)
20)
20)
20)
50 ing/ kg/ day
59 t
109 t
155 t
189 
217 
245 t
266 t
285 t
 301 i
307 i
319 
331 
342 i
7(
13C
17C
21 C
23(
25 (
25C
28(
33 C
35(
38C
44 (
42 (
30)
30)
30)
30)
30)
30)
20)
203
20)
20)
20)
20)
20)
175 mg/kg/day
55 t
102 t
145 i
180 t
207 i
234 *
252 
274 t
291 
301 i
311 t
326 
335 *
7(
11C
17(
20 C
21C
24C
24 (
25 (
Z7(
29<
32C
33 C
3Z(
30)*
303-
303*
30)
30)
30)
203
20)
20!
2(3)
203
20)
20!
600 mg/kg/day
31 t
72 t
110 t
142 
163 i
182 
205 i
222 t
239 *
244 i
253 *
271 i
283 t
165 303
17( 303*
19 30)*
23< 30)*
26C 30)*
28( 30)"
3H 20)*
36( 203*
38< 20)*
40C 20)*
43( 20)*
46C-20)*
48C 20)*
Statistically significant difference from control  group
using AHOVA and Dunnett's T-TesC (P<=0.05).

Results presented as mean  standard deviation (  M )
                              16

-------
                                                                       Study  No, 5221,08
                                         TABLE 4
                SUBCKRONIC TQXICm Of PARA-CRESQL IN SPRAGUi  DAWLEY  RATS
                               FEMALE BODY UEIGHT OATA (g)
TEST
UEEtC
"a
1
2
3
4
S
6
7
8
9
10
11
12
13
14
a
160
188
209
229
243
249
264
275
2B1
257
237
290
302
309
mg/kg/day
i 9<
t 12C
i 14C
t tec
t ire
t i<
i 21(
i 21C
i 23C
s 25{
* 24 (
 26C
 27(
 27C
30)
30!
30)
30)
303
30)
30)
20)
20)
20)
203
20)
20}
20}
50
152
177
195
214
230
240
251
260
265
275
279
280
290
298
nig/kg/day
i 12C 303*
t 13< 303*
s 14{ 30)*
i 17C 303*
t 17( 30)*
t 19( 30)
i 19( 30)*
i 22< 203
 23{ 20)
t 23{ 20)
i 23< 20)
 23 C 20)
 25 ( 20}
 25C 20)
175
159
182
203
224
239
247
261
269
274
281
2SS
289
299
304
mg/kg/day
 ac
 11C
t 13(
t 14c
* 13(
 17C
t 18C
t 19(
t 19(
 21 (
i 22<
t 23<
 25<
i 26(
30}
303
303
30}
30)
30)
30)
20)
20)
20)
20)
20)
20)
20)
MO
157
174
193
212
228
236
246
25S
262
269
263
274
232
285
mg/kg/day
i 10(
t 12C
s 1
-------
                                                                    Study No.  5221.08
                                      TABLE 5
             SUBCHRONIC TOXICITY OF PARA-CRESQL [N SPRACUE DAWLSY RATS
                         FEMALE 30DY UEtGHT GAIN DATA (g)
Test
Week
1
2
3
4
5
6
7
8
9
10
11
12
13

0
28
49
69
83
89
104
113
119
125
126
129
141
147

mg/icg/day
i 6{ 30)
* 8( 30}
 11( 30)
 11 C 30')
 13C 30)
t 15( 30)
t 14( 20)
 16< 20}
t 18( 20)
i 18( 20)
 1S( 20}
i 2Q( 20)
 20( 20}

50
25
44
62
78
89
99
107
112
122
126
127
137
145

mg/kg/clay
t 6{ 30)
 7( 303*
 9( 303*
 10( 30}
i 11( 30)
4 12( 30)
 14( -20}
 17( 20)
 14( 20)
 1S( 20}
 16( 20}
i 17( 20}
i 17( 20)

175
23 t
44 i
65 
80 *
88 
102 4
110 t
116 i
122 i
127 t
131 
140 i
146 t


ntg/kg/day
5(
7(
8<
8(
12C
1*C
H(
15C
17C
19(
19C
21<
23 <
30)*
30)*
30)
30)
30)
30)
20)
20}
20)
20)
20)
20)
20}

600
16 t
35 i
54 i
70 i
78 t
as t
97 t
105 i
111 t
111 
116' *
125 4
123 



mg/kg/day
71
9C
11C
14t
15C
13C
U<
17(
17?
19C
20 (
19C
22 (
27)
27)
27)
27}
27)
27)
18)
18)
18)
18)
18)
18)
*
*
*
*
*
*
*


*


18)*
Statistically significant difference from control  group
using AMOVA and Ounnett's T-Test (P<=0.05).

Results presented as mean t standard deviation  C N )
                               18

-------
                                                                         Study No.  5221.08
                                           TABLE 6
                  SUBCHRQN1C TQXICITY OF PARA-CRESOL IN SPRAGUE DAULET RATS
                             MAtE FOOD CONSUMPTION DATA 
-------
                                                                         Study No.  5221.08
                                           TA31E 7
                   SUBCHRQMiC TOX1C1TY OF PARA-CRESOt IN SPRAGUE DAWLEt RATS
                            FEMALE FOOD CONSUMPTION DATA (g/day)
     TEST
     WEEK        0 ms/kg/day        50 mi/kg/day        175 rag/kg/day       600 mg/kg/day

      1        18.8  *   1.SC 30)    17.6   1.7( 30)   18.7 t  1.7f 30)    15.8   1.7(  27}*

      2        18.9  i   2.0 30)    17.2 t  1.9C 30}*   18.2 t  1.7< 30}    17.1   1.8C  273*

      3        17.8  +   3.Q( 30)    17.8 t  3.6{ 30}    17.9   1.7C 30)    17.6 *  3.0C  275

      4        17.2  i   2.0C 30)    16.3   1.8( 30}    16.5 i  1.7{ 30)    16.1 t  1.8C  27)

      5        17.7  t   2.7C 30)    16.8 t  ZM 30}    17.7   2.0{ 30)    16.6 *  2.0C  27)

      6        18.3  *   3.0C 30)    16.9 *  2.4( 30)    17.7   2.1< 30)    16,5 *  1.7C  273*

      7        15.6  4   3.8C 30)    15.6 t  3.9< 30)    14.8 t  3.3< 30)    ,15.2 i  4.9(  27)

      8        17.5     3.7< 20)    16.5 t  4.0( 20)    16.3   2.0C 20)    17.1 t  2.CC  18)

      9        17.0  t   2.5< 20)    16.9   3.0( 20)    16.0 i  1.9( 20)    IS.9   1.9<  18)

     10        17.5 i  2.1C 20)    17.5 t  2.1C 203    17.6 i  2.3C 20)    16.5 i  1.6<  18)

     11        16.6   2.7C 20)    16.3   1.4C 20)    16.5 t  2.0C 20)    1S.7 s  1.9(  13}

     12        17.6 i  3.0( 20)     16.4 *  2.0C 20)    16.3   1.9{ 20}    15.6 t  1.3(.18)

    13       15.9   2.2< 20)     14.5 t   1.7C 20)    14.9 i  2.7C 20)    14.5  t   1.9C 18)
*  Statistically significant  difference  from control group
     using ftNQVA and Dunnett's  T-Test  (P<=0.05).

     Results presented as mean  -  standard  deviation C N )
                                   

-------
                                                                         Study No. 5221.08
                                            TABLE  3
                   SUBCHRONIC TQXICm  OF  PASA-CRgSOL  IN SPRAG'JE OAULEY RATS
                                    MALE  HEHATOLOGY VALUES
                                      [Interim Sacrifice]

  Parameter        0 mg/kg/day       50  mg/kg/day       175 mg/ki/day       600 mg/kg/day

     RBC        8.18 i 0.18<  10)     8.03  i 0.38( 103    8,19  Q.42( 10)    8.25  0.30( 10)

-------
                                                                          Study No.  5221.08
                                      TABLE 8 (.continued)
                   SUBCHRQMIC TOX1CITT OF PARA-CRESQL !N SPRAGUE OAWLEf RATS
                                    MALE HEMATOLQGY VALUES
                                      [Interim Sacrifice]

  Parameter        0 ing/kg/day        50 mg/kg/day        175 mg/kg/day       600  m/kg/day

     WBC        13.7 *  1.8C 10)    13.4 *  2.8C 10)    12.9 s  2.5C  105    13.7 t  3.2C  10)

-------
   Paramtter
                                                         Study No.  5221.03
                            TABLE 9
   SUBCHRONIC TOX1CITY OF  PARA-CRESQL  IN SPRAGUE DAULEY RATS
                    HALE  HEHATQIOCT VALUES
                     [Terminal  Sacrifice]

   0 mg/kg/day        50 mg/kg/day        175 mg/lcg/day       600 aig/kg/day

3. 48  Q.38 10)    3.54  0.55C 103    3.98  0.54C 10)    8.76 i 0.33C  10)


15.2 i  0.6( 105    15.3   0.7C 10)    15.* i' O.SC 10)    15.5 S  Q.BC  10)


42.6 i  1.<( 10)    42.6 *  1.9< 10)    43.6 t  1.9( 10)    43.6 i  2.7C  10)


10.5 t  1.6C 10)    10.7 t  1.6 10)    10.2 t  1.8C 10)    10.9 *  1.3{  10}


34.3 *  3.2C 10)    34.2   1.9{ 10)    34.9 t  2.6C 10)    37.S t  2.3(  10)


 0.8 i  0.4( 10)    0.6*   0.4C 10)     1.1 i  0.7( 10)     0.9*  0.5<  10)
      RBC
 (x  ia*6/ram*3

       HG8
     (9/dl)

      KCT
      a)

       PT
     (sec.)

     APTT
     (see. 3

     RET1C
   (X  rbc)
* - Statistically significant difference from control group
     using ANOVA and Ounnett's T-Test (P<=O.CS).

     Results presented as  mean s standard deviation C N )
                                  23
                                                                                26

-------
                                                                          Study Ho. 5221.08
                                      TABLE 9 (continued)
                   SUiCHRQNIC TOX1CITY OF PARA-CRESGL IN SPSAGUE  DAULEY  RATS
                                    HALE HEMATQIOGY VALUES
                                     [Terminal Sacrifice]

  Parameter         0 mg/kg/day        50 mg/fcg/day        175  rng/kg/day      600 mg/kg/day

     UBC        12.1 t  2.0( 10)    10.5 i  2.5C  10)    13.3  i  4.8C  10)   11.7 i  1.4< 10)

-------
  Parameter
                                                        Study No. 5221.08
                          TABLE 10
   SUBCHRON1C TQXIC1TY OF PARA -CRE SOU IN SPRAGUE OAULEY RATS
                   FEMALi HEMATOLQGf VALUES
                      [Interim Sacrifice]

    0 mg/kg/day       50 mg/kg/day        175  mg/kg/day       600 mg/kg/day

7.99 t Q.33C  10)    7.99 t 0.22C 10)    S.D2 t  0.46C  10)    8.14  Q.49(  9)


15.3 i  0.6C  10)    15.4 i  0.4C 10}    15.2 t   0.6C  10)    13. 2 t  0.6C  9)


43.0   1.4C  10)    43.2 i  1.3( 10)    42.9 t   2.0C  10)    42.9 t  1.8C  93
     SEC
(x 1Q*6/mn*3
      MGB
    Ci/dl)

     HCT
      PT         10.6 t  2.0C 10)    11.2 *   1.K  10)    10,5 i  1.4C 10)    11,9 i   1.0C  9)
    Csee.)

     APTT      ':39.3   6.7( 10)    35.9 *   7.1(  10)    36.6 s  6.2( 10)    38.5 i   4.2C  9)
    (sec.)

    SETIC        1.6   0.7C 10)     1.6 i   O.B(  105     1.4 4  O.B( 10)     1.2 t   0.6C  9}
   (% rbe)
     Results presented is mean 1 standard deviation < M )
                                 25
                                                                      28

-------
                                                                         Study No. 5221.08
                                     TABLE 10 (continued)
                   SUBCHRQNIC TOXtCITT OF PARA-CRESQL  IN SPRAGUE DAULEY RATS
                                   FEHALE HEHATOLOQY VALUES
                                      [Interim Sacrifice]

  Parameter        0 mg/kg/day        50 mg/kg/day        175 mg/kg/day       600 mg/kg/day

     UBC        11.4   1.7(  103     10.0 *  2. AC  10)     9.6   1.9( 10}     9.7 t  2.3<  9)
(x 4.

     SEGS        2.2   1.5(10)      1.0s  0.4(10)     1 .8   1.3C10)     1.7t  1.1(  9)
(x 10A3/mnr3)

    BAKDS        0.0   0.0(  10)      0.0  t  O.OC 10)     0.0 t  O.OC 10)     0.0   0.0{  9)
Cx 10*3/iwn*3)
    LY.MPHS       S.S t  1.1C  10)     8.8 t  2.2< 10)     7.5 t  1.2C 10)     7.6 *  1.S<   9)
(X 1CA3/f!TTl"3)

     MONO        0.4 i  0.2C  103     0.2 i  0.1( 10)     0,2 t  I). 1C 10)     0.4 4  Q.2(   9)
(x 10*3/imi*3)

     EOS         0.1 i  0.1(  10)     0.1   0.1C 10)     0.1 i  0.1< 10)     0.1    O.K   9)
(x 1
     Results presented as mean t standard daviition ( M )
                                   26
                                                                       29

-------
                                                                          Study No. 5221.08
                                           TABLE 11
                   SU8CHRQNIC TOXIC1TY OF PARA-CRESGL IH SPRAGUE DAULEY RATS
                                   FEMALE HEMATOLGGY VALUES
                                     [Terminal Sacrifice]

  Parameter        0 mg/kg/day        50 mg/kg/day        175 mg/kg/day       600 mg/kg/day

     SBC        8.83  0,48( 105    8.44 t Q.44( 10>    8,18  0.50C 105*   8,09 * 0.54C  105*
(x 10A6/(twi*3)

      HGS       16.3   0.7( 105    15.9 t  0.7( 10)    15.3 *  0.3C 105*   15,1 t  0.7l  10)1
    (g/dl)

     KCT        46.4 i  2.3< 103    44.4 i  2,Q< 10)    42.9 i  2.U 10)   42.1   1.8(  10)"
      PT        10.6   0.5C 105    10.1 *  2.4{ 10)    10.7 *  1.5C  10)     10.7 t  0.7<  10)
    (see. 5

     APTT       34.9   2.9C 10)    35.8 t  4.7( 105    38.2 t  5.2{  10)     37.4 t  5.4<  105
    (sec.)

    RET1C        0.7 t  0.5C 10)     0.8 *  0.3{ 105     0.9 t  0.4(  10)      0.7   0.3C  10)
   (% rbc)
* - Statistically significant difference from control  group
     using ANQVA and Burnett's T-Test (P<=0.053.

     Results presented as_raean t standard deviation (  N 5
                                  27

-------
                                                                         Study No. 5221.08
                                     TABLE 11  (continued)
                   SUBCHRONIC TQX1CITT OF PAaA-CSESOL  IN SPRAGUE DAWLEY RATS
                                   FEMALE HEMATOLQGr VALUES
                                     [Terminal  Sacrifice] ,
  Parameter        0 ing/kg/day        50  mg/kg/day        175 mg/kg/day       600 mg/kg/day
     U8C         7.8 *  1.2( 10)

Cx
     Results presented  as mean   standard deviation t N J
                                  28

-------
                                                                             Study do.  5221.08
                                              TABLE 12
                      SUBCHRQNIC TOXICITY OF PARA-CRESOL !N SPRAGUE DAWLEY RATS
                                   HALE CLINICAL CHEMISTRY VALUES
                                         [Interim Sacrifice]

 Parameter       0 mg/kg/day          50 mg/kg/day          175 mg/kg/day         600 mg/kg/day

    GLU      310.6   51. 4< 10)    207.7 i  38. 6< 10}    218.1 t  38. 7< 103    240.9    43. 6(  103
   Cmg/dl)

    iUN        15.9 *   1.9C 103     H.7 t   2.8? 103     14.8 t   3.2( 10)     13.7     1.2(  10)
   (mg/dl!

   SGPT         29 *     6C 10)       41 i    47C 10)       29 *     5( 103       33 i     6(  103
   (lu/t)

   SCOT         77 *    11E 10)       90 t    34 ( 10)       75      9(  9)       78 t     9(  103
   Uu/l)

   T PRO       7.4    0.5( 103      6.9    0.4( 10)      7.4    0.6C 10}  '   7.1 i    0,2(  103
   (g/dl)

    AL9        4.2    0.3< 10)      3, 8 i   0.2( 10)*     4.2    0.4C 103      4.0 t    0.2(  103
   GLOS        3.3 i   0.4{ 10)      3.1 *   0.4( 10)      3.2 i"  0.4(  103       3.1      0.3{  103
  (g/dl)

 ALB/CLQB    1.293  0.214C 10)    1,255 i 0.172< 10)    1.350 i  0.1d8<  10)     1.317  t  0.177<  10)
  (ratio)

    CHOL      86.3   21. 4( 10)     61.5 i  11, fi< 10}*    99.5    34. 4(  10}     91.3  *   14. 5(  10)
  (mg/dl)

     Ca       14.6 i   1.3C 10)     14.0 t   1;4C 10)     14.6 t    1.4(  10)     14.6  t    1.6(  103
  (mg/dl)
* - Statistically significant  diffarence  from control  group
     using ANOVA and Dunnett's  T-Test  i.

-------
                                                                         Study No.  5221.03
                                    TABLE 12 (continued)
                  SUBCHRQKIC TOXIC1TY OF PARA-CRESOL IN SPRAGUE DAULEY RATS
                               HALE CLINICAL CHEMISTRY VALUES
                                     tlnterim Sacrifice]

 Parameter     0 mg/ks/day        50 mg/kg/day        175 ng/kg/day       600  rag/kg/day

   D Bil     0.01  O.OK 10)    0.01 t O.OH 10)    0.01 t 0.01(  10)     0.01   0.01C  10)
  
-------
                                                                           Study No. 5221.08
                                             TABLE  13
                     SUSCHRONIC TOXICITY of  PARA-CRESCL  IH SPRAGUE OAULET SATS
                                  MALE  CLINICAL  CHEMISTRT VALUES
                                       [Terminal  Sacrifice]

Parameter       0 mi/kg/day          50 ntg/kg/day         175 mg/kg/day         600 ms/kg/day

   GLU      225.0   52. 4( 10)     234.5 *  47. &l  10)    250.6   43. 4< 10)    235.3  t  52. 5<  10)
   BUN       12.9 i   1.8C  10)      11.8 s   0.9C 10)     12. 6 t   2.7( 10)     13.1  t   2.71 10)
 (mg/dl)

  SGPT         26 t     4(  10)       28 *     4{ 10)       32 t     5( 105       80  i   107( 10)
 (lu/t)

  SCOT         70 s    12C  1C)       71     12< 10)       70     1ZC 103      113      85 ( 10)
 CIu/l)

  T PRO       6.8 t   0.3C  10)      7.0 t   0.3< 10)      7.3 i   0.4C 10)*     7.6  i   0.6( 10)*
 (g/dt)

   AL8        3.9    O.SC  10)      3.7 t   0.2C 10)      4.0 1   0.3C 10)      4.1     0.4( 10!
 (9/dl)
                                                                                             1
  GLOB        2.9    0.6(  10)      3.3    0.3C 10)      3.4 t   0.4C 105      3.4  t   0.4C 10)
 (g/dl)

ALB/GLOB    1.497 t 0.910C  10)     1.140 i 0.149C 10)    1.188 t 0.181J 10)    t.228  t. 0.168( 10)
 (ratio)

   CHOI      82.8 s   9.9C  10)      76.6 1  13. DC 10)    101.6 t- 13. 5( 10)    102.9  S  42. 8( 10)
 (mg/dl)
   Statistically significant difference from control group
    using AKOVA  and Dunnett's T-Iest (P<=0,05).

    Results  presented as mean  standard deviation < N )
                                  31                                              34

-------
                                                                         Study No. 5221.08
                                     TABLE  13  (continued)
                   SUSCHRONIC TOXICITT OF PSRA-CRESQl  IN SPRACUE DAUIEY SATS
                                HALE  CLINICAL  CHEMISTRY VALUES
                                     ^Terminal Sacrifice]

  Parameter      0 mg/kg/day       50 ng/kg/day        173 mc/kg/day       600 mg/kg/day

    0 Bit     0.01  t  O.OK  10)    0.01 4 O.OK 103    0.01 * O.OU  9)    0.01  O.OK  105
   (mg/dl)

    T nil     0.13   Q.07C  10)    Q.17 t O.Q6C 105    0.11 t O.Q6C  9)    0.14 * 0.05<  10)
   (mg/dl>

      Ca      14.3  *  3.0C   9)    13.3 t  1.8( 10)    17.6 i  3.4< 103*   13.8 t  1.6C  10!
   Cmg/dl)

      Ha       145  *     1<   45     145 *    1C  2)     146 t    0(  7)     145     1(  3)
   (Meq/l)

      1C         7.8    2.3<   4)     7.1t  1.5C  2)     6.5   1.1<  7)     7.4   2.5C  3)
   (Meq/l)

      Cl        105      2C  4)     104 t    K  25     104     1<   7)     104 i    1(  3)
   {Heq/l5

 ALK  PHOS      76  S   39C 10)      61    1B( 10)      60    27(  10)      73 t  30(  10)
   (lu/l)

    CD2        26     1<  45      27 *     3C   2)      26 t    4(   8)      26 *    4^  3)
   Heq/l)

   GREAT     0.70 4 0.07< 10)    0.64 t  O.C3C  10)   0.66  * 0.06<  10)    0.68  0.11C 10)
   (mg/dl)

    PHQS     10.0 i  2.CC 10)    8.9 S  0.9(  10)     9.9     1,3(   9)     8.4  *  1.0( 10)*
  (mg/dl)

    LDH       266   192C 10)    253 t  132<  10)     209'    124(  10)     339    116( 10)
* -- Statistically significant  difference  from control group
     using ANOVA and Ounnett's  T-Test  CP<=0.05).

     Results presented as  mean  i  standard  deviation ( H )


                                 32
                                                                                Ol r^
                                                                                ^  5

-------
                                                                             Study Ho. 5221.08
                                              TABLE 14
                       SUBCHRONIC TOXICITY OF PARA-CSES0L IN SPRAGUE DAULEY RATS
                                  FEHALE CLINICAL CHEMISTRY VALUES
                                         [Intel-id Sacrifice]

  Parameter       0 ing/kg/day          50 isg/kg/day          175 (fj/kg/day         600 mf/kg/day

    GLU      208.5 S   62.01 10}    186.7 *  59. OC 10)    194.2 i  43. 7(.  9)    204,6 t  82. 1(   93
   (mg/dt)

    SUN       19.8 s   4.8 10)     15.4    2.1< 10)     17.8 t   4.3C 10)     17.9 t   3.2<   9)
   mg/dl!

   SG?T         27 t     3< 10)       23 *     4( 10)       34      8(  9)       35 t    10<   9)*
   Clu/l)

   SCOT         79      8( 10}       79 t    18( 10)       85 t    19(  9)       88     27(   9)
   T PRO       7.4 4   0.8( 10)      7.2 t   0.3( 10)      7.2    0.2(   9)       7.3  t    0.5<  9)
  (g/dl)

    ALS        4.3    0.7( 1C)      4.3 t   0.4C 10)      4.2 i   0.3C   9)       4.4  i-   0.4{  95
  (g/dl)

   GLOB        3.1 t   0.3( 10)      2.8 1   O.S< 10)      3.0 *   0.3(   9)       2.9      0.4(  9}
  (9/dl)

 AL3/GLQB    1.424 e 0.264( 10)    1.563 i 0.372C 10)    1.445 t C.194C   9)     1.566    Q.254<  9)
  (ratio)

    CHOL     100.2   26. 9( 10)     74.7   11. 3( 10}*   1C8.6 . 13. 1(  10}     103.1  *  33.2!  9)
  (mg/dl)

     Ca       14.8    1.QC 10)     14.6    2.0C 10}     15.3 a   3.7(   9)      14.9  i    1.5(  f)
* - Statistically significant  difference from control  group
     using ANOVA and Dunnett's  T-Test  
-------
                                                                        Study No. 5221.03
                                   TABL1 14 (continued)
                 SU3CHRQN1C TOXIC1TY OF PARA-CRESQL IK SPRACUE DAWLEY RATS
                             FEMALE CLINICAL CHEMISTRY VALUES
                                    [Interim Sacrifice!

Parameter      0 mg/kg/day        50 m/ki/day        175 rag/kg/day       600 Kg/kg/day

 ' D BIL     0.00  O.OK 10)    0.01  O.OK 10)    0.01 i O.OH  9)    0.01   O.OU   93
 (rng/dl)

  T BIL     0.14  0.03C 10)    0.15 i 0.06C 10)    0.15 i C.08(  9)    0.13  t 0.04(   9)
 ;
                                                                                       

-------
                                                                            Study No, 5221.08
                                              TAIL! 15
                      SUBCHRONIC TOXIC1TY Of PARA-CRESQL  IN  SPRAGUE DAytiY IATS
                                  FEMALE CLINICAL CHEMISTRY  VALUES
                                        [Terminal Sacrifice]

  Parameter      0 mg/kg/day          50 mg/kg/day          175 mg/kg/day         600 wg/kg/day

    CLU      182.6 *  56. 2( 10)    236.6 *  63. 1C 10)     240.4 i  67.2C 10)    242.9 i  49. 6(  10)
  (mg/dl)

    BUM       14.2    2.8< 105     12.4    1.8( 10}     13.4 t   2.4C 10)     12.2    1.8C  105
  (mg/d!3

   SGPT         32 i    17< 10}       38 i    29<  10)       39 t    12C 10)      158 i   195C  10)
  Uu/t)

   SOOT         79 *    16< 10)       90 t    35(  10)       79 t    17< 10)      189    164<  103*
  du/l)

   T PRO       7.4 a   0.3C 10)      7.5 i   0.7(  10)      7.5 1   0.6C 10)      7.7 i   0.3<  103
  (g/dl)

    ALB        4.3 t   0.4( 10)      4.5 t   0.6(  10)      4.5 t   0.5< 10)      4.6 t   0.4<  10!
   GLDB        3.1    0.3C  10)      3.0  t   0.2C 10)      3.0 t   0.3( 10)      3.1  t   0.3(  103
 ALB/GLOB    1.440 i Q.260C  10)     1.491 i 0.16Q( 10)    1,490 i 0.187C 10)    1.513  t 0,310( 10)
  (ratio)

    CHOU      96.1 t  14. 0(  10)     95.2   14. 3( 10)    109.5 t  22 M 103    139.0  t  43. 4C 10)*
  (mg/dl)
* -  Statisticalty significant difference from control group
     using ANQVA  and Dunnett's T-Test  (P=O.OS).

     Results presented  as mean  standard deviation ( N )
                                    35                                    ;          38

-------
                                                                         Study No. 5221,08
                                    TABLE  15 (continued)
                   SUSCHRONIC TOXICiTY OF PARA-CRESOL IN SPRAGUE DAWLEY SATS
                               FEMALI CLINICAL CHEMISTRY VALUES
                                    CTerminal Sacrifice]

  Parameter       0  mg/kg/day        50 nig/kg/day        175 tn$/k$/day       600 mg/kg/day

    D  BIl      0.01  t  0.01<  10)    0.01 i 0.01C 10)    0.02  0.01( 10)    0.01 * 0.01( 10)
   (mg/dl)

    T  BIL      0.12  i  O.Q6C  10)    0.07  0.06C 10)    0.15  Q.Q7C 10)    0.12 * 0.07< 10)
   (mg/dl)

      Ca       13.8  i  4.1(  9)    16.fi i  3.1{ 10)    15.3 s  3.0( 10)    17.4 *  4.7C 10)
   (mg/dl)

      Ha        145  i     2<  5)     144     2(  63     146 i  ' 2(  4)     143 4    1(  5)
   {Meq/O

      K         6.8    0.7C  5)     7.8   1.3(  6}     9.1 t  2.3(  4)     8.2 1  3.4(  5)
   (Meq/l)

    , -Cl        104  t     2{  5)     104 t    1(  6)     106     1<  4)     103 i.    1C  5)
   (Heq/L)

 ALK  PHOS      57  s   23C  10)      45  i   23C  9)      55 t   38( 10)      55 S   34(  9)
   Ctu/l)

    CQ2        29  t    1{  S3      25  t    2<  6)      22     6(  4)*     26 *    3<  5)
   CHeq/t)

   CREAT     0.69  t 0.10{ 10)    0.69  i 0.04C 10)    0.69 * 0.05C 103    0.67 t 0.04< 10)
   (mg/dl3

    PHOS      9.6 t  1.9( 10)     8.2  t  0.7< 10)    9.9  2,2{  10)    9.1    1.4{ 10)
   (mg/dl)

    LDH       218 t  107( 103     221  t   112<  10)    209    S8(  10)    279     2C4(  10)
   Clu/O
* -- Statistically significant  difference  from control group
     using ANOVA and Dynnett's  T-Test  CP<=0.05).

     Results presented as mean  ;  standard  deviation  < N  3
                                 36

-------
                                                                        Study No.  5221.03
                                         TA31E 16
                 SUBCHRONIC TOXICITY OF PARA-CRESOL IN SPRAGUE OAWLEY  RATS
                 RELATIVE HALE ORGAN WEIGHT DATA (% Terminal  Body Weight)
                                   [Terminal SacrificeJ
Organ
HEART
LIVES
SPLEEN
KIDNEY-LFT
KIDNEY-RT
TESTIS-LFT
TESTIS-RT
ADRENALS
BRAIN
THY. /PARA.
0 mg/kg/day
0.313 
3.318 i
0.142 i
0.351 t
0.357 i
0.302 i
0.3QO t
0.010 i
0.399 *
O.OQ5 
0.025C 20)
0.272C 20)
0.021C 20)
0.032C 20)
Q.034C 203
0.029( 20>
0,034{ 20)
0.0025 20)
Q.Q4SC 20)
O.OOK 20)
SO mg/kg/day
0.309 i
3.232 i
0.142 
0.373 t
0.377 t
0.323 
0.323 t
0.01Q i
Q.4CS 
0.004 t
0.020C
0.242C
0.014<
C.031C
0.034(
0.032C
0.03U
O.OQ2C
0.030C
O.OOK
20)
20)
20)
20)
20)
20)
20)
19)
20)
20)
175 mg/kg/day
0.324 
3. SOS 
0.138 
0.382 
0.392 
0.31S 
0.321 t
0.011 t
0.419 
0.005 
0.022C
C.228C
O.C16<
0.038C
0.033(
0.035C
O.C32C
O.OD2<
0.030(
o.cou
20)
20)
20)
20)
2Cf>
20)
20)
20)
20)
20)
600 nig/kg/day
. 0.345
3.530
0.140
0.407
0.419
0.351
0.350
0.012
0.445
0.005
 0.069<
i 0.244(
 0.02U
 0.035(
 0.041C
i 0.048(
t 0.048C
i 0.003<
i 0.037(
t O.OOU
20)*
20)*
20)
20)*
203*
20)*
20)*
20)
20)*
20)
Statistically significant difference from control  group
using AMOVA and Dunnett's T-Test  (P<=0.05).

Results presented as mean t standard deviation C N )
                                37

-------
                                                                             Study No. 5221.08
                                              TASLE 17
                       SUBCHRONIC TQXICITY OF PARA-CRESOt IN SPRAGUE DAULSY RATS
                     RELATIVE FEHALE ORGAN UEIGHt DATA (% Ttrminal Body Weight}
                                         [Terminal Sacrffict]
Organ
HEART
LIVER
SPLEEN
K1DNEY-LFT
K1DNEY-RT
OVARY -LFT
OVARY-RT
ADREHALS
BRAIN
THY. /PARA.
0
0.370
3.405
0.186
0.398
0.398
0.015
0.017
0.023
0.723
0.007
mg/kg/day
i 0.032C
i 0.295C
i 0.015<
 Q.Q5QC
* 0.038C
 0.004?
 O.OOSt
i O.CC3<
i Q.06CC
1 0.002C
20)
20)
20)
20)
20)
20)
20
20)
20)
20)
50 mg/kg/day
0.378 i
3.417 t
0.204 
0.413 1
0.421 i
0.016 t
0,016 t
0.023 i
0.761 t
0.009 
0.027{
0.19K
Q.D23C
0.04K
Q.Q47C
O.OQ4C
0,005(
0.004C
0.062C
0.006C
20)
20)
203*
20)
20)
20)
20)
20)
20)
20)
175 mg/kg/day
0.3S3 *
3.346 
0.179 i
0.408 *
0.408 
0.013 
0.013 t
0.022 t
0.719 i
0,003 
0.022(
0.282C
0.032<
Q.044(
Q.046C
0.004C
Q.004C
O.OOSC
0.06SC
0.004C
20)
20)
20)
20)
20)
20)
20)
20)
20)
20)
600 mg/kg/day
0.385
3.531
0.186
0.437
0.441
0.013
0.013
0.024
0.733
0.003
i 0.077C 18)
i 0.230C 18)
 0.020C 18)
t 0.06K 18)
i 0.053C 18)*
s O.OOSC 13)
t O.OQ6C 18)
t Q.CQ4C 18)
 0.072C 13)
 0.002C 13)
* -- Statistically significant difference from control  group
     using ANOVA and Dunnett's T-Test (P<=0.05).

     Results presented as mean  standard deviation (  H )
                                    38

-------
                                                                                 Study No.  5221.08
                                                  TABLE 18
                          SUSCHRQNIC TQXICITY OF PARA-CRESQL IH SPRAGUE DAULEY RATS
                                         HALE ORGAN WEIGHT DATA 
0.129C 20)
0.135C 205
O.Q1K 20)
0.117C 205*
0.005( 20)
* --  Statistically significant difference from control group
     using ANQVA and Dunnett's T-Test  (P
-------
                                                                                 Study Mo. 5221.08
                                                  TABLE 19
                          SUBCHRQNIC TOX1CITY OF PARA-CRESOL IN SPRAGUE DAWLEY RATS
                                        FEMALE ORGAN WEIGHT DATA (g)
                                             [Terminal Sacrifice]
Organ
HEART
LIVER
SPLEEN
KIDNEY-LFT
KIDNEY-RT
0 VARY- L FT
OVARY -RT
AORiMAtS
BRAIN
THY. /PARA,
0 mg/kg/day
1.059 S
9.744 i
0.533 
1.141 i
1.138 i
0.042 
0.048 i
0.066 i
2.062 t
0.021 4
0.113C
0.942C
0.052C
0.154<
0.121C
O.Q12C
0.014C
Q.Q1Q<
0.097{
0.006C
20)
20)
20)
20}
20)
20)
203
20)
20)
203
50 mg/kg/day
1.041 i
9.336 i
0.562 i
1.133 i
1.155 i
0.042 i
0.045 4
0.064 
2.079 i
0.024 i
0.123<
O.S35(
0.07H
0.12K
0.131(
0.009C
0-.016C
0.010(
0.079C
O.Q16C
20)
205
20)
203
20)
20)
20)
20)
20)
20)
175 mg/icg/day .
1.015 
9.494 t
0.507 
1.153 t
1.155 
0.036 i
0.038 t
C.061 t
2.029 t
0.022 4
O.Q76C
0.974(
0.082C
0.1Q8(
0.1 07(
0.009C
0.011C
0.01K
0.033(
0.010C
20)
20)
20)
20)
20)
20)
20)
20)
20)
20)
600 nig/kg/day
1.023 *
9.361 
0.494 t
1-.160 i
1.170 
0.034 t
0.036 s
0.064 
1.946 t
0.022 t
0.232C 18)
0.946{ 18)
0.067C 13)
0.188C 18)
0.170< 18)
0.014C 18)
0.016C 185*
0,010< 18)
0.107( 18>*
0.007( 18)
* - Statistically significant difference from control group
     using ANQVA and Dunnett's T-Test (P<=0.05).

     Results presented as mean s standard deviation ( H )

-------
                                                           Study No, 5221.08
                                   TABLE 20

           SUECHEONIC TQXZeTTY OF PARA-CRESOL IN SPRAGUE DAWLE RATS
                            HISTOPATHOLOGY LESIONS
                                       Dose fina/kcr/dav)
                                    50
175
600
                                Kidney-Chronic Nephrooathv
Males
Present
Absent

Males
Present
Absent
Females
Present
Absent

4 11*
IS 9
Trachea-

0 0
20 20

0 1
20 19

7
13
-Epithelial Netaolasia

1
19

1
19

12*
8


10*
10

9*
10
* = Significantly different from control group using
    Fishers Exact Test (p < 0.05).
                                   1*1

-------
                                                                               Table 21a
                                                                      Subchrom'c Toxicity Study of
                                                                  Para-Cresol in Sprague Dauley Rats
                                                                       Hale Clinical Chemistry
                                                                            Baseline Values
                                                                                                                                                     Study Ho.  5221.08
ANIHAl
          TPRO
                   BALB
                            GLOB
                                     BUM
                                             CREA    GLUC
                                                               TBIL
                                                                        DBIL
                                                                                  AST
AIT
CHOI
AtP
                                                                                                                     PHQS
CALC
                                                                                                                                                          CL
                                                                                                                                                                  C02
0 mg/kg
3781
3782
3783
3784
^ 3785
3786
37B7
3788
3789
3790
MEAN
STD

6.0
6.2
5.8
5.8
6.0
5.5
5.6
5.8
5.7
6.2
5.9
0.2

3.9
4.0
3.7
3.5
4.1
3.7
3.6
3.7
3.6
3.9
3.8
0.2

2.1
2.2
2.1
Z.3
1.9
1.8
2.0
2.1
2.1
2.3
2.1
0.2

29.6
18.5
20.9
10.2
17.4
15.6
16.4
21.8
15.1
21.5
18.7
5.2

0.81
0.65
0.63
0.63
0.60
0.61
0.49
0.54
0.57
0.60
0.61
0.08

205.8
107.1
170.0
110.1
1B0.4
189.4
124.6
202.4
108.4
190.9
158.9
41.4

0.29
0.24
0.25
0.23
0.22
0.18
0.24
0.25
0.19
0.23
0.23
0.03

0.11
0.15
0.05
0.09
0.08
0.07
0.13
0.12
0.08
0.08
0.10
0.03

82
69
71
80
66
72
86
79
74
95
77
9

52
38
46
29
28
36
41
36
37
52
40
8

50.9
65.9
65.7
56.7
64.4
47.5
75.0
71.9
47.7
48.3
59.4
10.5

370
174
138
206
251
236
191
176
323
272
234
72

13.0
13.9
13.3
12.2
13.2
12.5
13.3
12.3
12.6
13.8
13.0
0.6

10.1
11.7
11.4
10.8
11.0
11.1
11.1
12.1
11.3
11.9
11.3
0.6

9.4
9.1
8.6
7.4
9.3
8.4
10.9
9.4
9.6
10.5
9.3
1.0

143
144
149
140
142
142
141
142
141
140
142
3

102
103
108
100
103
102
100
102
101
99
102
2

31
31
30
30
30
32
26
27
24
25
29
3

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                                                                                                                                                    Study No.  5221.08
                                                                                  Table 21b
                                                                          Subehronic Toxicity Study of
                                                                       Para-Cresol in Sprague Dawley Rats
                                                                             Female Clinical Chemistry
                                                                                 Baseline Values

ANIMAL    TPRO     BALB     GLOB     BUN     CREA     GLUC     TB1L     DBIL      AST       ALT    CHOL      ALP     PHOS     CALC       K        NA       CL      C02
0 mg/kg
3911
3912
3913
3914
3915
w 3'16
3917
3918
3919
3920
HEAH
STD

6.4
6.1
6.8
6.3
6.1
6.0
6.4
6,2
5.8
6.2
6.2
0.3

4.2
4.0
4.6
4,1
4,0
4.2
4.3
4.1
3.9
4.2
4.2
0.2

2.2
2.1
2.2
2.2
2.1
1.8
2.1
2.1
1.9
2.0
2.1
0.1

22.6
20.2
17.3
16.9
19.6
23.2
21.2
15.6
15.5
19.3
19.1
2.8

0.52
0.52
0.66
0.53
0.51
0.53
0.58
0.56
0.49
0.58
0.55
0.05

187.4
219.4
173.8
113.5
134.5
250.7
255.3
139.5
178.9
136.7
178.9
49.6

0.19
0.18
0.21
0.20
0.21
0.16
0.19
0.17
0.17
0.22
0.19
0.02

0.08
0.14
0.04
0.08
0.10
0.07
0.07
0.04
0.07
0.07
0.08
0.03

65
87
62
67
74
77
53
71
63
67
69
9

35
54
21
32
36
48
23
32
41
41
36
10

98.7
68.7
84.0
120.2
100.8
67.6
87.5
103.2
72.2
75.6
87.9
17.5

77
233
163
241
146
271
192
265
141
22!
195
63

11.3
12.3
11.8
11.5
11.4
11.4
11.1
11.2
11.8
12.0
11.6
0.4

11.6
11.7
11.8
11.7
11.0
11.4
12.0
11.7
12.6
11.8
11.7
0.4

9.4
7.9
a. a
8.9
10.1
a.a
9.3
9.8
7.4
7.9
8.8
0.9

140
123
142
142
136
139
141
141
102
143
135
13

101
87
100
103
99
101
101
106
66
108
97
12

26
15
24
22
19
20
21
21
18
23
21
3

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                                                                Study No, 5221.08

                                   Table 22a
                          Subchronlc Toxlcity Study of
                       Para-Cresol in Sprague Oauley Rats
                                Hale Hematology
                                Baseline Values

ANSMAl      UBC     SEGS     BANDS    LYMPHS    MONO      EOS     PT     APTT
0 rog/kg
3781
3782
3783
3784
3785
3786
3787
3788
3789
3790
MEAN
STD

12.8
12.0
17.8
12.7
17.5
15.8
13.0
16.1
13.0
13.2
14.4
2.2

20
6
15
18
17
12
4
10
15
16
13
5

0
0
0
0
0
0
0
0
0
0
0
0

78
85
64
76
83
84
92
86
82
82
83
4

2
8
1
6
0
2
3
4
2
2
3
2

0
1
0
0
0
2
1
0
1
0
1
1

11.5
11.9
10.8
11.5
11.7
12.1
11.1
12.8
12.3
11.9
11.8
0.6 ,

13.2
15.2
15.4
18.4
22.4
15.8
18.1
25.1
24.2
19.4
18.7
4.1

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                                                           Study No. 5221.08
                                   Table 22b
                           Subchronic  Toxicity Study of
                        Para-Cresol  in Sprague Dawley Rats
                                Female Heraatology
                                 Saseline Values
ANIMAL
W8C
                    SEGS
BANDS   UYHPHS
                                              HONO
EOS
PT
                                                                      APT!
0 rng/kg
3911
3912
3913
3914
3915
3916
3917
3918
3919
3920
MEAN
STD

14.4
17,7
13.1
13,8
9.5
13.9
10.5
18.1
16.4
15.6
14.3
2. S

14
22
13
11
7
13
11
10
4
8
11
5

0
0
0
0
1
0
0
a
0
0
0
0

86
73
84
84
89
87
83
87
96
92
87
5

0
0
2
4
3
0
1
1
0
0
1
1

0
0
1
1
0
0
0
2
0
0
0
1

11.5
11.7
11.2
11.1
10.9
10.8
11.2
11.0
11.4
11.6
11.3
0.3

23.4
25.4
27.4
23. 3
17.2
17.8
18.8
19.9
24.9
28.0
22.6
3.9
                                                                                  48

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                                             Experiment Number 5221.08
               SUECHRONIC TOXICTTY OF PARA.-CRSSOL IN
                        SFRAGUE DAWIZY RATS
 I.  RIRPCSS

     The purpose of this study is to determine the toxic effects of
     jxxesol when administered by gavage for 13 weeks to Sprague Cawley
     rats.

II.  SPONSOR AND TESTING FACILITY

     A.   Sponsor Name:  Research Triangle Institute (KIT)

     B.   Sronsor Authorization Date:  12 July 1985

     C.   Protocol Approval _Date_:_  (Sea last page)

     D.   Testing Facility:  I-Hcrcbiological Associates Inc. ,
                             5221 River Hoad
                             Bethesda, Maryland  20816

     E.   Principal Investigator f Study Director) : Louis T. Mulligan, Ph.D.

     F.   Toxicolcaist:  Barry S. Levine, D.Sc., D.A.3.T.

7TT. TEST S
     A.   Scheduled Initiation Date:  15 October 19S5

     B.   Prcccsei ^Termination .Data:  15 January 19S5

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                                             Experiment Number 5221.03
IV.  TEST
     A.   Name:  p-cresol

     B.   Source and Manufacturer

          Source:  Eastman Kodak Company
                   Rochester,  NY 14650

          Kanufacturer:   To be supplied

          Lot No. :   A-13-A

          Batch No. :   None

          Purity:  99% +

          In-house  Chemical No. :   25

     C.    Safety Precautions

          1.    Personnel Protection

                   Eye:   Safety goggles

                 Gloves:   Two  pairs of gloves should be worn when
                          handling the neat chemical; one pair of
                          gloves should be worn when handling dose
                          preparations .

               Clothing:   Protective laboratory clothing will be
                          worn when handling dose preparations or
                          neat chemical.

           Ventilation:   Handling of  open dosage containers
                          or chemical  should be conducted in a
                          properly vented hood.

            Respirator:   A respirator fitted with an organic
                          vapor  (or organic vapor/acid vapor)
                          cartridge equipped with a particulata
                          filter will  be used at all times when
                          working with open containers and when
                          working  in rooms with animals dosed
                          with this chemical.

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                              Exceriment Number 5221.08
Spills and Leakage

Persons not wearing' the appropriate protective
equipment and clothing should be restricted  from
areas of spills or  leaks until cleanup has been
completed.

If p-cresol or solutions of  it are spilled the following
steps should be taken;

a.  Ventilate area  of spill.  Eliminate all  heat
    and ignition sources.

b.  Use vermiculite, sodium bicarbonate, sand, or
    paper towels to absorb the oil.

c.  Wash area with  detergent and water or MiJcrc
    klene and water.  Rinse well with water.

d.  Dispose of all .material in the cleanup as
    hazardous waste.

Wasta srd. Disposal  Prccadures

Securely package and label, in double bags,  all
solid waste material and dispose of by
incineration or by burial at a secured landfill.
Dispose of liquid waste in liquid hazardous waste
drums.

Prsparation_of_Cpses

Doses will be prepared in the Carcinogen Handling
Boom,  3rd floor,  5221 River 3cad, Bethesda, MD 2Q31S.

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                                                  Experiment Number 5221.03
                5.  Analysis of Solutions

                    The stability of the test solution will be determined
                    after storage for the same period and under the same
                    condition to be used in the study.

                    The accuracy of formulation will be checked by analysis
                    of samples taken from solutions prepared for administration
                    durirg weeks 1, 2, 4, 8 and 13 of treatment.

   V.   TEST SYSTEMS

        A.  Animals

            1.  Strain/Species:  Sprague Cawley Fats

            2.  Number/Sex:  130 males/130 females

            3.  Age:  5-6 weeks old at start of dosing

            4.  Supplier:  Charles River Breeding Laboratories
                           Lakeview, NY

            5.  Justification of Test Animal:  The test animal  (Sprague
                Dawley Eats) was specified by the sponsor and is a routine
                laboratory animal utilized in small rodent subchronic toxicology
                studies.

  VI.   HOUSING

        The animals will be individually housed in polycarbonate slice boxes
        marked with a test article code and held on stainless steel racks
        equipped with an automatic watering system.  Keat treated hardwood
        chips will, be used for cage beiiirg*  Backs will be periodically
        repcsitioned within the rocra to minimize any effect of variation in
        light intensity, temperature,  etc.

VH.     ANIMAL ENVIRONMENT

        A.  Temperature: 72  3F

        B.  Humidity:  50  15%

        C.  Light Cycle:  12 hcur cycle

        D.  Water:  Washington Suburban Sanitary Cormissicn Fotonac
                    Plant;  untreated;  ad libitum.

-------
vm.
                                                  Experiment Number 3221,08


        E.  Fead:  Purina standard, lab chew.

        ?.  Cage Change Schedule:  Cages will be changed every other week.

        G.  Feeder Change Schedule:  Cnce weekly.

        H.  Rack Changes:  Every other week.

        I.  Air Charge:  At least 12-15 per hour.

        J.  Bedding Changes:  Twice weekly.                        " 

        K.  It is not expected that there are contaminants in the feed or
            water which would have any influence on the study. 
        A.  Animals will be maintained in quarantine for 12-16 days.  The
            cleaning, feeding and watering procedures will be the same as
            described above for the tast period.  Aniarals will be group
            housed during the quarantine period, but individually housed at  ,
            test animal selection.

        B.  Animals will be observed twice daily for signs of illness or
            death and all unusual observations will be reported to the Principal
            Investigator or Director of Veterinary Medicine.

        C.  Animals will be examined during quarantine and approved for use
            by the Director of Veterinary Medicine prior to being placed on
            tast.  Health Status Evaluation form SA/QA 11 will be completed
            by the Study Director and Director of Veterinary Medicine.


  IX.   RANDCMI2ATTCN',  ANTMAL NUMBERING, STATISTICAL ANALYSTS

        A.  Randcmizaticn:  During the quarantine period, the animals will be
            randomized as follows:  Starting with one sex of the species to
            be rardcmized, each animal will be weighed, placed into individually
            numbered cages and separated into one of a number of weight range
            groups which ara based en successive intervals of 5 grains.  The
            weight of each is recorded en paper.  After all anir?als have been
            placed into their appropriate weight range groups, 130 of the
            aniirals with weights closest to the median weight will be randomized.
            Outliers will be used for health check evaluation and baseline
            evaluations or killed.

            After the appropriate number of animals per sex have been selected,
            a random number table will be coirpitar generated for each sex and
            used to allocate animals to a treatment group.                 ^ e*.
                                                    *"   *          i       
-------
                                              Experiment Number 5221.08


    B.  Numbering:  Animals will be uniquely consecutively numbered using
         ear tags.

     C.  Statistics:   The data will be examined using analysis of variance
         techniques  followed by a multiple comparison procedure for
         detecting differences between pairs of means.   Some pathology and
         clinical data may require nonparametric techniques to aid in
         interpretation.

X.   EXPERIMENTAL METHODS

     A,  Dosing

         1.   Route:  Gavage (specified by sponsor)

         2.   Vehicle:  Corn Oil

         3.   frequency:  Daily, approximately the same time each day,
                        7 days a week, for a period of  thirteen weeks or
                        until sacrifice.

         4.   Dosage Volume:  Five (5)  ml/kg calculated on animal's most
                            recent body weight.

         5.   Controls:   Receive vehicle alone at the same  dosage volume
                        as treated animals.

         6.   Mixing Frequency:  Dosing solutions will be mixed on a weekly
                               basis.
                                        THIS PAGE REVISED
                                                Signature
                                                                   Date
                                                          MICROBIOLOGICAL
                                                          ASSOCIATES INC.

-------
                                          Experiment Number 5221.08
B.  Treatment Groucs
            will be randomly assigned to groups with the  following
design:


Group

  1

  2

  3

  4

  5
                                                 Number of Animals
                Treatment

             Negative control

                 p-cresol

                 p-cresol

                 p-cresol

             Baseline clinical
                 pathology
Dose Level
f-mq/ka/day)
	
50
175
600
_
Male
30
30
30 
30
10
Feruale
30
30
30
30
10
    The ten male and ten female animals in group 5 will be sacrificed
    prior to study initiation for collection of baseline data on
    heTtiatology and serum chemistry.

    Ten zala and ten female animals {selected prior to initation of
    the study) from each remaining group will be sacrificed at 45-days
    post-treat-nent initiation for clinical pathology and collection
    of tissues for pcssbile later evaluation.  The following organs
    will be weighed:  heart, liver, spleen, brain, kidneys (individually),
    gcnads (individually) , adrenals and thyroid/parathyroid.

C.  Clinical^ Observations
                                                                      ,
    1.  Animals will be observed twice daily (once in the iroming and
        once in afternoon) seven days per week for Trcribundity/mcrtality.
        Moribund animals unlikely to survive until the next observation
        will be sacrificed and necropsied immediately.

    2.  Each animal will be examined weekly for clinical signs of
        toxicity .

    3.  Signs of toxicity noted at other times will, be recorded en
        room schedules and transferred to the observation sheet if they
        persist,

    4.  Animal Weights - Individual animal weights for test and control
        groups will be recorded at initiation (day 1) and weekly
        thereafter.


-------
                                         Experiment Number 5221.08
    5.  Individual feed consumptions will be derived by calculating
        the difference in weight of each feed jar plus contents at
        the beginning and end of the feeding interval and dividing by
        the number of days involved.

D.  Cphthalmoscopy

    Funduscopic (indirect opthalmosccpy) examination will be
    performed pretreatment and at termination on all animals
    designated to be terminated  at 13-weeks.

E.  Clinical_ Pathology

    1.  The following hematology (all animals fasted overnight)  will
        be performed on the 20 animals designated for baseline values
        (day 1),  on 10 males  and 10 females/group designated to  be
        sacrificed at 45 days and on 10 males and 10 females/group
        designated to be sacrificed at termination of the study:

        Hemoglobin
        Hematocrit
        Erythrocyte count
        Total and differential leukocyte count
        Prothrombin time (FT)
        Activated partial thromboplastin time (APTT)
        Reticulocyte count

    2.  The following clinical chemistry will be determined on serum
        samples per the hematology schedule:

        Sodium
        Chloride
        Potassium
        Calcium
        Phosphorus
        Blood creatinine
        C02
        SGPT
        SCOT
        Glucose
        BUN
        Direct and total bilirubin
        SAP
        Total cholesterol
                                      THIS PAGE REVISED
        Albumin
        Globulin
        Total protein
Study No,
                                              Signelure              Data
                                                      MICROBIOLOGICAL
                                                      ASSOCIATES INC.

-------
                                          Experinent Number 5221.08
    3.  Urinalysis will be determined en days 45 and 90 as cutlinedfor
        clinical chemistry. The following parameters will be measured:

        Specific gravity
        pH
        Protein
        Glucose
        Ketones
        Bilirubin
        Urobilincgen
        Microscopic examination

F.  yecrqcsv and Histccatholcqv

    1.  A ccmplete, detailed necropsy will be performed on all animals,

    2.  Animals that die or are sacrificed prior to the scheduled
        sacrifice will ba necrcpsied as soon as possible after death.
        Animals that can not be necrcpsied irroediately will be stored
        in a refrigerator until necropsy but no longer than 24 hours,

    3,  Fran all animals on study, except those designated for baseline
        clinical chemistry the following tissues will be collected
        and preserved in buffered formalin.

        All gross lesions                       Corpus and cervix uteri
        3rain (3 levels)                        Spleen
        Eye                                     Eone (with marrow)
        Pituitary                               Skeletal irtuscle
        Salivary gland                          Lynch node
        Heart      .                             Spinal cord
        Thymns                                  Mammary gland
        Thyroid (with parathyroid)              Aorta
        lungs (with itainstem bronchi)            Sciatic nerve
        Trachea
        Esophagus
        Stomach
        Small and large intestine
        Adrenals
        Pancreas
        Liver
        Kidneys
        Urinary bladder
        Testas
        Prostate
        Ovaries

-------
G.
                                          Exserizent Number 5221. OS
        Kistcpathological  evaluation will be performed on all abnormal
        tissues and lesions of all animals on  study.  All listed
        tissues will be saved from all rats at the  45-day sacrifice
        for possible future evaluation.  All the above listed tissues
        will be evaluated  on all animals sacrif icad because of a moribund
        condition, those that die on test, and all  control and high-
        dose animals sacrificed at the 13 week termination.
        Histopathology in  the mid and low dose groups will only fce
        required for "gross lesions and apparent target organs.  Target
        organs will be determined frem previous studies, clinical .
        data., and the histopathology in the high-dose level group.
        All lesions will be rated according to their severity.

        At terminal sacrifice, in addition to  terminal body weight,
        the heart, liver,  spleen, brain, kidneys (individually) ,
        gonads (individually) , adrenala and thyroid/parathroid will
        be weighed to three significant figures.  Organ weight to
        body weight ratios will be corouted.
    In general, the data will be examined using analysis of variance.^
    techniques followed by a multiple ccncarison procedure for detecting
    differences between pairs of means.  Seine anatomical and clinical
    pathology data may require nonpsrairietric techniques to aid in
    interpretation.
H.  Data
    Abnormal observations, body weights, feed consumptions, dose
    formulation documentation, and general study Garments will be
    recorded in laboratory notebooks.  Clinical laboratory data
    will be recorded in notebooks or will be direct instrument or
    ccnaputer output.  Pathology data, including organ weights, will
    be recorded on individual locse-leaf pathology sheets (one per
    animal).  At the completion of the study, all data and specimens
    will be transferred to the Quality Assurance Unit for storage in
    the test laboratory archives.

    The following data will be collected and included in the final report:

    o Sections on introduction, materials and methods, conclusions arxi
      discussion
    o Results of all chemical analyses
    o Abnormal appearance or behavior
    o Individual and loean body weights initially and weekly through
      13 weeks
    a Sfisults of the ciphtralmological examination            ..      ? c.

-------
                                                  Experiment Number 5221.08
            o Individual and icean hematology, blood chemistry and urinalysis
              as outlined.
            o Individual and mean organ weights  (heart, liver, spleen, brain,
              kidneys, gcnads, adrenals, and thyroid/parathyroid) from all
              animals at termination
            o Individual necropsy observations of all anirrals
            o Individual histcpatholcgy of tissues as outlined.

   XI.  RECORDS TO 35 MAINTAINED

        All raw data pertaining to the conduct of this study including the
        final report will be retained as the regulations require  in the
        archives at Microbiological Associates Inc., 5221 River Read, Eethesda,
        MD 20816.  If at sane time in the future any of these data are to be
        discarded, the sponsor will be first notified to obtain perimission. 
 XII.
XIH.
        All procedures not specified in this protocol will be performed in
        accordance with the Microbiological Associates Inc.  Standard Operating
        Procedures' Manual and in compliance with the FDA's Good Laboratory -
        Practice Regulations.

        Alterations of the study may be made after the study has been initiated.
        In the event that the sponsor verbally authorizes a change in protocol,
        such change will be honored by Microbiological Associates Inc.
        However, it is then the responsibility of the sponsor to produce
        written verification of the verbal authorization, which will result
        in the issuance of an official protocol amendment.
        1.  L.T. Mulligan, Fh.D:  Principal Investigator/Study Director

        2.  Barry S. Lsvine, D.Sc. , D.A.3.T.:  Tcxicologist

        3.  Ducas H. Erennecke, V.M.D., Ph.D.:  Veterinary Pathologist

        4.  John Miller, DVM, ACLAM:  laboratory Animal Veterinarian

        5.  Harold J. Paulin, M.S., demist

        6.  Jean L. Causer, 3.S.:  Operations Supervisor

        7.  Nona S. Karten, M.A. :  Quality Assurance


-------
                                                  Excerisent Number 5221.08
 XIV.   REFERENCES

        1.  Contract with Research Triangle Institute.
L.T. Mulligari, Ph.D.   (                     Sponsor
Principal Investigator
Cata                                        Eate
                                       .12

-------
                                                           ORIGINAL
                             PROTOCOL AMENDMENT


 Date:  October 16,  1985

 Study No.:  5221.08

 Title:  Subchronic Toxicity of Para-Cresol in Sprague Dawley Eats


 Amendment:

 1.  Page 7, Part X,  Section B;  Treatment Groups:  Delete the following
    sentence.  "The following organs will be  weighed:  heart, liver, spleen,
    brain, kidneys (individually) , gonads (individually) , adrenals and thyroid/
    parathyroid.

    Reason:  Per discussion with the Sponsor, organ weights are not necessary
             at the 45-day interim kill.

 2.  Page 3, Part X,  Section E, No. 1: Add prothracbin t.jjra (PT) and activated
    partial thromboplastin fri-m*  (APTT) , and delete platelet count.
    Reason:   PT and APTT are better estimates of clotting potential than
             platelet count.
Study DirectorL                                Date
Sponsor Approval             ^"^               Date
                                                               Gi

-------
                                                            OR  GiNAL
                              PROTOCOL AMENDMENT


 Date:   November 26, 1985

 Study No.:   5221.08

 Title:   Subchronic Toxicity of Para-Cresol in Sprague Dawley Rats


 Amendment:


 3.   Page 5,  Part VII,  Section E,  Feed:   Substitute "Purina standard lab chow*'
     with "Purina Rodent Chew No.  5001."

     Reason:  Omitted in protocol.

 4.   Page 5, Part VII:   Add the following:  Section L.  Room Number:  Roam #371

     Reason:  Not included in protocol.

 5.   Page 5, Part VIII,  Quarantine, Section B:  Unusual observations
     during the quarantine period  can also  be reported to the Study lexicologist.

     Reason:  Omitted in protocol.

 6.   Page 9, Part X,  Section F,  No.2:  If necessary, .animals which die on test
     are  stored in a refrigerator unitl necropsy but no longer than 16 hours.

    Reason:  Incorrectly stated as 24 hours in protocol.

 7.   Page 11, Part XIII,  No.  3:  Change the Veterinary Pathologist to
     "Dr. Diana Copeland, Diplcmate, ACVP."

    Reason:  This is necessary to finish all four RTI study reports on  time.
                                               Date
Sponsor Approval                               Date

-------
                  QUALITY ASSURANCE  STATEMENT


Study Title: SUBCHRONIC TOXICITY OF  PARA-CRESOL  IN  SPRAGUE  DAWLEY  RATS




Study Number: 5221.08

Study Director:  Louis T. Mulligan,  Ph.D.

Initiation Date:  October 16, 1985

Review Completed Date:  September 30, 1986

     This study has been divided into a  series of phases. losing  a
     random sampling approach, Quality Assurance monitors each  of
     these phases over a series of studies.  Procedures,  documenta-
     tion, equipment, etc.,  are examined  in  order to  assure that the
     study is performed in accordance with the U.S. FDA  Good
     Laboratory Practice regulations  (21CFR58),  the U.S. EPA  GLPs
     [40CFR792 and 40CFR160), and the OECD guidelines  and to  assure
     that the study is conducted according to the protocol.

     The following are the inspection dates, phases inspected,  and
     report dates of QA inspections  of the study.


INSPECT ON 85/10/28 - 85/10/23,TO STUDY  DIR  85/10/28,TO  MGMT  85/10/28

PHASES:  PROTOCOL REVIEW


INSPECT ON 85/12/03 - 85/12/03, TO STUDY  DIR  85/12/03,TO  MGMT  85/12/09

PHASES:  CLINICAL CHEMISTRY


INSPECT 0 86/04/14 - 86/04/16,TO STUDY  DIR  86/04/16,TO  MGMT  86/09/29

PHASES:  DATA REVIEW


INSPECT ON 86/09/25 - 86/09/29,TO STUDY  DIR  86/09/29,TO  MGMT  86/09/30

PHASES:  FINAL REPORT


     This report describes the methods and procedures  used  in the
     study and the reported  results accurately reflect the  raw data
     of the study.
                     AssranceDate
             R"A/QA Department

-------

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                                        Study No. 5221,08
                   APPENDIX A


TWO-WEEK RANGE-FTNDING/EXPIJDRATORY STUDY CF FARA-CRESOL
              IN SERAGUE DANLEY RATS
                                    64
                  A"L                        MICROBIOLOGICAL
                                            ASSOCIATES INC.

-------
>
INJ
                                                                                                     Study Ho. 5221.08
                    TUO WEEK RAMGE-FIMDIHG/EXPIORATQRY STUDY  Of  PARA-CRESOL  \ti SPRAGUE DAULEY RATS
                                               HALE  BODY HEIGHT  DATA  *

 DAY  9      Z46.6 t   B.1< 10)    253.1 t  14.4( 10)    240.8 t  20.2(  10)    233.3 t   14.1( 10)     210.7 *   12.?(  10)*

DAY  14      281.9 t   9.8( 10)    287.5 t  17.2( 10)    273.8 t  22.7<  10)    269.3 t   15.7(  9)     242.9 t   20.7(  10)*
             * -- Statistically significant difference from control group
                  using ANOVA and Dunnett's T-Test 
-------
                                                                                      Study  No.  5221.00
                    TWO WEEK RANGE-F1ND1NG/EXPLORATORY STUDY OF PARA-CRESOL  IN  SPftAGUE  DAULEY  RATS
                                              FEMALE BODY WEIGHT DATA (g)
TEST
DAY
0 mg/kg/day
100 mg/kg/day
200 rag/ kg/day
400 rog/kg/day
800 mg/kg/day
 DAY   1       131.7 t   5.3C 10}    134.Z    5.6( 10)    133.3    5.1(  10)     130.5 *    4.9(  10)     131.6     5.2{  10)

 DAY   5       150.1 t   5.5< 10)    152.7 i   8.0( 10)    150.2    6.0(  10)     143.6 t    7.8C  10)     130.5     9.8(  fl)*

 DAY   9       164.6    8.6{ 10)    165.5 t   7.7( 10)    165.9 t   6.7(  10)     158.5 t    9.0(  10)     150.3 *   10.4(  B)*

DAY   14       179.6   11.5( 10)    132.3 t   B.0( 10)    179.7 t   B.7(  10)     174.6 i   12.6(  10)     167.7 t   10.1(  8)
-  Statistically  significant difference from control group
   using  ANOVA  and  Dunnett's T-Test  (P<=0.05).

   Results  presented  as  mean   standard deviation ( N )

-------
                                                                                Study No. 5221.OB
               TWO WEEK RANGE-FINOING/EXPLORATORY  STUDY  OF  PAHA-CRESQL  IN  SPRAGUE  DAULEt  RATS
                                     MALE  FOOD  CONSUMPTION  DATA (g/day)

  TEST
  DAY          0 ing/kg/day        100 nig/kg/day       200 mg/kg/day       400 mg/kg/day       800 mg/kf/day
 Day  5      22.2 t  2.0( 10)    22.0 t  2.5C  105     21.8 i  2.7(  10)     19.1     4.3{  10)    14.4 t  3.2( 10)*

 Day  9      Z1.5 t  1.6( 10)    19.7   5.7(  10)     19.8 t  3.5C  10)     20.4  i   3.2<  10)    18.8 t  1.7( 10)

Cay  14      24.0 i  2.2( 10)    24.0   t.4<  10)     23.4 i  2.8{  10)     23.7     2.0(   9)    21.7 *  3.9{ 10)
  Statistically significant difference from control  group
  using ANOVA and Ounnett's T-Test (P<=0.05).

  Results presented as mean t standard deviation {  H )

-------
                                                                                                   Study Mo. 5221,08
                                  TUO UEEK  RANGE-FINDING/EXPLORATORY  STUDY  OF  PARA-CRESOL  IN  SPRAGUE  DAHLEY  RATS
                                                       FEMALE  FOOD  CONSUMPTION DATA  (g/day)
Test
Day
Day 5
Day 9
Day 14
0 wg/kg/day 100 mg/kg/day 200 mg/kg/day 400 ma/kg/day
16.5 * 2.4( 10) 16.6 t 2.4( 10) 16.5 t 2. 1C 10) 15.0 t 2.0(
14.1  3.1< 10} 14.2 t 1.9( 10) 14.6 t 1.2C 10) 14.5 t 2.0(
17.4 i 5.9( 10) 16.2 * 1.6( 10) 16.1 t 1.5( 10) 15.5 t 1 .6(
10)
10)
9)
800 mg/kg/day
10.1 t 5.0( 10)*
14.0 t 1.1( 8)
15.4  1.2C 8)
                *  Statistically significant difference front control group
                     using ANOVA and Ounnett's f-Test (P<=0.05).

                     Results presented as mean * standard deviation { M )
GO

-------
                                                                       Study No.  5221.08
TWO WEEK RANGE-FINDtNG/EXPLQRATORY STUDY  OF  PARA-CRESOL  IN  SPRAGUE  0AULEY  RATS
                    MALE BODY WEIGHT DATA (g)
                  ANIMAL NUMBER  DAY  1   DAY  5  DAY  9  DAY  14
   DOSE LEVEL
   0 ing/kg/day
  100 mg/kg/day
  200 rng/kg/day
  400 mg/kg/day
2401
2402
2403
2404
2405
2406
2407
2408
2409
2410
2411
2412
2413
2414
2415
2416
2417
2418
2419
2420
2421
2422
2423
2424
2425
2426
2427
2428
2429
2430
2431
2432
2433
2434
2435
2436
2437
2438
2439
2440
179.4
181.5
198.8
177.0
175.0
182.8
179.5
186.2
184.4
188.8
186.1
133.5
182.2
184.1
183.7
189.5
187.1
177.1
210.8
192. B
174.3
176.1
171.8
176.7
169.9
196.4
176.6
177.1
191.3
173.5
171.5
188.7
176.1
188.5
189.6
190.9
175.7
185,7
176.7
182.5
203,7
206.3
216.3
203.4
205.5
218.8
211.3
217.0
222.9
218.7
216.5
216.1
212.1
210.1
214.8
220.7
214.9
208.0
248.5
223.2
203.9
202.0
193.7
203.7
197.9
231.5
200.1
210. S
232.1
203.3
177.6
212.9
206.3
215.2
200.5
221.9
188.2
214.3
214.1
200.5
235.5
242.6
250.8
234.3
243.7
250.1
244.7
250.1
260.1
254.4
252. 3
249.6
248.5
247.4
240.1
249.8
251.1
233.2
283.2
266.3
229.5
230.9
218.7
235.6
233.5
273.5
223.2
243. S
279.4
239,6
209.9
246,6
234.4
241.9
226.0
250.1
217.9
243.6
243.3
219.1
264.5
281.7
283.7
270.3
284. 1
264. 3
2B5.7
277.9
301.2
285.8
290.3
286.7
283.9
288.2
-276.3
281.3
264,8
276.5
328.9
293.2
263.2
260.1
243.3
275.5
266.3
306.7
262.4
278.0
318.7
264.3
244.3
282.7
269.3
274.3
254.5
294.2
dead
278.7
270.4
254.6
                             A-6
                                                                               6
9

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                                                                       Study No. 5221,08
TUO WEEK RANGE-FINDING/EXPLORATORY STUDY OF PARA-CRESOL  IN  SPRAGU6 DAULEY RATS
                    MALS  BODY WEIGHT  DATA (g)
                  ANIMAL  NUMBER   DAY   1   DAY   5   DAY  9   DAY   14
   DOSE LEVEL
  800 mg/kg/day
2441
2442
2443
2444
2445
2446
2447
2443
2449
2450
167,0
182.4
179.4
172.6
187.2
1SS.2
184.4
172.2
183.1
185.6
172.8
156.4
176.2
150.6
172.8
202.9
190.6
176.6
190.1
194.4
202.6
216.3
209.7
192. a
194.1
232.5
213.0
204.5
216.7
225.2
193.1
248.2
251.6
230.1
234.2
270.5
247.4
246.0
253. 1
254.4
                                                                            7 0

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                                                                       Study  Mo.  5221.08
T'WO UEEK RANGE-FIND IMG/EXPLORATORY STUDY OF PARA-CRESOL  IN  SPRAGUE  OAWIEY RATS
                   FEMALE BODY UflGHT DATA (g)
                  AN[HAL NUMBER  DAY  1   DAY  5   DAY   9   DAY   14
   DOSE LEVEL
   0 ng/kg/day
  100 mg/kg/day
  200 mg/kg/day
  400 mg/kg/day
2451
2452
2453
2454
2455
2456
2457
245fl
2459
2460
2461
2462
2463
2464
2465
2466
2467
2463
2469
2470
2471
H472
2473
2474
2475
2476
2477
2478
2479
2480
2481
2432
2483
2484
2485
2486
2487
2488
2489
2490
125,3
129.0
122.4
130.2
131.4
132.7
132.6
139.8
135.8
137.6
137.9
129.1
128.1
135.3
125.4
136.7
132-7'
137.7
135.2
144.4
127.0
127.5
134.9
128,3
131.3
133.2
132.6
135.4
141.4
141.2
122.9
125.4
126.8
129.2
132.2
128.7
132.2
132,4
136.3
13B.8
141.6
153.5
145.4
149.2
150.6
146.8
U5.2
153.1
154.0
157.0
153.6
148.2
146.3
157.1
143.5
148.0
153.9
166.0
145.0
165.0
141.8
146.4
152.1
142.5
146.6
149.9
155.4
150.5
156.9
160.0
139.0
143.3
138.2
144.3
144.0
142.1
144.7
130.0
151.0
159.6
157.2
170.9
160.0
159.2
166.7
154.9
153.7
177.0
172.4
174.3
166.1
163.6
160.0
176.5
160.0
160.2
163.0
167.4
181.0
157.0
153.6
166.7
169.3
156.7
163.7
168.0
171.5
165.2
167.8
176.3
147.9
152.0
154.0
157.5
158.4
156.8
166.3
150.0
163.3
178.4
178.2
183.5
177.7
174.0
179.9
160.3
164.0
194.2
191.2
192.6
179.7
183.3
172.7
192.0
180.1
176.9
181.7
197.0
172.0
188.0
161.0
179.3
185.3
176. S
173.8
182.8
"185.9
175.4
185.1
192.1
161.4
161.1
178.5
164.2
179.8
172.5
191.2
165.3
174.1
198.1
                                A-8

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                                                                      Study No. 5221.08
TUO UEEK SANGS-FiNOING/EXPLORATORY  STUDY OF PARA-CRESCl IN SPRAGUE DAWLEY RATS
                   FEMALE  BODY  WEIGHT DATA 
                  ANIMAL  NUMBER  DAY   1  DAY  5  DAY  9  DAY  14
   DOSE LEVEL
  800 mg/fcg/day
2491
2492
2493
2494
2495
2496
2497
2498
2499
2500
128.4
133.3
124.5
123.3
136.7
130.0
129.9
134.7
137.5
137.9
127.2
138.2
131.1
115.6
135.5
137.6
117.4
dead
141.8
dead
153.7
152.7
142,9
135.9
155.9
159.7
137.6
dead
164.2
dead
170.8
172.2
163.1
159.7
169.0
180.3
149.0
dead
177.2
dead
                          A-9                                    <         7 2

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                                                                       Study No. 5231.03
TWO WEEK RANGE-FINDING/EXPLORATORY STUDY QF .PARA-CRESOL  IN  SPRAGUE  DAWL6Y RATS
           HALE FOOD CONSUMPTION DATA (g/day)
                  AHIHAL NUMBER  Day  S   Oay  9  Day  14
   DOSE LEVEL
   0 mg/kg/day
  100 mg/kg/day
  200 mg/kg/day
  400 mg/kg/day
2401
2402
2403
2404
2405
2406
24C7
2408
2409
2410
2411
2412
2413
2414
2415
2416
2417
2418
2419
2420
2421
2422
2423
2424
2425
2426
2427
2428
2429
2430
2431
2432
2433
2434
2435
2436
2437
2438
2439
2440
17.7
23.1
22.9
20.0
22.9
24.3
21.3
22.3
23.6
23.8
22.8
21.2
21.9
22.0
15.7
24. D
22.0
21.8
24.9
23.7
21.4
21.9
13. 2
21.9
22.1
26.8
13.5
22.1
25.4
20.2
15.7
21.7
20. 3
22.4
17.1
26.3
10.8
20.6
19.2
16,1
20.9
21.6
21.8
18-5
23,4
21.8
20.4
20.2
22.5
23,9
23.0
4.3
20.0
19,8
19,8
21.3
22.0
19.3
23.6
23.9
17.8
18.0
15.6
20.7
20.0
25. 8
15.5
19.2
25.4
19.6
17.5
19.8
20.0
18.5
18.1
25.1
18.2
23.8
25.6
17.1
22.4
24.3
23.3
20. 1
26.1
24.7
24.3
21.8
26.0
27.4
23.5
22.5
23.7
24.6
23.5
23.5
24.0
22.2
26.5
26.2
23.1
21,0
18.7
23.1
22.8
28.1
23.9
23.4
27.7
21.8
22.5
24.9
24.6
22.1
21.5
27.4
na
24.6
24.1
21.4
                              " 10

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                                                                       Study No. 5221.03
TWO-UEK RANGE-FI Mf> I HE/EXPLORATORY STUDY OF PARA-CRESOl IN SPRAGUE DAULEY RATS
           KALE FOOD CONSUMPTION DATA (g/day)
                  ANIMAL NUMBER  D'ay  5  Day  9  Day  14
   OOSE LEVEL
  800 mg/kg/day
2441
2442
2443
2444
2445
2446
2447
2443
2449
2450
15.6
17.9
11.2
8.5
10.3
18.0
15.6
16.7
15.4
14.4
17.0
21.9
18.1
19.2
16.7
17.3
20.0
17.8
20.7
19.8
. 11.2
24.2
21.7
23.0
21.6
23.3
22.2
24.6
23.8
21.9
                              A-ll

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                                                                                  Study No. 5221.08
                TWO WEEK RANGE-FIND ING/EXPLORATORY STUDY OF PARA-CRESCL IK SPRAGUE DAULEY RATS
                                        MALE FOOD CONSUMPTION DATA . 1
481.2
494.9
506.0
527.1
552.0
532.3
492.5
521.4
561.2
550.6
516.5
518.9
494.9
512.6
495.1
495.5
436.2
470.3
494.2
514.2
456.7
465.9
505.9
538.8
460.5
518.6
482.9
422.2
523.2
473.9
511.4
530.8
425.3
421.9
522.2
439.2
537.1
562.9
421.8
378.2
394.1
395.3
411.1
441.6
464.5
459.3
404. S
433.1
454.0
476.7
428.3
417.3
414.1
449.8
403.4
412.1
396,6
401.9
389.1
471.1
374.3
389.1
441.7
538.8
551.3
590.4
565.8
531.7
595.8
579.9
5B4.3
571.6
558.3
571.2
591.3
480.3
590.5
562.9
477.3
446.3
440.5
480.7
454.9
474.5
520.3
494.0
442.1
499.5
504.3
476.7
428.3
452.9
466.6 .
493.3
454.8
465.2
467.4
449.3
501.1
517.3
467.5
448.9
521.9
455.1
464.9
503.4
491.7
438.3
508.7
498.3
503.5
481.6
462.7
479.2
574.2
400.4
511.5
483.6
392.2
358.2
363.2
386.4
" 359.1
403.5
448.1
431.6
359.5
419.4
401.2
414.9
351.6
351.4
388.3
423.4
' 375.7
385.3
393.3
377.1
400.7
444.4
372.3
346.6
453,7
574.1
606.7
629.0
603.4
571.1
534.1
596.6
642.2
599.0
602.7
619.8
528.8
523.6
542.4
573.6
561.4
564.9
563.2
554.5-
512.1
639.9
493. S
508.9
538,4
517.2
553.3
579.8
534.6
553. 0
538.2
580.4
550.0
562.8
599.2
587.9
529.9
saa.2
650.3 
592.1
595.5
462.2
485.2
512.4
507.8
440.7
460.5
475.2
533.1
469.1
465.7
502.2
416.2
405.0
419.3
456.2
444.0
445.1
452.2
421.8
381.1
524.5
389.0
415.3
423.0
403.2
412.9
460.4
417.7
414.5
429.2
467.9
425.7
439.6
483.9
480.3
393.1
dead
527.4
471.5
4S8.4
                                             A-12
7
a

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                                                                                 Study No. 5221.08
                TUG UEEK SANGE-FINDINS/EXPLQRATORY STUDY OF PARA-CRSSQL  IK  SPRAGUE DAUIEY RA1S
                                        MALE FOOD CONSUMPTION  DATA  (g)
                                               [Feeder Weights!
                ANIMAL NUMBER  new feeder 1   old feedtr 1   new feeder  2  old  feeder 2  new feeder 3  old feeder 3
 DOSE LEVEL

800 mg/kg/day
2441
2442
2443
2444
2445
2446
2447
2448
2449
4S0.7
508.7
471.6
466.7
453.3
534.8
537.5
482. 0
466.3
418.4
437.1
427.0
432.7
410.0
462.7
475. 1
415.1
404.7
475.7
480.3
506.9
467.6
512.7
531.8
522.7
448.0
477.9
407.7
393.4
434.3
391.0
446.1
462.6
442.9
376.9
395.2
601.8
680.8
695.9
623. 5
605.0
700.0
623.8
659.0
616.3
545.7
559.7
587.5
510.3
497.0
583.5
513.0
536.2
497.5
                    245Q          492.3         434.6         495.2         416.0         604.8         49S.5
                                          A-13                                    '76

-------
                                                                      Study No. 5221.08
TUO WEEK RANGE-FIND INC/EXPLORATORY  STUDY Qf PARA-CRESQL  IN SPRAGUE DAULEY RATS
          FEMALE FOOD CONSUMPTION DATA  Cg/day)
                  ANIMAL NUHSER   Day  5  Day  9   Day   14
   DOSE LEVEL
   0 mg/kg/day
  TOO mg/kg/day
  200 rag/kg/day
  400 mg/kg/day
2451
2452
24S3
2454
24S5
2456
2457
24SS
2459
2460
2461
2462
2463
2464
2465
2466
2467
2468
2469
2470
2471
2472
2473
2474
2475
2476
Z477
2478
2479
2480
2481
2482
2483
2484
2485
2486
2487
2488
2489
2490
15.2
17.1
17.2
15.3
12. 8
15.3
15.1
17.8
21.9
17.D
15.1
17.2
17.3
17.6
14.5
13.3
17.6
21 .3
K.3
17.8
14.7
16.2
18.2
16.5
16.2
16.8
21,0
15,7
16.6
13.2
14. B
15.6
14.9
14.9
18.7
13.1
15.9
9.8
13.1
19.6
13.6
15.5
14.7
6.4
15.8
12.7
12.8
16.1
17.9
15.4
12.3
14.2
13.4
17.1
15.3
11.3
13.7
17.4
13.3
14.2
12.5
14.4
14.9
13.8
16.1
14.6
16.0
12.9
15.0
15.5
11.1
15.3
13.2
14.1
14.3
13.8
,17.3
13.3
14.1
18.2
16.1
16.5
16.3
14.6
16.1
13.5
13.5
16.3
33.8
17.7
14.1
16.4
16.8
17.5
16.8
13.4
15.7
18.7
15.8
17.2
13.7
15.3
16.5
18.6
16.5
15.5
17.0
13.9
16.1
17.7
12.9
15.5
16.2
na
15.1
14.1
17.5
15.1
15.2
18.1
                                                                                    ,
                             A-14                                    '          <  *

-------
                                                                    Study No. 5221.08
TWO WEEK RANGE-FINDING/EXPLORATORY  STUDY OF PARA-CRESQL  IN SPRAGUE OAW'LEY RATS
          FEMALE FCCD CONSUMPTION DATA (g/day)
                 ANIMAL NUNBER  Day  5  Day  9  Day  14
   DOS!  LEVEL
  800 mg/kg/ciay
2491
2492
2493
2494
2495
2496
2497
2498
2499
' 2500
9.0
16,4
12.4
5.7
10.0
16.4
8.1
5.6
15.3
1.8
14.5
13.7
.13.0
14.2
13.2
15.3
12.4
na
15.5
na
15.5
15.1
15.8
16.9
15.3
16,4
12.8
na
15.2
na
                         A-15
78

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                                                                                  Study No.  5221.08
                T0 WEEK RAMGE-FINDTNG/EXPLQRATORY STUDY OF PARA-CRESOl IN 'PRAGUE DAULEY  SATS
                                       FEMALE FOOO CONSUMPTION DATA 
                                               [Feeder Weights]
                ANIMAL NUMBER  ntH fsedir 1  old feeder 1  nay feeder 2  old feeder 2   new feeder 3  eld feeder 3
 OOSc LEVEL
100 mg/kg/day
2CC n
400 mg/kg/day
2451
2452
2453
2454
2455
2456
245?
2453
2459
2460
2461
2462
2463
2464
2465
2446
2467
2448
2469
2470
2471
2472
2473
2474
2475
2476
2477
2478
2479
2430
24B1
2482
2483
2434
2485
2436
2437
2488
2489
2490
475,5
474.4
474.6
469.7
525.8
508.9
512.2
503.5
494.7
480.4
481.4
524.2
443. S
433.9
487.6
501.9
490.4
471.1
517.2
499.5
516.9
556.8
523.1
510.4
549.3
516.6
524.9
517.2
507.5
520.8
486.3
484.7
491.3
494.3
499.8
496.9
497.0
486.0
490.7
458.6
414.9
405.9
405.9
403,4
474,6
447.7
452.0
432.1
407.1
412.4
423.9
455.6
374.2
413.7
429.7
448.5
420.0
385.1
459,9
428.1
458.1
491.8
455.5
444.5
484.4
449.6
440.8
454.3
441.2
468.0
427.0
422.5
431.8
434.6
424.9
444.7
433.5
446.6
438.2
3S0.1
502.7.
499.5
450.7
464.6
474.6
481.5
472.6
473.3
452.0
460.7
470.9
516.3
439.0
464.2
491.0
509.7
470.8
452.4
524.7
479.5
492.5
491.8
455.5
494.0
484.4
449.6
461.0
454.3
474.7
468.0
474.6
473,1
477,9
483.9
507.3
479.5
475.4
482,8
483.3
510.4
448.2
437.6
391.8
- 439.0
411.4
430.6
421.5
408.9
380.3
399.1
42T.9
459.6
38S.4
395.6
429.8
464.5
415. 9
382.8
471.7
422.7
442.6
434.1
395.8
433.6
420.0
391.1
397.0
402.7
414.9
406.2
430,1
411.3
425.0
427.7
448.2
424.5
4C6.2
429.8
427,1
437.5
608.3
636.7
578.8
506.3
462.5
547.8
512.6
517.8
471.0
474.4
515.2
668,4
694.3
630.4
597.4
672.0
640.S
620.3
741.8
594.7
613.5
630.9
535.0
593.6
600.9
585.9
543.8
538.6
493.0
537.8
621.4
528.7
607.3
607.0
590.6
627,8
558.6
593.0
607,2
539.1
527.6
554.1
497.2
433.5
332.0
430.4
445.3
436.3
302.1
385. 5
444.6
586,6
610.3
543.0
513.3
605.0
562.2
526.8
663.0
508.6
545.1
551.9
452.4
SOD. a
518.4
508.4
458.9
519.1
412.5
449.2
556.7
451.3
526.!
331.4
515.0
557.4
470.9
517.5
53T.O
448,7
                                             A-16

-------
                                                                                 Study No. 5221.08
                TUO WEEK SANGc-FINDINC/EXPlCRATQRY STUDY Of  PARA-CRESQL  IN  SPRAGUE DAULEY RATS
                                       FEMALE FOOD CONSUMPTION  DATA  (g)
                                               [Feeder Weights]
                ANIMAL NUMBER  new feeder 1   old feeder 1   new  feeder  2   old  feeder 2  new feeder 3  old feeder 3
 DOSE LEVEL

800 mg/kg/day
2491
2492
2493
2494
2495
2496
2497
2498
2499
502.3
519.7
500.5
480.0
494.8
519.7
521.7
545.1
572.8
466.3
'454.2
450.8
457.4
454.8
454.1
489.2
522.9
511.6
466.3
454.?.
450.8
457.4
454.8
454.1
489.2
dead
511.6 
408.3
399.3
399.0
400.6
401.9
393.0
439.7
dead
449.7
558.4
573,9
541.6
534.1
546.7
602.0
629.1
dead
586.6
481.0
498.4
462.5
449.7
470.1
' 520.2
565.1
dead
510.7
                    2500          483.4         476.2          dead          dead          dead          dead
                                           A-17                               ,          8  0

-------

-------
                               Study No. 5221.08
         APPENDIX B




ANALYTICAL CHEMISTRY METHODOLOGY

        3-1                     *~ MICROBIOLOGICAL

-------
AMERICAN BICGENIC5 CORPORATION
ANALVTICAL  REPORT
PROJECT  NO.:
SUBJECT:     \flflrit
*/*>/*.
                                        PAGE
                                        DATS
                                                 2G1000C
                                            /     OF    /
                         /Q
                                DEPARTMENT NO.   440
                            TEST ARTICLE HO.:
                       Ul^u^L.

                              99?,
                          ,
TECHNICIAN
REVIEWED BY
                                                DATE
                                                DATE
                      B-2

-------
 ERGO >	_	c_ M_	^ ^wji!i ^^^^..^

                                                  ENSECO
                                                      INCORPORATED
                               June 2, 1986
Dr. Der.nis D.  Diets
Research Triangle  Institute
? .0. Box 12194.
Research Triangle  ?ari, NC  27709

Dear Denni3;

     Inclosed  please  find a description of the method *e  use  for
analysis of compounds by direct aqueous injection ag it pertains
to  Tori performed  under EFA WA-35.

     As 700. can  see,  the analysis procedure is generally  the
same for all compounds differing only in the case of the  cresols
ffhich use an alternate colunn and temperature program.

     If you have any  questions regarding the method or  other
specifics, please  do  not hesitate to contact me.
                               Sincerely ,
                               \V . Henry Camp
                               Analytical Chemist
                               VGA Laboratory
Zncl .
cc:  Dr.  Barry  Levine  (Microbiological Associates)
     Dr.  Dale Mayhew  (American 3iogenics Corp.)
     Dr.  Crosby Thotnpkins  (Toxicity Research Laboratories
                            B-3
                             -r^.M'^.i .r'.l.-


                                T -\ 

-------
i .   Applies" ion..

     This method covers the determination of compounds by direct
aqueous  injection.    The   following  compounds  can  be  detected
using  column A  and  temperature program  A:    acetone,  methyl
isobutyl ietone (MIBK), isobutyl alcohol,  methyl alcohol, ethyl
acetate,  n-butyl  alcohol  and   crotonaldehyde.    The  following
compounds  can  be  detected  using  system  B  and  temperature
program B:  p,  m-;  and ocresol.
2 .   Summary.

     A  portion  of  a sample  is  injected  directly  onto  a  gas
chromatograph  capillary  column.    The  gas  chromatograph  is
temperature programmed  to separate  the constituents  which  are
then detected by a flame ionization detector.
3.
Instrumentation and Apparatus.
     3-1.    Gas chromatograph -- Hewlett-Packard 5880 with auto-
            sampler and integrator.   Oven temperature profile A
            programmed as hold  8  min at  50*C,  then  to  -220*C at
            8'C/min and hold  5  min.   Program B:   hold  5 min at
            50'C then to 250*C at 10'C/rain and hold 15 min.

     3.2.    Column A   60  m  z  0.32 mm  ID,  0.25  um film SUPEL-
            COWAX 10  fused  silica  capillary  column.  Set linear
            velocity to 25 cm/sec, He, at 100'C (flow rate =  1.2
            ml/rain} .

            Column B -- 30 m x 0.318 mm ID, 0.25 u^ film SE  - 54
            fused silica capillary column.   Set linear   velocity
                              B-A
                                                     84

-------
            :o  2?  era/sec,  Hs,  at  IGCTC  (flow  rat*  =  1.2
            ml/min). ,

     3.3.   Injector  -- configure  for  sample splitting  and  ad-
            Just  ratio  to  100:1.   Set  heater  temperature  to
            200'C.

     3.A.   Detector   --  Hewlett-Packard   flame  ionizaticn  de-
            tector,    Hydrogen  flow set at 40 ml/min.   Air flow
            set at 4-00 ml/min.   Set sensitivity at 2 + 2 and ad-
            Just  if   necessary.    Set  heater  temperature   to
           250'C.

     3.5.   Syringes  -- 1 ml, 100  ul,  and  10  ul gas-tight glass
            for diluting and for sample transfer.
4-.    Reagents.
     4.1.   Reagent Water -- prepare with Corning Mega-Pure dis-
            tillation   system   and  filter   through  activated
            charcoal prior to use.

     4.2.   Methylene Chloride -- J. T. Baker "Resi-analyzed" or
            equivalent,.

     4.3-   Standard Solution -- prepare by adding pure material
            to water.  Pure material should be assayed reference
            liquid such  as  Chea Serve  reagents.   If not immedi-
            ately available, supplied compound may be used.

     4-3.1. Place about  9  ml  of solvent into a  stoppered  10 ml
            flask.   Weigh the  flask.   Add one  or  two  drops of
            pure material  to  the  flask and reweigh.   Dilute to
                                                       85
                              B-5

-------
            volume,   nix  well,   and  store  in  a  teflon-sealed
            screw-cap vial at  4*C.
5.   Calibration.

     5.1.   External  Standard  Calibration  --  Prepare  working
            standards  to  bracket  the  concentration  range,  of  the
            samples of interest,   Working  standards are  prepared
            by diluting  the standard  solution  with  water  or
            aethylene   chloride   if   the  samples  are  corn  oil
            based.   Analyze according to procedure  section then
            calculate  response  factors  using  this equation:

                            concentration  of  standard
                       HF = 	        ^
                                area  of standard

            If  the  response   factors   are   constant  over   the
            working range (10*  Relative Percent Difference), an
            average  response   factor may  be  used  for  calcu-
            lations ,
6 .    Quality Control.

     6.1.    Interference  -- a water blank must be run with  each
            test  to  check  for  system  contamination.   A blank
            should  also be run  between  samples of high  concen-
            tration .

     6.2     Purity    reagents  used  in the procedure  should  also
            be   analyzed   with   each  test   to   determine  their
            purity,
                                                          8
                              B-6

-------
     6.3    Spikes -- sample matrixes  sh.ou.ia  be  spiked  with  the
            compounds of Interest and  a percent  recovery  calcu-
            lated to access matrix effects and method accuracy.

     6.-4.   Duplicates  --  Some  samples  should  'be  analyzed  in
            duplicate and  a  relative percent  difference  calcu-
            lated to access method precision.
7.    Procedure,.

     7.1,    Calibration as  in section 5.

     7.2.    Sample Preparation -- allow samples to come to  room
            temperature'before handling.   Dilute  if necessary to
            bring concentrations within system working  range  by
            adding portion  of saaple  to  water or to  methylene
            chloride  if corn oil based.

     7.3.    Analysis  -- introduce sample by direct injection  of
            1 -  2  u 1 into  the  GC  injection port and begin  the
            temperature program.

     7.4    Identification   --  as  the  compounds  are   analyzed
            individually,  there  should be  no coelution  inter-
            ferences ,   Retention time should  still  be checked
            against the standard.
3 .    Calculation .

     8.1.    Concentration --  calculate  using peak  area  and  RF
            determined in section 5.1.
                              8-7

-------
3,2.   Dilution -- take into account any dilution, performed

       on the sample or the standard.

                                V
3.3    Report  results  In  mg/znl   without  correction  for
       recovery percentage.
                                                 88
                       B-8

-------
                                                   Study No. 5221.08
                             APPENDIX C
                    CLTNICAL PMHOKX3Y MEIKDDOITXSf
cm PC
                               C-l
                                                      MICROBIOLOGICA

-------
                                  HBRTOIOGY

 Hemoglobin

      Cyarsnethemoglobin method
           Baker Cell Counter
           Hematology Series 7000

 Heiratocrit

      Indirect method; calculated value based on erythrocyta
      count and mean corpuscular volume
           Baker Cell Counter
           Hematology Series 7000

 Erythrocyte Count

      Electronic Counting Procedure
           Baker Cell Counter
           Kematology Series 7000

 Mean  Corpuscular Volume (MO/)

      Electronic Sizing Procedure
           Baker Cell Counter
           Hematology Series 7000

Mean  Corpuscular Hemoglobin fMCH)

      Indirect method; calculated value based on erythrocyte
      count and hemoglobin
           Baker Cell Counter
          Hematology Series 7000

Mean Corpuscular... Hemoglobin. Concentration fMCHCi

     Indirect method? calculated value based on hematocrit
     and hemoglobin
          Baker Cell Counter
          Hematology Series 7000

Leukocyte Count:

     Electronic Counting Procedure
          Baker Cell Counter
          Hematology Series 7000
CFM.PC
                                     C-2
                                                                   80

-------
 Leukocyte Differential Count

      Neutxcphils - Iramature (bands)
      Neutrophils - Mature (segs)
      Mcnccytes
      Basophils
      Lymphocytes
      Eosinophils
      Wright stain procedure
           Schalm,  O.W. ,  Jain,  N.C.  and Carroll,  E.J.
           Veterinary Keraatology,  Color Plates Chapter,
           3rd Edition,  Lee and Febiger, 1975.

 Bgtigulocyte Count

      New methylene blue staining procedure
           Brecher,  G.    Am.  J. Clin.  Path.  19,
           895,  1949.

                  (FT)
     Pate of change in absorbance due to clot formation
           Coag-A-Mate

Activated.. Partial ..ThroirbQplastm.Time (APT!)

     Rate of change in absorbance due to clot formation
           Coag-A-Mate
                              CLINICAL CHEMISTRY

Creatinine

     Jaffa's alkaline picrate reaction
          Centrifichem Centrifugal Analyzer System
          Fabiny, D.L. and Ertingshausen, G.
          Clin. Chem., 17, 696, 1971.


JnQrganic_ Hipsphorus

     Phosphomolybdate reaction
          Centrifichem centrifugal Analyzer System
          Daly, J.A., and Ertinghausen, G,
          Clin. Chem., 18, 263-, 1972.
CPN.PC
                                     0-3                 -     '      91

-------
 Glucose

      Eexokinase method
           Centrifichem Centrifugal Analyzer System
           Eondar,  J.L. and Mead,  D,C.
           Clin. Chem.  20,  586,  1974.

 Urea Nitrogen (BUN)

      Modified urease tedinique
           Centrifichem Centrifugal Analyzer System
           TaUce, H.  and Schubert/ G.E.  ,
           Klin. Wdinschr.  43, 174, 1965.

 Total Protein.

      Biuret technique'
           Centrifichem Centrifugal Analyzer System
           Kingsley,  G.R., J. Biol. Chem. 131,  197, 1S39.

 Albumin

      Broroocresol Green method
           Centrifichem Centrifugal Analyzer System
           Douraas, B.T.  snd Biggs,  E.G.
           standard Methods of Clinical Chemistry,  7,  175/ 1972.

Globulin

      Total protein - Albumin  = Globulin   (Calculated value)
  Calcium

      Modified alizarin procedure
           Centrifichem Centrifugal Analyzer System
           Frings, C.S., et. al., din. Chem., 16, S16,  1970.

  Aspartate. Anting Transf erase (AST/SCOT)

      Mcdif ied Karmen procedure
           Centrifichem Centrifugal Analyzer System
           Bergmeyer, H.V., Scheibe, P., and Wahlefeld,  A.W.
           Clin. Chem., ,24, 58, 1973.

 Alanine..J^mino Transf erase (AHT/SGPT)

      Modified Henley & Pollard procedure
           Centrifichem Centrifugal Analyzer System
           Bergmeyer, H.V.,  Scheibe, P., and Wahlef eld,  A.W.
           din.  Chem., 24,  58, 1978.
                                                                         C) 9
                                                                         -' **
 CPM.K:
                                     C-4

-------
 Alkaline Phosphatase

      Modified Bawers-McCarrib procedure
           Centrifichem Centrifugal Analyzer System
           Bowers,  Jr.,  G.N., McComb,  R.B.
           Clin.  Chan.,  12,  70,  1966.

 Cholesterol

      Allain enzymatic procedure
           Centrifichem  Centrifugal Analyzer System
           Allain,  C.C.,  et. al.,  Clin.  Chem.  20,  470,  1974.

 Total BiliruMn

      Diazo colorimetric procedure
           Centrifichem  Centrifugal Analyzer System
           Ertinghausen,  G., Fabiny-Byrd, D.L., Tiffany, T.o.,
           and Carey,  S.J.,  Clin.  Chea.  19,  1366,  1973.

 Direct	Bilirubin

      Diazo colorimetric procedure
           Centrifichem  Centrifugal Analyzer System
           Ertinghausen,  G., Fabiny-Byrd, D.L., Tiffany, T.O.,
           and Carey,  S.J.,  Clin.  Chem.  19,  1366,  1973.

 Electrolytes (Na+, K*",  Cl", C02)

           Ion specific  electrodes (Metpath,  Inc.)
                                  UE^IHALYSES

Qual itatiye Meagorgments

     pH        Ketones     Urobilinogen

     Protein   Bilirubin

     Glucose   Blood

     Chemstrip 7L - Chemistry Reagent Strips
          Bio-Dynamics/brtic
          Indianapolis, Indiana
OK. PC
                                     C-5

-------
gpecific Gravity

     Optical terperature compensated refractometer

Microscopic Evaluation

     Urinary sediment stained with Sedi-stain and evaluated using the Ames
     Atlas of Urine Sediment, Ames Co., Division Miles laboratories, Eikhart,
     Indiana.
CM. PC
                                     "     '                     .       o

-------
                        Study No. 5221.08
     APPENDIX D


INDIVIDUftL MSimL EftIA
                      95                .    .

     13-1                  ~  MICROBIOLOGICAL
                            ASSOCIATES INC.

-------
                                                                                                                           Study Ho. 5221.08
                                             DISPOSITION OF AHIHALS IN 13-WEEK PARft-CRESOl STUDY 1M SPRAGUE DAWLEY RATS
        O
        I
Dose Level
(mg/kg/day)
0
50
175
600
-
0
50
175
6QQ

Baseline Clinical
Sex Pathology Animals3
N
H
H
H
H 3781 -3790
F
f
F
F
F 3911-3920
45-Day Sacrifice
12/2-12/3/85
3661-3670
3691-3700
3721-3730
3751-3760
-
3791-3800
3821-3830
3851-3860
38ai-3890b

90-Day Sacrifice
1/15-1/17/86
3671-3690
3701-3720
3731-3750
3761 -3780

3801 -3820
3831 -3850
3861 -3880
3891-3910
"
                         a  Animals selected for baseline clinical pathology were discarded without necropsy after the collection of blood

                            samples.
                             Early death, animal number 3883 on 10/18/85.

                             Early deaths, animal numbers 3899 and 3910 on 10/17/85.
O

-------
                                                       Study No. 5221.08
                      SUBCHRQNIC TOXICZK OF PABA-CKESGL
                            IN SPRAGUE DMCEY RATS
                                           OQDES
Bcdv Weights 'and Food_Consumption

ISAC - interim sacrifice
na   - no data available
dead - unscheduled death

Organ.. Weights

e           - raw data entry error
na          - no data available
dead        - unscheduled death
term. wgt.  - terminal body weight

Urinalvsis
                                             thy./para. - thyroid/parathyroid
                                             rt         - right
                                             1ft        - left
 tb   -  turbid
. c     -  clear
 cl   -  cloudy
 hz   -  hazy
 y     -  yellow
 py   -  pale  yellow
 ly   -  light yellow
 a     -  amber
 dy   -  dark  yellow
 s     -  straw color
 tp   -  triple phosphate
 co   -  calcium oxalate
 ap   -  amorphous phosphate
 n     -  none
 tr   -  trace
m     -  many
 f     -  few
 ng   -  negative
nr   -  normal
nod   -  moderate
nura   -  numerous

Hematoloav &  Clinical Chemistry

QNS   - quantity not sufficient
dead  -'unscheduled death
 z     - no clot was formed
 sc   - specimen clotted
g     - greater than 110 seconds
                                    ec
                                   dead
                                   vol
                                   uro
                                   bili
                                   ery
                                   RBC/HPF   -

                                   WBC/HFF

                                   Casts/tPF -

                                   EPI/HPF   -
occasional
greater than .
unscheduled death
appearance
volume
urobilincgen
bilirubin
erythrccytes
number of red blood cells
  under high power field
number of white blood cells
  under high power field
number of casts under low
  power field
number of epithelial cells
  cells under high power
  field'
                                      D-2

-------

-------
                                                                   Study  Mo, 5221.08
       SUBCHRONIC TOX1C1TY  OF  PARA-CRESCL IN SPRAGUE OAULEY SATS
                       MALE BODY WEIGHT DATA (g)
     r.

               ANIMAL  NO.   UEEK1  UEEK2  WEEK3  WEEK4  WEEKS  WEEK6 WEEK?
OOSf LEVEL
                                                       443    473   491
                                                       438    465   496
                                                       424    458   485
                                                       465    507   545
                                                       423    447   473
                                                       374    399   427
                                                       461    492   493
                                                       434    466   493
                                                       435    467   496
                                                       410    431   463
                                                       420    443   473
                                                       377    412   443
                                                       436    462   489
                                                       467    511   540
                                                       359    379   406
                                                       431    463   491
                                                       401    426   458
                                                       462    498   541
                                                       387    419   450
                                                       424    449   483
                                                       385    406   426
                                                       414    423   460
                                                       436    454   485
                                                       442    460   493
                                                       425    442   472
                                                       430    458   499
                                                       440    484   504
                                                       428    455   479
                                                       400    421   443
                                                       452    436   512

                                                       458    489   524
                                                       448    477   503
                                                       412,    449   477
                                                       443    484   521
                                                       433    462   494
                                                       334    404   435
                                                       423    455   438
                                                       397    422   449
                                                       412    437   459
                                                       406    434   433
                                                       450    469   501
                                                       443    472   497
                                                       460    486   521
                                                       392    416   443
                                                       447    473   503
                                                       451    47!   500
                                D-3                                                 88
0 mg/kg/day 3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682 -
3683
3684
3685
3686
3687
3688
3639
3690
50 mg/kg/day 3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
37C6
253
233
215
255
238
207
246
234
247
224
231
221
249
259
220
233
227
237
203
236
217
214
229
236
232
226
251
239
225
248
229
236
225
237
251
206
231
232
232
211
259
254
253
215
246
256
317
296
290
325
307
260
314
303
307
277
293
282
308
333
271
292
286
313
262
298
267
273
292
300
291
296
307
302
288
311
299
297
232
305
308
261
289
290
295
26S
319
313
322
272
314
322
368
346
343
379
355
301
363
365
362
327
337
317
354
391
295
338
334
3,69
312
343
312
331
347
353
348
339
362
354
324
370
359
352
330
365
350
306
339
320
332
322
370
356
379
320
363
367
410
399
392
435
397
344
412
406
405
380
389
360
401
442
330
387
375
418
356
391
356
372
400
397
393
384
404
397
369
418
413
399
378
412
399
351
386
366
374
373
413
412
433
361
403
420

-------
                                                                    Study Mo. 5221,03
       SU3CHRONJC TOXICITY Of PARA-CSESQL IN SPRAGUE  DAWLEY  RATS
                       HALE BODY WEIGHT DATA C3)
               ANIMAL NO.  UEEK1  WEEK2  UEIK3  WEftt  UEEKS  WEEKS  UEEK7
DOSE LEVEL
50 mg/kg/day 3707
(continued) 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 mg/kg/day 3721
3722
3723
3724
3725
- 3726
3727
3728
3729
3730
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
222
254
229
241
222
223
221
203
222
209
203
201
243
230
221
234
240
264
224
219
223
242
216
240
234
237
239
209
250
231
224
220
189
231
209
220
214
214
202
217
245
235
"231
237
274
316
266
301
268
.289
284
249
281
274
254
247
300
294
270
293
301
324
281
269
278
3Q5
262
304
293^
298-
301
259
314
279
283
270
232
286
258
274
273
262
242
271
303
289
284
284
333
369
339
364
311
339
339
286
332
335
290
289
354
344
327
342
348
376
338
301
334
350
307
358
335
346
355
304
372
318
330
312
278
334
298
320
323
305
282
324
360
339
322
324
383
412
394
419
358
382
402
327
370
390
331
329
396
355
384
382
393
434
394
330
388
397
352
400
391
391
398
341
420
363
373
350
309
371
338
363
362
340
318
375
397
387
363
364
424
443
437
452
392
415
429
360
405
436
348
354
431
381
424
421
433
471
440
352
433
423
337
442
428
 423
433
388
442
391
401
380
343
412
367
397
410
373
349
411
420
420
406
392
451
466
468
487
424
446
464
387
424
466
373
373
451
427
456
446
464
511
451
375
449
453
413
471
467
452
447
413
468
426
422
412
371
440
395
432
437
395
363
436
452
432
439
419
480
494
502
517
459
469
488
409
458
492
394
396
472
466
484
473
498
533
476
395
479
485
437
501
49i
479
480
438
504
450
451
445
390
458
415
461
481
422
394
461
431
460
4S6
437
                               D-4
                                                                                  Q O

-------
                                                               Study No. 5221.08
        SuaCHROHIC TOXICITY OF  PARA-CRESOL  IN SPRAGUE DAWLEY RATS
                      MALi BODY WEIGHT DATA 
-------
                                                                   Study No. 5221.08
           SUBCKRONIC TOXICtn OF FARA-CRESOL IM SPRAGUE DAWLEY RATS
                          HALE iOOY WEIGHT DATA (g)
                ANIMAL NO.  WEEKS  WEEK9  WEEK1Q  UEEK11  UEEK12  UEIK13  UEEK14
 DOSE LEV!I
 0 mgAg/day
50 mg/kg/day
3661
3662
3663
3664
3665
3646
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3673
3679
3680
3681
3682
3683
3684
'3685
3686
3687
3688
3689
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
1SAC
[SAC
SSAC
493
482
511
581
416
519
478
564
466
496
445
481
516
516
496
521
535
501
463
533
1SAC
1SAC
[SAC
I SAC
I SAC
I SAC
I SAC
1SAC
I SAC
I SAC
525
518
547
462
526
518
na
na
na
na
na
na
na
na
na
na
528
507
536
616
418
547
510
601
488
522
464
501
548
541
516
547
556
516
484
561
na
na
na
na
na
na
na
na
na
na
548
545
566
4 BO
544
544
na
na
na
na
na
na
na
na
'na
na
544
524
559
633
440
569
536
627
511
547
473
529
564
560
545
578
584
537
504
581
na
na
na
na
na
na
na
na
na
na
563
564
592
493
562
561
na
na
na
na
na
na
na
na
na
na
561
532
567
636
438
576
548
638
525
560
4B2
533
570
569
556
583
586
539
521
587
na
na
na
na
na
na
na
na
na
na
573
575
595
504
571
562
na
na
na
na
na
na
na
na
na
na
571
551
565
661
457
591
559
652
537
573
498
557
591
575
570
583
598
551
524
597
na
na
na
na
na
na
na
na
na
na
581
592
600
511
583
578
na
na
na
na
na
na
na
na
na
na
591
524
587
678
467
612
572
677
552
596
504
559
606
598
580
615
627
563
548
614
na
na
na
na
na
na
na
na
na
na
586
610
623
531
602
588
na
na
na
na
na
na
na
na
na
na
600
543
597
697
469
615
580
694
562
611
513
573
618
601
590
614
632
575
540
616
na
na
na
na
na
na
na
na
na
na
600
620
624
536
597
613
                                 D-6
                                                                                         1

-------
                                                                Study o,  5221.08
          SU3CHRON1C TOXICITY  OF PARA-CRESOL IN  SP8AGUE OAWLEY RATS
                         MALI ICDY WEIGHT DATA  (g>
              ANIMAL NO.   WEEKS  UEEK9  UEEK10  WEEK11  UEEK12 *UEEK13  WEEK14
DOSE LEVEL
SO iflf/icg/day 3707
(continued) 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 mg/kg/day 3721
3722
3723
3724
3725
3726
3727
3723
3729
3730
3731
3732
3733
3734
3735
3736
3737
3733
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
515
511
518
533
482
495
517
427
477
517
423
422
497
490
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
I SAC
530
500
509
452
527
477
463
469
415
481
439
481
506
457
402
486
512
472
489
459
481
542
548
563
498
521
540
451
493
540
446
427
524
514
na
na
na
na
na
na
na
na
na
na
562
525
535
477
548
492
487
488
440
501
460
503
524
431
422
499
536
496
503
480
450
560
570
530
520
531
567
463
510
553
458
451
533
526
na
na
na
na
na
na
na
na
na
na
580
546
548
494
579
504
483
511
463
521
471
518
546
496
434
521
547
519
535
498
447
562
579
593
527
533
577
473
518
555
462
451
554
527
na
na
na
na
na
na
na
na
na
na
587
558-
551
508
597
508
500
521
476
528
478
543
562
506
442
533
550
534
529
506
443
570
602
601
551
553
594
482
530
565
478
470
552
546
na
na
na
na
na
na
na
na
na
na
601
569
566
511
618
515
504
531
480
537
476
556
577
516
458
542'
553
541
538
511
424
591
612
615
560
572
611
492
544
580
490
474
570
557
na
na
na
na
na
na
na
na
na
na
620
582
585
524
626
525
515
546
500
562
499
576
592
524
470
557
575
555
558
518
446
600
623
624
531
580
620
500
553
589
492
487
582
573
na
na
na
na
na
na
na
na
na
na
609
595
592
531
654
542
526
557
498
564
510
582
600
534
484
563
535
565
567
530
                             D-7
                                                                              10

-------
                                                                  Study No. 5221.08
           SUBCHRONIC TOXICITY OF  PARA-CRESOL IN SPRAGUE DAULEY RATS
                          MALE BODY WEIGHT DATA (g)
               ANIMAL NO.  WEEKS  WEEK9  WEEK10  UEEK11  WEEK12  WEEK13  WEEK14
 DOSE LEVEL
600 mg/kg/day
3751
3752
3753
3754
3755
3756
3757
3753
3759
3760
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
3780
I SAC
I SAC
I SAC
I SAC
1SAC
I SAC
JSAC
I SAC
I SAC
I SAC
365
416
438
468
439
414
424
501
388
445
400
512
473
368
363
463
403
425
461
415
na
na
na
na
na
na
na
na
na
na
381
423
453
488
450
427
433
524
395
461
422
552
490
386
373
483
417
440
481
437
na
na
na
na
na
na
na
na
na
na
384
433
481
513
467
441
452
545
408
462
438
564
506
410
397
505
433
461
508
461
na
na
na
na
na
na
na
na
na
na
392
430
481
524
477
44S
462
555
409
471
443
577
508
418
401
501
434
464
518
462
na
na
na
na
na
na
na
 na
na
na
394
436
500
542
494
473
474
567
412
486
462
600
524
436
420
510
443
473
533
482
na
na
na
na
na
na
na
na
na
na
402
452
511
563
507
490
490
576
424
496
473
631
543
443
431
524
447
469
539
439
na
na
na
na
na
na
na
na
na
na
403
472
530
575
516
497
505
596
433
501
480
640
557
460
437
544
456
432
561
500
                              D-8
                                                                       103

-------
                                                                    Study Ho. 5221.08
        SUBCHRONIC TCX1C1TY  OF  PARA-CRESQt  IN SPRAGUE DAULEY RATS


                     HALE BODY  WEIGHT  GAIN  DATA  (5
                AMIMAL HO,   UEEK1  UEEK2  WEEK3  WEEK4  UEEK5  UEEK6  UEEK7


 DOSE LEVEL
 0 mg/kg/day
SO mi/kg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
'. 3681
3682
3683
3684
3685 '
3686
3687
3688
3689
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
64
63
75
70
69
13
68
69
60
53
62
61
59
74
51
59
59
76
59
62
50
64
63
64
59
70
56
63
63
63
70
61
57
68
57
55
58
56
63
57
60
59
69
57
68
66
115
113
128
124
117
94
117
131
115
103
1C6
56
105
132
75
105
107
132
109
107
95
117
118
117
116
113
111
115
99
122
130
116
105
123
99
100
108
88
100
111
111
102
126
105
117
111
157
166
177
180
159
137
166
172
158
156
158
139
152
183
110
154
148
181
153
155
139
158
171
161
161
158
153
158
144
170
184
163
153
175
148
145
155
134
142
162
154
158
180
146
157
164
195
205
209
210
185
167
215
200
188
186
189
156
187
208
139
198
174
225
184
188
168
200
207
206
193
204
189
189
175
204
229
212
187
211
187 
178
192
165
180
195
191
194
207
177
201
195
220
232
243
252
209
192
246
232
220
207
217
191
213
252
1S9
230
199
261
216
213
189
209
225
224
210
232
233
216
196
238
260
24!
224
247
211
198
224
190
205
223
210
218
233
201
227
215
238
263
270
290
235
220
247
259
249
239
242
222
240
281
186
258
231
304
247
247
209
246
256
257
240
273
253
240
218
264
295
267
252
284
243
229
257
217
227
227
242
243
268
228
257
244
na
na
na
na
na
na
na
na
na
na
267
261
262
322
196
286
251
327
263
260
22S
267
287
280
264
295 '
284
262
238
285
na
na
na
na
na
na
na
na
na
na
266
264
294
247
280
262
                                 D-9
^  A
 0

-------
                                                                   Study Mo. 5221.08
       SUBCHRONIC TOXICm OF PARA-CHESQL  IN  SPRAGUE DAULEY RATS
                    HALE BOO*" WEIGHT  GAIN  DATA  
-------
                                                                    Study No.  5221.08
        SUSCHRQNIC TQXIC1TY  Of PARA-CRESOl W SPRAGUE DAULEY RATS

                     MALI  iODY yElGHT CAIN DATA Cg3
                ANIMAL NO.   WEEK!  WEEK2  WEEK3  UEEK4  WEEKS  UEEK6  WEEK?
 DOSE LEVEL
600 mg/kg/day
3751
3752
3753
3754
3755
3756
3757
3753
3759
3760
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
3780
28
47
39
24
28
33
32
35
26
41
-9
' 23
34
10
45
36
48
29
1
16
39
47
27
7
35
56
44
47
36
42
74
89
78
47
. 71
69
79
74
62
78
32
61
79
55
89
74
82
87
41
69
81
95
64
30
64
97
67
82
85
91
112
134
108
86
118
107
122
111
89
122
75
59
126
94
118
109
117
137
91
118
103
141
110
62
84
123
87
118
131
136
144
162
146
106
154
135
154
141
108
149
100
136
160
135
148
141
150
184
123
155
131
182
150
91
110
178
133
152
149
163
169
193
153
126
171
163
170
151
113
168
118
146
182
164
176
161
174
206
139
178
143
217
in
115
130
186
164
184
178
191
188
205"
183
141
182
188
192
172
131
177
131
153
198
200
195
167
196
237
160
204
165
244
198
141
138
208
183
200
208
176
na
na
na
na
na
na
na
na
na
na
148
175
222
229
219
199
214
254
179
222
187
264
221
148
162
214
197
220
217
206
                                 D-ll
                                                                      J
                                                                       t

-------
                                                               Study No. 5221.08
      SUSCHRONIC  TQXICITY OF PARA-CRESOL  IN SPRAGUE OAWIEY RATS
                  MALE BODY i/!GHT GAIN  DATA (g)
               ANIMAL NO.   yiEK3  WEEK?  WEEK10  WEEK11  WEEK12  UEEK13
 DOSE  LEVEL
 0 mg/kg/day
50 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
363!
3682
3683
3684
3685
3666
3687
3688
3689
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
37Q3
3704
3705
3706
na
na
na
na
na
na
na
na
na
na
297
286
237
357
198
314
283
364
285
226
247
287
319
305
284
321
305
277
259
313
na
na
na
na
na
na
na
na
na
na
289
291
313
265
298
288
na
na
na
na
na
na
na
na
na
na
313
303
310
374
220
336
309
390
308
311
256
315
335
324
313
352
333
298 .
279
333
na
na
na
na
na
na
na
na
na
na
304
310
339
278
316
305
na
na
na
na
na
na
na
na
na
na
33 D
311
313
377
218
343
321
401
322
324
26S
319
341
333
324
357
335
300
296
339
na
na
na
na
na
na
na
na
na
na
314
321
342
2S9
325
306
na
na
na
na
na
na
na
na
na
na
340
330
316
402
237
358
332
415
334
342
281
343
362
339
338
357
347
312
299
349
na
na
na
na
na
na
na
na
na
na
322
338
347
296
337
322
na
na
na
na
na
na
na
na
na
na
360
303
338
419
247
379
345
440
349
360
287
345
377
362
348
339
376
324
323
366
na
na
na
na
na
na
na
na
na
na
327
356
370
316
356
332
na
na
na
na
na
na
na
na
na
na
369
322
343
438
249
382
353
457
359
375
296
359
389
365
358
388
381
336
315
368
na
na
na
na
na
na
na
na
na
na
341
366
371
321
351
357
                              D-12
                                                                       107

-------
                                                                   Study No. 5221.C8
      SUSCHRONIC TQXICITY OF PAHA-CRESQL  IN SPRACU6 BAULEY RATS
                   MALE BQQY WEIGHT  GAIN  DATA  CsJ
               ANIMAL NO.   WEEKS  WEEK9  UEE<10  WEEK11  UEEK12  UEEK13
DOSE LEVEL
50 mf/kg/day 3707
(continued) 3703
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 nig/kg/day 3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
259
263
319
322
276
298
319
243
271
331
243
226
281
254
na
na
na
na
na
na
ni
na
na
na
328
288
296
268
298
261
263
268
251
270
251
283
310
267
220
282
291
261
272
243
223
306
341
339
298
308
346
265
288
344
255
250
295
296
na
na
na
na
na
na
na
na
na
na
346
309
309
285
329
273
259
291
274
290
262
293
332
282
232
304
302
284
3C4
261
225
308
350
352
305
315
356
270
296
346
259
250
311
297
na
na
na
na
na
na
na
na
na
na
353
321
312
299
347
277
276
301
287
297
269
323
348
292
240
316
305
299
298
269
221
316
373
360
329
330
373
279
303
356
275
269
309
316
na
na
na
na
na
na
na
na
na
na
367
332
327
202
368
2S4
280
311
291
306'
267
336
363
302
256
325
308
306
307
274
202
337
383
374
338
349
390
289
322
371
237
273
327
327
na
na
na
na
na
na
na
-na
na
na
386
345
346
315
376
294
291
326
311
331
290
356
378
310
268
340
" 330
320
327
281
224
346
394
383
359
357
399
297
331
380
289
286
339
343
na
na
na
na
na
na
na
na
na
na
375
358
353
322
404
311
302
337
309
333
301
362
386
320
282
346
340
330
336
293
                             D-13

-------
                                                                 Study Mo.  5221.03
       SUBCHSONIC TQXICITY OF PARA-CRESOL IN SPRAGUE DAWLEY RATS
                   MALE BODY WEIGHT GAIN DATA  (g)
               ANSKAl NO.   yEK8  UEEK9  WEEK10  WEEK11  UEEK12  UEEK13
 DOSi LEVEL
600 mg/kg/day
3751
3752
3753
3754
3755
3756
3757
3753
3759
3760
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
37BO
na
na
na
na
na
na
na
na
na
na
164
187
242
249
230
212
228
277
186
238
209
304
238
166
172
239
206
235
237
223
na
na
na
na
na
na
na
na
na
na
167
192
265
274
247
226
242
298
199
239
225
316
254
190
191
256
222
256
264
252
na
na
na
na
na
na
na
na
na
na
175
189
265
285
257
233
252
308
200
248
230
329
256
198
195
252
. 223
259
274
253
na
na
na
na
na
na
na
na
na
na
177
195
284
303
274
258.
264
320
203
263
249
352
272
216
214
261
232
268
289
273
na
na
na
na
na
na
na
na
na
na
185
211
295
324
287
275
280
329
215
273
260
383
296
228
225
275
236
264
295
2SQ
na
na
na
na
na
na
na
na
na
ni
191
231
314
336
296
282
295
349
224
278
267
392
305
240
231
295
245
277
317
291
                              D-14
                                                                              10
C"

-------
                                                               Study No. 5221.08
        SUBCHROMIC TQXICITY Of  PARA-CRESOL  IN SPRAGUE OAWLEY RATS
                     FEMAL1 BODY WEIGHT DATA (g)
               ANIMAL HO.  VJeekt  WeekZ Ueek3  Ueek4  WeekS  Ueek6  Week?
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3800
3801
3802
3803
3804
3805
3806
3807
2808
3809
3810
3811
3812
3813
-3814
3815
3816
3817
3818
3819
3820
3821
3822
3823
3824
3825
3326
3827
3828
3829
3830
3831
3832
3833
3834
3835
3836
155
147
154
164
163
160
150
157
150
161
157
162
165
152
167
165
150
183
166
155
170
173
161
175
164
161
169
143
146
150
148
162
148
149
157
145
149
15S
135
146
162
178
162
154
147
152
185
177
172
192
178
187
175
179
182
204
182
178 .
190
180
196
194
175
215
194
183
196
209
185
212
200
187
202
173
170
178
153
136
176
182
184
167
190
185
159
171
180
198
196
175
176
177
210
196
200
217
197
207
198
201
201
229
205
204
218
207
220
209
190
231
220
201
214
234
202
235
224
207
225
193
180
200
174
2CS
190
196
200
183
211
203 
176
185
201
221
216
192.
199
197
234
215
213
233
220
230
209
228
213
257
227
231
223
234
229
240
214
248
207
222
236
256
226
255
235
229
263
201
198
224
195
230
218
218
218
200
220
220
193
210
213
250
245
204
191
218
254
234
233
249
230
244
210
240
225
273.
239
248
242
246
250
249
224
264
247
237
244
263
237
2SO
255
238
264
223
209
235
205
250
222
231
232
214
241
239
211
222
231
258
258
225
236
232
255
239
233
257
.250
250
223
241
233
280
248
246
248
249
250
269
228
270
249
242
249
277
246
284
267
254
279
226
209
228
215
252
225
240
236
219
243
257
225
239
241
276
276
238
253
249
267
253
242
261
243
258
228
259
256
304
263
267
283
271
265
276
235
282
271
252
267
298
256
305
232
268
 293
240
220
250
224
260
237
255
255
241
270
268
237
249
249
287
283
244
257
257
                             D-15
                                                                        110

-------
                                                              Study No,  5221.08
      SUBCHRONIC TOXIC1TY  OF PARA-CRESOL JM SPRAGUE DAUIEY SATS
                    FEMALE BODY WEIGHT DATA CgJ
              ANIMAL NO.  Week!  Week2  Week3  Ueek4  UeekS  W*ek6  Wtek7
DOSS LEVEU
50 mg/kg/day 3837
(continued) 3838
3339
3840
3841
3842
3843
3844
'3845
3846
3847
3848
3849
3850
175 mg/kg/dey 3851
3852
3853
3854
3355
3856
3357
3858
3859
3860
3861
3862
3863
3864
3865
3866
3867
3868
3869
3870
3871
3872
3873
3874
3875
3876
3877
3878
3879
3880
165
177
134
139
147
156
159
132
153
168
148
142
143
140
154
163
149
159
160
176
156
155
157
174
157
141
165
157
153
163
140
173
153
161
169
160
166
159
164
163
160
153
155
153
190
202
156
162
170
183
180
157
179
193
179
165
169
154
174
185
168
176
178
204
186
177
174
198
172
158
182
183
183
185
163
205
176
190
195
186
189
172
194
193
182
181
176
180
202
226
174
176
196
205
202
178
198
213
194
187
190
170
189
201
184
189
205
223
210
194
196
227
199
178
203
198
195
211
173
229
197
212
220
206
208
203
220
214
201
208
193
193
217
246
186
197
221
222
222
195
217
237
216
200
212
190
211 '
221
2C8
217
207
254
237
208
225
244
207
200
229
222
218
233
197
248
220
230
244
232
236
223
240
227
224
228
217
223
237
260
203
20Z
244
233
234
205
230
256
234
222
230
199
222
242
224
229
230
262
256
226
241
254
227
224
247
236,
223
245
217
269
228
235
264
247
252
233
247
247
234
240
226
234
248
264
211
215
250
248
247
213
249
267
243
228
234
207
240
254
234
227
227
275
273
232
243
Z6S
230
236
247
246
230
256
217
283
236
248
283
262
260
255
251
249
242
244
232
242
257
280
216
225
262
257
257
217
260
273
245
246
249
217
247
265
250
234
245
291
282
249
264
282
232
246
263
267
246
269
237
299
247
268
303
285
265
263
264
263
255
255
240
2S6
                            D-16
                                                                       ill

-------
                                                                    Study Ho. 5221.03
        SUBCHRONIC TOX1CITY OF PARA-CRESOL  IN  SPRAGUE DAULEY RATS
                       FEMALE BODY WEIGHT DATA CgJ
                ANIMAL NO.   Weekl   Week2  Ueek3  Week4  UeekS  Ueek6  Week/
 DOSE LEVEL
600 nig/kg/day
3881
3882
3883
3884
3385
3886
3837
3358
3389
3890
3891
3892
3393
3894
3895
3896
3397
3898
3899
3900
3901
3902
3903
3904
3905
3906
3907
3903
3909
3910
150
157
146
151
159
171
158
165
170
151
143
152
169
153
157
164
162
174
166
153
153
153
148
166
143
141
159
167
167
135
166
168
dead
173
173
195
170
180
182
163
173
159
175
170
163
173
191
201
dead
152
171
164
166
188
162
157
172
195
179
dead
181
184
dead
194
187
210
190
196
206
190
isa
160
196
195
196
200
203
231
dead
123
138
183
184
210
178
172
192
216
197
dead
197
203
dead
212
210
233
202
217
230
204
203
168
2ZO
223
222
221
223
252
dead
206
208
197
205
224
197
190
203
233
211
dead
209
214
dead
245
223
244
218
238
247
219
235
185
234
236
236
233
234
272
dead
231
231
205
223
246
206
202
218
245
236
dead
209
213
dead
252
233
246
223
241
255
229
231
193
249
249
249
242
252
277
dead
239
241
213
227
257
207
209
229
263
244
dead
222
235
dead
256
246
255
231
250
263
232
242
206
257
256
259
253
261
286
dead
251
251
228
239
263
226
215
240
272
255
dead
                                D-17
                                                                                      <>

-------
                                                                    Study No.  5221.08
           SUBCHRON1C TOX1C1TY DF  PARA-CRESQL IM SPRAGUS DAULEY RATS
                          FEMALE BODY WEIGHT DATA CgJ
ANIMAL NO.  UeekS  Week9
                                                 Weefcll  Ueek12  Ueek13  WeekU
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3300
3801
3802
3803
3304
3805
3806
3307
3803
3809
3S10
3811
381 2
3813
38H
3815
3816
3817
3818
3819
3820'
3821
3822
3823
3824
3325
3826
3827
3828
3829
3830
3831
3832
3833
3834
3835
3836
I SAC
ESAC
1SAC
1SAC
ISAC
ISAC
I SAC
ISAC
ISAC
ISAC
270
261
274
285
284
283
245
292
286
266
266
306
275
311
285
277
304
24S
229
257
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
259
2S6
294
253
265
263
na
na
na
na
na
na
na
na
na
na
233
275
267
231
278
296
249
302
279
279
277
323
274
329
292
281
302
252
235
267
na
na
na
na
na
na
na
na
na
na
272
303
230
262
270
276
na
na
na
na
na
na
na
na
na
na
295
265
280
284
272
304
243
303
296
281
282
336
281
323
293
294
327
248
249
269
na
na
na
na
na
na
na
na
na
na
277
307
294
273
275
279
na
na
na
na
na
na.
na
na
na
na
290
277
286
285
272
302
248
298
302
277
286
338
281
324
295
297
224
254
250
263
na
na
na
na
na
na
na
na
na
na
279
309
298
274
284
287
na
na
na
na
na
na
na
na
na
na
300
286
273
283
278
315
251
306
306
286
286
340
282
330
293
288
332
249
250
269
na
na
na
na
na 
na
na
na
na
na
275
310
311
27B
285
286
na
na
na
na
na
na
na
na
na
na
307
303
294
306
286
334
261
313
305
293
298
352
298
340
310
300
349
262
259
279
na
na
na
na
na
na
na
na
na
na
292
31S
325
298
289
296
na
na
na
na
na
na
na
na
na
na
313
304
293
309
291
332
267
327
321
294
308
365
303
346
317
312
355
270
266
291
na
na
na
na
na
na
na
na
na
na
296
319
336
307
297
306
                                D-18

-------
                                                              Study No. 5221.08
         SUBCHRONIC TOXlCITr OF PARA-CRESOL IN SPRAGUE DAWLEY RATS
                       FEMALE BODY WEIGHT DATA (g)
              ANIMAL MO.  UeekS  Ueek9  WeeklO  Week11  Week12  Week13  Week14
DOSE LEVEL
50 mg/kg/day 3837
(continued) 3838
3839
3840
3841
3842
3843
3844
3345
3846
3847
3348
3349
3850
175 mg/kg/day 3351
3352
3853
3854
3855
3556
3857
3853
3359
3860
3861
3862
3863
3864
3865
3866
3867
3868
3369
3870
3871
3872
3873
3874
3875
3876
3877
3378
3879
3380
255
291
216
234
279
265
255
220
262
290
261
260
259
227
I SAC
I SAC
ISAC
I SAC
I SAC
I SAC
I SAC
I SAC
1SAC
I SAC
244
258
278
267
246
275
245
308
258
268
313
289
272
264
275
269
262
272
250
259
271
294
226
233
287
262
266
232
259
302
272
266
27 '4
240
na
na
na
na
na
na
na
na
na
na
246
263
280
277
256
271
251
316
276
266
321
290
284
276
284
265
264
279
252
271
277
299
233
240
299
280
283
230
272
303
276
277
280
241
na
na
na
na
na
na
na
na
na
na
246
. 273
283
274
257
291
251
313
281
282
329
302
280
283
293
279
275
272
257
274
239
305
236
241 '
296
231
282
237
273
315
280
273
291
245
na
na
na
na
na
na
na
na
na
na
252
289
235
283
254
293
255
320
271
291
335
317
297
296
299
276
277
233
258
271
232
300
235
250
295
232
279
235
274
314
284
287
297
249
na
na
na
na
na
na
na
na
na
na
256
294
294
233
265
301
261
327
285
286
347
3"14
297
295
307
279
273
279
260
275
294
319
240
257
306
284
287
240
232
325
295
294
307
253
na
na
na
na
na
na
na
na
na
na
267
309
307
293
265
315
266
340
302
299
358
324
300
309
307
295
287
236
264
281
307
321
246
263
315
300
298
249
290
332
302
301
310
260
na
na
na
na
na
na
na
_ na
na
na
276
317
309
294
253
326
272
346
318
304
366
328
318
303
315
296
296
293
270
281
                          D-19
                                                                          114

-------
                                                                     Study Ho. 5221.08
           SUBCHRONIC TOXlCin Of PARA-CRESOL IN SPRAGUg  DAULEY  RATS
                          FEMALE BODY WEIGHT DATA 
-------
                                                                 Study No.  5221.08
        5USCHRCNIC TOXICITY OF  PARA-CRESOL IN SPRAGU6 DAULEY RATS
                   FEMALE iOOY WEIGHT GAIN DATA  Cg)
ANJMAL NO.  Ueekl  WeekZ  Ueek3  Ueek4
                                                            eek6  yeak7
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3791
2792
3793
3794
3795
3796
3797
3798
3799
3800
3801
3802
3803
3804
3805
3806
3807
3808
38D9
3810
3811
3312
3813
3814
3815
3816
3817
3318
3819
3820
3821
3822
3823
3824
' 3825
3826
3827
3828
3829
3830
3831
3832
3S33
3834
3835
3836
30
30
18
28
15
27
25
22
32
43
25
16
25
23
29
29
25
32
28
23
26
36
24
37
36
26
33
30
24
28
10
24
28
33
27
22
41
27
24
25
IS
20
34
21
29
25
55
49
46
53
34
47
43
44
51
63
48
42
53
55
53
44
40
48
54
46
44
61
41
60
0
46
56
50
34
50
26
46
42
47
43
38
62
45
41
39
39
43
54
38
52
45
79
68
64
69
57
70
59
71
63
96
70
69
63
82
62
75
64
65
41
67
66
83
65
80
71
63
94
58
52
74
47
63
70
69
61
55
71
62
53
64
51
72
83
50
44
66
99
87
79
85
67
S4
60
83
75
112
82
86
77
94
83
84
74
81
81
82
74
95
76
105
91
77
95
80
63
85
57
as
74
62
75
69
92
81
76
76
69
80
96
71
89
80
100
92
34
93
67
90
73
84
83
119
91
84
83
97
83
104
78
87
83
87
79
104
85
109
103
93
110
83
63
78
67
90
77
91
79
74
99
99
90
93
79
98
114
84
106
97
112
106
83
97
80
98
78
102
106
143
106
105
118
119
98
111
85
99
105
97
97
125
95
130
118
107
124
97
74
100
76
98
89
106
98
96
121
110
102
103
87
109
121
90
110
105
na
Hi
na
na
na
na
na
. na
na
na
113
99
109
133
117
113
95
109
120
111
96
133
114
136
121
116
135
102
83
107
na
na
na
na
na
na
na
na
na
na
97
108
132
104
118
111
                                                                            116
                                D-21

-------
                                                                   Study No.  5221.08
       SUBCHRONIC TOXICITY  OF  PARA-CRESQL IN SPRAGUE DAytET SATS
                   FEMALE BODY WEIGHT GAIN DATA 
-------
                                                               Study No. 5221.08
       SUBCHRQNIC TOXICITY  OF PARA-CRESOL IN SPRAGUE OAULEY  RATS
                  FEMALE BODY WEIGHT  GAIN DATA (g)
               ANIMAL NO.  Weekl  WeekZ  Week3 Ueak4  UeekS  Ueekfi  Week?
 DOSE  LEVEL
600 mg/kg/day
3881
3182
3883
3884
3885
3886
3887'
3888
3889
3890
3891
3892
3893
3894
3895
3896
3897
3898
3899
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
3910
\6
11
T\
22
14
24
12
15
12
12
25
7
6
17
11
9
29
27
na
1
18
11
18
22
14
16
13
23
12
na.
31
27
r,a
43
28
39
32
31
36
39
40
8
27
42
39
36
41
57
na
30
35
30
36
44
30
31
33
49
30
na
47
46
na
61
51
62
44
52
60
53
55
!6
51
70
65
57
61
78
na
53
55
44
57
58
49
49
49
66
44
na
59
57
na
94
64
73
60
73
77
6&
87
33
65
83
79
69
72
98
na
78
78
52
75
SO
58
61
59
78
69
na
59
56
na
101
74
75
65
76
85
78
83
41
80
96
92
73
90
103
na
86
83
60
79
91
59
68
70
96
77
na
72
78
na
105
B7
84
73
85
93
81
94
54
88
103
102
94
99
112
na
98
98
75
91
97
78
74
81
105
88
na
na
na
na
na
 na
na
na
na
na
na
96
63
101
107
106
103
103
na
na
505
107
76
101
113
81
79
95
104
94
na
                                D-23
                                                                         iis

-------
                                                                Study No.  5221.08
      SUiCHRQMIC TOXICITY OF  PARA-CRESOL  !H SPRAGUE DAUIEY RATS

                  FEMALE BODY UEIGHT GAIN DATA 
-------
                                                                   Study Mo. 5221.08
      SUSCHRONIC TCXICITY OF PARA-CBESQL  IN  SPRAGUE DAULEY RATS
                  FEMALE BODY yEIGHT  CAIN DATA  (g>
               ANIMAL NO.   WEEKS  WEESC9   WEEK1Q  WEES11  UEEK12  UEEK13
DOSE LEVEL
50 mg/kg/day 3837
(continutd) 3838
3339
3840
3841
3842
3843
3844
3845
3846
3847
3843
3849
3850
175 mg/kg/day 3851
3852
3853
3854
3855
3856
3857
3858
3859
3860
3861
3362
3863
3864
3865
3866
3867
3868
3869
3870
3871
3872
3873
3S74
3875
3876
3877
3878
3879
3880
106
117
92
94
140
106'
107
100
106
134
124
124
131
100
na
na
na
na
na
na
na
na
na
na
89
122
115
120
98
108
111
143
123
105
152
130
118
117
120
1Q2
104
126
97
113
112
122
99
101
132
124
124
98
119
13S
128
135
137
101
na
na
na
na
na
na
na
na
na
na
89
137
118
117
99
128
111
145
128
121
160
148
114
129
129
116
115
119
102
121
124
128
102
102
149
125
123
105
120
H7
132
131
148
105
na
na
na
na
na
na
na
na
na
na
95
148
120
126
96
130
115
147
118
130
166
157
131
137
135
113
117
130
103
118
117
123
101
111
148
126
120
103
121
146
136
145
154
109
na
na
na
na
na
na
na
na
na
na
99
153
129
126
107
138
121
154
132
125
178
154
131
136
143
116
118
126
105
122
129
142
106
118
159
128
128
108
129
157
147
152
164
118
na
na
na
na
na
na
na
na
na
na
110
168
142
136
107
152
126
167
149
135
189
164
134
ISO
143
132
127
133
109.
128
142
144
112
129
168
144
139
117
137
164
154
159
167
120
na
na
na
na
na
na
na
na
na
na
119
176
U4
137
100
163
132
173
165
143
197
168
152
144
151
133
136
140
115
128
                                D-25
                                                                               1 9

-------
                                                               Study No.  5221.03
      SUBCKRONIC TOXICITY OF PARA-CRESOL IN SPRAGUE DAULEY RATS
                 FEMALE BODY UE1GHT GAIM DATA Cg)
              AM1MAL NO.  UEEKS  UEEK9  UEEK10  UEEK11  WEEK12  UEEK13
 DOSE  LEVEL
600 mg/kg/day
3881
3882
3S83
3384
3335
3886
3887
3888
3889
3890
3391
3892
3893
3894
3895
3896
3897
3393
3899
3900
3901
3902
3903
39C4
3905
3906
3907
3908
3909
3910
na
na
na
na
na
na
na
na
na
na'
109
59
112
116
117
103
111
127
na
106
111
78
103
126
92
85
104
123
99
na
na
na
na
na
na
na
na
na
na
na
108
71
108
122
116
117
117
135
na
113
125
92
110
131
97
84
111
132
117
na
na
na
na
na
na
na
na
na
na
na
103
61
115
127
117
110
115
135
na
109
129
94
115
135
96
85
107
131
113
na
na
na
na
na
na
na
na
na
na
na
110
69
122
134
124
121
129
135
na
99
125
101
126
145
88
87
118
136
121
na
na
na
na
na
na
na
na
na
na
na
115
75
131
139
123
134
134
146
na
117
135
106
132
149
122
S3
131
146
121
na
na
na
na
na
na
na
na
na
na
na
116
69
136
139
121
136
139
153
na
121
138
115
133
153
121
92
134
160
123
na
                                D-26
                                                                           121

-------
                                                                    Stydy Ho. 5221.08
        SUBCHRONIC TOXICITY OF PARA-CR6SQI  !M SPRAGUE DAUtEY RATS
                     MALE FOOD COKSUMPTSOM  DATA  (g)
                            IFeeder ueightsl
                ANIMAL NO.  new  1   old  1   new  2  old  2  ntw  3  old  3
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
3683 .
3684
. 3685
3686
3687
3688
36B9
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
445.6
449. 5
450.1
448.7
45B.4
450.8
452.3
453,3
451.9
446.2
442.4
445.5
440.2
440.8
446.7
444.6
433.7
462.4
446.7
441.5
456.0
454.8
438.9
447.2
436.7
445.9
442.3
445.5
439.2
459.4
439.9
431.4
442.0
437.4
444.6
450,0
433.6
433.1
440.8
446.4
437.1
435.0
439.8
448.1
436.9
441.0
222.0
255.3
231.2
219.7
241.9
274.7
235.6
220.6
254.0
261.2
249.5
266.7
246. S
220.5
288.0
239.2
248.3
258.5
277.9
213.4
295.0
25S.4
253.3
234,9
243.6
243.7
245.5
226.7
243.3
242.2
211.6
231.2
253.4
228.3
231.5
273.5
240.6
210.6
235.9
251.7
229.0
223.8
236.3
275.7
231.1
246.2
500.6
504.3
500.2
496.4
496.1
496.6
496.6
455.7
493.5
500.7
498.9
498.4
496.8
501.5
494.3
494.5
500.4
519.6
508.8
496.6
494.0
499,6
500.4
499.8
493.3
492.1
495.8
495.6
494.5
500.4
486.4
488.6
483.2
491.1
480,5
484.4
494.7
483.1
474.0
480.5
478.8
483.5
490.4
469.6
476.5
497.3
291.5
310.0
272.3
263.4
280.5
324.0
282.9
263.1
290.4
313,4
309.2
314.2
307.0
278.5
333.9
289.9
309.7
299.3
340.6
279.5
327.0
294.9
298.9
285,5
294.0
289.0
2S6.3
269.5
315.9
2BO.O
256.0
278.0
302.0
276.1
275.2
301.8
295.5
262.1
278.9
261.5
280.7
282.6
267.0
284.8
280.4
307.5
510.2
503.5
.505.1
508.4
502.6
500.8
501.4
502.3
502.7
502.0
502.7
502.2
499.8
502.7
490.6
501 .a
493.1
525.9
492.3
501.9
497.8
501.6
501.1
502.0
500.8
498.2
503.1
500.2
494.8
498,1
502.1
501.5
500.7
501.3
501. S
494.5
502.6
500.1
500.9
499.9
501.8
495.3
502.4
506.0
497.0
514.3
317.9
318.5
272.5
287. 1
205.4
333.9
295.4
301.5
317.2
316.0
303.3
333.5
313.6
284.3
336.7
292.8
320.1
323.9
317.4
299.4
347.0
319.3
312.1
299.0
318.7
312.5
319.5
304.2
326.1
288.9
2S2.4
290.0
325.1
305.4
299.2
327.0
313.1
297.5
318.7
294.5
312.1
301.8
301.2
330.9
305.9
321.7
                                   D-27

-------
                                                                   Study No. 5221.08
       SUBCHROHIC TOXICIJY OF PARA-CRESOL  EN SPRACUE OAWLEY RATS
                    KALE FOOD CONSUMPTION  DATA  
                           [Feeder  Heights]
               ANIMAL NO.   new  1   old   1  "  2  old  2  nM  3  old  3
DOSE LEVEL
50 mg/kg/day 3707
(continued) 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 mg/kg/day 3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
443
445
435
428
438
443
442
439
435
437
433
430
431
441
392
408
402
406
398
398
397
379
399
379
.9
.0
.5
.8
.5
.5
.1
.7
.0
.8
.3
.2
.7
.2
.6
.3
.2
,9
.2
.3
.4
.5
.6
.7
392.1
387
394
396
390
389
396
376
376
.5
.5
.2
.0
.1
.6
.2
.7
381.0
379
380
384
379
378
374
405
385
380
401
.7
.1
.4
.8
.3
.2
,4
.6
.8
.9
273
215
246
231
278
243
243
279
236
251
265
271
248
246
207
203
203
261
208
231
227
206
207
205
204
20B
206
221
208
2C8
210
208
231
213
207
212
208
213
224
211
211
208
205
230
.0
.5
.6
.2
.8
.8
.3
.2
.7
.9
.8
,4
.6
.2
.4
.1
.7
.7
.7
.7
.7
.6
.0
,4
.4
.4
.7
.2
.6
.9
.8
.7
.3
,3
.4
.9
.3
.4
,7
.4
.7
.9
.9
.3
476
475
480
477
477
,475
468
463
460
473
472
472
475
474
488
489
490
495
488
484
484
482
473
481
481
485
4S6
.4
.8
.6
.4
,7
.6
.0
.5
.6
.9
.1
.2
.6
.4
.a
.7
.2
.7
.5
.3
.0
.7
.5
.7
.3
.0
.8
479.1
478
476
483
478
479
486
474
479
475
476
476
475
474
476
479
480
.6
.7
.3
.6
.3
.6 ,
.3
.5
.1
.2
.7
.7
.9
,6
.9
.7
289
264
236
259
309
279
264
303
260
272
309
299
230
277
289
288
293
273
286'
325
295
260
270
240
267
275
253
300
248
305
288
299
322
272
267
304
255
300
314
289
281
280
293
.6
,5
.4
.7
.9
,3
.8
.4
.1
.3
.8
.9
.0
.5
.3
.0
.7
.3
.0
.8
.6
.0
.9
.9
.4
.3
.3
.9
.8
.9
.3
.7
.9
.4
.2
.1
.1
.5
.7
.4
.6
,7
.0
284.0
495.1
498.
498.
499.
491.
496.
499.
.503.
500.
498.
488.
497.
494.
505.
502.
500.
498.
505.
506.
499.
.500.
499.
494.
504.
500.
502.
502.
483.
503.
493.
498.
495.
492.
501,
497.
501.
499.
496.
481.
498.
495.
492.
499.
513.
5
5
2
5
0
1
1
5
5
6
0
8
0
3
7
6
0
3
1
6
a
6
1
3
5
9
3
2
8
1
7
1
4
7
4
4
7
7
7
3
2
1
5
312.1
300.0
314.6
292.0
320.6
315.5
299.9
350.6
308.6
297.9
331.6
340.1
312.2
338.1
292.2
315.4
307.1
290,2
299.2
247.3
311.6
307.5
295.1
287.7
293.2
322.0
302.3
320.4
297.0
323.2
322.0
332.9
339.6
291.1
308.5
335.9
305.2
328.9
324.9
327.3
321.9
317.6
320.0
340.8
                                                                                 o ^
                                 D-28                  '                       ~

-------
                                                                    Study No. 5221.08
        SUBCHRON1C TOX1C1TY OF PARA-CRESOL  IN  SPRAGUE  DAULEY RATS
                     HALE FOOD CONSUMPTION  DATA  (g)
                            [Feeder weights]
                ANIMAL NO.   new  1   old  1   neu   2   old   2  new  3  old  3
 DOSE LEVEL

00 mg/kg/day
3751
3752
3753
3754
3755
3756
3757
3758
3759
3760
3761
3762
3763
3764
3765,
3766
3767
3768
- 3769
3770
3771
3772
3773
3774
3775
3776
3777
3773
3779
3780
421.7
433.3
423.4
430.3
431.0
464.4
425.1
391.9
426.4
409.2
414.3
122.5
427.8
436.2
424.6
434.9
453.7
436. B
413.4
430.8
436.6
436.2
423.0
429.2
417.4
433.7
430. 2
424.3
423.0
421.7
292.0
250.9
274.8
279.6
247.6
320.6
271.7
222.7
294.0
257.9
291.3
271.8
268.4
312.3
252.2
256.0
263.5
2S9.9
318.9
308.5
2B8.1
283.6
268.2
301.3
269.5
251.9
262.2
268.7
267.9
263.1
474.5
472.1
472.1
470.2
472.9
476.4
474.4
470.3
469.1
469.2
469.6
473.2
471.5
471.4
476.8
475.0
464.6
464.4
465.9
467.3
473.6
465.1
470.1
465.3
472.2
464.0
471.1
478.0
469.3
482.3
312.1
271.1
293.2
305.3
271.3
328.7
231.1
297.4
323.7
283.9
330.5
319.8
313.1
300.4
282.3
309.6
279.3
274.9
320.5
294.5
3C4.3
283.0
268.7
296.3
320.5
271.9
315. S
310.9
279.5
312.9
491.8
506.9
500.1
503.4
501.0
512.9
511.8
503.3
501.7
505.6
514.2
513.0
513.0
520.2
-516.9
516.5
510.7
515.3
506.4
507.7
508.7
538.4
511.6
507.9
515.9
508.1
524.1
515.3
510.2
522.3
333.8
313.0
342.0
349.8
313.5
368.5
331.3
329.5
367.5
321.2
370.3
361.0
353.4
357.7
344.2
366.5
343.3
323.8
343.6
337.1
363.5
322.8
335.7
365.0
388.3
311.5
355.8
345.8
336.4
355.6
                                                                                   *
                                                                                      O
                                                                                   .
                               D-29

-------
                                                               Study No, 5221.08
       SUBCHRON1C TQX1C1TT OF PARA-CRESOL IM SPRAGUE OAULET RATS
                   HALE FOOD CONSUMPTION DATA (g)
                          [Feeder weights]
               ANIMAL NO.   new  4  old 4  neu  5   old  5  new 6  old  6
 DOSE  LEVEL
 0 mg/kg/day
50 mg/lcg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
367S
3676
3677
3678
.3679
3680
3681
3682
3683
3684
3685
3666
3687
368S
3689
3690
3691
3652
3653
3694
3655
3696
3697
3693
3699
3700
3701
3702
37C3
3704
3705
3706
499.4
496.6
504.8
500.4
507.4
505.1
508.5
502.6
500.7
502.7
504.6
501.4
507.2
501.4
SOS. 9
508.1
502.6
509.2
504.8
500.8
500.8
502.9
503.1
501,3
501.4
500.8
501.7
501.0
502.9
500.0
510.6
500.9
502.3
501.3
503.1
504.0
501.4
500.4
502.5
501.3
501.9
504.4
500.3
501.5
501.6
503.3
309.7
309.4
.295.7
279.6
328.8
341.8
302.8
304.9
313.9
319.8
323.9
351.8
329.6
302.5
356.2
290.6
339.2
303.8
335.4
311.1
345.9
321.9
312.4
306.9
314.3
316.4
319.0
298.4
333.5
294.5
287.8
306.9
322.4
307.2
320.8
343.8
307.4
320.0
319.1
303.1
318.3
308.6
319.0
333.8
312.0
325.3
503.2
503.0
503.4
505.1
503.2
510.0
504.4
507.4
504.6
505.4
507.2
502.3
506.0
_507.3
506.4
511.1
507.3
503.8
500.1
506.0
502. 6
501.0
503.3
505.3
505.4
503.8
501.6
510.2
502.5
510.7
502.4
519.7
504.9
509.4
510.7
506.8
505.9
505.0
504.4
503.8
504.4
505.0
505.8
504-.0
522.0
502.4
306.7
310,0
308.7
271.2
319.8
333.9
305.2
301.8
308.6
312.7
323.7
322.2
324.6
288.5
353.3
278.0
339.4
295.5
324.0
297.5
340.6
329.7
315.0
316.5
323.2
310.4
296.8
308.9
330.7
295.7
283.7
317,6
321.7
323.1
323.9
341.8
310.1
330.9
328.3
306.4
320.6
317.3
332.5
340.5
339.4
329.8
498.9
492.7
494.6
498.3
498.1
494. S
498.9
498.4
494.1
493.1
495.0
495.4
494.1
499.1
499.2
.495.8
499.9
492.4
494.0
494.0
492.6
494.0
493.2
493.5
492.1
492.7
495.8
494.9
493.4
497.2
494.2
497.9
496. S
496.9
498.3
498.2
498.8
499.5
498.0
495.2
496.2
498.7
497.4
497.3
497.1
500.4
328.0
302.0
284.2
255.5
325.3
328.9
345.3
291.2
308.2
313.1
328.6
315.9
326.0
279.5
341.8
290.8
326.1
272.9
326.8
296.5
341.3
321.7
306.8
299.1
313.9
300.3
313.2
306.4
238.9
296.3
257.1
295.3
306.0
300.7
306.1
312.9
289.8
312.7
330.9
344.0
304.4
311.2
309.8
335.2
302.7
325.4
                                                                               125
                              D-30

-------
                                                                   Study No. 5221.08
       SU8CHRONIC 10XICITY OF PARA-CRESCt  IN  SPRAGUE DAMLET SATS
                    HAUi FOOD CONSUMPTION  DATA  (g)
                           [Feeder weights]
               AMI HAL NO.   new  4   old  4  new  5  old  5  new  6  old  6
DOSE LIVEL
SO ng/kg/day 3707
(continued} 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 mg/kg/diy 3721
3722
3723
3724
372S
3726
3727
3728-
3729
3730
3731
3732
3733
3734
3735
3736
3737
1738
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
' 3750
500.2
501.9
502.6
. 501.2
501.0
503.3
504.1
498.4
501.3
530. 9
493.2
497.2
501.3
504.4
506.0
5C1.1
502.1
504.9
501.4
503.3
503.6
502.0
498.1
503.4
503.7
505.3
499.8
503.5
505.3
505.5
498.2
502.7
493.1
508.8
498.8
504.7
495.4
500.8
499.8
507.2
495.4
495.4
498.8
504.2
318.2
317.6
316.6
290.9
332.0
320.2
319.6
358.3
327.8
301.1
346.0
343.9
333.2
367.1
309.3
315.9
329.0
296.0
288.4
366.4
319.1
312.4
313.2
298.1 '
292.9
329.3
 304.2
331.0
327,3
338.3
319.9
333.7
339.9
314. 5
324.0
343.3
300.0
339.7
346.6
343.6
331.1
331.4
314.1
338.1
504.0
503. a
506.5
508.2
5D6.2
502.4
506.1
502.1
504.1
506.0
507.1
508.6
504.5
503.5
506.6
504.6
509.3
501.2
507.2
505.6
509.0
501. 0
504.6
508.2
508.9
510.5
508.4
507.0
510,5
510.5
507.9
502.5
506.6
506.9
502.0
501.9
506.8
506.2
501.1
503.0
507.4
502.0
503.9
508.0
325.9
316.8
322.6
309.1
325.0
322.6
327.6
358.6
333.3
318.5
351.5
349.1
344.6
303.5
301.6
317.7
335.0
285.8
316.6
367.2
351. 3
317.0
322.2
303.5
299.9
333.6
321.3
338.2
324.7
336,1
341.8
330.2
351.4
310.3
310.5
329.6
313.4
342.7
342.6
341.2
331.8
343.2
318.8
335.4
498.3
497.8
498.3
500.4
499.1
497.6
499.8
498.4
504.4
498.4
495.0
498.5
500.9
495.5
498.9
498.6
500.0
500.4
499.3
499.0
497.5
497.3
.496.3
499.7
498.1
497.7
497.6
496.1
497.4
496.6
500.3
495.2
498.3
500.6
495.5
501.9
500.0
497.0
498.3
492.6
495.5
502.3
499.5
498.7
318.0
31B.7
315.7
302. 4
324.4
314.0
316.5
361.7
333.3
314.8
340,8
337.9
328.0
316.2
306.0
316.6
315.6
281.9
321.2
365.4
319.7
301.4
319.5
295.9
289.0
325.9
307.6
339.2
292.2
326.3
337.0
314.6
345.3
314.0
307.1
331.5
295.5
320.3
350.1
333.5
328.9
348.5
325.4
335.1
                                D-31

-------
                                                                    Study No. 5221.08
        SU3CHRONIC TOXICITY OF PARA-CRESOL IN SPRACUE  DAULEY  RATS
                     MALE FOOD CONSUMPTION DATA 
-------
        SUSCHSONIC TOXICITT OF PARA-CRESOL  IN  S?RAGUI BAWLED RATS
                     MALE FOOD CONSUMPTION  DATA  (g)
                            [Feeder  Heightsl
                                                                    Study Ho.  5221.08
                AW1MAL NO.   new  7  old  7 new  8  old  &  new  9  old  9
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3663
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
3683
3684
3685
3686
3687
3688
3689
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
497.5
498.4
498.9
493.0
496.9
495.1
498.9
497.2
499.3
498.6
498.4
500.0
497.5
497.0
500.3
500.4
498.4
495.4
494.6
498.8
497.7
494.7
497.4
500.0
497.2
497.4
499.0
494.0
496.2
497.2
500.2
493.0
495.7
498.5
497.7
494.2
500.3
496.5
496.1
498.7
498.7
496.2
496.9
496.9
497.2
497.6
380.1
394.5
342.7
355.6
377.7
395.0
367.1
341.1
391.5
371.8
325.0
307.1
332.5
274.9
340.6
301.3
327.1
273.1
324.4
290. S
349.9
324.6
319.0
310.4
316.4
296.0
305.3
297.6
335.6
295.0
335.8
393.6
364.9
386.8
370.9
386.3
382.5
408.0
383.0
367.0
321.3
317.6
326.6
338.3
309.3
332.9
na
na
na
na
na
na
na
na
na
na
488.2
495.2
495.9
490.3
494.3
492.9
491.6
491.9
496.1
492.1
490.7
497.5
488.7
491.1
433.6
495.1
499.8
494.1
489.7
493.3
na
na
na
na
na
na
na
na
na
na
491.0
497.3
490.2
492.1
495.2
498.3
na
na
na
na
na
na
na
na
na
na
319.3
313.6
318.3
268.3
357.0
"313.3
309.8
285.7
339.6
301.0
344.9
330.9
292.8
305.8
314.1
305.9
312.6
321.0
329.3
315.0
na
na
na
na
na
na
na
na
na
na
316.6
316.0
312.8
338.9
320.9
333.8
na
na
na
na
na
na
na
na
na
na
494.3
488.2
488.8
485.1
484.5
497.3
495.1
486.8
481.6
489.2
494.7
484.6
492.3
490.3
487.3
491.4
490.8
484.4
485.3
492.2
na
na
na
na
na
na
na
na
na
na
494.0
486.9
486.5
484.5
493.2
493.2
na
na
na
na
na
na
na
na
na
na
329.4
310.0
318.9
276.5
335.7
301.1
309.4
282.3
326.8
314.2
365.0
318.8
314.6
311-6
306.6
294.9
315.2
306.7
326.6
302.2
_na
na
na
na
na
na
na
na
na
na
322.3
313.4
305.2
341.3
322.2
357.3
                                  D-33

-------
       SUBCHRON1C TOXICtn  OF  PARA-CRESQL  1H SPRAGUE OAWLEY RATS
                    MALE FOOD  CONSUMPTION  DATA (g)
                           EFteder weights]
                                                                   Study No.  5221.08
               ANIMAL NO.   new  7  old  7  new  8  old  8  new  9  old  9
DOSE LEVEL
50 mg/kg/day 3707
(continued) 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 mg/kg/day 3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3741
3742
' 3743
3744
3745
3746
3747
3748
3749
3750
499.3
495.7
497.1
500.1
495.8
496.6
499.5
497.7
496.5
498.3
497.5
500. 4
498.9
495.2
549.5
508.2
517.7
495.0
499.2
499.2
507.8
497.8
499.9
102.9
433.2
516.1
522.7
509.0
510.5
520.0
501.2
514.9
498.3
515.2
502.1
504.4
508.6
492.9
512.4
505.3
514.2
530.5
513.4
517.8
305.2
323.3
321.8
312.2
328.6
325.1
317.3
362.1
324.4
316.5
333.9
344.7
323.4
320.2
443.7
384.4
390.7
352.2
385.8
406.0
409.8
365.8
372.0
352.1
278.2
343.9
333.2
351.3
328.2
346.9
329.2
349.6
356.7
332.3
320.4
340.4
392.0
307.6
373.2
339.9
342.1
373.1
341.3
353.7
498.3
494.0
490.4
492.2
490.4
497.2
498.6
493.5
499.1
493.3
494.2
493.3
493.5
498.2
na
na
na
na
na
na
na
na
na
na
459.9
482.0
452.5
451.2
517.7
592.8
471.3
482. 3
410.1
437.9
425.8
468.6
433.4
421.8
440.0
478.5
468.3
489.3
526.4
' 508.5
391.3
321.6
309.4
305.6
330.1
324.9
321.9
359.0
345.9
314.9
344.1
350.4
320.3
326.5
na
na
n
na
na
na
na
na
na
na
250.1
305.6
253.4
296.5
315.3
431.8
311.2
319.0
258.3
262.7
246.6
296.7
262.0
239.1
3C2.3
319.5
293.9
330.7
362.7
326.1
433.3
489.4
486.5
484.8
487.2
496.2
494.7
491.7
490.9
489.7
495.6
491.3
495.3
487.3
na
na
na
na
na
na
na
na
na
na
489.2
489.1
494.2
492.2
499,1
495.8
489.5
492.3
487.9
488.7
485.0
492.7
433.4
498.6
495.0
494.6
435.0
498.6
499.1
490.1
454.9
320.2
318.6
299.9
336. a
331.5
325.2
367.5
337.9
321.5
354.0
340.4
333.5
345.6
ns
na
na
na
na
na
na
na
na
na
300.4
323.3
301.6
345.3
293.7
352.8
367.0
332.4
339.4
314.2
335.0
332.1
293.5
320.2
360.4
340.6
328.9
338.6
330.4
323.5
                                D-34

-------
   tenacity.OF PARA-CRESQL  in SPRAGUE DAWIEY RATS
     HALE  FOOD CONSUMPTION  DATA (g)
            [Feeder weights]
                                                  Study Mo. 5221.08
ANIMAL  NO.  new  7  old 7  new  8  old 8  new  9  old 9
DOSE LEV1L
600.ms/kg/day 1751
3752
3753
3754
3755
3756
3757
3753
3759
3760
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
3780
529.3
520.2
500.9
509.0
499.0
492.5
492.7
493.4
498.3
481
501
507
505
513
503
489
491
477
499
535
508
498
503
499
513
529
492
509
500
499
.7
.9
.2
.8
.7
.3
.5
.1
.3
.9-,
.6
.9
.0
.2
.5
.6
.3
.5
.1
.8
.9
414.1
419.8
407.7
408.2
422.6 -
4Q0.7
395.3
386,5
414,3
393.4
367.
366.
359.
307.
301.
340.
324.
298.
356.
377.
359.
311.
336.
362.
359.
362.
331.
338.
371.
338.
.0
7
7
,5
.4
6
5
9
8
2
6
0
0
7
4
7
9
9
1
1
491
472
464
477
473
539
615
533
565
614
601
499
532
507
511
479
538
507
522
540
na
na
na
na
na
na
na
na
na
na
.1
.2
.2
.8
.4
.2
.0
.9
.4
.4
.9
.7
.0
.7
.9
.9
.a
.9
.5
.7


342
334
300
na
na
na
na
na
na
na
na
na
na
.0
.4
.1
287.8
295
360
429
330
415
437
407
285
342
344
364
304
377
339
339
371
.1
.5
.0
.8
,2
.2
.1
.3
.2
.6
.0
.7
.0
.4
.3
.8
na
na
na
na
na-
na
na
na
na
na
496.5
493.6
489.
3
491.6
493.8
497.
497.
488.
499.
489.
488.
491.
486.
484.
499.
487.
499.
496.
486.
502.
3
0
3
8
2
2
3
8
9
0
4
4
4
2
6
na
na
na
na
na
na
na
na
na
na
376.0
371.8
319.2
307.2
318.4
338.5
338.5
314.0
376.4
342.8
345.8
323.4
317.3
346.5
355.8
304.8
349.9
335.6
298.5
341.1
               D-35
                                                           130

-------
                                                                           Study Mo. 5221.08
                     SUBCKRONIC  TOXIC1TY OF  PARA-CRISOL  1M SPRAGUE OAULEY RATS
                       -          HALE  FOOD  CONSUMPTION  DATA 
-------
                                                                         Study Na. 5221.08
                   SUBCKRONIC TOXICITY OF PARA-CRESQL  1H  SPRAGUE DAULEY RATS


                                MALE FOOD CONSUMPTION  DATA  
-------
                                                                          Study Wo. 5221.06
                    SUBCHROHIC TOX1CITY OF PARA-CRESOL  IN  SPRAGUE OAWLEY RATS
                                 HALE FOOD CONSUMPTION  DATA  (g)
                                        [feeder  weights]
                ANIMAL NO.   new  10  old  10   new   11  old  11  new  12  old  12  neu  13  old  13
 DOSE LEVEL
600 mg/kg/day
3751
3752
3753
3754
3755
3756
3757
3753
3759
3760
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
37SO
na
na
na
na
na
na
na
na
na
na
486.0
495.7
502.0
478.2
462.6
473.8
513.9
474.4
525.5
476.3
516.1
433.4
487.8
475.9
497.3
466.9
503.6
498.6
473.1
497.0
na
na
na
na
na
na
na
na
na
na
356.6
364.2
324.9
289.9
279.8
308.2
344.9
294.6
388.5
315.8
358.7
297.3
320.9
330.1
351.6
292.7
351.5
336.7
256.2
329.3
na
na
na
na
na
na
na
na
na
na
499.5
496.4
480.5
493.4
491.2
494.7
502.6
533.7
492.8
497.5
504.8
490.8
436.8
4S8.7
483.4
488.9
488.2
501.9
503.3
501.4
na
na
na
na
na
na
na
na
na
na
390.2
375.3
323.4
315.2
316.2
331.0
338.2
365.9
371.3
348.2
356.3
307.8
319.5
350.1
343.3
333.0
339.8
340.4
337.8
345.5
na
na
na
na
na
na
na
na
na
na
429.1
469.2
458.9
444.6
448.9
500.2
498.9
492.8
475.2
495.7
477.1
465.3
430.7
457.7
456.6
444.4
447.2
456.4
454.0
453.4
na
na
na
na
na
na
na
na
na
na
356.2
343.5
298.0
262.0
275.1
345.7
336.3
321.1
342.9
341.7
323,2
263.0
253.3
314.0
314.4
277.5
296:9
300.8
292.3
300.7
na
na
na
na
na
na
na
na
na
na
495.2
497.5
496.5
497.4
492.9
494.1
498.5
496.7
494.5
490.1
495.4
502.8
486.7
493.6
488.1
490.5
498.3
493.0
493.6
525.3
na
na
na
na
na
na
na
na
na
na
381.5
359.8
336.3
311.8
319.7
352.5
334.2
339.0
371.9
341.2
354.8
314.6
343.4
360.2
351.8
337.3
367.8
341.2
331.6
383.0
                                         D-38

-------
                                                                     Study No. 5221.08
        SUBCHRQH1C TOXICITY OF PARA-CRESQL IM SPRAGUE DAWLEY RATS


                   MALE FOOD CONSUMPTION DATA (g/day)
                ANIHAL NO.  ueekl  ueek2  week3  week4  ueekS  eek6  week?
 DOSE LEVEL
 0 uig/kg/day
50 mg/kf/day
366 1
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
3683
3684
3685
3686
3687
3688
3689
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
31.9
27.8
31.3
32.7
30.9
25.2
31.0
33.2
28.3
26.4
27.6
25.5
27 .7
31.5
22.7
29.3
27.2
29.1
24.1
32.6
23.0
23.1
26.5
30.3
27.6
28.9
28.1
31.3
28.0
31.0
32.6
28.6
26.9
29.9
30.4
25.2
27.6
31.8
29.3
27.8
29.7
30.2
29.0
24.6
29.4
27.8
29.9
27.8
32.6
31.3
30.8
24.7
30.5
33.2
29.0
26.8
27.1
26.3
27.1
31.9
23.0
29.2
27,2
31.5
24.0
31.0
23.9
29.2
28.8
30.6
28.5
29.0
29.9
32.3
25.5 '
31.5
32.9
30.1
26.6
30.7
29.3
26.1
28.5
31.6
27.9
31.3
28.3
28.7
30. 5
26.4
28.0
27.1
27.5
26.4
33.2
31.6
42.5
23. 8
29.4
28.4
26.5
26.6
28.5
24.1
26.6
31.2
22.0
29.9
24.7
28.9
25.0
28.9
21.5
26.0
27.0
29.0
26.0
26.5
26.2
23.0
24.1
29.9
31.4
30.2
25.1
28.0
28.9
23.9
27.1
28.9
26.0
29.3
27.1
27.6
27.7
25.0
27.3
27.5
27.1
26.7
29.9
31.5
25.5
23.3
29.4
28.2
26.7
26.1
25.8
21.4
25.4
23.4
21.3
31.1
23.3
29.3
24.2
27.1
22.1
25.9
27.2
27.8
26.7
26.3
26.1
28.9
24.2
29.4
31.8
27.7
25.7
27.7
26.0
22.9
27.7
25.8
26.2
28.3
26.2
28.0
25.9
24.0
27.1
25.4
28.1
27.6
27.8
33.4
26.2
25.2
28.5
29,4
28.0
27.5
26.2
25.7
25.9
31.3
21.9
33.3
24.0
29.8
25.2
' 29.8
23.1
24.5-
26.9
27.0
26.0
27.6
29.3
28.8
24.5
30.7
31.2
28.9
26.2
26.6
26.7
23.6
28.0
24.9
25.2
28.2
26.3'
26.8
24.8
23.4
26.1
24.7
24.4
27.2
30.1
34.7
24.7
23.7
21.9
29.6
26.6
25.7
23.8
25.6
24.0
31.4
22.5
29.3
24.8
31.4
23.9
28.2
21.6
24.6
26.6
27.8
25.5
27.5
26.1
26.9
22.1
28.7
33.9
28.9
27.3
28.0
27.5
26.5
29.9
26.7
23.9
21.6
27.4
26. B
26.8
23.2
27.8
25.0
16.8
14.8
22.3
20.3
17.0
14.3
18.8
22.3
15.4
18.1
24.8
27.6
23.6
31.7
22.8
28.4
24.5
31.8
24.3
29.7
21.1
24.3
25.5
27.1
25.8
28 .8
27.6
28.1
22.9
23.9
23.5
14.2
18.7
16.0
18.1
15.3
16.8
12.6
16.2
18.8
25.3
25.5
24,3
22.7
26.8
23.5
                                  D-39
                                                                                         ~1  /
                                                                                          -1 4

-------
                                                                   Study No. 5221.08
       SUSCHRQNIC TOXICITY  OF  PARA-CRESOL  IN SPRAGUE DAWLEY RATS
                  MALE FOOD CONSUMPTION DATA (g/day)
               ANIMAL NO.   weekl  weekZ  week3  *eek4  weeks  week6  wetk7
POSE LEVEL
50 mg/kg/day 3707
(continued) 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 rag/kg/day 3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3731
3732 .
3733
3734
3735
3736
3737
3738
3739
 3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
24
32
27
28
22
28
28
22
23
26
23
.4
.8
.0
,2
.8
.5
.4
,9
.3
.6
,9
22.7
26
27
26
23
28
20
27
23
24
24
27
24
26
.2
.9
.5
.6
,4
.7
.1
.8
.2
.7
.5
.9
.8
25.6
26
25
25
25
26
23
20
24
24
23
25
23
21
23
27
25
25
24
.8
.0
.9
.7
.5
.9
,a
.0
.6
.9
.2
.a
.9
.3
.7
.2
.0
.5
26.
30.
27.
31.
24.
28.
29.
7
2
7
1
0
0
0
22.9
28.
28.
23.
24.
27,
28.
28,
28.
27.
31.
28.
22.
26.
31.
28.
34.
30.
30.
33.
25.
32.
24.
27.
25.
22.
30.
29.
25.
31.
25;
23.
26.
27.
28.
26.
25.
6
8
2
6
9
1
5
s
4
8
9
6
9
S
9
4
6
0
4
5
S
4
9
6
3
6
6
1
4
1
1
6
6
0
7
1
26.
23.
26.
29.
24.
25.
28.
21.
27.
28.
22.
22.
26.
23.
30.
26.
27.
30.
29.
36.
27.
27.
23.
30.
29.
25.
28.
24.
29.
24.
25.
23.
21.
30.
27.
23.
27.
24.
22.
24.
24.
24.
25.
24.
1
4
3
6
4
8
5
8
4
7
4
4
1
8
0
5
4
7
6
0
0
5
5
9
6
3
6
0
5
4
2
3
8
0
0
6
7
0
4
4
3
9
6
7
26.0
26.3
26.6
30.0
24.1
26.2
26.4
20.0
24.8
23.5
21.7
21.9
24.0
19.6
28.0
26.5
24.7
29.8
30.4
19.6
26.4
27.1
26.4
29.3
30.1
25.1
27.9
24.6
25.4
23.9
25.5
24.1
21.9
27.3
25.0
23.0
27.9
23.0
21.9
23.4
23.5
23.4
26.4
23.7
25.
26.
26.
28.
25.
25.
25.
20.
24.
26.
22.
22.
22.
28.
29.
26.
24.
30.
27.
19.
22.
26.
26.
29.
29.
. 25.
26.
24.
26.
24.
23.
24.
22.
28.
27.
24.
27.
23.
22.
23.
25.
22.
26.
24.
4
?
3
4
9
7
5
5
4
8
2
8
S
6
3
7
9
8
2
8
5
3
1
2
9
3
7
1
5
9
7
6
2
1
4
6
6
4
6
8
1
7
4
7
25.8
25,6
26.1
28.3
25.0
26.2
26.2
19.5
24.4
26.2
22.0
22.9
24.7
25.6
27.6
26.0
26.3
31.2
25.4
19.1
25.4
28.0
25.3
29.1
29.9
24.5
27.1
22.4
29.3
24.3
23.3
25.8
21.9
26.7
26.9
24.3
29.2
25.2
21.2
22.7
23.8
22.0
24.9
23.4
27.7
24.6
25.0
26.8
23.9
24.5
26.0
19.4
24.6
26.0
22.7
22.2
25.1
25.0
15.1
17.7
18.1
20.4
16.2
13.3
14.0
18.9
18.3
21.5
30.0
24.6
27.1
22.5
26.0
24.7
24.6
23.6
20.2
26.1
26.0
23.4
16.7
26.5
19.9
23.6
24,6
22.5
24.6
23.4
                              D-40

-------
                                                                    Study No. 5221.03
        5UBCHRONIC TOXICITY OF PARA-CRESOL IN  SPRAGUE  DAULEY  RATS

                   MALE FOOD CONSUMPTION DATA  (g/day)
                ANIMAL NO.  weekl   week2  week3  week4  ueekS  ueek6  week?
 DOSE LEVEL
600 nig/kg/day
3751
3752
3753
3754
3755
3756
3757
3753
3759
3760
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3773
3779
3780
18.5
26.2
21.2
21.5
26. 2
20.5
21.9
24.2
18.9
21.6
17.6
21.5.
22.3
17.7
24.6
25.6
27.2
21.0
13.5
17.5
21.2
21.8
22.1
13.2
21.1
26.7
23.1
22.2
22.2
22.7
23.2
28.7
25.6
23.6
28.8
21.1
27.6
24.7
20.3
26.5
19.9
21.9
22.6
24.4
27.7
23.6
26.4
27.1
20.8
24.7
24.1
26. 0
28.8
24.2
21.7
30.3
22.2
23.9
27.1
24.2
22.6
27.7
22.6
21.9
26.8
20.6
25.8
24.8
19.2
26.3
20.6
21.7
23.5
23.2
24.7
21.4
23.9
27.4
22.5
24.4
20.0
30.8
25.1
20.4
lfl.2
28.1
24.0
24.2
24.3
23.8
22.7
26.7
23.3
20.0
25.6
22.5
24.4
24.9
19.7
24.7
20.1
20.4
23.0
26.5
22.3
21.5
23.1
27.6
22.1
23.6
21.2
25.7
26.3
19.9
18.9
25.3
22.6
23.1
22.7
21.9
23.1
25.8
22.6
22.6
24.5
21.8
22.0
23.9
18.4
24.8
20.5
21.6
23.3
27.0
25.7
22.1
24.6
27.1
23.4
23.4
22.4
26.2
25.7
23.0
22.6
24.2
22.6
24.5
32.0
22.9
23.1
23.5
21.5
20.6
21.4
22.9
21.9
24.2
22.3
16.7
21.9
18.8
19.9
20.5
27.2
25.0
22.9
26.2
19.9
23.4
21.4
27.8
26.4
22.6
18.3
24.3
21.7
24.6
27.8
12.5
16.5
14.3
13.3
14.4
10.9
13.1
13.9
15.3
12.0
12.6
19.3
20.1
20.9
29.5
28.8
21.3
23.8
25.5
20.4
22.6
21.3
26.7
23.9
19.5
22.0
23.9
22.9
24.3
18.5
23.1
                                 D-Al
                                                                               4  O
                                                                               JL  O

-------
        SUBCHRONIC TOXICITY OF PARA-CRESQI IN SPRAGUE  DAWtEY  RATS
                  HALE FOOD CONSUMPTION DATA (g/day)
                                                                    Study No. 5221.08
ANIMAL HO,  ueekS  week9
                                                  ueekll   week12  ueek13
 DOSE LEVEL
 0 ng/kg/day
50 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
3683
3684
3685
36S6
3687
3688
3689
3690
'3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
na
na
na
na
na
na
na
na
na
na
24.1
25.9
25.4
31.6
19.6
25.7
26.0
29.5
22.4
27.3
20.8
23.8
28.0
26.5
24.9
27.0
26.7
24.7
22.9
26.3
na
na
na
na
na
na
na
na
na
na
24.9
25.9
25.3
21.9
24.9
23.5
na
na
na
na
na
na
na
na
na
na
23.6
25.5
24.3
29.6
21.3
23.0.
26.5
29.2
22.1
25.0
18,5
23.7
25.4
25.5
25.8
28.1
25.1
25.4
22.7
27.1
na
na
na
na
na
na
na
na
na
na
24.5
24.8
25.9
20.5
24.4
19.4
na
na
na
na
na
na
na
na
na
na
25.2
24.9
24.7
27.3
20.7
26.9
26.0
29.2
22.7
26.1
20.1
23.6
26.6
25.8
26.2
27.3
24.7
26.4
22.6
26.2
na
na
na
na
na
na
na
na
na
n
23.4
26.5
25.9
21.6
25.1
20.9
na
na
na
na
na
na
na
na
na
na
23.0
24.7
20.9
25.2
22.5
25.5
23.3
29.0
21.9
24.0
22.7
23.5
25.1
22.8
24.3
24.4
24.2
22.7
22.0
24.1
na
na
na
na
na
na
na
na
na
na
24.3
25.7
22.7
22.6
24.5
20.7
na
na
na
na
na
na
na
na
na
. na
22.2
16.7
22.4
27.6
21.1
26.0
22.6
27.8
23.0
24,9
19.5
22.2
25.8
23.5
22.2
25.1
24.6
23.1
21.7
24.6
na
na
na
na
na
na
na
na
na
na
21.8
25. Q-
22.3
22.6
24.5
21.1
na
na
na
na
na
na
na
na
na
na
23.7
14.9
19.3
27.4
17.6
20.7
17.8
24.8
17.1
21.3
17.4
13.0
22.8
21.4
22.6
23.0
23,6
22.7
15.8
21.9
na
na
na
na
na
na
na
na
na
na
23.7
14.9
19.3
27.4
17.6
20.7
                                  D-42

-------
      SUBCWRONIC TCXIC1TY OF PARA-CRESQL  IN SPRAGUE DAULEY RATS
                HALI FOOD CONSUMPTION DATA Cg/day)
                                                                Ssudy No. 5221,08
              ANIMAL  NO.  weekS  week?  week'O  week11  week12  ueek13
DOSE LEVEL
50 mg/kg/day 3707
(continued) 3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
175 nig/kg/day 3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
15.3
24.6
25.9
26.7
22.9
24.6
25.2
19.2
21.9
25.5
21.4
20.5
24.7
24.5
na
na
na
na
na
na
na
na
na
na
30.0
25.2
28.4
22.1
28.9
23.0
22.9
23.3
21.7
25.0
25.6
24.6
24.5
26.1
19.7
22.7
24.9
22.7
23.4
26.1
4.1
24.2
24,0
26.4
21.5
23.5
24.2
17.7
21.9
24.0
20.2
21.6
23.1
20.2
na
na
na
na
na
na
na ,
. na
na
na
27.0
23.7
27.5
21.0
29.3
20.4
17.5
22. 8
21.2
24.9
21.4
22.9
27. S
25.5
t9.2
22.0
22.3
22.9
24.1
23.8
13.6
25.6
25.2
27.2
22.7
25.3
25.2
18.4
23.1
24.6
21.0
20.1
23.4
21.2
na
na
na
na
na
na
na
na
na
na
27.0
24.9
27.3
22.0
30.4
22.2
22.2
24.5
21.2
25.3
24.2
24.6
27.0
23.8
17.5
24.1
23.5
25.2
22.8
24.4
8.9
22.4
24.6
26.1
22.7
23.3
24.9
17.6
22.0
24.1
26.1
20.4
22.2
19.2
na
na
na
na
na
na
na
na
na
na
25.5 '
22.3
26. 5
19,2
28.6
20.9
20.1
21.2
18.0
25.1
20.8
23.3
24.9
13.9
19.0
22.4
22.2
21,1
21.0
20.7
7.7
22.7
22.6
26.1
20.6
24.8
24.4
17.2
21.5
22.2
18.8
19.1
21.7
19.3
na
na
. na
na
na
na
na
na
na
na
26.2
23.2
27.9
21.4
27.5
22.0
20.4
21.3
20.5
25.5
24.5
23.3
25 .8
23.3
20.5
21.0
22.7
21.5
22.7
21.4
17.8
24.8
17.1
21.3
17.4
18.0
22.8
21.4
22.6
 23.0
23.6
22.7
15.8
21.9
na
na
na
na
na
na
na
na
na
na
17.1
20.0
21.8
19.7
25.5
20.8
17.3
17.8
14.2
20.3
21.8
21.3
22.7
22.5
20.1
20.0
20.0
19.9
19.7
20.7
                            D-43
i'38

-------
       SUBCHRQMIC TOXICITY OF  PARA-CRESOL  IN SPRAGUE DAWLEY RATS
                  HALE FOOD CONSUMPTION DATA 
-------
                                                                       Study No. 5221.08
        SUBCHRONIC TOXICITY OF PARA-CRISQL IN SPRAGUE  BAWLEY  IATS
                    FEMALE FOOD CONSUMPTION DATA Cg)
                            {Feeder Uelghts]
                ANIMAL HO.  new  1   old  1   new  2   old  2   new 3  old  3
 DOSE LEVEL
- 0 tug/kg/day
50 mg/kg/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3300
3301
3802
3803
3804
3305
3306
3807
3808
3809
3B10
3811
3812
3813
3814
3815
3816
3817
3S1S
3819
3820
3821
3822
3823
3824
3825
3826
3827
3828
3829
3130
3831
3832
3833
3834
3835
3836
401,6
394.3
401.3
398.6
413.9
413.7
397.0
393.3
402.8
444.8
419.4
412.0
405.5
40S.7
401.1
404.8
400.2
405.6
403.9
396.9
410.2
399.7
416.6
417.1
437.2
417.7
421.0
421.6
418.1
408.6
396.6
400.0
403.6
408.9
408.3
412.7
410.5
410. t
412.4
410.1
410.3
411.5
412.0
410.3
419.2
411.7
266.4
263.5
290.5
261.9
277.3
282.3
279.0
269.5
283.7
273.1
286.3
277.5
259.1
273.0
275.6
278.7
271.2
265.3
265.6
280.5
279.0
251.4
290.7
282.7
290.7
294.5
272.7
300.3
302.9
286.5
274.0
279.6
290.5
288.8
289.1
309.9
274.6
278.7
306.1
297.5
281.2
282.7
269.9
289.1
285.6
287.7
500.0
483.6
479.1
471.2
459.8
463.2
458.9
456.6
463.8
477.1
457.4
461.5
457.4
474.2
473.8
461.9
460.7
461.9
467.0
463.8
479.8
472.9
470.0
477.1
470.5
469.4
471.0
463.0
469.3
468.8
467.9
454.5
455.4
453.0
458.7
456.2
456.4
459.9
471.1
466.1
470.2
456.2
464.6
460.5
463.0
467.1
350.7
349.8
347.4
332.7
326.1
325.6
340.4
326.5
346.2
309.0
321.3
320.2
314.4
333.1
343.7
339.9
345.0
329.1
321.6
346.7
350.8
312.9
350.0
340.3
328.5
344.8
33S.6
343.2
363.8
347.5
364.6
331.1
346.4
342.6
349.2
351.0
315.1
332.1
369.7
351.5
330.4
324.8
322.1
355.8
336.9
347.1
446.2
444.9
445.8
438.7
443.6
443.3
440.6
442.5
442.7
453.9
442.9
442.1
443.1
462.1
461.8
445.0
446.0
443.9
466.5
446.9
470.6
459.7
469.3
461.9
461.2
459.2
463.7
462.8
-463.5
464.5
440.7
460.1
459.9
462.4
454.8
460.2
461.4
457.4
459.6
461.2
448.7
462.3
465.6
470.5
467.0
463.8
299.0
320.3
329.2
307.2
319.3
314.1
340.8
317.5
334.8
256.0
320.2
299.9
315.4
324.0
347.3
321.0
339.3
328.2
383.6
342.0
344.0
316.8
349.6
336.1
320.5
332.4
309.1
359.9
364.9
349.3
269.2
343.9
345.0
355.5
345.0
355.9
339.2
331.3
361.2
354.1
316.6
328.5
322.8
364.2
354.2
347.0
                                  D-45                                             140

-------
                                                                   Study No. 5221.08
       SUSCHRONIC TOXIC1TY  OF PARA-CRESOL IN  SPRAGUE OAULEY  RATS
                  FEMALE FOOD CONSUMPTION DATA  
                          [Feeder Weights]
              ANIMAL NO.  new  1  old  1   new  2  old  2  new  3  old  3
DOSE LEVEL
50 mg/kg/day 3837
{continued) 3838
3839
3840
3841
3842
3843
3344
3845
3846
3847
3843
3849
3850
175 mg/kg/day 3851
3852
3853
3854
3855
3856
38S7
3858
3859
3360
3861
3862
3863
3864
3865
3866
3867
3868
3869
3370
3871
3S72
3873
3874
3875
3876
3877
3878
3879
3880
413.
396.
395.
415.
418.
406.
392.
409.
409.
414.
407.
411.
411.
404.
400.
397.
398.
411.
409.
399.
392.
397.
410.
410.
402.
394.
387.
400.
39S.
373.
8
0
1
3
2
0
7
3
7
9
9
5
5
3
0
9
3
3
0
0
4
5
6
7
4
3
1
3
7
6
330.5
412.
417.
409.
417.
391.
412.
413.
383.
399.
381.
386.
385.
387.
3
2
1
1
4
3
0
2
1
0
3
3
4
292.
26S.
298.
301.
298.
281.
249.
292.
282.
286.
2S7.
294.
238.
251.
272.
264.
244.
274.
280.
260.
260.
271.
280.
272.
292.
280.
256.
267.
263.
249.
264.
270.
296.
267.
266.
251.
282.
281.
229.
267.
267.
248.
278.
254.
4
3
4
5
2
7
5
4
3
4
5
1
1
2
5
0
7
1
5
2
6
5
9
8
5
0
8
a
8
4
8
7
2
9
7
5
6
9
6
5
7
0
0
6
471
461
443
452
453
460
460
454
460
457
465
465
460
475
451
448
446
461
444
450
446
. 447
442
465
444
450
448
448
440
446
447
452
462
X53
454
459
4S3
450
468
450
446
448
454
459
.1
.0
.4
.9
.8
.5
.7
.3
.8
.1
.5
.2
.9
.4
.3
.1
.8
.4
.6
.3
.8
.6
.6
.0
.7
.8
.4
.2
.6
.7
.1
.0
.0
.6
.1
.7
,7
.0
.6
.9
.3
.6
.3
.2
355
328
351
340
331
332
314
347
333
324
348
344
336
351
334
330
319
334
320
319
318
328
322
313
325
342
315
317
316
323
341
301
340
318
317
317
334
316
.9
.9
.4
.1
.3
.8
.3
.4
.4
.1
.9
.9
.2
.3
.6
.1
.5
.4
.8
.8
.2
.6
.6
.1
.0
.2
,4
.6
.0
.1
.9
.4
.2
.2
.6
.5
.3
.4
319.0
316
336
306
341
331
.9
.2
.7
.1
.9
464.
445.
455.
460.
465.
460.
447.
463.
464.
464.
462.
465.
470.
466.
448.
446.
452.
464.
446.
449.
447.
448.
469.
461.
456.
445.
450.
450.
3
2
6
1
1
3
2
1
0
8
8
7
4
9
4
3
1
3
1
6
7
1
4
2
3
6
1
5
449.7
447.
446.
467.
462.
468.
467.
2
7
4
3
3
9
-447.4
467.
462.
455.
446.
448.
447.
468.
449.
2
2
5
4
3
5
7
8
347.3
305.2
326.6
347.9
340.3
339.7
212.0
358.0
340.5
333.9
336.3
348.3
350.7
352.1
326.7
324.0
322.0
330.1
341.6
316.4
316.9
339.8
343.1
326.7
350.0
336.0
311.7
321.8
332.0
320.0
340.0
325.5
347.7
336.9
332.1
304.8
329.6
329.1
315.5
318.1
338.1
319.2
362.7
326.6
                              D-46
41

-------
                                                                        Sturfy  Mo. 5221.08
        SUICHRONIC TOXICITY OF PARA-CRESQL IK SPRAGUI DAULEY RATS
                    FEMALE FOOD CONSUMPTION DATA (3)
                            [Feeder Heights]
                ANIMAL NO,  new  1  old  1  new  2  old  2  new  3   old  3
 DOSE LEVEL

600 rng/kg/day
38B1
3682
3883
1884
3885
3886
3887
3888
3889
3890
3891
3892
3893
3894
3895
3896
3897
3898
3899
3900
3901
3902
3903
3904
 3905
3906
3907
3908
3909
3910
392.6
364.9
392.2
389.7
409.1
384.5
379.2
374.6
380.8
388.9
392.6
381.4
400.9
402.3
379.5
374.9
376.5
376.1
419.2
370.6
388.7
419.1
405.6
376.1
378.4
410.5
404.0
415.2
413.7
408.8
287.6
258.8
na
237.8
299.5
260.3
271.2
264.8
270.4
275.1
285.6
277.7
293.0
292.2
272.7
260.1
259.6
253.8
na
289.4
297.5
313.9
288. S
241.3
272.9
314,1
293.2
275.2,
303.3
na
455.2
453.4
na
452.3
454.9
467.9
457.4
452.5
462.3
459.4
452.6
445.7
494.5
452.6
462.7
457.2
453.0
477.9
na
460.6
463.2
466.8
498,1
412.1
455.4
469.5
467.7
467.2
468.1
na
345.2
340.4
na
320.6
324.0
341.1
349.5
334.9
341.3
336.2
335.1
360.2
376.1
336.5
328.8
322.6
335.7
332.4
na ,
336.1
364.7
351.7
373.9
321.6
347.0
367.6
342.5
333.1
350.0
na
442.4
443.1
na
442.9
442.4
441.1
443.2
444.9
442.9
447.0
444.9
449.3
456.3
460.6
443.0
444.2
446.1
447.0
na
444.6
448.5
464.5
460.0
442.7
445.1
482.1
462.1
452.5
457.fi
na
336.2
237.5
na
304.4
305.8
311.1
341.3
321.3
310.2
327.1
339.2
361.8
332.2
341.3
319.3
306.9
334.4
315.9
na
318.2
334.6
354.0
337.7
312.7
321.7
313.8
345.1
320.8
335.7
na
                                D-47
                                                                                         4  *>
                                                                                         i  f^l

-------
                                                                        Study No. 5221.08
        SUSCHRQNIC TOXICITT OF PARA-CRES.OL IN SPRAGUE DAULEY SATS
                    FEMALE FOOD CONSUMPTIOM DATA 
                            [Feeder UeightsI
                ANIMAL Ma.  new  4  old  4  >new  5  old  5  new  6  old  6
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3791 
3792
3793
3794
3795
3796
3797
3798
3799
3800
3BQ1
3802
3803
3804
3805
3806
33Q7
3808
3809
3810
3311
3812
3813
3314'
3815
3816
3817
3818
3819
3820
3321
3822
3823
3324
3825
3826
3827
3828
3829
3830
3831
3832
3833
3834
3835
3836


471.7
470.1
470. S
470.5
472.4
469.9
474.1
469.7
471.3
477.5
469.6
469.2
471.6
473.6
470.2
468.4
467.7
470.6
465.5
470.3
472.6
470.5
474.3
475.7
470.7
471.4
473.7
472.3
477.3
471.0
474.6
472.5
472.7
471.9
472.3
473.5
474.2
474.0
471.9
472.6
464.0
472.8
471.8
474.2
474.8
473.8


338.0
351.1
354.7
338.9
354.6
346.5
382.4
353.6
367.1
319.5
350-5
335.0
337.4
344.5
352.8
351.9
363.1
348. 7
330.4
364.2
355.5
338.8
353.7
350.9
340.8
351.1
339.6
367.5
388.4
353.2
365.9
355.1
370.4
368.4
367.6
376.0
357.5
343.8
373.7
366.3
337.9
348.0
344.9
368.7
354.4
357.0
D-48

476.2
476.9
478.3
476.7
474.1
477.0
474.6
480.9
479.4
475.9
479.9
478.7
470.7
473.0
476.3
477.4
478.7
476.1
470.6
481.2
486.4
478.3
472.8
482.5
478.8
473.9
472.1
475.3
481.3
470.5
467.9
467.8
461.9
462.5
464.8
466.4
465.0
465.8
469.9
468.1
466.6
469.0
463.6
483.6
482.5
479.6


345.3
348.3
356.2
347.3
341.4
351.9
373.3
366.8
379.4
275.5
354.7
347.8
345.7
332.3
364.2
363.5
371.3
355.1
331.5
369.3
367.6
338.1
353.7
360.4
342.8
345.9
333.6
367.0
388.0
355.6
300.7
357.1
366.2
354.9
355.0
363.6
336.5
342.9
363.4
356.6
338.6
344.4
327.5
373.4
345.7
359.1


465.1
468.3
469.7
468.1
-467.7
468.9
467.4
467.7
469.7
468.5
468.9
470.0
469.7
467.6
467.4
470.2
468.5
466.8
468. 6
469.8
465.4
467.7
469,5
468.1
469.7
465.5
468.3
469.0
468.4
465.9
464.0
466. B
469.4
469.3
469.2
466.3
466.4
468.2
464.7
469.7
468.7
467.7
468.2
466. S
468.2
469.4

-
336.7
343.7
356.5
345.4
347.0
345.7
373.0
350.8
349.5
283.1
345.9
324.8
281.0
332.9
349.3
337.4
370.5
344.9
322.2
352.5
338.7
320.0
345.7
340.7
332.8
328.5
324.7
361.6
368.2
347.1
341.6
352.8
360.6
367.9
354.2
356.4
339.7
338.3
357.3
359.1
336.8
340.9
333.8
365.3
343.6
352.5
A A 9>
* 4 o

-------
                                                                Study Ho. 5221.OS
      SU8CHRONIC TOXICITY OF PAftA-CRESOL IN SPRAGUE DAWLEY RATS
                 FEMALE FOOD CONSUMPTION DATA  (g)
                         [Feeder Weights]
              ANIMAL NO.  new  4  old  4  new 5  old  5  new  6  old  6
DOSE  LEVEL
SO mg/kg/day 3837
(continued) 3328
3839
3340
3841
3342
3843
3344
3845
3846
3847
3845
3849
3550
175 mg/kg/day 3S51
3852
3853
3854
3855
3856
3857
3858
3859
3860
3861
3362
3863
3864
3865
3866
3867
3868
3869
3870
3871
3872
3873
3874
3875
3876
3877
3878
3879
3880
471
471
471
475
469
471
473
474
470
471
474
472
470
474
473
463
468
477
469
468
470
470
470
469
469
470
471
470
472
472
467
472
490
491
462
470
472
473
469
463
469
476
473
470
.1
.8
.4
.9
.5
.8
.3
.6
.3
.6
.0
.1
.8
.3
.0
.8
.8
.6
.2
.6
.1
.7
.8
.4
.9
.0
.2
.2
.0
.5
.3
.0
.7
.4
.9
.3
.9
.7
.0
.6
.5
.8
.9
.6
359.
347.
383.
369.
348.
360.
324.
379.
359.
344.
360.
354.
349.
360.
358.
345.
346.
361.
362.
350.
345.
367.
357.
348.
366.
367.
348.
356.
360.
360.
365.
343.
385.
378.
328.
308.
361.
355.
. 348.
349,
4
4
3
7
1
4
9
0
2
7
5
0
2
4
2
2
0
0
8
2
8
0
7
4
8
7
9
7
3
2
2
5
5
6
8
4
7
8
6
1
366.9
364.
375.
361.
1
0
0
483
477
479
482
481
479
475
484
486
479
483
472
482
479
470
471
464
472
461
466
472
465
470
464
467
471
473
463
465
467
.3
.0
.1
.5
.9
.9
.6
.6
.0
.2
.0
.1
.0
.6
.0
.9
.4
.4
.3
.3
.3
.1
.6
.8
.8
.7
.2
.5
.6
.9
463.3
466
469
464
465
465
472
466
465
473
474
476
466
471
.5
.6
.6
.8
.1
.1
.5
.3
.6
.4
.4
.0
.5
369.
349.
387.
372.
366.
362.
329.
3E4.
370.
347.
352.
354.
363.
399.
344.
316.
335.
360.
352.
332.
337.
354.
352.
326.
362.
356.
343.
317.
351.
343.
359.
325.
358.
340.
321.
325.
343.
331.
334.
362.
364.
357.
364.
354.
5
4
4
8
6
4
7
8
0
6
3
2
0
3
9
1
6
1
9
0
4
4
3
0
4
1
4
1
5
7
6
3
8
1
0
7
4
6
1
6
5
7
3
6
468.
468.
467.
467.
464.
467.
465.
468.
463.
468.
469.
465.
-468.
469.
463.
469.
466.
467.
466.
466.
466.
467.
466.
466.
464.
465.
464.
464.
470.
465.
466.
470.
468.
470.
469.
467.
467.
461.
467.
467.
466.
467.
469.
468.
4
8
1
8
3
3
9
4
8
6
6
9
4
5
3
9
2
7
7
4
6
6
1
4
1
4
6
3
3
9
5
0
2
1
0
6
9
6
3
9
2
7
4
1
356.3
339.5
379.4
356.2
343.2
354.4
284.0
374.1
3S7.1
341.7
361.5
329.0
349.9
353.3
339.4
297.9
332.6
348.7
353.3
336.9
344.6
351.5
347.7
327.2
357.3
353.6
341.9
336.5
352.2
341.4
362.9
330.3
355.1
333.5
321.1
327.9
349.0
334.9
339.3
340.0
357.0
349.0
369.9
353.0
                             D-49
                                                                 144

-------
                                                                       Study No. 5321.08
        SUSCHRONIC TOXICITY OF  PARA-CftESOl  IH  SPRAGUi DAytEf RATS
                    FEMAlf FOCO CONSUMPTION DATA  
-------
                                                                       Study Ho.  5221.08
        SUBCHRONIC TOXICITY  Of  PARA-CRESQL IH SPRAGUE DAWLEY RATS
                    FEMALE FOOD CONSUMPTION DATA (g)
                            [Feeder Weights]
                ANIMAL  NO.   new  7  old  7  new  8  old  8  new  9  old  9
 DOSS LEVEL
 0 mg/kg/day
50 mg/kg/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3800
3801
3802
3803
3804
3805
3806
3807
3803
3809
3810
3811
3312
3813
3314
3815
3816
3817
3818
3319
3S20
3821
3822
3823
3824
3825
3826
3827
3828
3829
3830
3831
3832
3833
3834
3835
3836
463.7
468.2
470. 0
465.7
460.6
464.3
467.7
468.0
468.4
471.3
471.0
462.5
469.6
465.1
471.4
466.4
471.6
469.9
464.8
468.3
468.2
468.3
470.3
468.6
476.1
466.1
471.0
462.9
469.5
469.0
467.2
463.2
463.2
466.6
468. 8
460.6
461.2
462.0
466.4
461.6
463.3
464.4
462.6
469.5
469.5
473.4
386.0
387.5
397.7
388.7
370.0
376.5
406.3
403.0
401.2
372.7
355.4
329.8
312.2
319.5
350.1
351.3
170.9
348.2
336.0
350.9
347.6
319.6
344.1
345.9
352.3
339.0
331.5
347.8
367.4
351.3
374.1
390.9
384.3
379.1
389.7
393.7
386,0
403.4
381.7
385.6
330-.3
336.5
348.3
323.3
339.8
364.2
1SAC
I SAC
I SAC
I SAC
ISAC
I SAC
ISAC
ISAC
ISAC
ISAC
451.6
454.6
452.1
457.2
456.5
454.0
455.0
456.8
455,8
494.5
487.5
540.5
540.5
479.9
444.5
433.2
476.7
450.9
481.0
468.7
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
435.6
460.3
523.6
466.8
429.1
447.2
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
331.3
313.8
338.2
342.2
362.4
340.2
358.4
328.3
341.3
337.1
381.3
330.9
429.9
358.9
320.7
306.2
342.9
345.7
384.1
343.9
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
314.0
335.8
491.9
358.1
317.9
338.3
na
na
na
na
na
na
na
na
na
na
449.1
450.1
452.6
456.8
456.7
450.1
451.9
454.9
455.8
454.0
453.6
452.3
453.8
_454.7
450.7
451.8
451.7
456.4
462.S
452.6
na
na
na
na
na
na
na
na
na
na
448.7
453.8
452.8
458.4
456.1
458.2
na
na
na
na
na
na
na
na
na
na
325.2
312.8
330.0
332.6
351.2
327.1
359.4
335.0
318.9
347.0
336.5
292.7
348.3
333.8
328.3
324.9
310.2
363.7
364.1
352.3
na
na
na
na
na
na
na
na
na
na
320.5
332.1
329.4
349.8
332.2
347.7
                                D-51

-------
       SUICH8QNIC TOXICITY OF PARA-CRESOl IN SPRAGUI DAULEY RATS
                 FEHALE FOOD CONSUMPTION DATA (3)
                         [Feeder Weights}
                                                                 Study No.  5221.03
              ANIMAL NO.   new  7  old  7  new  8  old  2  new  9  old  9
DOSS LEVEL
50 mg/kg/day 3837
(continued) 3838
3839
3840
3841
3842
3343
3844
3845
3846
3847
3848
3849
3850
175 mg/kg/day 3851
3852
3853
3854
385S
3856
3857
3858
3859
3860
3861
3862
3863
3864
3865
3866
3867
3868
3869
3870
3871
3872
3873
3874
3875
3876
3877
3878
3379
3880
466,0
464.0
463.9
463.4
464,3
466.8
466.9
467.1
463.4
464.7
464.1
467.4
461.5
466.4
468.5
463.3
460.1
464.7
466.9
460. 6
459.2
463.6
453.1
453.3
443.2
471.7
480.0
475.1
473.7
485.5
483.4
464.4'
471.8
460.4
475.6
453.9
466.9
496.3
460.9
453.5
473.6
473.1
508.5
489.1
351.9
325,4
371.8
336.5
341.8
345.6
334.6
367.9
343. B
336.5
328.7
294.1
337.1
348.1
389.3
371.4
387.3
404.9
390.8
383.5
386.7
404.6
374.2
369.0
334.4
363.1
355.3,
348.5
364.2
361.2
372.7
332.0
360.3
341.9
343.7
310.6
350.1
380.0
324.4
337.3
377.4
358.9
412.4
38D.9
423.7
445.2
441.7
485.7
437.4
423.5
413.1
444.1
426.1
479.2
447.?
411.2
455.2
441.3
1SAC
I SAC
I SAC
ISA:
1SAC
I SAC
IS AC
1SAC
I SAC
ISAC
383.2
425.9
436.1
431.2
437.8
429.8
450.2
438.0
451.0
461.1
442.1
415.9
467.1
473.5
458.3
464.4
476.6
463.3
462.9
475.9
309.7
324.3
349.9
374.4
314.8
310.8
221.0
346.0
313.1
348.3
322.0
291.1
329.9
319.0
I SAC
':SAC
iSAC
1SAC
ISAC
ISAC
ISAC
ISAC
ISAC
ISAC
290.7
316.4
320.0
310.6
332.1
342.2
351.1
306.9
332.5
331.7
320.4
316.2
328.9
3S4.3
326.7
347.4
371.0
345.0
364.1
356.4
453.1
455.5
456.9
450.5
457.2
457.2
456.1
461.1
456.8
454.9'
453.1
453.8
465.4
459. S
na
na
na
na
na
na
na
na
na
na
457.2
452.4
453.5
451.4
452.6
455.6
_451.6
459.0
452.4
459.3
456.3
454.2
453. S
453.2
457.7
452.8
452.8
455.2
456.0
454.2
333.9
329.1
370.3
347.4
341.0
347.6
261.5
366.1
346.8
333.3
332.9
343.3
339.4
347.4
na
na
na
na
na
na
na
na
na
na
360.0
330.3
339.7
347.2
353.7
341.6
353.8
332.3
337.7
347.7
331.7
315.2
345.0
332.0
318.5
341.2
350.8
260.6
362.3
348.8
                             D-52
                                                                   147

-------
                                                                       Study No. 5221.08
                  SUBCHRONJC TQX1C1TY Of  PARA-C3ESQL  IN SPRAGUE OAULEY RATS
                             FINALE FOOD CONSUMPTION DATA (g)
                                     [Feeder Weights]
               ANIMAL NO.  new  10  old 10  new  11  old  11 .new  -12  old  12  new 13  old  13
 DOSE LEVEL
 0 ing/ kg/day
50 mg/kg/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3800
3801
3802
3303
3804
3S05
3806
3807
3808
3809
3S10
3811
3812
3813
3314
3815
3816
3817
3818
3819
3820
3821
3822
3823
3S24
3B25
3826
3327
3828
3829
3830
3831
3332
3833
3834
383S
3836
na
na
na
na
na
na
na
na
na
na
448. a
448,7
450.3
453.5
453.5
449.5
448.7
447.8
458.4
462.0
450.5
450.5
450.0
450.0
447.5
451.9
449.6
465.1
457.0
459.9
na
na
na
na
na
na
na
na
na
na
443.7
452.5
449.9
449.1
446. a
449.0
na
na
na
na
na
na
na
na
na
na
324.2
293.4
325.7
332.7
340. S
327.1
353.9
326.4
308.5
343.0
324.0
309.6
336.2
333.5
326.0
322.1
316.0
350.1
357.4
342.0
na
na
na
na
na
na
na
na
na
na
318.7
327.8
310. D
340.8
305.5
333.1
na
na
na
na
na
na
na
na
na
na
499.5
495.1
491.3
468.9
477.4
491.3
472.7
471.9
500.4
495.0
469.5
482.3
487.1
486.8
488.3
485.8
478.8
452. B
498,7
482.5
na
na
na
na
na
na
na
na
na
na
460,5
476.1
486.3
484.7
475.6
465.5
na
na
na
na
na
r,a
na
na
na
na
383.3
343.6
368.3
388.8
365.7
368,1
387.0
354.0
367.5
351.0
356.0
345.5
375.3
372.4
369.0
381.1
343.4
357.5
405.2
371.6
na
na
na
na
na
na
na
na
na
na
349.1
360.6
359.4
379.4
346.1
355.4
na
na
na
na
na
na
na
na
na
na
523.3
514.7
509.1
507.5
488.2
473.2
482.0
489.2
439.5
516.1
500.4
462.4
503.4
466.8
498.5
477.8
441.3
467.1
513,0
523.3
na
na
na
na
na
na
na
na
na
na
459 ."2
570.9
550.1
497.6
492.6
470.0
na
na
na
na
na
na
na
na
na
na
406.0
344.0
377.8
367.2
373.7
346.1
393.4
374.5
359.1
345. S
384.?
334.5
381 .a
351.0
380.5
367.7
307.7
364.0
423.8
406.5
na
na
na
na
na
na
na
na
na
na
335.4
448.1
423.7
377.5
367.7
362.6
na
na
na
na
na
na
na
na
na
na
470.1
471.3
471.3
478.6
472.8
470.2
473.7
474.4
472.2
471 . 1
470.2
470.5
468.1
473.0
477.0
470.0
472.4
477.0
469.5
469.7
na
na
na
na
na
na
na
na
na
na
470.1
470.8
471.7
470.7
466.8
473.3
na
na
na
na
na
na
na
na
na
na
370.9
342.5
328.9
358.4
380.0
362.4
334.3
352. a
360.4
381.2
362.8
338.9
359.0
356.9
355.9
357.5
333. S
378.5
374.6
367.3
na
na
na
na
na
na
na
na
na
na
363.9
374.7
363.4
358.4
356.7
373.8
                                       D-54
148

-------

-------
                                                                     Study No. 5221,08
                 SUBCHROHIC TOXICltr OF PARA-CRESOL IN SPRAGUE DAULEY RATS
                            FEMALE FOOD CONSUMPTION DATA 
                                   [Feeder Weights]
              ANIMAL NO.  new 10  old  10  new  11  old  11  new  12  old 12  new 13  old 13
DOSE  LEVEL
50 mg/kg/day 3837
(continued) 3838
3839
3840
3841
3S42
3843
3844
3845
3346
3847
3848
3849
3850
175 mg/kg/day 3851
3852
3853
3854
3855
3856
3857
3858
3359
3860
3861
3862
3S63
3864
3865
3866
3867
3868
3869
3870
3871
3872
3873
3874
3875
3876
3877
3878
3879
3880
449.0
447.7
444.7
443.6
449.2
441.0
458.3
454.9
451.6
453.5
455.2
454.3
452.9
457.8
na
na
na
na
na
na
na
na
na
na
443.6
449.8
449.9
445.6
446.7
445.6
448.3
451.4
438.5
447.3
447.4
449.0
448,6
453.8
445.4
447.3
444.7
454.5
456.2
455.2
333.5
310.4
348.4
321.9
334.5
317.5
302.2
358.5
338.0
318.7
327.8
335.2
323.4
346.9
na
na
na
na
na
na
na
na
na
na
329.3
319.5
332.2
319.5
326.0
311.1
343.3
316.7
329.0
310.1
318.6
284.9
325.1
317.0
303.6
340.7
330.4
35Q.7
360.4
340.7
467.5
461.0
467.6
476. D
473.0
473.8
463.7
476.3
467.4
472.6
463.7
477.6
475.0
467.4
na
na
na
na
na
na
na
na
na
na
467.6
460.3
467.4
465.2
468.9
467.6
475.6
466.9
471.4
470.0
472.0
467.1
477.6
473.0
473.9
453.8
475.5
468.3
470.6
467.5
352.8
343.2
365.1
353.8
368.8
372.8
340.5
377.5
365.7
342.2
345.6
361.6
352.0
356.0
na
na
na
na
na
na
na
na
na
na
363.7
335.7
354.3
349,0
362.8
344.5
337.9
336.3
363.6
359,3
342.1
340.3
368.7
353.3
330.3
346.7
375.5
366.3
381.7
362.0
472.2
470.0
466.3
545.0
497.2
487.6
467.6
463.0
453.1
459.8
490.1
515.7
476. Q
432.6
na
na
na
na
na
na
na
na
na
na
457.6
469.4
457.0
450.0
458.~9
463.6
479.5
461.1
470.5
460.9
441.0
449.7
460.2
455.5
446.4
. 461.9
462.6
467.2
486,7
462.7
358.9
343.7
385.1
426.6
374.9
386.6
340.0
379.4
350.1
328.2
370.4
399.1
356.0
368.4
na
na
na
na
na
na
na
na
na
na
350.6
342.4
338.0
326.4
354. 5
331.0
388.9
331.0
342.8
327.8
313.9
319.3
344.9
338.0
312.6
345.4
356.1
358.2
393.5
356.2
472.7
467.3
469.9
470.9
465.9
469.4
475.7
474.6
477.1
475.2
464.2
496.2
466.9
465.7
na
na
na
na
na
na
na
na
na
na
472.1
479.6
476.4
475.3
474.3
480.0
466.4
474.3
466.5
464,3
469.8
470.9
473.0
469.4
466.9
471.0
468.3
462.9
471.9
468.1
377.7
359.9
400.1
369.7
361.3
369.4
353.0
392.9
386.0
362.0
349.7
395.5
357,5
370.3
na
na
na
na
na
na
na
na
na
na
375.4
361.9
373.0
365.8
411.5
363.7
380.6
324,0
366.0
361.6
360.9
359.6
342.0
370.9
340.2
365.4
371.5
377.1
389.8
376.9
                                    D-55
149

-------
                                                                           Study Ho. 5221.03
                   SUSCHRONIC TQXICITY  OF  PARA-CRESOL  IN SPRAGUE DAULEY RATS
                               FEMALE FOOD CONSUMPTION DATA (g)
                                       [Feeder Weights]
                ANIMAL NO.   new  10   old   10  new  11  old  11  new  12  old  12  new 13  old 13
 DOSE LEVEL
600 mg/kg/day
3581
3882
3883
3334
3865
3636
3387
3883
3889
3390
339 1
3892
3893
3894
3895
3896
3897
3893
3899
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
3910
na
na
na
na
na
na
na
na
na
na
441.1
444.5
442.4
443.5
450.8
450.3
445.0
445.6
na
443.9
448.0
456.8
455.9
453.3
~ 450.2
452.4
453.1
460.4
449.4
na
na
na
na
na
na
na
na
na
na
na
327.4
354.4
327.9
332.6
335.4
339.3
332.6
332.4
na
340.7
329.1
346.3
325. 5
315.3
333.6
357.4
336.3
327.8
332.0
na
na
na
na
na
na
na
na
na
na
na
4S1.6
481.7
465.1
476.3
482.0
462.4
467.8
469.1
na
465.0
462.3
477.1
461.6
474.4
472.4
477.3
468.2
486.3
470.3
na
na
na
na
na
na
na
na
na
na
na
372.6
398.0
348.4
372.3
373.6
360.9
352.0
361.7
na
365.9
349.5
366.5
345.6
343.3
374.1
393.7
345.3
353.1
349.0
na
na
na
na
na
na
na
na
na
na
na
470.9
435.9
455.8
449.2
475.1
469.2
454.9
452.8
na
482.4
455.8
469.0
450.2
453.7
482.2
496.4
468.7
476.2 .
471.1
na
na
na
na
na
ra
na
na
na
na
na
365.5
395.9
338.9
343.7
376. a
360.2
346.4
346.9
na
376.6
341.6
358.9
336.9
330.5
361.3
401.9
348. 9
364.3
356.5
na
na
na
na
na
na
na
na
na
na
na
473.2
468.2
470.5
471.4
469.8
486.8
464.6
469.3
na
473.1
476.3
470.2
470.7
467.6
460.4
466.4
489.4
476.1
460.2
na
 i
na
na
na
na
na
na
na
na
na
na
362.5
390.1
353.0
375.9
382.6
405.2
361.4
363.7
na
363.4
379.9
372.5
357.7
345.0
363.8
385.3
382.5
362.0
348.9
na
                                          D-56

-------
                                                                  Study No. 5221.03
        SU8CHRONIC TOXICITY OF  PARA-CRESQL IN SPRAGUE OAWLET RATS
                 FEMALE FOOD  CONSUMPTION DATA (g/day)
               ANIMAL NO.  weekl  ueek2  week3  week4  weekS  Heek6  week?
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3800
3801
3802
3803
3804
3805
3806
3807
3808
3809
3810
3811
3812
3313
3814
381 S
3816
3817
3818
3819
3820
3821
3822
3823
3824
3825
3826
3827
3828
3829
3830
3831
3832
3833
3834
3835
3836
19.3
18.7
15.3
19.5
19.5
18.8
16.9
17.8
17.0
24.5
19.0
19.2
20.9
19.0
17.9
18.0
18.4
20.0
19.3
16.6
18.7
21.2
18.0
19.2
20.9
17.6
21.2
17.3
16.5
17.4
17.5
17.2
16.2
17.2
17.0
14.7
19.4
18.8
15.1
16.1
18.4
IS. 4
20.3
17.3
19.1
17.7
21.3
19.1
18.8
19.8
19.1
19.7
16.9
18.6
16.8
24.0
19.4
20.2
20.4
20.2
18.6
17.4
16.5
19.0
20.8
16.7
18.4
22.9
17.1
19.5
20.3
17.8
19.3
16.4
15.1
17.3
14.8
17.6
15.6
15.8
15.6
15.0
20.2
18.3
14.5
16.4
20.0
18.8
20.4
15.0
18.0
17.1
21.0
17.8
16.7
18.8
17.8
18.5
14.3
17.9
15.4
28.3
17.5
20.3
18.2
19.7
16.4
17.7
15.2
16.5
11.8
15.0
18.1
20.4
17.1
18.0
20.1
18.1
22.1
14.7
14.1
16.5
24.5
16.6
16.4
15.3
15.7
14.9
17.5
18.0
14.1
15.3
18.9
19.1
20.4
15.2
16.1
16.7
19.1
17.0
16.6
18.8
16.8
17.6
13.1
16.6
14.9
22.6
17.0
19.2
19.2
18.4
16.8
16.6
14.9
17.4
19.3
15.2
16.7
18.8
17.2
17.8
18.6
17.1
19.2
15.0
12.7
16.8
15.5
16.8
14.6
14.8
15.0
13.9
16.7
18.6
14.0
15.2
18.0
17.8
13.1
15.1
17.2
16.7
18.7
18.4
17.4
18.5
18.0
17.9
14.5
16.3
14.3
28.6
17.9
18.7
17.9
20.1
16.0
16.3
15.3
17.3
19.9
16.0
17.0
20.0
17.0
17.4
19.4
18.3
19.1
15.5
13.4
16.4
23.9
15.8
13.7
15.4
15.7
14.0
18.4
17.6
15.2
15.9
18.3
17.8
19.4
15.7
19.5
17.2
18.3
17.8
16.2
17.5
17.2
17.6
13.5
16.7
17.2
26.5
17.6
20.7
27.0
19.2
16.9
19.0
14.0
17.4
20.9
16.8
15.1
21.1
17.7
18.2
19.6
19.6
20.5
15.3
14.3
17.0
17.5
16.3
15.5
14.5
16.4
15.7
18.1
18.6
15.3
15.8
18.8
18.1
19.2
14.5
17.3
16.7
11.1
11.5
10.3
11.0
12.9
12.5
8.8
9.3
9.6
14.1
16.5
19.0
22.5
20.8
17.3
16.4
14.4
17.4
18.4
16.8
17.2
21.2
18.0
17.5
17.7
18.2
19.9
16.4
14.6
16.8
13.3
10.6
11.3
12.5
11.3
9.6
10.7
8.4
12.1
10.9
19.0
18.3
16.3
20.9
18.5
15.6
                              D-57
                                                                          151

-------
                                                                   Study Na. 5221.08
       SU8CHRONIC TOXiCITY OF PARA-CSESCL  IN  SPRAGUE DAWLEY RATS
                 FEMALE fOOD CONSUMPTION DATA (fl/day)
               ANIMAL NO.  weekl   week2  ueek3   week4  weekS  neek6  week?
DOSE LEVEL
50 mg/kg/day 3837
(continued) 3838
3839
3340
3341
3842
3843
3844
3845
3346
3347
3348
3349
3850
175 (itg/kg/da/ 3851
38S2
3853
38S4
3855
3856
3857
3858
3859
3860
3861
3862
3863
3864
3865
3866
3867
3868
3869
3370
3871
3872
3873
3874
3875
3876
3877
3878
3879
3880
17
18
13
16
17
17
20
16
18
18
17
16
17
21
18
19
21
19
IS
19
18
18
18
19
15
16
18
18
18
.3
.2
.8
.3
.1
.8
.5
.8
.2
.4
.2
.8
.6
.9
.2
,1
.9
.6
.4
.8
.8
.0
.5
.7
.7
.4
.6
.9
.8
17.7
16
20
17
20
21
20
18
18
21
18
16
19
15
19
.5
.2
.3
.2
.5
.0
.5
.7
.9
.8
.2
.8
.3
.0
16
18
13
16
17
13
20
.5
.9
.9
,1
.5
.2
.8
15.3
13
19
16
17
17
17
16
16
18
18
17
18
18
17
17
21
17
15
19
18
17
17
15
21
17
19
19
20
17
19
21
19
16
20
16
18
.2
.0
.7
.2
.8
,7
J
.9
.2
.1
.7
.6
.4
.0
.1
.7
.1
.5
.0
.7
.8
.7
.0
.5
.4'
.3
.5
.3
.0
.1
.4
.1
,1
.3
.2
.2
16.6
20.0
18.4
16.0
17.8
17.3
33.6
15,0
17.6
18.7
18.1
16.7
17.1
16.4
17.4
17.5
18.6
19.2
14.9
19.0
18.7
15.5
18.0
19.2
15.2
15.7
19.8
18.4
16.8
18.2
15.2
20.3
16.4
18.8
19.4
20.4
19.7
19.0
20.0
18.3
15.8
18.3
15.1
17.6
16
17
12
15
17
15
21
13
15
18
16
16
17
16
16
.0
.8
.6
.2
.3
.9
.2
.7
.9
.1
.2
.9
.4
.3
.4
16.9
17
16
15
16
17
14
16
17
14
14
17
16
16
16
14
18
15
16
19
23
15
16
17
17
14
16
14
.5
.7
,2
.9
.8
.8
,2
.3
,7
.6
.5
.2
.0
.0
.6
.4
.0
.1
.2-
.1
.9
.3
.2
.1
.7
.1
.1
15.7
16.3
18.2
13.1
15.7
16.5
16.8
20.8
14.3
16.6
18.8
18.7
16.8
16.3
11.5
17.9
22.3
' 18.4
16.0
15.5.
19.2
19.3
15.8
16.9
20.1
15.1
16.5
18.5
20.9
16.3
17.7
15.5
20.2
15.8
17,8
20.7
19.9
18.4
19.3
18.7
15.9
15.7
17.0
14.5
16.7
16.
ia.
12.
15.
17.
16.
26.
13.
16.
18.
15.
19.
16.
15.
17.
24.
19.
17.
16.
18.
17.
16.
16,
19.
0
5
5
9
3
1
0
5
0
1
4
6
9
9
7
6
1
0
1
5
4
6
9
9
15.2
15.
17.
18.
16.
17.
14.
19.
16.
19.
21.
20.
17.
18.
18.
18.
15.
17.
14.
16.
3
5
3
9
3
8
9
2
5
1
0
0
1
3
3
6
0
2
4
16.3
19.8
13.2
18.1
17.6
17.3
18.9
14.2
17.1
18.3
19.3
24.8
17.8
16.9
11,3
13.1
10.4
8.5
10.9
11.0
10.4
8.4
11.3
12.0
15.5
15.5
17.8
18.1
15.6
17.8
15.8
18.9
15.9
16.9
18.8
20.5
16.7
16.6
19.5
16.6
14.5
16.3
13.7
15.5
                                                                                  -5  fj  (
                                D-SS

-------
                                                                    Study Ho. 5221.08
        SU8CHRQNIC TOXICITY OF PARA-CRESOL IN  SPRAGUE D'AWLEY  RATS
                  FEMALE FOOD CONSUMPTION DATA (g/day)
                ANIMAL NO.  weekl   week2  neek3   wetk4  ueekS  week6  week?
"DOSE LlVit
600 mg/kg/day
3881
3S82
3883
3884
3SS5
3886
3887
3888
3889
3890
3891
2892
3893
3894
3895
3896
3897
3898
3899
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
3910
15.0
15.2
na
18.8
15.7
17.7
15.4
15.7
15.8
16.3
15.3
14.8
15.4
15.7
15.3
16.4
16.7
17.5
na
11.6
13.0
15.0
16.7
18.3
15.1
13.8
15.8
20.0
15.8
na
15.7
16.1
na
18.8
18.7
18.1
15.4
16.8
17.3
17.6
16.8
12.2
16.9
16.6
19.1
19.2
16.8
20.8
na
17.8
14.3
16.4
17.7
18.6
15.5
14.6
17.9
19.2
16.9
na
15.2
29.4
na
19.8
19.5
18.6
14.6
17.7
19.0
17.1
15.1
12.5
17.7
17.0
17.7
19.6
16.0
18.7
na
18.1
16.3
15.8
17.5
18.6
17.6
14.0
16.7
18.8
17.4
na
14. S
17.7
na
19.6
18.0
16.3
13.2
16.7
16.7
IS. 3
16.6
12.5
15.8
15.3
17.7
17.4
16.0
17.9
na
16.6
16.0
14.2
17.2
18.1
14.6
12.2
14.7
16.7
15.9
na
12.7
12.5
na
21.0
17.6
16.3
14.5
15.7
18.0
16.3
16.0
13.3
17.6
16.5
19.0
18.0
17.8
18.3
na
16.3
16.8
16.1
17.5
18.9
15.3
13.5
17.7
19.1
16.5
na
14.4
18. 0
na
19.5
20.2
16.3
13.8
15.0
15.8
15.6
15.9
12.3
15.9
16.7
17.7
17.0
17.4
17.0
na
17.2
17. Q
15.4
16.2
18.1
15.7
14.2
17.3
17.9
16.8
na
8.4
10.8
na
11.3
7.1
13.1
11.9
8.7
9.7
14.0
14.4
14.1
32.2
15.6
16.6
16.8
18.3
17.2
na
16.9
16.4
14.6
17.1
21.4
15.4
13.2
18.5
19.7
17.3
na
                                 D-59
                                                                                     O

-------
       SUBCHRON1C TQXICm OF PARA-CRESOL IS  SPRAGUE OAULEY RATS
                FEMALE FOOD CONSUMPTION DATA 
-------
      SUSCHRDNIC TOX1CITY Of PARA-CR6SQL  IK SPSAGUE DAULE? RATS


                FEMALE FOOD CONSUMPTION DATA 
-------
       SUBCKRONIC TOXICITY OF PARA-CRESOL IN SPRACUE DAULEY RATS
                FEMALE FOOD CONSUMPTION DATA 
-------
                                                                    Study He. 5221.08
           SUBCHRONtC TOXieiTY OF PARA-CRESQL  IN  SPRAGUE DAWLET RATS

                            MALE HEMATOLQGY VALUES

                              [Interim Sacrifice]
 OOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
175 rng/kg/day
600 ng/kf/day
ANIMAL NO.

3661
3662
3663
' 3664
3665
3666
3667
3668
3669
3670
3691
3692
3693
3694
3695
3696
3697
3693
3699
3700
3721
3722 >
3723
3724
3725
3726
3727
3723
3729
3730
3751
3752
3753
3754
3755
3756
3757
3758
3759
3760
R3C
(x 10A6/mn"3)
8.22
8.21
8.60
8.00
8.20
8.18
8.10
8.05
8.28
7.96
7.63
7.74
8.26
7.94
7.88
7.93
8.93
7.71
8.28
7.95
8.17
8.88
8.86
7.65
8.09
7,75
7.89
8.29
8.37
7.95
8.15
7.80
8.38
8.07
8.51
8.11
7.91
8.78
8.31
8.48
HG3

14,7
15.8
15.4
15.4
15.2
15.1
14.9
15.5
15.3
15.3
14.5
14.6
15.6
14.2
14.2
14.5
15.7
15.0
15.4
14.7
15.1
15.4
15.8
14.7
15.4
14.4
15.3
15.2
14.6
14. S
14.9
15.1
16.0
15.0
15.6
14.8
15.0
15.3
14.5
15.3
HCT
<%)
42.0
45.9
42.1
44.6
43.3
43.2
42.7
43.7
44.6
43.7
41.4
41.6
44.5
40.1
40.5
42.2
47.0
42.0
44.6
41.1
43.0
43.7
44.1
41.6
43.9
40.9
43.2
42.5
41.9
41.5
43.3-
43.8
45.7
42.5
44.1
42.3
43.1
43.5
40.9
43.5
PT
(sec.)
11.1
14.3
7.2
12.4
12.2
13.0
11.7
11.5
14.9
11.9
10.3
13.3
11.9
8.3
11.5
12.7
15.3
11.2
11.5
11.3
11.5
11.5
13.0
11.8
11.3
12.3
14.6
6.6
10.9
11.6
12.8
9.0
11.8
12.1
13.7
15.3
15.2
12.8
11.0
12.1
APTT
(sec.)
36.1
40.1
45.3
34.8
41.6
31.2
35.8
36.0
38.0
38.6
39.2
33.1
37.3
34.8
38.1
36.4
41.8
9
29.0
43.3
31.4
33.5
48.2
39.0
32.4
46.3
40.4
46.3
34.8
37.0
37.3
32.2
37.7
31.0
35.3
37.2
33.6
58.7
36.5
35.7
RET 1C
<% rbc)
0.4
1.5
0.8
2.6
1.5
0.7
0.4 
0.3
0.7
1.2
0.6
2.2
0.5
0.4
0.5
2.4
1.8
1.1
1.1
1.3
2.3
1.2
0.7
0.6
1.0
1.3
0.5
2.4
0.5
0.9
0.4
0.6
0.7
2.5
1.1
0.3
1.1
2.4
1.4
1.9
                                 D-63
                                                                             j  r->
                                                                             1 5

-------
                                                                    Study No.  5221.03
              SU3CHROMIC  TOXICITY OF PARA-CRESOL IN SPRAGUE DAWLEY RATS
                              KALE HEMATOLOGY VALUES
                                 CInterim Sacrifice]
 DOSE LEVEL
 0 mg/kg/day
ANIMAL NO.       UBC         SEGS
            (x 10-3/iroT3)   (X USC)
                                                    BANDS    LYMPHS    MONO     EOS
                                                   
-------
                                                                                   Study No, 5221.08
                             SUBCHRCN1C TQXiCITY OF  PARA-CRESOL  IN SPRAGUe DAWLET RATS
                                              MALE HEHATQLCGT VALUES
                                                Clnttrim Sacrifice]
AHI HAL NO.
                                 UBC
 DOSE LEVEL
 0 msAa/day
            
-------
                                                               Study No. 5221.08
          SUBCHRONIC TOXIC1TY  OF PARA-CRESOL IH SPRAGUE DAULEY RATS
                          HALE HEMATOLOGY VALUES
                           [Terminal Sacrifice]
 DOSE LEVEL
 0 rag/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
ANIMAL NO.

3671
3672
3673
3674
3675
3676
3677
3678
3679
36BO
3701
3702
3703
3704
3705
3706
3707
3703
3709
3710
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
R8C
(x 10A6/mn'2
3.13
8.33
3.66
8.21
8.48
8.37
3.56
8.42
9.45
8.16
8.66
8.57
9.62
8.80
8.74
8.18
7.65
8.14
3.97
8.09
8.31
9.06
8.90
9.06
8.99
9.63
8.13
8.94
9.96
8.84
8.51
8.70
8.92
8.96
8.35
9.05
8.32
8.50
9.24
9.10
HG3
i) Cg/dl)
14.9
15.3
15.4
15.1
15.0
14.3
15.1
14.3
16.7
15.3
15.9
15.0
16.3
15.1
15.2
14.5
14.5
15.2
15.9
15.1
15.1
16.0
15.3
15.5
15.5
16.7
15.1
15.2
16.3
15.3
14.8
15.3
16.1
16.0
14.2
15.2
14.7
15.2
16.8
16.0
HCT
(X)
42.8
42.1
42.4
42.6
42.5
42.1
42.7
41.0
46.3
41.3
42.5
41.4
46.4
42.0
42.9 .
40.5
40.5
42.4
45.0
42.0
42.4
43.9
42.8
44.3
42.8
43.0
41.7
42.1
45.6
42.3
41.9
44.2
45.9
45.7
39.4
44.6
40.3
40.7
47.3
45.7
PT

-------
                                                                   Study No. 5221.08
              SU8CHROM1C TOXICITY OF PARA-CRESOL  IN SPRAGUE DAWLEY RATS

                              HALE HEMATQLOGY VALUES

                               [Terminal  Sacrifice]
 DOSE LEVEL
 0 rag/kg/day
ANIMAL MO.      WBC         SECS    BANDS    LYMPHS    MONO     EOS
            cx io~3/mf3>  (% wee)  ex wee)   c% ys   <% UBO  cs WBO
50 mg/kg/day
175 rag/kg/day
600 ing/kg/day
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3761
3762
3763
3764
376i
3766
3767
3768
3769
3770
12.3
12.2
10.5
12.9
12,3
8.2
12.2
10,6
15.9
13.7
8,9
12.3
10.7
7.8
8.2
9.9
15.3
9.9
8.5
13.7
14.2
24.8
9.2
12.1
13.0
12.1
12.0
9.5
9.1
17.4
11.7
10.0
13.7
12.5
10.4
 13.4
9.4
12.5
11.5
11.6
29
17
16
9
, 22
15
22
19
10
23
23
20
13
15
15
23
17
17
18
2T
22
16
19
21
27
18
13
16
12
17
26
26
22
22
19
18
22
10
28
20
1
0
0
0
0
2
0
0
0
1
0
2
2
0
0
1
0
0
0
0
3
0
1
0
1
1
0
1
1
1
1 .
0
0
0
0
0
0
0
0
0
64
79
82
88
69
81
77
74
89
74
74
75
SO
82
83
71
76
76
77
71
'73
82
79
76
65
78
87
82
86
81
72
69
78
77
77
77
78
89
71
76
3
4
2
3
5
1
1
S
0
1
3
1
2
2
1
5
7
5
5
4
2
0
0
3
7
2
0
0
0
1
1
4
0
0
4
5
0
1
1
3
3
0
0
0
4
1
0
2
1
1
0
2
3
1
1
0
0
2
0
4
0
2
1
0
0
1
0
1
1
0
0
1
0
1
0
0
0
0
0
1
                                 D-67
                                                                                        64
                                                                                        1

-------
                                                                              Study No. 5221.08
                           SUSCHRdNIC TDXJCITY Of PARA-CSESOl  IN SPRAGUE OAWIEY RATS
                                           MALE HEMATOIQGY VALUES
                                            [Terminal Sacrifice!
               AM I HAL MO.
                               UBC
                                             SEGS
 DOSE LEVEL
 0 ng/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
                          (x
(x
                  BANDS
                 10*3/nnr3)
                                                                        LYMPHS
                                                                                      MONO
                                                                                                    EOS
                                                                    (x
                                                                                                (x
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
12.3
12.2
10.5
12.9
12.3
3,2
12.2
10.6
15.9
13.7
8.9
12.3
10.7
7.8
8.2
9.9
15.3
9.9
8,5
13.7
14. E
24.8
9.2
12,1
13.0
12.1
12.0
9.5
9.1
17.4
11.7
10.0
13.7
12.5
10.4
13.4
9.4
12.5
11.5
11.6
3,6
2.1
1.7
1.2
2.7
1.2
2.7
2.0
1,6
3.2
2.0
2.5
1.4
1.2
1.2
2.3
2.6
1.7
1.5
2.9
3.1
4.0
1.7
2.5
3.5
2.2
1.6
1.5
1.1
3.0
3.0
2.6
3.0
2,8
2.0
2.4
2.1
1.3
3.2
2.3
0.1
O'.O
0.0
0.0
0.0
0.2
0.0
0.0
0.0
0.1
0.0
0,2
0.2
0,0
0.0
0.1
0.0
0.0
0.0
0.0
0.4
0,0
0.1
0.0
0.1
0.1
fl.Q
0.1
0.1
0,2
0.1
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
7.9
9.6
8.6
11.4
8.5
6.6
9.4
7.S
14.2
',0.1
6.6
9.2
8.6
6.4
6.3
7.0
11.6
7.5
6.5
9.7
10.4
20.3
7.3
9.2
8.5
9.4
10.4
7.8
7.8
14.1
a. 4
6.9
10.7
9.6
8.0
10.3
7.3
11.1
8.2
8. a
0.4
0.5
0.2
0,4
0.6
0.1
0.1
0.5
0.0
0.1
0.3
0.1
0.2
0.2
0.1
0.5
1.1
0.5
0.4
0.5
0.3
0.0
0.0
0.4
fl.9
0.2
0.0
0.0
0.0
0.2
0.1
0.4
0.0
0.0
0.4
0.7
0.0
0.1
0.1
0.3
0.4
0.0
0.0
0.0
0.5
0.1
0.0
0.2
0.2
0.1
0.0
0.2
0.3
0.1
0.1
0.0
0.0
0.2
0.5
Q.5
0.0
0.5
0.1
0.0
0.0
0.1
0.0
0.1
0.1
0.0
0.0
0.1
0.0
0.1
0.0
0.0
0.0
0.5
0.0
0.1
                                          D-68
                                                                                    162

-------
                                                                    Study No. 5221.08
           SUBCHRONIC TOXICITY  OF  PARA-CRESOL  1M SPRAGUE DAULEY RATS
                           FEMALE  HEMATOLOGY VALUES
                              [Interim  Sacrifice]
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
ANIMAL NO.

3791
3792
3793
3794
3795
3796
3797
3793
3799
3300
3321
3322
3323
3324
3825
3326
3827
3328
3829
3330
3351
3352
3353
3354
3355
3356
3357
3858
3859
3360
3381
3382
38S4
3885
3886
3837
3888
3889
3890
RBC
(x 10"6/im*3
7.60
7.90
7.95
8.05
8.04
8.22
7.70
8.77
7.97
7.73
8.40
7.83
8.02
8.17
8.06
7.82
7.70
8.07
7.72
8.15
7.75
8.52
3.43
8.31
7.94
8.23
7.24
8.46
7.35
7.91
8.03
7.65
8.09
8.70
8.97
7.44
8.46
3.00
7.94
HC3
i) (g/dl)
14.6
16.2
15.0
15.3
15.0
15.1
14.6
16.2
15.8
15.4
15.7
14.7
14.9
15.3
15.3
15.2
15.6
15.8
15.7
15.5
14.9
16.3
15.6
16.0
14.7
15.0
14.6
15.3
14.4
15.5
15.5
14.3
15.1
15.3
15.5
14.1
16.1
15.1
15.0
HCT
(*)
41.9
44.6
42.3
42.7
41.6
43.0
40.9
45.2
44.5
43.4
44.9
41.3
41.2
43.5
43.0
44.4
43.0
45.1
43.1
42.6
41.3
46.0
43.5
44.9
40.6
44.6
40.9
44.0
40.1
43.0
43.5
40.6
43.8
45.2
43.9
39.9
44.3
42.3
42.0
PT
(Sec.)
8.6
7.3
11.0
13.3
11.4
11.6
8.5
9.4
13.1
11.8
11.1
10.6
10.9
11.7
10.9
12.4
8.8
12.2
12.7
10.8
8.3
11.4
9.9
9.3
11.0
8.7
12.2
10.7
11.0
12.2
11.0
12.2
11.7
12.4
12.0
10. 3
14.0
11.0
11.8
APTT
(sec.)
43.8
43.5
33.8
33.3
40.9
44.9
34.6
43.4
31.6
33.7
39.0
46.8
37.3
34.9
19.5
40.3
30.7
34.5
37.7
37.8
45.6
39.5
36.3
37.4
39.9
32.4
36.5
40.2
35.9
21.9
33.4
39.7
41.2
41.2
45.3
34.0
38.8
34.6
32,7
RETIC

-------
                                                                                                Study No. 5221.08
                                          SUBCHRONIC TOXICITY  OF  PARA-CRESOL  ]M SPRAGUE DAULEY RATS
                                                          FEMALE  HEMATOLOGY VALUES
                                                             [Interim Sacrifice]
                             DOSE LEVEL
                             0 ing/kg/day
ANIMAL NO.       UBC         SEGS  .  BAUDS     LYMPHS    MONO     EOS
            (x 10"3/im*3l   4
85
76
79
76
64
87
6
5
2
2
4
3
2
7
1
1
2
1
2
3
3
2
4
3
2
1
1
2
3
2
3
3
1
4
2
0
4"
5
4
7
2
1
3
2
3
0
0
0
0
1
0
1
1
0
3
2
1
1
0
1
1
1
0
0
0
0
0
0
2
2
0
2
0
0
0
1
1
0
0
1
3
0
2
0
                                                              D-70
6

-------
                                                                                   Study No. 5221.08
                             SUSCHRON1C TOXieilY OF PARA-CRESOL  1M  SPRAGUE DAWLEY RATS
                                             FEMALE HEMATOLOCY VALUES
                                                {Interim Sacrificel
                ANIMAL NO.
                                 use
 DOSE LEVEL
 0 mg/kg/day
50 fig/kg/day
175 mg/kg/day
600 mf/kg/day
(x
     SEGS
{x 10*3/^3)
                                                              BANDS
                                                LYMPHS
                                                          (x
                                            
-------
                                                                  Study Ho. 5221.08
           SUBCHROMIC TOXICITY OF PA3A-CRESGL SM SPHAGUE DAULEY RATS
                          FEMALE HEMATOLQGY VALUES
                            [Terminal Sacrifice]
 DOSE LEVEL
50 mg/kg/day
175 ing/kg/day
600 mg/kg/day
ANIMAL NO.

3801
3802
3803
3804
3805
3806
3807
3803
3809
3810
3831
383Z
3833
3834
3835
3836
3837
3838
3839
3840
3861
3862
3863
3864
3865
3366
3867
3868
3869
3S70
3891
3892
3893
3894
3895
3896
3897
3898
3900
3901
R3C

-------
                                                                    Study No, 5221.08
              SUBCHRQNIC TCXIC3TY OF PARA-CRSSGL  IN SPRAGUE DAULEY RATS
                              FEMALE HEMATCLOGY VALUES
                                [Terminal  Sacrifice]
 DOSE LEVEL
 0 rag/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kf/day
ANIMAL NO.

3801
3802
3803
3804
3805
3806
3807
3808
3809
3810
3831
3832
3833
3834
3835
3836
3837
3838
3839
3840
3861
3862
3863
3864
3865
3S66
3867
3868
3869
3870
3891
3892
3893
3894
3895
3696 -
3897
3898
39CO
3901
ysc
(x 10"3/mnA3J
7.4
8.7
8.9
6.5
9.6
6.9
5.9
8.0
8.9
6.9
8.4
10.7
8.6
8.3
8.1
9.4
10.7
9.9
6.5
8.1
7.5
7.0
11.4
3.2
11.9
11.8
11.2
7.3
8.1
9.5
7.9
6.3
8.2
7.2
10.7
6.0
7.6
12.7
7.7
5.5
SEGS
(% UBC}
22
16
21
13
3
11
10
10
23
31
25
20
20
12
14
21
16
32
9
17
11
27
36
' 17
18
12
13
11
15
15
24
12
26
11
26
31
34
10
25
9
BANDS
{X UBC)
0
1
0
1
1
0
 1
0
0
0
0
0
3
0
0
3
4
1
2
0
0
0
0
0
2
0
0
a
0
1
a
0
0
1
i
a
1
0
i
0
LYMPHS
(X UBC)
75
78
73
82
89
87
84
85
77
'68
73
78
75
83
84
73
80
66
39
82
88
71
62
80
75
33
84
89
84
82
67
87
72
87
67
66
62
.88
66
89
HONO
(X UBC)
2
5
5
4
1
1
4
5
0
1
0
1
1
2
1
2
0
1
0
a
1
1
1
2
3
0
3
0
1
2
5
1
1
0
4
0
2
2
6
1
EOS
<% WBC)
1
0
1
0
1
1
1
0
0
0
2
1
1
3
1
1
0
0
0
1
0
1
1
1
2
0
0
0
0
0
. 4
0
1
1
2
1
2
0
2
1
                                 D-73
                                                                             -J . f  f;
                                                                             i U  

-------
                                                                                    Study No. 5221.08
                             SU8CHRON1C TOXICITY OF PARA-CRESCL IN SPRAOUE DAMLEY RATS
                                             FEMALE HEMATOLQGY VALUES
                                               [Terminal Sacrifice]
                ANIMAL NO.
                                 wac
                                                SEGS
 DOS 6 LEVEL
 0 mg/fcg/ciay
50 irs/kg/day
175 mg/fcg/day
600 nig/kg/day
                            Cx
                                           (x
    BANDS          LYHPHS          MONO
(X 10"3/iT3)  
-------
                                                                                 Study No. 5221.08
                           SUBCHRON1C TOXIC1TY OF  PARA-CRESOL  IN SPRAGUE DAULEY RATS
                                        KALE CLINICAL  CHEMISTRY VALUES
                                              [Interim Sacrifice]
 DOSE LEVEL
 0 ing/ki/dsy
ANIMAL NO.    GLU      BUN     SGPT    SGQT    T  PRO   ALS    GLOB   ALB/GLOB    CHQL      Ca
            (mg/dU    CIu/l)  (lu/l)   (g/dl)  (g/dl)   {g/dl)    (ratio)  (,ig/dt)  
50 mg/kg/day
175 rag/kg/day
600 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
 3670
3691
3692
3693
3694
3695
3696
3697
3693
3699
3700
3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3751
3752
3753
3754
3755
3756
3757
3758
3759
3760
238.7
159.7
252.4
121.8
151.7
226.5
193.0
228.7
258.7
274.8
183.7
245.3
275.1
218.9
231.8
145.5
189.1
169.6
192.9
224.8
187.7
195.4
189.4
247.8
224.0
192.3
174.0
242. S
302.0
225.8
184.2
270.9
227.7
203.3
302,5
256.2
218.3
188.0
302.8
255.4
16.4
16.0
13.6
20.5
15.3
16.4
15.6
13.3
15.7
16.0
1Z.6
13.3
20.6
17.5
14.2
14.7
16.5
13,0
11.3
13.2
13.2
13.3
18.3
12.5
17.4
13.3
21.4
11.0
14.6 ,
13.2
13.5
13.2
13.8
13.6
14.4
12.9
15.3
11.2
13.8
14.8
30
23
32
28
26
44
25
27
25
33
31
25
39
27
39
32
25
51
179
33
27
33
37
27
27
24
24
37
32
27
31
42
29
21
27
36
39
36
37
29
73
77
97
81
60
76
61
82
89
74
76
77
58
71
,72
122
68
169
107
81
91
72
62
na
81
64
77
81
77
70
66
85
82
62
77
79
90
73
83
88
6.5
7.5
7.8
7.1
7.7
7.3
8.0
7.8
6.9
7.7
6.5
7.6
6.8
6.9
6.4
6.6
7.2
7.2
7.2
7.0
6.9
6.9
7.2
8.6
7.2
6.3
7.6
7.6
7.9
7.8
7,4
7.2
7.2
7.0
7.3
6.8
7.2
7.3
7.2
6.8
3.7
4.7
4.2
4.4
4.1
3.9
4.5
3.9
3.9
4.3
3.6
3.9
3.9
3.B
3.6
4.0
4.3
3.8
3,6
3.9
3.8
4.2
3.9
5.0
4.3
3.8
4.5
4.4
4.0
4.. 4
4.1
3.9
4.5
4.1
4.1
4.1
4.0
4.0
3.7
3.9
2.8
2.8
3.6
2.7
3.6
3,4
3.5
3.9
3.0
3.4
2.9
3,7
2.9
3.1
2.8
2.6
2.9
3.4
3.6
3.1
3.1
2.7
3.3
3.6
2.9
2.5
3.1
3.2
3.9
3.4
3,3
3.3
2.7
2.9
3.2
2.7
3.2
3.3
3.5
2.9
1.321
1.679
1.167
1.630
1,139
1.147
1.286
1.000
1.3CO
1.265
1.241
1.054
1.345
1.226
1.236
1.538
1.483
1.118
1,000
1.258
1.226
1.556-
1.182
1.389
1.483
1.520
1.452
1.375
1.026
1,294
1.242
1.182
1.667
1.414
1.281
1.519
1.250
1.212
1.QS7
1.345
61.7
75.0
67.8
104.1
115.4
58.8
118.0
78.7
92.1
91.9
58.6
68.4
63.0
65.6
55.1
43.8
68.3
48.6
58.7
85.1
61.6
97.9
61.2
173.2
73.7
126.1
87.5
120.7
84.3
109.3
96.2
104.4
93.4
88.7
110.0
78.8
72.2
87.6
111.2
70.9
11.9
16.3
14.5
16.5
14.2
14.7
14.4
14.1
15.5
13.9
12.8
16.8
14.5
13.6
13.0
12.3
' 14.9
15.3
13.3
13.3
14.7
13.2
14.1
15.0
17.7
13.6
16.3
13.5
14.0
13.9
13.6
15.4
15.0
13.9
16.0
16.5
15.0
12.7
16,1
11,8
                                            D-75
                                                                                 P,
                                                                                 U
                                                                                                    O,

-------
                                                                          Study Ha. 5221.03
                        SUSCHRONIC TOXICiTT OF PARA-CRESQU IN  SPRACUE DAWCEY RATS
                                   HALI CLINICAL CHfMISTRT VALUES
                                         Clnterim Sacrifice]
 DOSE LEVEL
 0 nig/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
ANIMAL HO.

3661
3662
3663
3664
3665
3666
3667
3663
3669
3670
3691
3692
3693
3694- 
3695
3696
3697
3693
3699
37SQ
372T
3722 -
3723
3774
3725
3726
3727
3728
3729
3730
3751
3752
3753
3754
3755
3756
3757
3758
3759
3760
D BIL
(rag/dl)
0.00
0.00
0.01
0.01
0.01
0.00
0.01
0.01
0.01
Eh 04
0.02
0.01
0.01
0.01
a. oo
a. ao
0.00
0.01
0.01
0.01
0.01
0.03
0.01
0.01
0.00
0.01
0.02
0.01
0.01
O.Q2
0.01
0.00
0.01
0.02
0.01
0.01
0.01
0.00
0.01
0.00
T BIL
Cmg/dl)
0.14
0.13
0.06
0.18
0.05
0.19
0.06
0.09
0.13
0.16
0.13
0.16
0.14
0.09
0.11
0.15
0.12
0.22
0.11
0.12
0.16
0.10
0.12
0.18
0.15
0.06
0.15
0.14
0.14
0.08
0.13
0.14
0.15
0.11
0.16
0.12
0.15
0.17
0.12
0.09
Na
CMeq/l)
194
147
166
155
174
177
161
166
149
165
158
155
162
153
164
149
149
173
157
157
153
156
174
na
149
167
153
162
157
153
161
149
"143
162
147
153
152
156
154
179
K

10.7
6.3
7.3
5.9
7.3
7.6
7.0
8.1
6.2
6.5
7.4
5.8
8.7
9.6
7.3
7.4
6.1
10.0
6.1
6.5
6.3
5.0
12.0
na
7.7
9.3
7.1
7.0
5.8
7.S
8.9
6.2
6.7
10.9
6.9
6.9
8.5
a. 2
7.1
8.0
Cl
(Meq/U
138
99
112
99
117
120
110
114
100
111
106
96
113
108
109
103
101
111
101
104
104
104 '
118
na
102
118
98
110
107
111
112
97
102
112
98
102
98
108
102
119
ALK PHOS
CIu/13
57
59
125
86
74
83
56
125
87
63
146
94
111
72
84
123
81
80
119
62
70
63
60
46
67
35
67
69
79
53
59
113
79
120
47
82
108
86
63
164
CQ2
(Meq/l)
24
na
20
27
na
27
23
na
30
23
21
26
31
24
20
27
20
25
27
22
21
na
na
na
25
24
32
na
24
26.
25
27
na
27
25
27
25
28
25
24
CSEAT
(nti/dl}
0.62
0.80
0.78
0.76
0.62
0.61
0.66
0.72
0.65
0.66
0.71
0.67
0.67
0.72
0.95
0.78
0.63
0.58
0.75
0.72
0.61
0.70
0.68
0.64
0.65
0.60
0.82
0.59
0.75
0.70
0.67
0.70
0.64
0.59
0.56
0.73
0.76
0.85
0.69
0.60
PHOS
(rag/dl )
9.9
11.3
11.4
10.2
12.8
11.1
11.6
13.9
11.9
12.5
11.2
11.2
11.1
13.4
11.7
11.7
11.1
13.1
12.1
10.5
10.7
11.0
13.2
12.3
15.5
11.4
10.3
11.5
9.5
11.4
10.0
12.1
12.8
8.0
10.8
11.8
13.2
10.1
10.8
10.2
                                            D-76
                                                                                           170

-------
                                                                          Study Ho. 5221.08
                     SUBCHRONIC TOXJCm OF PARA-CRESQL  IN SPRAGUE DAULEY RATS
                                  HALS CLINICAL CHEMISTRY VALUES
                                       [Terminal Sacrifice]
 DOSE LEVEL
 0 mg/kg/day
50 tns/kg/day
175 mg/kg/day
600 mg/kg/day
ANIMAL NO.

3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
OLU

220.7
230.3
195.7
194.2
204.5
336.5
275.7
253.6
155.2
183.4
277.0
192.6
235.1
176.1
279.3
259.7
295.9
209.4
261.1
159.3
272.2
220.5
235.3
343.5
229.2
271.0
278.1
223.6
183-2
244.4
213.7
285.6
219.6
201.5
233.6
198.8
349.2
164.9
220.0
265.7
SUN
Cmf/dl)
12.5
10.3
16.3
12.9
15.4
13.3
11.8
12.3
12.6
11.6
12.6
13.1
12.1
11.5
11.6
12.4
10.0
11.0
12.7
11.5
13.2
14.1
11.5
12.5
16.1
11.9
17.5
9.7
9.1
10.9
14.7
9.7
15.7
10.7
10.8
17.2
16.6
12.5
11.2
12.4
SGPT
(Iu/1)
23
27
23
26
35
20
24
27
25
32
22
28
26
21
32
28
25
29
30
34
31
32
41
32
24
36
25
27
37
33
383
59
54
27
35
52
49
34
39
67
SGCT
Uu/l)
59
68
73
57
85
64
61
62
92 -
80
57
73
74
45
86
77
68
77
68
82
94
72
74
56
62
69
51
70
79
77
352
93
106
57
82
98
74
81
83
100
T PRO
(3/dl)
7.1
7.1
6.4
7.0 '
6.6
7.0
7.0
7.1
6.7
6.4
7.0
6.9
6.5
7.0
7.2
7.5
7.1
6.3
7.3
6.5
7.2
7.2
7.0
7.4
6.6
7.5
7.8
7.2
7.9
7.6
8.6 .
7.5
8.1
7.3
7.6
8.2
7.4
7.2
6.3
7.5
ALB
(f/dl>
4.0
3.9
3.5
4.0
5.3
3.9
3.7
3.7
3.5
3.6
3.5 '
3.4
3.8
4.0
3.8
3.7
3.9
3.7
3.8
3.4
3.9
3.7
3.8
4.4
3.5
4.3
4.0
4.1
3.6
4.3
5.0
3.9
4.2
4.0
4.0
4.4
4.4
3.9
3.8
3.9
GLOB
tg/dl)
3.1
3.2
2.9
3.0
1.3
3.1
3.3
3.4
3.2
2.8
3.5
3.5
2.7
3.0
3.4
3.8
3.2
3.1
3.5
3.1
3.3
3.5
3.2
3.0
3.1
3.2
3.8
3.1
4.3
3.3
3.6
3.6
3.9
3.3
3.6
3.8
3.0
3.3
2.5
3.6
ALB/GLOB
(ratio)
1.290
1.219
1.207
1.333
4.077
1.258
1.121
1.088
1.094
1.286
1.000
0.971
1.407
1.333
1.118
0.974
1.219
1.194
1.086
1.097
1.182
1.057
1.188
1.467
1.129
1.344
1.053
1.323
0.837
1.303
1.389
1.083
1.077
1.212-
1.111
1.158
1.467
1.182
1.520
1.083
CHOL

-------
                                                                                        Study Ho.  5221.08
                                 SUBCHRONIC TOXICITY OF PARA-CSESQL IN SPRAGUE DAULEY SATS
                                              HALS CLINICAL CHEMISTRY VALUES
                                                   [Terminal Sacrifice]
 DOSE LEVEL
 0 mg/icg/day
50 rag/kg/day
175 mg/leg/day
600 mg/kg/day
AN [HAL NO.

3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3701
3702
3703
3704
37C5
3706
3707
37C8
37C9
3710
3731
3732
3733
3734
3735
3736
3737
373B
3739
3740
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
D BIL
(mg/dl.J
0,02
0,01
0,01
C.02
0.00
0,00
o.oa
0.01
0.00
0.01
0.01
o.ao
0.01
0.01
o.co
0.01
0.01
0.01
O.C2
0.01
0.02
0.01
0.00
cms
0.02
0.02
0.02
O.OT
0.01
0.01
0.01
O.OQ
0.00
0.02
C.01
0.00
0.02
0.00
0,01
0.01
T BIL
(mg/dl)
0.05
0.05
0.23
0.05
0.22
0.07
0.14
0.15
0.22
0.16
0.22
Q.ZO
0.10 '
0.03
0.18
0.19
0.19
0.20
0.16
0.19
0.11
0.19
0.07
QMS
0.11
n.oz
0.16
0.06
0.18
0.09
0.14
0.17
0.19
0.07
0.20
0.18
0.10
O.OS
0.14
0.13
Ca
Cmg/dU
10.3
18.5
15.6
13.0
12.1
18.7
15.8
12.3
12.3
QNS
16.6
13.1
16.7
15.3
11.8
13.9
12.2
12.6
13.3
12.3
14.5
17.6
17.3
16.8
26.0
16.9
18.7
17.3
13.2
17.6
15.4
13.1
12.7
15.7
13.0
14.5
11.9
12.6
16.6
13.0
Ha
(Keq/l)
QNS
145
144
QNS
QNS
CMS
145
147
QNS
QNS
145
QNS
H6
QNS
QNS
QNS
. QNS
QNS
QNS
QNS
145
146
146
QNS
146
QNS
145
146
146
QMS
QNS
QNS
144
QNS
QNS
146
QNS
145
QNS
QNS
K
(Keq/t>
QNS
8.6
6.0
QNS
QNS
QMS
10.6
5.9
CNS
QNS
8.2
QNS
6.1
QNS
QNS
QNS
QNS
QNS
QNS
QNS
8.3
7.8
5.7
QNS
5.8
QNS
6.2
6.1
5.7
QMS
QNS
QNS
10.3
QNS
QNS
5.9
QNS
5.9
QNS
QNS
Cl
(Heq/U
QNS
106
102
QNS
QNS
cms
107
105
SNS
QNS
104
QNS
135
QNS
QNS
QNS
QNS
QNS
QNS
QNS
104
106
103
QNS
105
QMS
103
103
104
QMS
QNS
QNS
105
QNS
QNS
103
QNS
103
QNS
QMS
ALK PHOS
(!u/l)
59
46
75
43
128
56
39
61
104
154
39
72
50
47
50
53
95
51
68
83
42
84
53
125
46
32
49
53
53
61
37
62
59
52
47
56
115
94
126
83
COS
CMeq/l)
QNS
26
26
QNS
QNS
QNS
24
27
QMS
QNS
25
" QNS
29
QNS
QNS
QNS
QNS
QNS
QNS
QNS
27
23
28
17
25
QNS
27
27
29
CMS
QNS
QNS
22
QNS
QNS
25
QNS
30
QNS
QNS
CSEAT
(mg/dl)
0.65
0.70
0.69
0.66
0.77
0.63
0.72
0.58
0.86
0.68
Q.63
0.59
0.67
0.64
0.67
0.61
0.84
0.56
0.59
0.62
0.74
0.68
0.66
0.62
0.57
0.64
0.63
0.69
0.63
0.76
0.64
0.69
0.75
0.62
0.59
0.93
0.62
0.52
0.72
0.76
PHOS
(rcg/dU
7.2
10.2
12.0
3.3
7.7
11.1
12.3
12.5
6.7
10.4
10.9
8.9
10. a
8,3
8,7
8.3
9.1
7.6
8.6
8.2
10.7
12.2
9.6
8.6
11.5
S.4
G!JS
9.0
9.0
10.0
6.8
8.4
9.4
7.9
8.3
8.1
10.7
8.3
8.4
7.9
IDH

-------
                                                                                 Study Mo. 5221.03
                           SUBCHROMIC TOXICITY  OF  PARA-CRESOL  IN SPRAGUE DAULEY RATS
                                       FEMALE CLINICAL  CHEMISTRY VALUES
                                              [Interim  Sacrifice]
 DOSE LEVEL
 0 mg/kg/day
ANIMAL HO.    GLU      BUN     SGPT     SCOT     T  PRO    AL3    GLOB   ALB/GLOB    CHQL      Ca
              (mg/dl)     (ratio)  (rng/dl)  (mg/dl)
SO mg/kg/day
175 mg/kg/day
600 mg/kg/day
3791
3792
3793 .
3794
3795
3796
3797
3798
3799
3800
3821
3S22
3323
3824
3825
3826
3827
3828
3S29
3830
3851
3852
3853
3854
3855
3856
3857
3858
3859
3860
3881
3882
3284
3885
3886
3887
3888
3889
3890
221.9
303.0
189.6
172.6
194.6
332.1
195.5
146.1
148.9
181.2
172.2
307.2
113.3
240. 5
177.5
180.1
196.0
113.0
147.3
219. S
172.3
231.1
na
163.7
201.1
200.9
286.0
165.3
136.1
186.7
124.4
124.1
207.8
147.3
209.8
188.5
217.9
396.6
225.0
22.3
25.9
Z4.1
21.8
14.4
18.7
12.8
25.2
14.3
17.8
17.9
12.6
14.6
11.8
14.3
17.4
16.7
15.5
16.0
17.3
16.4
18.7
14.3
24.3
22.9
19.7
16.2
14.5
20.3
10.2
14.6
25.0
18.9
18.0
17.9
17.1
19.7
14.0
16.3
22
29
25
31
27
26
25
27
27
33
33
28
29
23
29
32
30
26
19
26
34
43
35
49
na
27
32
31
29
26
28
21
37
35
28
38
55
43
29
89
83
79
80
69
66
84
89
79
75
63
75
57
63
63
103
92
85
103
73
84
67
na
122
59
96
85
101
71
79
119
64
70
74
69
77
118
135
70
3.0
a.o
9.0
7.2
6.6
6.8
7.0
7.5
7.3
6.6
6.5
7.2
7.1
7.4
7.0
7.5
7.6
7.2
7.0
7.1
7.1
6.9
na
7.5
7.2
7.2
7.2
7.5
6.9
7.4
7.2
6.9
7-8.
7.0
6.4
7.3
7.6
8.2
7.6
5.0
5.2
5.1
4.1
3.4
3.8
4.2
4.8
4.1
3.6
4.4
4.5
4.Z
4.3
3.6
4.8
4.5
4.8
4.6
3.6
3.9
4.3
"na
4.2
4.5
3.9
4.5
4.5
4.0
4.4
4.5
4.5
4.9
4.6
3.9
4.0
4.4
5.0
4.2
3.0
2.3
3.9
3.1
3.2
3.0
2.8
2.7
3.2
3.0
2.1
2.7
2.9
3.1
3.4
2.7
3.1
2.4
2.4
3.5
3.2
2.6
na
3.3
2.7
3.3
2.7
3.0
2.9
3.0
2.7
2.4
2.9
2.4
2.5
3.3
3.2
3.2
3.4
1.667
1.857
1.303
1.323
1.063
1.267
1.500
1.778
1.281
1.200
2.095
1.667
1.448
1.387
1.059
1.778
1.452
2.000
1.917
1.029
1.219
1.654
na
1.273
1.667
1.182
1.667
1.500
1.379
1.467
1.667
1.87S
1.690
1.917
1.560
1.212
1.375
1.563
1.235
121.8
116.6
157.3
91.8
81.8
104.8
64.6
77.4
83.7
102.3
66.6
82.1
75.8
79.4
73.3
95.0
SO. 2
76.2
53.3
64.8
86.5
112.2
120.7
107.4
126.1
118.0
94.7
118.5
107.2
94.4
102.4
77.6
138.3
106.1
44.7
67.8
133.2
132.0
125.6
15.1
14.5
16.2
15.8
12.8
13.8
15.1
15.5
14.5
15.1
12.3
14.0
16.4
12. Z
13.0
18.3
16.0
15.4
15.1
12.9
12.4
15.0
na
14.6
13.3
24.9
15.1
15.6
13.2
13.7
14.5
16.2
16.2
15.9
12.5
12.3
14.7
15.5
16.0
                                           D-79
                                                                                           i 7

-------
                                                                              Study Ko.  5221.CO
                         SUBCHRONIC TOXICin OF PARA-CRESOL  IN  SPRACUE DAULEY RATS
                                    FEMALE CLINICAL  CHEMISTRY  VALUES
                                           [Interim Sacrifice]
 DOSE LEVEL
 0 mgAg/day
50 mg/kg/day
175 tngAg/day
600 mg/kg/day
ANIMAL HO.

3791
3792
3793
3794
3795
3776
3797
3798
3799
3BOQ
3821
3822
3823
3824
3S25
3S26
3827
3823
3S29
3830
3851
3852
3B54
3855
3856
3857
3853
3859
3860
3381
3822
3834
3S85
3886
3887
3838
3S39
3890

D SIL

-------
                                                               Study No. 5221.08
                  SUBCHRON1C TOXICtTY OF PARA-CRfSOl IN SPRAGUE DAUIEY RATS
                            FEHALI CLINICAL CHEMISTRY VALUES
                                 [Terminal Sacrifice]
 DOSE LEVEL
 0 mg/kg/day
ANIMAL NO.   CLU     BUN    SGPT   SCOT    T PRO   ALB    GLOB  ALi/GLCB   CHOI
          (mo/ell)  
-------
                                                                                  Study NO. 5221.08
                               SUBCHROMIC TOXICITY OF PARA-CRESQL IN SPRAGUE PAUlEt RATS
                                          FEMALE CLINICAL CHEN1STRT VALUES
                                                [Terminal Sacrifice]
 DOSE  LEVEL
 0 rag/kg/day
50 rng/kg/day
175
600 rng/kg/day
AN1HAL HO.

3801
3802
3803
3804
3805
3806
380 7
3808
3809
3810
3831
3332
3833
3834
3835
3336
3837
3838
3839
3840
3861
3862
3363
3864
3865
3866
3867
3868
3869
3870
3891
3892
3893
3894
3895
3S96
3897
3898
3900
3901
D 811

-------
                                                                     Study No. 5221.03
       SU3CHRON1C TOX1CITY OF PARA-CRESOL IN SPRAGUE  DAULEY  RATS
                      MALE ORGAN WEIGHT DATA (g)
                         [Terminal Sacrifice]
                ANIMAL NO.  HEART   LIVER  SPLEEN   KIDNEY-LFT  KJDNEY-RT
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3671
3672
3673
3674
3675
3676
3677
3678
3679
36SO
3681
3682
3653
3684
3685
3686
3687
3688
3689
3690
3701
3702
3703
3704
3705
3706
3707
3703 .
3709
3710
3711
3712
3713
3714
3715
3716
3717
37-13
3719
3720
1.769
1.616
1.795
1.795
1.394
1.997
2.033
2.159
1.780
1.875
1.436
1.795
1.622
1.739
1.847
1.814
1.981
1.528
1.577
1.801
1.725
1.818
1.707
1.638
1.621
1.331
1.514
1.645
1.982
1.919
1.739
1.634
1.622
1.474
1.635
1.782
1,527
1.4Z7
1.776
1.553
18.773
14.427
13.673
18.934
14.543
19.589
20.627
23.882
17.941
20.082
15.795
20.271
18.904
20.706
19.445
 21.399
17.351
19.122
15.947
18.924
18.061
20.030
22.055
16.692
18.195
19.106
13.780
17.448
21.948
19.913
18.355
17.457
17.699
14.750
16.921
16.840
13.102
13.986
19.619
16.594
0.832
0.773
0.366
0.633
0.594
0.753
Q. 775
0.842
0.906
0.853
0.826
0.715
0.732
0.801
0.808
0.803
0.683
' 1.077
0.810
0.818
0.715
0.975
0.896
0.758
0.692
0.839
0.551
0.762
0.854
0.955
0.801
0.649
0.765
0.692
0.687
0.858
0.729
0.61S
0.840
0.782
1.985
1.582
2.298
2.029
1.605
2.020
2.358
2.341
1.885
2.186
1.613
2.126
1,935
1.822
1.891
2.092
1.926
2.000
1.831
2.06T
2.302
2.290
1.997
2.150
2.138
2.194
1.671
2.080
2.213
2.259
1.911
1.323
2.195'
1.515
2.183
1.964
1.573
1.666
2.247
2.186
1.941
1.576
2.455
2.094
1.563
2.136
2.252
2.397
2.073
2.264
1.669
2.123
1.858
1.927
1.981
2.088
1.936
2.057
1.856
2.025
2.323
2.377
2.105
2.181
2.054
2.299
1.659
2.163
2.129
2.216
1.910
1.755
2.127
1.533
2.074
1.385
1.769
1.675
2.431
2.272
                                D-83
                                                                                   ^.  (  (

-------
                                                                   Study No. 5221.08
               SUBCHRONIC TOXICITY OF PARA-CRESOL IH SPRAGUE  DAULEY RATS
                             MALE ORGAN WEIGHT DATA (g>
                                [Terminal Sacrifice]
               ANIMAL HO  TESTIS-LFT  TESTIS-RT  ADRENALS  BRAIW  THY./PARA.  TERM.WGT.
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3671
3672
3673
3674
3675
3676
3677
3675
3679
3680
3681
3682
3683
3684
3685
3686
3687
3688
3689
3690
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3711
3712
3713 .
37U
3715
3716
3717
3718
3719
3720
1.811
1.460
1.746
1.651
1.711
1.713
1.783
1.647
1.570
1.770
1.542
1.732
1.807
1.753
1.616
1.688
1.889
1.618
1.681
1.725
1.779
1.704
1.782
1.614
1.722
1.611
1.671
1.300
1.847
1.666
1.641
1.545
1.869
1.799
1.835
1.852
1.693
1.746
1.893
1.847
1.777
1.612
1.789
. 1.675
1.609
1.766
1.850
1.580
1.520
1.844
1.152
1.761
1.822
1.721 .
1.642
1.583
1.791
1.893
1.677
1.6S4
1.758
1.745
1.922
1.512
1.691
1.642
1.646
1.693
1.827
1.745
1.646
1.525
1.967
1.761
1.863
1.900
1.727
1.738
1.847
1.793
0.074
0,053
0.069
0.040
0.046
0.075
0.072
0.056
0.064
0.054
0.063
0.042
0.051
0.076
0.033
0.065
0.059
0.053
0.056
0.054
0.040
0.063
0.062
0.060
0.053
0.054
0.063
0.035
0.073
0.043
0.065
0.054
na
0.053
0.072
0.043
0.054
0.050
0.047
O.Q61
2.149
2.274
2.301
2.033
2.357
2.356
2.349
2.311
2.291
2.238
2.196
2.235
2.385
2.056
2.110
2.283
2.294
2.006
2.120
2.361
2.328
2.251
2.298
2.208
Z.303
2.336
2.083
2.170
2.243
2.403
2.170
2.235
2.190
2.229
2.212
2.203
2.024
1.961
2.186
2.052
0.017
0.020
0.034
0.020
0.016
0.037
0.030
0.033
0.019
0.037
0.021
0.020
0.026
0.033
0.020
0.024
0.027
0.028
0.024
0.024
0.036
0.024
0.039
0.018
0.020
0.024
0.017
0.027
0.027
0.015
0.021
0.025
0.029
0.026
0.022
0.013
0.020
0.020
0.025
0.022
587
506
566
663
43 S
582
547
657
533
595
493
536
588
583
570
595
597
550
521
600
557
582
599
504
567
578
430
576
599
533
543
544
594
486
523
566
470
463
553
548
                                 D-84
                                                                               178

-------
                                                                     Study No. 5221.03
       SU8CHRONIC TOXICITY OF PARA-CRESOl IN SPRAGUi DAULEY  RATS
                      HALE ORGAN yEIGHT DATA (|)
                         [Terminal Sacrifice]
                ANIMAL NO.  HEART   LIVES  SPLEEN  KIDNEY-LFT   KtDNEY-RT
 DOSE LEV1L

175 mg/kg/day
600 mg/kg/day
3731
3732
3733
3734
3735
3736
3737
3738
3739
1740
3741
3742
3743
3744
3745
, 3746
3747
3748
3749
3750
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3773
3779
3780
1.665
1.879
1.840
1.658
1.945
1.820
1.558
1.631
1.523
1.961
1.575
1.777
1.768
1.921
1.371
1.727
f.778
1.768
1.749
1.552
1.484
1.403
1.629
1.795
1.830
1.706
1.555
1.752
1.309
1.629
1.419
1.718
1.882
1.294
1.318
1.741
2.633
1,419
1.776
1.491
19.622
21.432
20.462
19.375
20.981
19.186
18.286
19.494
14.712
19.009
16.173
17.649
20.769
17.713
14.588
21.091
18.750
17.461
19.552
17.225
14.032
14.300
17.311
18.934
20.581
15.122
17,152
19.630
13.553
15.498
16.098
20.846
18.956
13,993
13.971
19.005
16.275
15.685
19.730
17.643
0.830
0.816
0.724
0.624
0.892
0.586
0.897
0.702
0.700
0.734
0.539
0.700
0.759
0.762
0.605
0.783
0.875
0.635
0.803
0.685
0.667
0.505
0.547
0.633
' 0.6S4
0.630
0.609
0.695
0.540
0.591
0.725
0.860
0.670
0.707
0.520
0.680
0.655
0.864
0.901
0.690
1.844
2.125
2.317
1.797
2.650
1.930
1.972
2.202
1.522
2.227
1.829
1.995
1.7S6
2.038
1.678
2.260
2.290
1.886
2.254
2.057
1.584
1.784
. 2.014
2.029
2.013
1.549
1.834
2.461
1.535
1.733
2.256
2.453
2.293
1.762
1.718
2.307
1.892
1.881
2.173
1.734
2.127
2.092
2.307
1.887
2.445
2.117
1.957
2.297
1.635
2.305
1.947
1.925
1.977
2.186
1.683
2.258
2.286
1.844
2.240
2.152
1.756
1.931
1,911
2.094
2.037
1.673
1.901
2.499
1.454
1.744
2.365
2.511
2.411
1.805
1.874
2.398
1.884
1.969
2.007
1,831
                                                                                        O
                                                                                        ->J
                                D-85

-------
                                                                     Study No. 5221.03
               SUBCHRONIC TOXICITY OF  PARA-CRESOL  IN SPRAGUE DAWLEY RATS
                              MALE ORGAN  WEIGHT DATA 
-------
                                                                    Study No. 5221.08
      SUBCHRCNtC TQXICITY OF PARA-CRESOl  IN  SPRAGUE DAWLEY RATS
      RELATIVE HALE ORGAN HEIGHT DATA (X  Terminal  Body Weight)
                        [Terminal Sacrifice]
                ANIMAL NO.  HEART  LIVER  SPLEEN   KIDNEY-LFT  ICIONEY-RT
 DOSE LEVEL
 0 mg/kg/day
50 rog/kg/day
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
36S3
3684
3685
3686
3637
3688
3689
3690
3701
3702
3703
3704
3705
37C6
3707
3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
0.301
0.319
0.317
0.271
0.318
0.343
0.373
0.329
0.334
0.315
0.291
0.334
0.276
0.296
0.324
0,305
0.332
0.278
0.303
0.30Q
0.310
0.312
0.2SS
0.325
0.286
0.317
0.352
0.286
0.331
0.329
0.320
0.300
0.273
0.303
0.310
0.315
0.325
0.305
0,321
0.283
3.193
2.851
3.300
2,856
3.320
3.366
3.771
3.635
3.366
3.375
3.204
3.768
3.215
3.521
3.411
3.596
2.906
3.477
3.061
3.154
3.243
3.442
3.682
3.312
3.209
3.306
3.205
3.029
3.664
3.416
3.380
3.209
2.980
3.035
3.205
2.975
2.783
2.988
3.548
3.023
O.U2
0.154
0.153
0.095
0.136
0.129
0.142
0.128
0.170
0.144
0.168
0.133
0.124
0.136
0.142
0.135
0.114
0.196
0.155
0.136
0.128
0.168
0.150
0.150
0.122
0.145
0.123
0.132
0.143
0.164
0.143
0.119
0.129
0.142 
0.130
0.152
0.155
0.131
0.152
.0.143
0.333
0.313
0.406
0.306
0.366
0.347
0.431
0.356
0.354
0.367
0.327
0.395
0.329
0.310
0.332
0.352
0.323
0.364
0.351
0.344
0.413
0.393
0.333
0.427
0.377
0.380
0.389
0.361
0.369
0.387
0.352
0.335
0.370
0.312
0.413
0.347
0.335
0.356
0.406
0.399
0.331
0.311
0.434
0.316
0.357
0.367
0.412
0.365
0.390
0.381
0.339
0.395
0.316
0.328
0.348
0.351
0.324
0.374
0.356
0.338
0.417
0.408
0.351
0.433
0.362
0.398
0.386
0.376
0.355
0.380
0.352
0.323
0.358
0.326
0.393
0.333
0.376
0.35B
0.440
0.415
                                                                               -  O  i
                                                                               j. 5  i

                               D-87

-------
                                                                     Study KQ. 5221.08
          SUBCHRCNIC TOXIC1TY OF PARA-CRESOL IN SPRAGUE  DAULEY  RATS
          RELATIVE HALE ORGAN WEIGHT DATA {% Terminal  Body Weight)
                            [Terminal, Sacrifice]
                ANIMAL NO.  TESTIS-LFT  TESTIS-RT   ADRENALS  BRAIN   THY./PARA.
 DOSE LEVEL
 0 mg/kg/day
50 rag/kg/day
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
3683
3684
36S5
3686
3687
3688
3689
3690
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
3720
0.309
0.239
0.3Q8
0.249
0.391
0.294
0.326
0.251
0.295
0.297
0.313
0.322
0.307
0.298
0.284
0.284
0.316
0.294
0.323
0.233
0.319
0.293
0.297
0.320
0.304
0.279
0.3S9
0.313 '
0.308
0.286
0,302
0.284
0,315
0.370
0.348
0,327
0.360
0.373
0.342
0.337
0.303
0.319
0.316
0.253
0.367
0.303
0.338
0.240
0.285
0.310
0.234
0.327
0.310
0.293
0.283
0.266
0.300
0.344
0.322
0.276
0.316
0.300
0.321
0.300
,0.298
0.284
0.383
0.294
0.305
0.299
0.303
0.280
0.331
0.362
0.353
0.336
0.367
0.371
0.334
0.327
0.013
0.011
0.012
0.006
0.011
0.013
0.013
0.009
0.012
0.009
0.013
0.003
0.009
0.013
0.007
0.011
0.010
0.010
0.011
0.009
0.007 "
0.011
0.010
0.012
0.010
0.009
0.015
0.006
0.012
0.007
0.012
0.010
na
0.012
0.014
0.008
0.011
0.011
o.cca
0.011
0.366
0.449
0.407
0.307
0.538
0.405
0.429
0.352
 0.430
0.376
0.445
0.415
0.406
0.350
0.370
0.385
0.384
0.365
0.40?
0.394
0.418
0.387
0.384
0.438
0.406
0.404
0.484
0.377
0.374
0.413
0.400
0.411
0.369
0.459
0.419
0.389
0,431
0,419
" 0.395
0.374
0.003
0.004
0.006
0.003
0.004
0.006
0.005
0.005
0.004
0.006
0,004
0.004
0.004
0.006
0.004
0.004
0.005
0.005
0.005
0.004
0.006
O.OC4
0.007
0.004
0.004
0.004
0.004
0.005
0.005
0.003
0.004
0.005
0.005
Q.OQS
0.004
0.003
0.004
O.QQ4
0.005
0.004
                                 D-88
                                                                                         9
                                                                                         
-------
                                                                    Study No. 5221.08
      SUBCKRONIC TOXIC1TY OF PARA-CRESQL  IN  SPRAGUE DAULEY  RATS

      RELATIVE MALE ORGAN WEIGHT DATA (.%  Terminal  Body Weight)

                        [Terminal Sacrifice]
                AHIMAL NO.  HEART  LIVER  SPLEEH  K10NEY-LFT   KIDNEY-RT

 DOSE LEVEL



171 mg/kg/day
600 mg/kg/day
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3741
3742
3743
3744
3745
3746
3747
3748
3749
3750
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
3780
0.290
0.323
0.334
0.319
0.321
0.360
0.313
0.312
0.321
0.369
0.316
0.313
0.31(3
0.381
0.301
0.315
0.322
0.331
0.317
0.303
0.381
0.321
0.329
0.332
0.377
0.364
0.328
0.312
0.323
0.342
0.309
0.233
0.358
0.296
0.31S
0.338
0.618
0.311
0.336
0.316
3.413
3.740
3.714
3.726
3.462
3.792
3.679
3.727
3.104
3.573
3,249
3.157
3.637
3.514
3.199
3.849
3.397
3.270
3.548
3.35B
3.558
3.272
3.497
3.506
4.235
3.224'
3.619
3.499
3.397
3.256
3.507
3.434
3.604
3.202
3.334
3.690
3.820
3.440
3.737
3.733
0.144
0.142
0.131
0.120
0.147
0.116
0.180
0.134
0.148
0.133
0.108
0.125
0.133
0.151
0.133
0.143
0.159
0.119
0.146
0.134
0.171
0.116
0.111
0.117
0.135
0.134
0.128
0.124
0.135
0.124
0.153
0.142
0.127
0.162
0.124
0.132
0.154
0.189
0.171
0.146
0.321
0.371
0.421
0.346
0.437
0.381,
0.397
0.421
0.321
0.419
0.367
0.357
0.313
0.404
0.368
0.412
0.415
0.353
0.409
0.401 .
C.406
0.408
0.407
0.376
0.414
0.330
0.387
0.439
0.385
0.364
0.492
0.404
0.436
0.403
0.410
0.448
0.444
0.413
0.412
0.367
0.370
0.365
0.419
0.363
0.403
0.418
0.394
0.439
0.345
0.433
0.391
0.344
0.346
0.434
0.370
0.412
0.414
0.345
0.407
0.419
0.450
0.442
0.386
0.388
0.419
0.357
0.401
0.445
0.364
0.366
0.515
0.414
0.453
0.413
0.447
0.466
0.442
0.432
0.380
0.388
                                                                                *!  O r*
                                                                                 b o

                                D-89

-------
                                                                  Study Ho. 5221.03
          SUBCHRON1C TOXIC1TY OF PARA-CRESOL IM SPRAGUE DAULEY RATS
          RELATIVE HALE ORGAN HEIGHT DATA  (X Terminal Body Weight)
                           [Terminal Sacrifice]
               ANIMAL NO.  TESTIS-LFT   TESTIS-RT  ADRENALS  BRAIN   THY./PARA.
 DOSE LEVEL
175 mg/kg/day
600 mg/kg/day
3731
3732
3733
3734
3735
3736
3737
3733
3739
3740
3741
3742
3743
3744
3745
3746
3747
3743
3749
3750
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
3771
3772
3773
3774
3775
3776
3777
3773
3779
3780
0.236
0.295
0.293
0.322
0.273
0.311
0.314
0.359
0.367
0.336
0.340
0.233
0.235
0.302
0.325
0.331
0.233
0.349
0.303
0.383
0.451
0.442
0.275
0.306
0.322
0.341
0.356
0.276
0.387
0.332
0.357
0.295
0.351
0.3S6
0.384
0.326
0.403
0.330
0.335
0.356
0.297
0.299
0.302
0.315
0.296
0.303
0.317
C.372
0.376
0.329
0.343
0.284
0.276
0.329
0.311
0.337
0.293
0.327
0.311
0.400
0.440
0.465
0.279
0.310
0.329
0.328
0.345
0.273
0.375
0.340
0.353
0.293
0.351
0.375
0.333
0.323
0.396
0.343
0.324
0.361
0.010
0.011
0.013
0.014
0.011
0.011
0.011
0.013
0.011
0.011
0.015
0.009
0.003
0.010
0.011
o.ooa
0.009
0.003
0.011
0.011
0.013
0.013
0.010
0.007
0.011
0.013
0.009
0.010
0.014
0.007
0.014
0.014
0.011
0.012
0.017
0.009
0.013
0.014
0.010
0.011
0.387
0.368
" 0.433
0,419
0.376
0.419
0.448
0.448
0.463
0.405
0.432
0.404
0.372
0.446
0.471
0.440
0.409
0.395
0.409
0.435
0.503
0.479
0.407
0.377
0.434
0.439
0.452
0.424
0.508
0.438
0.446
0.389
0.433
0.431
0.503
0.437
0.465
0.446
0.392
0.457
0.006
0.006
0.006
0.005
0.007
0.005
0.006
0.007
O.C07
0.004
0.004
0.004
0.004
0.005
0.003
0.005
0.004
0.005
0.004
0.004
0.004
0,005
0.004
0.004
0.005
0.003
0.005
0.006
0.005
0.005
0.005
0.004
0.005
0.005
0.006
0.007
0.005
0.005
0.005
0.005
                              D-90
                                                                                   18

-------
                                                                     Study Mo. 5221.03
       SUBCHRCNIC TOXIC1TY Of PARA-CRESOl IN SPRAGUE  DAWLEY  RATS
                     FEMALE ORGAN WEIGHT DATA'(3)
                         [Terminal Sacrifice]
                ANIMAL NO.  HEART   LIVER  SPLEEM  KJDMEY-LFT   K1DNEY-RT
 DOSE LEVEL
 0 tng/kg/day
50 ing/kg/day
3801
3802
3803
3804
3805
3806
3807
3aoa
3809
3810
3311
3812
3813
3814
3815
3816
3817
3818
3819
3820
3831
3332
3833
3334
3835
3836
3837
3838
3839
3340
3841
3342
3843
3844
3845
3846
3847
3843
3849
3850
1.122
1.236
1.144
1,075
0.931
1.048
0.8S6
1.086
1.208
0.958
1.065
1.063
0.943
1.218
1.013
1.120
1.174
0.880
0.927
1.106
1.100
1.178
1,344
1.058
0.925
1.059
1.061
1.180
0.881
0,892
1.007
1.016
0.939
0.837
1.103
1.139
0.964
1,023
1,146
0.961
10.654
11.468
10.897
9.544
9.516
9.904
8.202
9.903
10.173
9.768
9.064
10.854
9.809
10.215
9.571
9.340
9.830
8.260
7.629
10.225
9.352
10.768
9.767
10.703
9.749
8.855
9.997
9.997
7.740
8.794
9.665
9.071
8.792
-7.944
8.983
9.868
9.108
9.565
10.528
8.475
0,553
0.492
0.421
0.493
0.569
0.541
0.430
0.517
0.571
0.555
0.534
Q.624
0.515
0.590
0.548
0,559
0.610
0.495
0.522
0.512
0.595
0,716
0.574
0.575
0.555
0.553
0.693
0.552
0.464
0.420
0.512
0.627
0.533
0.517
0.570
0.589
0.578
0.570
0.594
0.448
1.167
1.512
1.096-
1.035
1.091
1.108
0.866
1.228
1.379
1.216
1.207
1.236
1.111
1.278
1.148
1.027
1.081
0.882
0.970
1.180
1.473
1.220
1.166
1.147
1.011
1.055
1.277
1,198
1.020
0.959
1.151
1.105
1.114
1.047
1.131
1.149
1.232
1.148
1.134
0.918
1.174
1.330
1.178
1.000
1.155
1.172
0.875
1.235
1.347
1.182
1.190
1.206
1.154
1.210
1.203
1.008
1.117
0.971
0.970
1.091
1.362
1.245
1.216
1.196
1.019
1.128
1.296
1.296
1.132
0.977
1.121
1.093
1.076
0.948
1.440
1.156
1.194
1.081
1.168
0.960
                                                                                     85
                                D-91

-------
                                                                    Study No. 5221.08
              SU3CHRONJC TOXIC1TY OF PA8A-CRESOL  IN  SPRAGUE DAWIEY RATS
                            FEMALE ORGAN  WEIGHT DATA (g)
                                [Terminal Sacrifice]
                ANIHAL NO.  OVARY-LFT  OVARY-RT   ADRENALS  BRAIN  THY./PARA.  TERM.WGT.
 DOSi LEVEL
 0 rag/kg/day
50 ing/kg/day
3801
3802
3803
3804
3805
3806
3807
3808
3809
3810
3811
3812
3813
3814
3815
3816
3817
3818
3819
3820
3831
3832
3833
3834
3835
3836
3837
3833
3839
3840
3841
3842
3843
3844
3845
3846
3847
3848
3849
3850
0.043
0.032
0.035
0.042
0.055
0.044
0.041
0.027
0.039
0.045
0.054
0.056
0.025
0,044
0.062
0.048
0.060
0.035
0.03?
0.020
0.045
0.049
0.057
0.028
0.036
0.047
0.023
0.034 .
0.043
0.049
0.043
0.036
0.030
0.034
0.044
0.046
0.057
0.051
0.052
0.044
0.043
0.071
0.032
0.076
0.050
0.045
0.032
0.056
0.046
0.047
D.042
0.059
0.026
0.077
0.054
0.043
0.051
0.044
0.041
0.026
0.050
Q.Q63
0.060
0.033
0.030
0.041
0.062
0.014
0.041
0.047
0.044
0.033
0.036
0.034
0.045
0.050
0.043
0.090
0.046
0.037
O.C57
0.0S7
0.079
O.C63
O.OS9
0.054
0.054
0.067
0.083
0.064
0.071
0.070
0.068
0.070
0.054
0.064
0.074
0.051
O.OS3
0.064
0.066
0.057
0.049
0.065
0.063
0.060
0.055
0.057
0.053
0.063
0.072
O.C58
0.063
O.Q52
0.086
0.088
0.066
0.073
0.066
0.059
2.170
2.139
2.027
1.897
1.932
2.143
1.946
2.119
2.172
2.113
2.127
f.980
2.052
2.209
2.064
1.831
2.150
2. 068
2.015
2.036
2.141
2.230
2.029
2.149
2.047
2.061
2.097
2.197
2.033
1.995
2.115
2.042
2.012
1.903
2.150
2.114
2.103
2.154
2.008
1.995
0.023
0.032
0.012
0.022
0.025
0.021
0.013
0.013
0.027
0.034
0.027
0.016
0.023
0.021
0.020
0.013
0.017
0.019
0.016
0.017
0.026
0.086
0.013
0.020
0.012 .
0.022
0,026
0.030
0.032
0.012
0.022
0.011
0.021
0.015
0.034
0.022
0.017
0.026
0.014
0.014
284
283
278
284
274
316
245
302
290
264
282
331
2S5
325
297
293
331
253
250
271
271
296
312
281
276
281
282
297
227
243
296
277
277
228
265
306
281
281
297
230
                                   D-92
                                                                                       o /?
                                                                                       o to

-------
                                                                    Study Ho.  5221.08
       SUBCHRONIC TCX1CITY OF  PARA-CRESOL  IN SPRAGUE DAULEY RATS

                     FEMALE ORGAN WEIGHT DATA (g)

                         [Terminal  Sacrifice]
                ANIMAL NO.   HEART    LIVER  SPLEEN  KIDNEY-LFT  KIDNEY-RT

 DOSE LEVEL



175 mg/kg/day
600 mg/kg/day
3S61
3362
3363
3864
3865
3666
3867
3863
3869
3870
2871
3872
3873
3874
3875
3876
3877
3878
3879
3880
3891
3892
2893
3894
3895
3896
3897
3898
3900
3901
3902
3903
3904
3905
3906
3907
3903
3909
0.968
1.051
1.109
0.886
0.951
1,096
0.937
1.073
1.124
0.983
1.176
1.006
0.983
0.973
1.072
1.037
0.975
0.999
0.930
0.908
0.932
0.767
1.036
1.001
0.920
1.878
1.001
1.006
0.945
1.069
0.861
0.936
1.087
0.940
O.B63
0.975
1.145
1.060
9.340
10.500
10.839
10.412
3.351
8.572
3.121
10.921
10.260
9.065
10.341
9.934
9.611
8.647
10.331
8.954
8.510
10.387
7.964
8.267
8.839
7.645
10.198
9.786
9.638
8.436
10.137
9.620
8.231
10.050
7.981
9.939
9.315
9.359
8.277
9.575
11.402
9.527
0.433
0.415
0.626
0.572
0.574
0.455
0.464
0.539
0.429
0.637
0.589
0.564
0.444
0.413
0.422
0.451
0.578
0.552
0.427
0.495
0.398
0.441
0.551
0.542
0.562
0.530
0.514
0.578
0.458
0.552
0.557
0.501
0,512
0.446
0.316
0.469
0.504
. 0.454
1.212
1.063
1.191
1.150
1.179
1.094
1.007
.1.228
1.434
1.210
1.109'
1.258
1.140
1.104
1.209
1.121
1.116
1.263
1.029
0.941
1.011
0.851
1.344
1.130
1.343
1.104
1.609
1.159
0.877
1.162
1.041
1.050
1.035
1.273
1.039
1.193
1.289
1.362
1.227
1.067
1.199
1.146
1.286
1.003
0.967
1.300
1.202
1.257
1.174
1,280
1.129
1.136
1.205
1.153
1.105
1.280
1.015
0.961
1.076
0.892
1.367
1.289
1.369
1.100
1.349
1.194
0.864
1.330
1.001
1.026
1.030
1.207
1.046
1.210
1.359
1.353
                                                                                *'  O "!
                                                                                1.8 Y


                                D-93

-------
                                                                Study Mo. 5221.08
             SUBCHRQNIC TQXICITY OF 'PARA-CRESOL  1M SPRAGUE DAWLEY RATS
                          FEMALE ORGAN WEIGHT DATA (3>
                              [Terminal Sacrifice]
               ANIMAL NO.  OVARY-LFT  OVARY-RT  ADRENALS  BRAIN  THY./PARA.  TERM.yCT,
 DOSE  LEVEL
175  mg/kg/day
600 mg/kg/day
3861
3862
3363
3864
3865
3866
3867
3868
3869
3870
3 371
3872
3873
3874
3875
3876
3877
3878
3879
3880
3891
3892
3893
3394
3895
3896
3897
3898
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
0.025
0.021
0.034
0.049
0.029
0,045
0.045
0,044
0.025
0.056
O.D38
0.039
0.035
0.027
0.028
0.030
0.041
0.041
0.040
0.032
0.022
0.034
0.021
0.045
0.036
0.045
0.036
0,064
0.024
0.060
0.039
0.017
0.017
0.041
0.023
0.037
0.023
0.034
0.025
0.016
0.052
0.047
0.027
0.044
0.050
0.043
0.031
0.057
0.042
0.046
0.036
0.026
0.029
0.039
0,040
0.045
0.037
0.029
0.029
0.019
0.029
0.073
0.050
0.056
0.045
0.046
0.014
0.029
0.033
0.020
0.025
0.052
0.023
0.045
0.022
0.025
0.074
0.054
0.026
0.052
0.065
O.C78
0.057
. 0.055
0.071
0.074
0.060
0.068
0.057
0.064
0.060
0.064
0.063
0.064
0.062
0.048
0.057
0.056
0.072
0.076
0.066
0.071
0.078
0.057
0.061
0.071
O.OS6
0.056
0.041
0.055
O.Q66
0.074
0.077
0.063
2.042
1.37&
2.111
1.961
2.191
2.035
1.988
1.983
1.968
2.094
2.056
1.987
2.076
2.141
2.083
1.949
2.121
2.062
1,931
1.919
'1.933
1.794
2.041.
1.905
2.088
1.931
2.135
1.944
1.825
2.081
1.883
1.801
1.844
1.849
2.004
1.968
2.095
1.910
0.017
0,021
0.056
0.015
0.020
0.017
0.022
0.020
0.021
0.038
0.023
0.016
0.013
0.013
0.024
0.020
0.013
0.030
0.023
0.018
0.018
0.013
0.013
0.029
0.031
0.030
0.035
0.026
0.012
0.029
0.022
0.019
0.016
0.019
0,016
0,015
0.027
0.021
257
292
287
276
245
290
255
319
296
272
346
301
302
292
295
281
272
277
255
273
249
210
279
276
260
274
282
303
249
274
249
262
300
246
218
277
304
269
                                                                              18*
o
                                 D-94

-------
                                                                    Study No. 5221.03
      SUBCKROWIC TQXICm  OF  PASA-CRESOL  IN SPSAGUE DAWLEY RATS
     RELATIVE FEMALE  ORGAN WilGHT  DATA  
-------
                                                                  Study No. 5221,08
         SUBCHRONIC TOXICSTY OF PARA-CRISQL IN SPRACUE DAULEY  RATS
        RELATIVE FEMALE ORGAN WEIGHT DATA tt Terminal  Body Weight)
                          [Terminal Sacrifice]
               ANIMAL NO.  QVA8Y-LFT  OVARY-RT  ADRENALS  BSAIN  THY,/PAW.
'DOSE LEVEL
 0 mg/kg/day
50 mg/ks/day
3801
3802
3803
3804
3805
3806
3807
3808
3809
3810
3811
3812
3813
3814
3815
3816
3817
3818
3819
3820
3831
3832
3833
3834
3835
3836
3837
3838
3839
3840
3841
3842
3843
3844
384S
3846
3847
3843
3849
3850
0,015
0.011
0.013
0,015
0.020
0,014
0.017
0.009
0.013
0.017
0.019
0.017
0.009
0.014
0.021
0.016
0.018
0.014
0.015
0.007
0.017
0.017
0.018
0.010
0.013
0.017
O.QOS
0.011
0.019
0.020
0.015
0.013
0.011
0.015
0.017
0.015
0.020
0,013
0.018
0.019
0.015
0.025
0.014
0.027
0.018
0.014
0.013
0.019
0.016
0.01S
0.015
0.018
0.009
0.024
0.018
0.015
0.015
0.017
0,016
0.010
0.018
0.021
0.019
0.012
0.011
0.015
0.022
0.005
0.018
0.019
0.015
0.014
0.013
0.015
0.017
0.016
0.015
0.032
0.015
0.016
0.020
0.031
0.028
0.022
0.022
0.017
0.022
0.022
0.029
Q.C24
0.025
0.021
0.024
0.022
0.018
0.022
0.022
0.020
0.023
0.024
0,024
0.019
0.016
0.023
0.025
0.021
0.020
0.019
O.C23
0.026
0.024
0.021
0.023
0,023
0.032
0,029
0.023
0,026
0.022
0.026
0.764
0.756
0,729
0.668
0.705
0.678
0.794
0.702
0.749
0.800
0.754
0.598
0.720
0.680
0.695
0.642
0.650
0.817
0.80&
0.751
0.790
0.753
0.650
0.765
Q. 742
0.733
0.744
0.740
0.898
a. 821
0.715
0.737
0.726
0.337
0.311
0.691
0.743
0.767
0.676
Q.867
0.008
0.011
0.004
0,003
0.009
0.007
0.005
0.004
0.009
0.013
0.010
0.005
0.003
0.006
0.007
0.004
0.005
0.008
0.006
0.006
0.010
0.029
Q. 004
0.007
0.004
0.008
0.009
0.010
0.014
0.005
0.007
0.004
0.003
0.007
0.013
0.007
0.006
0.009
0.005
0.006
                                                                           190
                              D-96

-------
                                                                     Study Ho. 5221.08
      SUBCHRONIC TOX1CITY OF PA.RA-CRESOL IN SPRAGUE  DAULEY  RATS
     RELATIVE FEMALE ORGAN yglGHT DATA {% Terminal Body Weight}
                        [Terminal Sacrifice!
                ANIMAL NO.   HEART  LIVER  SPLEEM   KIDNET-LFT   KIDNEY-RT
 DOSE LEVEL

175 mg/kg/day
600 mg/kg/diy
3861
3862
3S63
3864
3865
3866
3867
3868
3869
3870
3871
3872
3873
3874
3875
3876
3877
3878
3379
3880
3891
3892
3893
3894
3895
3896
3897
3893
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
0.377
0.360
0.386
0.321
0.388
0.37B
0.387
0.338
C.380
0.361
0.340
0.334
0.325
0.333
0.363
0.369
0.353
0.361
0.365
0.333
0.374
0.36S
0.371
0.363
0.354
0.685
0.355
0.332
0.380
0.390
0.346
0.357
0.362
0.382
0.396
0.352
0.377
0.394
3.634
3.596
3.794
3.772
3.613
2.956
3,185
3.424
3.466
3.333
2.989
3.300
3.182
2.961
3.502
3.186
3.129
3.750
3.123
3.028
3.550
3.640
3.655
3.546
3.707
3.079
3.595
3.175
3.326
3.668
3.205
3.794
3.272
3.804
3.797
3.457
3.751
3.542
0.170
0.142
0.218
0.207
0.234
0.157
0.182
0.169
0.145
0.253
O.T70
0.187
0.147
0.141
0.143
0.160
0.213
0.199
0.167
0.181
0.160
0.210
0.197
0.196
0.216
0.193
0.182
0.191
0.184
0.201
0.224
0.191
0.171
0.181
0.145
0.169
0.166
0.169
0.472
0.364
0.415
0.417
0.481
0.377
0.395
0.335
0.484
0.445
0.321
0.418
0.377
0.378
0.410
0.399
0,410
0.458
0.404
0.345'
0.406
0.405
0.4S2
0.409
0.517
0.403
0.571
0.383
0.352
0.424
0.418
0.401
0.345 '
0.517
0.477
0.431
0.424
0.506
0.477
0.365
0.418
0.415
0.525
0.346
0.379
0.403
0.406
0.462
0.339
0.425
0.374
0.389
0.408
0.410
0.406
0.462
0.398
0.352
0.432
0.425
0.490
0.467
0.527
0.401
0.478
0,394
0.347
0.485
0.402
0.392
0.343
0.491
0.480
0.437
0.447
0.505
                                                                                  1 Cl 1
                                                                                  .j- \J JL
                                 D-97

-------
                                                                                                Study No. 5221.08
                                     SUBCHRONIC TOX1CITY  OF  PARA-CRESOL  IN SPRAOJE DAULEY RATS
                                    RELATIVE  FEMALE  ORGAN WEIGHT DATA  (X Terminal Body Weight)
                                                       [Terminal Sacrifice]
                                            ANIMAL  NO.  CVARY-LFT  OVARY-RT  ADRENALS  BRAIN  THY./PARA.
                             DOSE  LEVEL
                            175  mg/kg/day
f
                           600  mg/kg/day
3861
3862
3863
3364
3865
3866
3867
3868
3869
3870
3871
3872
3873
3874
3875
3876
3877
3878
3879
3880
3891
3892
3893
3894
3895
2896
3897
3898
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
0.010
0.007
0.012
0.018
0.012
0.016
0.018
C.014
0.008
0.021
0.011
0.013
0.012
0.009
0.009
0.011
0.015
0.015
0.016
0.012
0.009
0.016
0.008
0.016
0.014
0.016
0.013
0.021
0.010
0.022
0.016
0.006
0.006
0.017
0.011
0.013
0.008
0.013
0.010
0.005
0.018
0.017
0.011
0.015
0.020
0.013
0.010
0.021
0.012
0.015
0.012
0.009
0.010
0.014
0.015
0.016
0.015
0.011
0.012
0.009
0.010
0.026
0.019
0.020
0.016
0.015
0.006
0.011
o.ois
0.003
0.008
0.021
0.011
0.016
0.007
0.009
0.029
0.018
0.009
0.019
0.027
0.027
0.022
0.017
0.024
0.027
0.017
0.023
0.019
0.022
0.020
0.023
0.025
0.023
0.024
0.018
0.023
0.027
0.026
0.028
0.025
0.026
0.028
0.019
0.024
0.026
0.022
0.021
0.014
0.022
0.030
0.027
0.025
0.023
0.795
0.642
0.736
0.711
0.894
0.702
0.780
0.622
0.665
0.770
0.594
0.660
0.687
0.733
0.706
0.694
0.780
0.744
0.757
0.703
0.776
0.854
0.732
0.690
O.B03
0.70S
0.757
0.642
0.733
0.759
0.756
0.687
0.615
0.752
0.919
0,710
0.689
0.710
0.007
0.007
0.020
0.005
0.008
0.006
0.009
0.006
0.007
0.014
0.007
0.005
0.004
0.004
0.008
0.007
0.005
0.011
0.009
0.007
0.007
0.009
0.005
0.011
0.012
0.011
0.012
0.009
0.005
0.011
0.009
0.007
0.005
0.008
0.007
0.005
0.009
0.008
                                                                                                            J
                                                             D-98

-------
                                                                                   Study No.  5221.08
                             SUBCHROM1C  TOXIC1TY OF PftRA-CRESOL IN SPRAGUE DAULEY RATS
                                               MALE URINALYS1S DATA
                                                [Interim Sacrifice]
                Animal  no.   App.   Vol.  (ml)   Sp, Gr.  Color   pH  Protein  Clucose  Ketones  Uro.   Bill.   Blood Hgb.
 DOSE LEVEL
 0 mg/kg/day
50 mg/ki/day
175 mg/kg/day
600 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3668
3669
3670
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3751
3752
3753
3754
3755
3756
3757
3758
3759
3760

hi
cl
hz
ct
hz
ct
cl
cl
cl
hz
cl
cl
hz
hz
cl
cl
cl
cl
el
hz
Cl
hi
hz
cl
cl
hz
cl
 cl
cl
cl
hz
cl
cl
hz
hz
cl
cl
hz
hz
hz

10
15
15
15
13
15
13
15
15
4
15
15
15
9
7
13
15
15
15
15
15
14
13
9
15
14
15
12
12
14
15
15
15
15
15
15
15
15
15
8

10.340
1.029
1.030
1.021
1.020
1.030
1.033
1.030
1.031
>1.Q35
>1.035
1.021
1.023
>1.035
s-1.035
>1.035
1.016
1.027
1.026
1.029
1.018
1.012
1.026
1.025
1.027
1.017
1.030
>1.035
>1.035
>1.035
1.033
1.026
1.033
1.020
1.025
1.033
1.034
1.024
1.035
>1 .035

y
y
y
ly
y
a
y
y
y
Y
y
ly
y
y
y
y
s
y
y
y
ly
s
y
s
y
s
s
y
y
s
y
s
y
y
ly
s
y
y
s
y

6.5
9.0
6.5
9.0
7.0
8.0
7.0
6.5
7.5
5.5
5.5
9.0
6.5
5.5
6.5
7.5
6.5
9.0
6.5
5.5
8.0
7.5
6.5
8.0
6.5
7.5
7.0
6.5
7.0
6.5
6.5
7.5
6.0 
6.0
6.0
6.0
6.5
5.6
6.0
6.5

1*
tr
2+
1 +
2+
2+
2*
2+
2*
2*
3+
1*
1+
2+
1+
2+
1 +
Z+
1*
2*
1+
2+
1+
3+
1*
1+
2*
2+
3+
2+
1+
1*
1+
tr
tr
tr
tr
tr
1 +
2+

nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr

1+
ng
1+
ng
ng
1 +
ng
H
ng
2+
1*
ng
1*
ng
1*
1 +
ng
ng
ng
1*
1+
"3
"3
1 +
1 +
ng
1+
1+
1+
1+
1 +
1+
1 +
ng
ng
1*
1+
ng
ng
ng

nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
1+
1+
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
-f
ng
1 +
ng
ng
ng
ns
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
"9
ng
ng
ng
ng
ng
ng
ng
ng ,
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
90
0
ng
ng
50ery\ul
ng
"3
ng
50ery\ul
SQeryAuV
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
10ery\ul
ng
ng
ng
10ery\ui
ng
ng
ng
10ery\ul
10ery\ul
r.9
10ery\ul
ng
ng
ng
ng
ng
ng
50ery\ul
ng
ng

                                              D-99

-------
                                                                      Study No. 5221.08
                SUBCHRON1C TQXICITY  OF  PARA-CRESOL  IN SPRAGUE DAytSY RATS
                                  HALS  URINALYSIS DATA
                                   [Interim Sacrifice]
                Animal no.  RBC/HPF  WBC/HPF   EPI/HPF   CASTS/IFF  CRYSTALS  YEAST  BACTERIA
 DOSE LEVEL
 0 nig/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
3661
3662
3663
3664
3665
3666
3667
3678
3669
3670
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
' 3721
3722
3723
3724
3725
3726
3727
3728
3729
3730
3751
3752
3753
3754
3755
3756
3757
3758
3759
3760
0
0
3-4
0
0
0
2-3
2-3
0
0
0
0
0
0
0
0
0
0
0
0-1
0
0
0
0-1
0
0
0-1
0-1
0-1
0
1-2
0
3
0
0
0
0
2-4
0
0
0
0
2-3
0
0
0
0-1
0-1
0
0
0
0
0
0
0
0
0
0
0
1-2
0
0
0
0
0
0
0
0
0
0
0-1
0
c
0
0
0
0
0-2
0
0
0
0
2-3
0
0
0
0-1
2-3
0
0
0
0
0
0
0
0
0
0
0
0-1
0
0
0
0
0
0
0
0 <
2-3
0
0-1
0
0
0
0
0
0
0-1
0
0
0
o-
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
. 0
0
0
0
0
0
0
0
0
0
0
0
0
Q
0
0
0
0
0
0
0
0
tp
tp
co\tp
tp
CO
' tp
tp
co\tp
tp
CO
CO
tp
co\tp
CO
co\tp
P
tp\co
tp
tp
CO
tp
tp
tp
tp
co\tp
tp
tp\co
tp
tp
tp
eo\tp
tp
eo\tp
CO
CO
tp\co
tp
CO
CO
tp
f
m
m
occ
n
f
f
f
f
f
f
occ
n
n
f
n
f
f
f
occ
f
f
ra
n
in
n
m
m
m
n
n
n
f
n
f
n
f
f
oce
f
num
num
num
ra
m
num
nun
num
m
ra
num
Rl
m
m
num
num
num
nun
ra
num
num
num
m
m
mm
m
num
nuni
num
num
tn
m
nun
m
m
m
num
f
m
num
                                    D-100

-------
                                                                                   Study Ho. 5221.08
                             SU3CHRONIC TOXIC1TY  Of PARA-CRESOL  IN SPRAGUE DAUiEY RATS
                                               MALE URINALYSIS DATA
                                               [Terminal Sacrifice]
                Animal no.  App.   Vol.  (ml5   Sp.  Gr.  Color   pH  Protein  Glucose  Ketones  Uro.   Bili.   Blood Hgb.
 COSE LEVEL
 0 mg/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
3671
3672
3673
3674
3675
3676
3677
3673
3679
3680
3701
3702
3703
3704
3705
3706,
3707
3708
3709
3710
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3761
3762
3763
3764
3765
3766
3767
3768
3769
3770
hz
cl
cl
hi
hz
cl
cl
cl
hi
cl
cl
hi
cl
hz
hi
hi
hz
hz
hz
hz
hz
cl
cl
hz
cl
hz
cl
cl
cl
cl
hz
hz
hi
hz
hz
hz
hz
hi
hz
hz
5
5
5
5
3
5
5
5
2
5
5
5
5
5
4
5
1
4
4
4
5
5
5
5
5
5
5
5
5
5
3
5
4
5
4
4
4
5
4
4
1.021.
1.020
1.028
1.023
1.023
1.023
1.015
1.026
>1.035
>1.035
1.020
1.033
>1.035
> 1.035
1.021
1.030
>1.035
>1.035
1.030
1.027
>1.035
1 .021
1.016
1.021
1.016
1.026
>1.03S
1.024
1.024
>1.035
>1.035
1.023
>1.035
>1.035
1.013
>1.035
1.026
 1.035
>1.035
1.023
y
y
y
y
y
y
y
y
y
y
y
y
a
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
7.0
7.0
6.5
7.0
7.0
7.0
7.0
6.5
6.5
6.5
8.0
6.5
6.5
9.0
7.5
7.0
9.0
9.0
9.0
9.0
6.5
6.5
5.1
6.5
. 6.0
6.5
8.0
6.5
6.5
6.5
5.0
6.0
5.5
6.5
8.0
5.0
5.5
6.0
5.5
7.5
tr
2*
2+
2+
1+
tr
3+
tr
U
2*
2+
2*
2*
2*
2*
2+
3+
3-f
2+
2*
2+
1*
3*
1*
2+
ng
1+
2*
 2+
2+
2*
2*
2*
2+
2*
1+
1+
3*
2*
1+
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
ng
ng
ng
ng
ng
ng
ng
ng
3+
ng
ng
1*
1+
ng
ng
ng
2+
ng
nfl
ng
ng
ng
1+
. ng
1+
ng
ng
1+
1*
1+
1+
ng
1+
ng
ng
ng
ns
ng
1 +
ng
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ns
ns
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
"9
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
10ery\ul
10ery\ul
ng
ng
10ery\ul
ng
ng
ng
ng
ng
ng
ng
ns
ng
ng
ng
ng
ng
ng
ng
ng
ns
ng
50ery\ul
ng
ng
ng
ng
na
ng
ng
ns
ng
ng
"S
10ery\ul
ng
ng
                                              D-101
                                                                                                    o

-------
                                                                  Study No,  5221.08
               SUBCHRQNIC TOXIC3TY  OF PARA-CRESOL  IN SPRAGUE DAULEY RATS
                          HALi MICROSCOPIC URINALYSIS DATA
                                [Terminal Sacrifice]
               Animal  no.  RBC/HPF   WBC/HPF  EPI/HPF  CASTS/IPF  CRYSTALS  YEAST  BACTERIA
 DOSE  LIVEL
 0 mg/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3701
3702
37Q3
3704
3705
3706
3707
3708
3709
3710
3731
3732
3733
3734
3735
3736
3737
3738
3739
3740
3761
3762
3763
3764
3765
3766
3767
3768 '
3769
3770
0-1
0
0
0
0
0
0-1
0
0
0
0
0
0
0-1
0-1
a
0-1
0
0-1
0-1
0
0
a
0
0
0
0
0
0
0
0
0-1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0-1
0
0-1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
a
0
0
0
a
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
a
0
0
0
0
0
0
a
0
0
0-1
0
0
0
0
0
a
3-4
0
1-2
0
0-1
0
0
0
0
0
0
0
0
0
a
0
0
0
a
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
a
0
a
0
0
0-1
0
0
0
0
0
0
0
0
0
eo\tp
co\tp
tP
tp
tp
tp\co
tp
tP
tp
CO
tp
co\tp
CO
tp
tp
tp
tp
tp
tp
tp
CO
tp
CO
tp\eo
tp\co
co\tp
tp
tp
tp
n
CO
co\tp
CO
co\tp
tp
CO
tp\co
tp
CO
co\tp
n
n
n
n
n
n
n
n
n
n
f
f
n
n
n
f
m
m
f
f
n
f
n
n
n
f
f
n
n.
n
n
n
n
n
f
f
n
n
n
n
f
tn
n
m
f
m
f
m
f
f
nun
nuin
n
m
nun
nun
nun
nun
num
nun
f
m
m
1
m
m
m
f
f
n
m
num
num
f
num
n
m
f
num
num
                                 D-102
                                                                             196

-------
                                                                                   Study No. 5221.08
                             SUBCNRONIC TOXIC1TY Of PARA-CRESOl IN SPRAGUE DAWLEY RATS
                                             FEMALE UR1NALYSIS DATA
                                               (Interim Sacrifice]
                Animal  no.  App.  Vol. (ml)  Sp. Gr.  Color   pH  Protein  Glucose  Katones  Uro.  IHi.  Blood Hgb.
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
175 mg/kg/day
600 mg/kg/day
3791
3792
3793
3794
3795
3796
37?7
3798
3799
3800
3821
3822
3823
3824
3825
3826
3827
3828
3829
3830
3851
3852
3853
3854
3855
3856
3857
3858
3859
3860
3681
3882
38S3
3884
3885
3886
3887
3888
3889
3890
cl
hz
cl
cl
cl
hz
hz
cl
cl
hz
hz
cl
hx
cl
hz
hz
cl
cl
cl
hz
cl
cl
hz
cl
hz
cl
cl
cl
cl
hz
hz
el
dead
cl
cl
hz
hz
cl
cl
c
9
15
15
15
8
15
9
12
15
12
15
13
5
6
8
15
5
15
10
15
13
15
13
15
8
15
15
15
15
15
9
K
dead
12
7
14
11
15
15 .
12
1.025
1.016
1.021
1.028
1.028
1.013
>1.035
1.019
1.023
1.C35
1,006
1.018
> 1.035
>1.035
1.020
1.007
1.031
1.018
1.023
1.016
t.019
1.013
1.025
1.021
1.018
1.021
1.023
1,020
1.021
1.010
1.023
1.021
dead
1.030
>1.035
1.027
1.028
1.031
1.027
>1.035
iy
s
y
y
y
y
y
Y
f
y
S '
s
y
y
y
s
y
iy
y
y
s
s
y
y
s
y
y
s
s
s
y
s
dead
y
y
s
y
y
iy
y
9.0
8.0
9.0
7.5
7.0
7.0
7.5
7.0
7.0
7.0
7.0
7.0
 6.0
6.0
6.5
7.5
9.0
8.5
9.0
7.0
7.0
7.0
5.6
7.0
8.0
7.0
6.5
6.5
6.5
7.0
6.0
9.0
dead
6.5
8.0
6.5
6.5
6.0
6.0
6.0
2+
tr
1+
1+
1+
tr
tr
U
1+
1+
tr
1*
tr
1+
tr
tr
: tr
1+
2+
2*
1+
ng
1*
tr
tr
tr
tr
tr
tr
tr
2*
1+
dead
1 +
1 +
tr
1+
tr
1*
tr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
dead
nr
nr
nr
nr
nr
nr
nr
ng
ng
ng
ns
ns
1+
ng
ng
ng
1+
ng
ng
ng
1+
ng
ng
ng
"9
ng
ng
"3
ng
ng
1+
ng
ng
1+
ns
ng
ng
ng
1+
dead
ng
1+
ng
ng
1+
1+
1+
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
dead
nr
nr
nr
nr
nr
nr
nr
ng
ng
ng
ng
ng
ng
ng
1+
ng
ng
ng
ng
"9 ,
ng
ng
ng
ng
1*
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
dead
ng
ng
ng
ng
ng
ng
ng
10ery\ul
ng
ng
1Cery\ul
5ery\ul"
ng
ng
ng
ng
50ery\ul
ng
ng
tr
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
10ery\ul
ns
ng
ng
ng
ng
"S
dead
ng
ng
ng
ng
ng
50ery\ul
ns
                                              D-103

-------
                                                                      Study Mo. 5221.08
                SUBCHRONIC TQXtCm OF PARA-CRESQL  IN  SPRAGUE DAWLEY RATS
                           FEMALE HICROSCOP1C URINALYSIS  DATA
                                   Clnterim SaerificsJ
                Animal no.  RBC/HPF  WBC/HPF  EPI/HPF   CASTS/LPF  CRYSTALS  YEAST  BACTERIA
 DOS! LEVEL
 0 mi/kg/day
50 Bi/kg/day
175 mg/kg/day
600 mg/ki/day
3791
3792
3793
3794
3795
3796
3797
3798
3799
3800
3321
3822
3823
3824
3825
3826
3827
3328
3829
3830
3851
3852
3353
3854
3855
3856
3857
385S
3859
3860
3881
3882
3883
3884
3885
3886
3887
3888
3889
3890
0
0
0
0
0
0
0
0
0
2-3
0
0
0
0
0
0
0
Q
0
0
0
0
0
0
0
0
0
a
0
0
0
0
dead
0
0
0
0
0-1
23
Q
0
0
0
0
0
0
0
0
0
0-1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Q
0
0
0
dead
0
D
0
0
0
1-2
0
0
0
0
0
0
0
0
0
Q
0
Q
0
0
0
0
0
0
Q
0
0
0-1
0
0
0
0
Q
0
0
' 0
Q
0
0
dead
0
0
0
0
0
1-2
0-1
0
0 .
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
dead
0
0
0
0
0
0
0
tp
tp
tp
tp
co\tp
tp
tp
co
tp
tp
tp
tp
CO
tp\co
tp
tp
tp
tp
tp
tp\eo
tp
eo\tp
CO
tp.
tp
tp
tp
tp
CO
tp
CO
tp
dead
co\tp
tp
C<5\tp
tp
tP
tp\eo
CO
f
f
f
f
m
n
m
m
n
f
n
m
n
f
f
n
f
m
tn
n
oce
m
m
f
n
n
ra
f
f
n
f
oee
dead_
m
f
f
f
n
f
n
num
m
m
nun
nun
num
num
m
num
n
nm
m
m
f
m
m
m
m
nun
m
ra
m
m
nun
f
ft!
m
num
m
m
num
num
dead
nun
nun
nun
n
m
m
f
                                  D-104

-------
                                                                                    Study No.  5221.08
                             SUBCHSONIC TOXICITY of PARA-CRESGL IN SPRAGUE  DAWLIY RATS
                                              FEMALE URINALYSES DATA
                                               [Terminal  Sacrifice]
                Animal no.  App.  Vol. (ml)  Sp.  Gr.  Color   pH  Protein  Glucose  Ketones  Uro.  Bill.  Blood Wgfa.
 OOSE LEVEL
 0 mg/kg/day
50 mg/lcg/day
175 mg/kg/day
600 nig/kg/day
380 1
3802
3803
3804
3805
3806
3807
3803
3809
3810
3831
3832 
3333
3834
3835
3836
3837
3838
3839
3840
3861
3862
3863
3864
3865
3866
3867
3863
3369
3870
3891
3892
3893
3894
3895
3896
3897
3898
3899
3900
3901
cl
cl
hz
hz
cl
hz
hz
hz
cl
cl
cl
cl
cl
hz
hz
hz
cl
cl
cl
hz
hz
hz
cl
hz
cl
hz
hz
hz
cl
cl
hz
hz
hz
cl
cl
cl
cl
hz
dead
hz
cl
5
2
4
4
5
4
5
4
4
5
5
5
5
5
5
4
5
5
5
5
5
5
5
4
4
3
5
5
4
5
3
4
5
5
5
5
4
4
dead
4
5
1.010
>1.03S
1.012
1.017
1.025
1.022
1.018
1.011
1.034
1.016
1.009
1.030
1.017
>1.035
1.016
1.025
1.027
1.026
1.029
1.020
1.030
>1.035
>1.035
1.022
1.009
>1.035
1.017
1.016
>1.035
1.030
>1.035
1.014
1.013
1.018
>1.035
>1.035
1.023
1.031
dead
1.023
1.029
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
y
dead
y
y
7.0
6.0
7.0
6.5
6.0
9.0
9.0
6.5
6.0
6.5
7.0
6.5
6.0
6.5
6.5
6.5
6.5
6.5
6.5
6.5
7.0
6.5
5.0
9.0
6.5
6.5
8.0
9.0
5.5
6.0
6.5
6.0
7.0
6.5
6.0
5.5
6.0
7.0
dead
7.5
6.0
tr
U
tr
tr
ng
1+
tr
2+
1+
tr
ng
tr
ng
2+
tr
2+
1 +
tr
ng
tr
tr
2
1+
tr
ng
tr
tr
tr
1 +
tr
2+
1+
tr
tr
1+
1+
tr
2+
dead
1+
tr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
dead
nr
nr
ng
1*
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
. ng
ng
ng
ng
ng
ng
dead
ng
ng
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
nr
dead
nr
nr
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
dead
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
10ery\ul
ng
50ery\ul
250ery\ul
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
ng
dead
ng
ng
                                               D-105
                                                                                           4 C> f-l
                                                                                           1 b J

-------
                                                                      Study Wo, 5221.08
                SUBCHROH1C TOXICITY CF PARA-CRESOL  IN  SPRAGUE DAWLEY RATS
                           FEMALE'MICROSCOPIC  URINALYSIS DATA
                                  [Terminal  Sacrifice!
                Animal no.   RBC/HPF  VJ9C/HPF   EPI/HPF   CASTS/LPF  CRYSTALS  YEAST  BACTERIA
 DOSE LEVEL
 0 ing/kg/day
50 mg/kg/day
175 mg/kg/day
00 mg/kg/day
3801
3302
3803
3804
3805
3806
3807
3803
3809
3810
3831
3832
3833
3834
3835
3336
3837
3838
3839
3840
3861
3362
3863
3864
3865
3866
3867
3863
386?
3870
3891
3892
3393
3894
3895
3896
3897
3898
3899
3900
3901
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0-1
0
0
2-3
0
0
0
0
0
0
0
2-3
0
0
0
0
0
0
0
dead
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
dead
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1-2
dead
0
0
0
0
0
0
0
, 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0 .
0
0
dead
0
0
tp
CO
tP
CO
tp
tp
tp
tp
tp
CO
tp\co
tp
CO
ccAtp
tp
tp\co
n
co\tp
tp\co
co\cp
tp\co
co\rp
coUp
tP
n
CO
tp
tp
n
tp
co\tp
eo
tp
n
CO
CO
CO
tp\co
dead
"UP
CO
n
n
n
n
n.
f
n
n
f
n
n
n
n
n
n
m
n
n
n
n
f
f
f
f
n
n
n
n
n
f
m
n
n
n
f
n
n
n
dead
n
n
n
f
m
f
1
m
m
num
n
f
f
m
n
m
i
nun
f
m
f
f
m
f
f
m
n
nun
f
m
f
n
nun
m
m
f
m
f
f
m
dead
nun
n
                                 D-106

-------
                         Study No. 5221.08
    APPENDIX E

OPHTHAIMOIDGY REPORT
                *t! A 1
                ,- V? 4-

                            MICROBIOLOGICAL
                            ASSOCIATES INC.

-------

-------
                                                       Study No. 5221,08
                      SUBCHRDNIC TOXZCTTY OF PARA-CRESOL
                            IN SPE&OJE DAWLEY RATS

                             ABBREVIATION CODES
Eye Examinations

nvl  = no visible lesions
dead = unscheduled death
ph   = persistent hyaloid
e    = conjunctivitis
f    = small amount of hyphens.
g    = cornea! opacity, vitreal clot
h    = vitreal hemorrhage
                                 E-2

-------

-------
                 Nancy M. Bromberg, V.M.D., M.S.
                 Diplomate, American College of Veterinary Ophthalmologists
                 4105 Brandywine Street, Northwest
                 Washington, D.C. 20016
                 202^363-7303
 Y E  C I
t Q B  A N I M A I S


   Barry S.  Levine, D.Sc., DABT
   Microbiological Associates, Inc.
   5221 River Road
   Bethesda, MD  20816
September 25,  1986
   SUBJECT:  Ophthalmoscopic Evaluations
             Study 5221 .08

   PRETEST EXAMINATION October  10,  1985

           All animals examined were  found  to have no visible lesions except
   the following:

      Male 3672 - persistent hyaloid  remnant left eye
      Male 3748 - persistent hyaloid  remnant right eye
      Male 3766 - small amount of hyphema secondary to persistent hyaloid right  eye
      Female 3871 - persistent hyaloid remnant left eye
           Persistent hyaloid remnant is a  common developmenatal finding in
   young rats.

   TERMINAL EXAMINATION January 10,  1986

           All animals examined had  no visible lesions except the following;

      Male 3707  (50 mg/kg/day) - bilateral  conjunctivitis with brick red serous
                                 discharge  (consistent with problems associated
                                 with bad teeth!
      Female 3809 (o rag/kg/day) - vitreal hemorrhage right eye
      Female 3865 (175 mg/kg/day) -  corneal opacity and small vitreal clot in
                                     left eye

           Based on the distribution  of  the above abnormalities identified at
   terminal examination, they were  not considered treatment related.
                                           Naflcy M.flromlierg, V.M.D.,
                                           DiplomatW, A/C.V.O'.
                                             E-3

-------
                                                                        Study No. 5221.08
                     5UBCHRCNIC TOXICITY OF PARA-CRE.SQL IN SPRAGUE DAULEY RATS
                                     HALE EYE EXAMINATIONS
               Animal  no.  PRETEST-Right Eye  PRETEST-left Eye  TERMINAL-Right  Eye  TERHINAL-Lef t Eye
 DOSE LEVEL
 0 mg/kg/day
50 mg/kg/day
3671
3672
3673
3674
3675
3676
3677
3678
3679
3680
3681
3682
3683
3684
3685
3686
3687
3688
3689
3690
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3713
3719
3720
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
ph
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvt
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl .
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
e
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvt
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
e
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
                                         E-4
                                                                             204

-------
                                                                            Study No. 5221.03
                      SUBCHRONIC TOXICITY OF PARA-CRESQL  IN  SPRAGUE DAULEY RATS
                                        MALE EYE  EXAMINATIONS
                Animal no.   PRETEST-Right Eye  PRETEST-Left  Eye   TERHINAL-Right Eye  TERMlNAL-Left Eye
 DOSE LEVEL

175 mg/kg/day
fiOO mg/kg/day
3731
3732
3733
3734
373S
3736
3737
3733
3739
3740
3741
3742
3743
3744
3745
3746
3747
374S
3749
3750
3761
3762
3763
3764
3765
3766
3767
3768
3769'
3770
3771
3772
3773
3774
3775
3776
3777
3778
3779
3780
nvL
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
ph
nvl
nvl
nvl
nvl
nvl
nvl
nvl
f
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
. nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
 nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl '
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvt
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl

-------
                                                                            Study No. 5221,08
                      SU8CHROK1C  TOX1CITY OF PARA-CRSSQl IN SPHAGUE DAUIEY RATS
                                       FIKALE EYE EXAMINATIONS
                Animal  no.   PREIEST-Right  Eye  PRETEST-left Eye  TERMINAL-Right Eye  TERMlNAL-teft Eye
 DOSE LEVEL
 0 rng/kg/day
50 mg/kg/day
3801
3802
3803
3804
3805
3BC6
3807
3808
3809
3310
3811
3812
3S13
3814
3815
3816
3817
3818
3819
3820
3831
3832
3833
3834
3835
3336
3537
3333
3839
3340
3841
3842
3843
3344
3845
3846
3847
3848
3849
3850
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvt
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
'nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
 nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
h
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl 
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
                                          E-6

-------
                                                                            Study No.  5221.08
                      SUBCKRONIC TCXJCITY  OF  PARA-CRESQl IN SPRAGUE DAUIEY RATS
                                       FEMALE EYE EXAMINATIONS
                Animal  no.   PRETEST-Right  Eye   PRETEST-Left Eye  TERMIMAL-Right ya  TERMlNAl-Left Eye
 DOSE LEVEL

175 mg/kg/day
600 mg/kg/day
3861
3862
3863
3864
3865
3866
3867
3868
3869
3B7Q
3371
3872
3873
3374
3375
3376
3877
3873
3879
3880
3891
3892
3893
3S94
3895
3896
3897
3898
3899
3900
3901
3902
3903
3904
3905
3906
3907
3908
3909
3910
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
ph
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvt
nvl
dead
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
dead
nvl
nvl
nvl
nvl
9
nvl
nvl
nvl
nvt
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvt
nvl
dead
nvt
nvt
nvl
nvl
nvl
nvl
nvl
nvl
nvl
nvl
dead
                                           S-7

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Page Intentionally

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  APPENDIX F

PATHOLOGY REPORT
                     Study No. 5221,08
                              208
     F-1               ^ MICROBIOLOGICAL
                         ASSOCIATES INC.

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Page Intentionally Blank

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SUBCHRONIC TOXICITY OF PARA-CRESOL
      IN 5PRAGUE DAWLEY RATS
          PREPARED FOR

 MICROBIOLOGICAL ASSOCIATES, INC.
                                        >i v *-

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Page Intentionally Blank

-------
                    TABLE OF CONTENTS
                                            PAGE
 (. PATHOLOGY NARRATIVE

 II. PROJECT SUMMARY TABLE

III. TABULATED ANIMAL DATA

IV. GROSS VS. MICROSCOPIC FINDINGS
    Terminal Sacrifice
    Interim Sacrifice

 V. INTERIM SACRIFICE-EARLY DEATH

VI. QUALITY ASSURANCE STATEMENT

   APPENDIX  1 REPORTS CODE TABLE
   APPENDIX 2 ABBREVIATION LIST
IV-1
IV-44

V-l

Vl-l
                                                    *? 1
                                                    r-v .X

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Page Intentionally Blank

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                          FINAL REPORT AMENDMENT





 STUDY  MAMS  Subchrom'c Toxicitv of  Para-Cresol  in SoramiP Oawlgv Rats	



 STUD?  NUMBER 5221.08	._	^_	



 INITIATION  DATS October 16,  1985   pATE OP  FINAL REPORT June 5,  1986



 PART OF FINAL REPORT  TO BE AMENDED  (EXACT LOCATION)Table of  Contents.



    Pages 1-2. 1-3, 1-4 and V-l, Divider pages for sections V and VI.	



 REASON FOR  THE AMENDMENT The Table of Contents was changed to reflect the



    proper title  of Quality Assurance Statement,  not Quality Assurance Report.



    A paragraph was added on p.  1-2 to address three early death animals. The



    other pages were changed due to format requirements resulting from the add-



    ition of the  new paragraph.  Page  V-I was inadvertantly omitted from the final


    See  attached  page.

 AMENDMENT  (Attach  additional  sheets as  necessary)     	
    TABLE OF  CONTENTS should read  Quality Assurance  Statement.	



    P.1-2 The last sentence in  the first paragraph  is deleted.  A new  second



    paragraph beginning with "Three high-dose female rats..."  is added.



    P.  1-3 and 1-4 reformated due  to additional  paragraph.



    Section V Divider Page should  read "V. INTERIM  SACRIFICE- EARLY DEATH"



    Page V-l.  (See attachment)  is  added.



    Section VI  [Divider Page should read VI. QUALITY  ASSURANCE STATEMENT.


APPROVALS
SKTODY DIRECTOR       /
 A      o n   i   I
 0/4*14  o. C/Avv/
DATS /                                  ""T-
_                                             In-lM
DATE                                            QUALITY ASSURANCE
                                                                 ? 1  1
                                                                 * JL  J.

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Page Intentionally

-------
REASON FOR THE AMENDMENT (cont.)
report.   Divider pages for Section V and VI accompany the previously
omitted  Section V and the Quality Assurance Statement.

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Page Intentionally Blank

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I. PATHOLOGY NARRATIVE
61
                                       -\ O
                                       1 O

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                SUBCHRONIC  TOXIC1TY  OF PARA-CRE50L
                       IN 5PRAGUE  DAY/LEY RATS
                        Experiment No. 5221.08

                           PATHOLOGY  REPORT

                      INTRODUCTION  AND METHODS

      A 13 week gavage  study was conducted on Sprague Dawley  rats  to
determine the toxicity of p-cresol.  Male and female rats were divided into 5
groups at study initiation:
                                    Dose Level             Huiftbenpf, Animals
   Group    Treatment               fmg/kq/day)           Mate        Female

    1        Negative Control           Vehicle only           30*          30*
    2       p-cresol                   50                30*          30*
    3       p-cresol                   175               30*          30*
    4       p-cresol                   600               30*          30*
    5       Baseline clinical             	               10**         10**
            pathology

   *10 animals sacrificed during study week seven (interim sacrifice);  20 sacrificed after 13
   weeks for histopatholcg/ (terminal sacrifice)
   "Sacrificed prior to study initiation

      Animals  were  gavaged  daily,  7 days a week;,  for 13  weeks.   Dosed
animals received p-cresol  in a corn-oil vehicle at 5  ml/kg body  weight.
Negative  control  animals  received corn-oil  vehicle  only,   At the  interim
sacrifice, all scheduled  rats  were killed using carbon dioxide gas and were
necropsied.  All required tissues  (see  below) were  fixed in formalin  for
possible future evaluation. At the  terminal sacrifice, all surviving rats were
killed using carbon dioxide gas and were necropsied.  Body and organ weights
(heart,  liver,  spleen, brain,  kidneys [individually],  gonads [individually],
adrenals, and thyroids/parathyroids), were recorded for  all rats  at terminal
sacrifice.  All  tissues specified by  the protocol were fixed  in 10%  neutral
buffered formalin.  Protocol   specified tissues included all  gross lesions,
brain,  eyes, pituitary,  salivary  glands,  heart,  thymus,  thyroids (with
parathyroids),  lungs (with mainstem bronchi),  trachea, esophagus, stomach,
small and large intestines, adrenals, pancreas, liver, kidneys, urinary bladder,
testes,   prostate,   ovaries,   corpus and cervix uteri,  spleen,  bone (with
marrow), skeletal muscle,  lymph  node, spinal cord,   mammary  gland/skin,
aorta, sciatic nerve.
                                                                     214-

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Page Intentionally Blank

-------
                                       TilB i'AOE SE'/lSSD
      Fixed  tissues  were  trimmed,  dehydrated,  embedded  in  paraffin,
sectioned at 5jim and stained with hematoxylin and eosin.   Representative
sections were examined  from all control, and high (600 rng/kg) dose rats of
both sexes.  All gross lesions from  terminal sacrifice rats and from  interim
sacrifice  rats were evaluated and are listed in table  form in  Chapter  IV.
Potential  target organs  (kidney in  male;  trachea .in male  and female) were
evaluated for all low (50 mg/kg) and mid dose (175 mg/kg)  terminal sacrifice
rats.

      Three high-dose female rats  were found dead during the course of the
study.  In each case the cause of death was uncertain.  Animal No. 3899 and
Animal No. 3910  were from  the terminal sacrifice group.  The microscopic
findings  and the  gross-microscopic  correlations  are included  with their
respective group.   The gross and microscopic for Animal No. 3883, originally
scheduled for interim sacrifice, are reported in Chapter V.

      Results from all complete histopathologic examinations as well as all
target organs in low and  mid dose terminal sacrifice rats were recorded into
a computer which required an accounting  for  every organ listed in  the
protocol.  Computer generated tables are included in the following sections of
this  report.  Where appropriate, incidences of lesions between  treated and
control animals were compared using Fishers Exact Test.

                               RESULTS

      Tracheal epithelial metaplasia was noted in high dose male and female
rats  but not in control rats of either sex (statistically significant, at P<0.05).
This  lesion was characterized by multifocal to diffuse  replacement of goblet
and  secretory  granular  cells by  squamous  epithelial cells which were
flattened,  had   nuclei   parallel  to  the   basement  membrane   and were
occasionally stratified.  Trachea,  therefore, was considered a target organ
and was examined in all  low and mid dose  male rats.   The  lesion was
predominately restricted to  the  high dos9 rats and  occurred in the upper
trachea.  Bronchi and lower airways did not exhibit this change.  Three cases
noted in the mid and low  dose animals were associated with focai underlying
areas of chronic inflammation:
                                                                  ,:  i 5
                              1-2

-------
                              K
                              UlSd
                                                           /'   /
                                                           {,,(
INCIDENCE OF TRACHEAL EPITHELIA! MFTAP1 ASIA

                        SOmq/kq
0/20(02)
0/20(0-*)
0/20(02)
1/20(52)
1/20(52)
1/20(5*)
10/20(502)
9/19*(47*)
  Trachea
     Epith. Metaplasia
     Incidence- Male
     Incidence-Female

     * Trachea of one female rat was too autolytic for evaluation.


      Kidney was also considered a potential target organ in the male since a
slight increase  in incidence of minimal nep'hropathy was noted in  all dosed
male rat groups when compared to the control male rat group.  (Dosed female
rats showed no increase  in nephropathy over control female rats.) Increase in
incidence in the dosed males was significantly greater CP< 0.05) at the low
and  high  dose but  not at the middle dose.  No increase in  percentage of
severity was noted  in the dosed male rats when compared to the control male
rats (see following table).

             INCIDENCE AND SEVERITY OF CHRONIC NEPHPQPATHY
  Kidney (Male)
     Nephropathy, chronic
        Incidence

        Severity-minimal
              -mild
                         Qmg/kg
                       SQmg/kg
I75mg/kij     6QOmg/icg
           4/20(202)    11/20(55*)  7/20(352)   12/20(601)

           3/4(75*)     9/11(82*)   7/7(100?)   9/12(752)
           1/4(25*)     2/11(18*)   0/7(0*)     3/12(252)
      Certain lesions noted in the lung of  both  control and dosed male and
female rats were  suggestive of infection with an adventitious agent. These
lesions consisted of perivascular lymphocytic infiltrate and scattered foci of
chronic  interstitial  inflammation.  No specific etiological agent was  noted.
Statistically significant (P< 0.05) increase in the  incidence of interstitial
inflammation of the lung occurred in high dose male rats when compared to
control male rats, however a decrease  in incidence was noted in the female
rats (see following table).  Although  minimal  potentiation of interstitial
inflammation in high dose male rats can not be  ruled out, clinical significance
is questionable.
                                                                   o
                                 1-3

-------
    INCIDENCE AND SEVERITY OF PULMONARY INTFRSTIT1AI  IMF! AMMAT|OM
  Lung
     Inflam.. IS-
        Incidence

        Severity'
         minimal
         mild
       MALE

Qmg/kg       60Qmg/kg


9/20(45Z)   16/20(808}
8/9(89*)    10/16(62*)
1/9(112)    6/16(38*)
                                                       FEMALE
                                                            6QQmg/lcg
 1/20(552)  8/20(408)
5/11(452)   2/8(25)
6/1K55X)   6/8(75;?)
      Additional  lesions were of low incidence and/or equally  distributed
between control and  dosed  animals and  were considered incidental lesions
commonly seen in this age and strain of rat.
                      SUMMARY  AND CONCLUSIONS

      Sprague Dawley rats of both sexes were gavaged once a day, 7 days a
week for  13 weeks with 0,  50,  175, or 600 mg/kg of  p-cresol in  a corn-oil
vehicle.

      A statistically significant  (P  <  0.05)  increase in  the incidence  of
trachea! epithelial metaplasia was noted in the high dosed rats of both sexes
when compared to the control rats. Incidence was 50%  in the high dose males
and 47% in the high dose females. Similar, focal lesions in 3  lower dosed rats
were associated with underlying inflammation.

      Statistically significant (P < 0.05) increases in incidence of minimal to
mild chronic nephropathy occurred in low and  high dosed  male rats when
compared  to control male rats.  No statistically significant increase however
was noted for the middle dosed male rats. Clinical significance is equivocal.

      In conclusion, trachea (epithelial metaplasia) in males and females, and
possibly kidney (nephropathy) in males are considered target organs  in rats
under conditions of this study.                  ^
                                     Diana 5. Copeland, D.V.M.
                                     Diplomate, A.C.V.P.
                                     September 22 , 1986
                                1-4

-------

-------
PROJECT SUMMARY TABLE

-------


-------
PATHOLOGY  ASSOCIATES,   INC,
                  STUDY NO.  5221.08
                 SPRA8UE-MULEY  RATS
Project Summary Table
SimY: InctdsRCS ci NON-NEOPIASTIC Microscopic Findings
PROJECT 10. NO: P.CRESOL
MYS: LL
GSflUP:
NOTES OF W3MAIS:

BMIN
SCIATIC NEWS
SPIWL CORD
BCNE
80JE fWRROU
SM.MWY Sl/TO
ATROPHY
fWOIIULAR LYHPH NQEE
HEHflfiRWGE, CUTE
LYMPHOID HYPERPWS1A
THWUS
H&WRRHASc, ACUTE
HBWSIOERCSIS
B18WOIAL RBtWfT
PWCREAS
ACIfttR ATROPHY
LWHOCTTIC INFILTRATE
PITUITARY
CfST

FATES:
SEX: FEJW.E
O.D MS
20
1 I
a Ex 20
1 It j 23
S Ex 20
t Ex 20
 Ex 20
I Ex 20
0 <03
 Ex 28
0 <0>
9 <)
its 20
14 (70)
1 (S)
0 (0)
 * 23
1 (51
1 <5)
K Ex 1?
4 <2t!
Il-i
All

50 HG
20
i 7,
0
0
0
a
0
0
0
5
D
i!
o-
0
0
0
0
3
0
0
0



175MB
20
1 X
0
D
0
B
0
0
0
0
D
0
0
0
g
0
0
0
0
I
j (05



600 MS
20
I X
20
20
23
23
25
20
1 (5)
20
1 (5)
7 (35)
21
13 C5)
fl (0)
i (5)
20
i (5)
0 CO)
20
3 US
218
(Resort Cantir.ued)

-------
PATHOLOOY
                                ASSOCIATES,
                                   WW-CSES3L
                                STUDY NO, 522 S. 08
                                             RAT3
IMC
Project Summary Table
SltflARY; Incidence ol NON-ftEDPWST'C Microscopic Findings
PROJECT ID. NO: P.CREEQL
DAYS; ALL
6ROUP:
NUMBER OF tfHMALS;

THTIOIO
EPITHELIAL CYST
IWHBCmC INFILTRATE
tmimm
TRACHEA
LWHOCrriC INFILTRATE
1NFLAW1AT3CN, CHRCNIC-AC7IVI
EPITHELIAL METAPLAilA
INFLATION, CHRCNIC
MINERALIZATION
ESQPWiUS
AOREWL iLAND
ECTASIA, HEOULIA
LUN6
LYMPHOCTTIC INF1L,,PERWASC.
INFLfll., INTERSTITIAL .CHRONIC
CTCESTIW
HJSTIQCYTOSIS
OIL MOPLETS
EDBtt
HEART
INFLAM^TION, CHRONIC
FATES: All
SEX: FELE
0


1 Ex 20
13
0
I Ex ;;
1 Ex 20
3
I
0
0
0
i s 23
 Ex 20
I
K E: ID
20
11
0
0
0
a
 Ex 23
0
,0 MS
29
y.

5)
(0)


<15)
(53
(03
(0)
fl)


(5)

UflO)
(55)
(0)
(tt)
(Q)
(0)

(0)
5(3 H6
2(3
It Y.
D
3
0
0
20
D (0)
8 (0)
I (5)
C J)
i CO)
II
a
0
0
0
0
9
0
0
(1
0
3
175 ME
20
* y.
0
0
0
Q
20
3 (15)
0 (0)
1 <5>
3 (15)
i (5)
a
Q
3
3
3
3
0
J
a
8
0.
0
403 KS

1
20
1!
I
1(5
15
!
2
9
D
0
23
20
1
20
1?
8
2
3
2
1
23
1
20
X

(55)
(5)



(5)

<5)
AORTA
               * EJ 20
C3LCN
                EJ 20
            20
                                   11-2
                              (Riuart Continued)
                                                                        9

-------
PATHOLOGY  ASSOCIATES,   INC.
                     WRA-CHE30L
                  STUDY NO, 5221.38
                                SATS
Pr oj ec
SUWARY: Incidtnce
PROJECT ID. NO; P.CSESQL '
MYS; ALL
GROUP:
NUniEi OF miWLS',

DUODENUM i
FDRESTOHACH i
SbWULAft STCWCK 
SKIN *
fWtfcSY 6WW t
SKELETAL HUSCLE 1
LIVER X
iNFiAwr, mmt
NECROSIS
LIP01DOSIS
SPLEEN *
KIDNEY ' I
NECROSIS, TUBULES
LYMPfflCYTIC INFILTOTE
(1MMLIZA7ICN
NEPKRffiWWf , CKRWIC
CYST
HYORCNEPHROSiS
mmm BLAOCES *
7ESTES 


t Summary
of NCN-NEQPLASTIC
FATES; All
SEX: FBW.E
0.0 HG
20
K '/. i
EJ 21 e
Ex 20 0
Ex 20 3
Ex 20 0
Ex S9 0
Ex 20 a
Ex 20 0
13 (45) 0
II  i
cs 20 0
Ex 0 .0
n-3
'^ejort Continued)
Tab! e
dicroscopic Findings


53 ME 175 HG ^DO MG
20 20 2tl
X  X t X
0 20
o a
0 28
0. 2
0 1?
0 20
0 20
0 1C (503
0 2 (10)
0 0 <03
. 0 20
i 20
(0) 0 (0) 1 (S3
<0) S (0) 4 (201
(SO) 0 (0) i (51
(0) 0 (0) 1 (5)
<0> a (0) 0 !8)
(EC) I 
-------
             PATHOLOGY  ASSOCIATES,  INC.
                                 Wltt-CSESGt
                              STUDt NO. 5221,01
                             SPRAGUE-WULEY RATS
                   Project  Summary Table
                  :  Incidence of NON-NEOPLASTIC Hicroscopic Findings
PROJECT  ID. NO; P.CSESQL             WTES: All
              DAYS: ALL       SEX:
SfiOUP;                             0,0 MG       50 HS      [75 MG      4GO MS
NiJHBES 0? W1WLS:                   20          20          20          20
                                  IX      *    X      I    X
PSOSTATE   -                  I Ex  0           0           0
EYES                         Es 20           0           0          20
  RETIWL ATROPKT                   1   (5)     0           0           2  (U)
  LWH.INFH...  mKMtt 51.        0   
-------
               PATHOLOGY   ASSOCIATES.   INC.
                                    PAfW-CSESOL
                                 STUDY NO. 5221.08
                                              RATS
                    Project   Summary  Table
                   i   Incidence  
-------
PATHOLOGY   ASSOCIATES.   INC.
                     WRA-CRESOL
                  STUDY NO. 52Z1.09
                 SPRflGiJE-MULEY RflTS
Project Summary Table
StftWKY; Incidence oi NEOPLA5TIC Microscopic Findings
PROJECT ID. NO: P.CRESOL
MYS: ALL
GROUP !
NUMBER CF ftNlWLS:
BRAIN
SCIATIC NESWE
SPINAL CORD
BONE
BONE tttRROU
L1WRY GUflD
WND1BULAR LYMPH NODE
THYHUS
PANCREAS
PITUITARY
THYROID
PARATHYROID
FATES : ALL
SEX: FEMALE
0,0 MG 50 KG 175 Nfi
20 20 20
ix it x K ;:
14 Ex 20 0 Q
1 Ex 20 0 0
41 EJ 20 0 G
B Ex 20 0 0
II Ex 20 0 0
8 Es 20 0 0
ft ii 20 0 0
 Ei ZQ 0 0
9 Ex 20 0 3
II Ex 19 0 1
* E 20 0 0
If Ex 14 D ;]

dOD i16
20
* y.
20
20
20
20
21!
20
2D
20
211
20
2D
li
                '.Report  Continue^]
                     11-6

-------
PATHOLOGY   ASSOCIATES,   INC.
                     P(W-CRSOL
                  STUDY NO, 5221.08
                 SPRrtGUE-MULEY RATS
Project Summary Table
S1MWRY: Incidents si NECPLAST1C Microscopic Findings
PROJECT ID. NO: P.CRESQL
MYS: dLL
GROUP:
NU1BER OF ftNIfttLS:
TRACHEA
ESOPHAGUS
ADRENAL GbW
LINE
HEART
AORTA
COLON
DUODENUM
mmK.
GLANDULAR STDWCH
SKIN
fWWRY BUND
SKELETAL MUSCLE


FATES: ALL
SEX: FEMALE
0,0 KG 5(1 MG 175 KG
20 20 20
8 7. H '/. It X
1 EJ 20 23 20
tt Es 20 } 0
S Ex 20 3 0
H Ex 20 3 Q
 Ex 20 0 3
tl Ex 20 0 tt
i Ex 20 0 0
* Ex 20 0 0
1 Ex 20 0 0
II Ex 20 0 0
It Ex 20 0 0
It Es 1? 0 0
II Ex 20 0 0
(Report Continued)
II-7

400 KG
20
1 I
19
20
20
20
20
2fl
20
20
20
20
20
19
20

< .- 0

-------
PATHOLOGY   ASSOCIATES,    INC.
                    PflRA-CRESOL
                  STUDY HO. 5221.03
                SPRAGUE-MULEY IWTS
Project Summarx Tab1
SUtttSY: Incidence o^ NEOPWSTIC Microscopic
PROJECT ID. NO: P.CRESDL
MYS: ALL
GSOUP:
N1M3ER OF ANIrttLS:
LIVES
SPLEffl
KIDNEY ,
URIWRY BLADDER
TESTES
PROSTATE
EYES
OWRY
l^ERUS
CERVIX
FATES; ALL
SEX; FtWLE
0.0 KG 50 KG
20 20
ft '/. H '/.
H Ex 20 0
It Ex 20 D
it Ex 20 2
8 Ex 20 0
1 Ex 0 0 .
 Ex 0 0
II E* 20 0
 Ex 20 C
1 Ex 20 , 0
It Ex 20 0
e
Findings

175 G
20
It 7.
0
0
1
0
0
0
0
0
0
0


400 KG
20
 "I.
20
20
20
20
0
0
20
20
20
20
                        Continued)
                      II-8

-------
             PATHOLOGY  ASSOCIATES,   INC.
                                PflRA-CRESCL
                             STUDY NO. 5221.00
                            SPRAGUE-MULEY RATS
                  Project  Summary  Table
             SUGARY:   Incidence a< NEQPW5TIC Microscopic Findings
PROJECT 10. NO: P.CRESQL             FATES: ALL
             DAYS: flLL       SEC: FEME

ssou?:                            a.o HG      sore      175 c      MOMS
NIH8ER OF rtNIWLS:                  20         20         20         2S
                                 IX     K      I   X      II    X
OTHER TISSUES WD LESINS:
                                 II-9

-------
PATHOLOGY  ASSOCIATES,   INC.
                     PARA-CRE30L
                  STUDY NO.  5221.08
                 SPRAGUE-MULEY RATS
Project Summary Table
SlttttRY; Incidence of NEOPLASTIC and NON-NEOPLASTI C Microscopic Findings
PROJECT ID. NO: P.CRESOL
OAYS: ALL
GROUP:
NUMBER OF ftNIMLS:

BRAIN
SCIATIC NERVE
SPINAL CORD
BONE
BONE WRRDU
SALIUARY GLAND
ATRGPKY
IWWBJLAR LYHPH NODE
HEMORRHAGE, ACUTE
LYHPHOID HYPERPLASIA
TKYHUS
HEMORRHAGE, ACUTE
HEHQSIDEROSIS
EMBRYONAL RETHANT
PANCREAS
ACIMR ATROPHY
lYHPHOCrnC INFILTRATE
PITUITARY
CYST
FATES: ALL
SEX: FBttLE
Q. 0 KG
20
It /.
it Ex 20
It Ex 20
ft Ex 20
It Ex 20
 Ex 20
1 Ex 20
0 (0)
II Ex 20
fl (0)
? (45)
II Ex 20
14 <70>
! (5)
0 (3)
tt Ex 20
1 '15)
I (5)
fl Ex !?
4 (21)

SO MG
20
It X
0
0
0
a
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

173 MS
20
II X
0
1)
0
a
D
0
0
0
0
0
0
0
Q
0
0
0
3
t
0 UJ)

M MS
20
1 7.
20
20
20
20
20
20
1 
-------
PATHOLOGY  ASSOCIATES,   IMC.
                     PARfl-CRSSOL
                  STUDY NO.  5221.38
                 SPRAGUE-MULEY RATS
Project Summary Table
SUtWRYi Incidence of NEOFtASTIC and NCN-NEOPLASTIC Hicroscopis Findings
PflOJECT ID, NO; P.CRISOL
MYS; ALL
mm?'.
NLMSEi? QF iWIMALS:

THYROID
EPITHELIAL CYST
LYMPHOCYTIC INFILTRATE
PARATHYROID
TRACHEA
LYHPHOCYTIC W1LT3ATE
INFLAmtflON, CHRONIC-ACTIVE
EPITHELIAL HETAPLASIA
INFUM1ATION, CHflffilC
MINERAL! ZAT I CN
ESflPWSUS
ADRWL 5WNO
ECTASIA, MEDULLA
IUNS
LYMPHOCYTIC INFIL,,PERMSC.
INFLtfi, , INTSRSTITlALjCHRCNlC
CONGESTION
HISTIOCYTOSIS
OIL WOPLETS
ED Em
HEART
iNFLtfWmCN, CHRONIC
AORTA
COLON

FATES:
ALL



' SEX: FEME
0

1
1 Ex 20
13
0
i Ei 16
1 Ex 20
3
1
0
0
8
1 E* 20
It Ex 2fl
1
1 Ex 20
20
(1
11
8
0
It
It Ex 28
0
 is 20
1 Ex 20
.3 H5
20
7.

C<5)
(0)


(15)
<5)
(0)
(fl)
(0)


C5)

(100)
(55)
(8)
(0)
CD!
CO)

CJ3


50 MS
20
i %
u
0
0
&
20
fl (0)
S (03
1 (5)
0 (8)
0 (5)
0
0
0
0
0
jj
0
a
0
0
0
Q
0
(1
175 HG
20
S 7.
0
0
0
fl
20
3 (15)
0 (S)
1 (55
3 (15)
1 (5)

0
fl
0
0
(S
fl
0
0
0
0
0
0
0
m
20
i
20
11
1
14
If
i
2
?
0
0
28
20
I
29
19
8
2
3
2
t
21
1
20
23
MS

y.

(55)
(5)


(5)
(ID
(473
(0)



<5>

(95)
(40)
(10)
(15!
(10)
(5)

(5!


II-H



(Rtjor

t Cant

inyid!




 2 9


-------
PATHOLOGY  ASSOCIATES,   INC,
                    PARA-tRESfll
                 STUOYNQ. 5221.08
                SPWGUE-flWLF? SATS
Pr
SUtttRY; lncidin
PSCJECT ID. NO; P.CRESOL
DAYS: ALL
SiQUP:
NU1BEI OF fiNTOLSi

DUODENUM
FORESTTOCH
GUVWULAR STOmCK
SKIN
NW1ARY 6WNO
SKELETAL HL'SCLE
LIVER
INFUWA7ION, CHRONIC
NECHQS1S
L1FOIDOSIS
SPLEEN
KIDNEY
NECROSIS, TUBULES
LWHOCrriC INFILTRATE
dlNEiWLIZATICH
NEPHRQPfflW , CIRCNie
CYST
HYDRONEFHROS1S
SJBIHA3Y 3WQOE3
TESTES


oject Summary Table
a^ NEOPLASTIC and NCN-UEOPWSTIC
FATES: ALL
SEX: FB^-E
0 .0 H6 58 MS
20 20
17. B 'A
 Ex 20 i
It Ex 20 0
\ EJ n a
1 Ex 20 0
1 Ei 1? 0
* Ex 20 3
It Ei 20 9
13 US) 0
0 (0) 0
1 (5) 0
1 Ex 20 S
It Ex 20 2
D (0) 0 (0!
3 (15) 0 (05
1 (I) \ (50)
1 <5) 0 (0)
2 <10) 0 (3)
i <5) 1 (513)
 Ex 20 0
* .t 0 0
II -12
(5?-jOft Continued)
Microscopic Findings


( ^c MA f n n uf*
I/j nu cuu no
20 20
i % IX
0 ffl
0 21
0  23
0 21
0 1?
0 23
0 20
(1 10 (SB)
D 2 (10) '
3 0 (0)
0 20
1 21
0 (0) I (5)
0 (0) 1 S2U5
0 (05 1 (5)
fl <8) ' 1 <5)
0 (S) 0 (8)
1 (100! 0 <0)
0 20*
C 0
6> P 0
?* * y \/


-------
             PATHOLOGY  ASSOCIATES,   INC.
                                  PARfl-CRESQl
                               fTUDY NO. 5221.03
                              S?M8UE-WWLEY RrtTS
                   Project   Summary  Table
    SUMMARY:  Incidtncf  of NQ3PWSTIC and HCNHHeOPWSTID Microscauic  Findings
PROJECT ID, NOi f.tmm              FATES: ALL
              DflYS;  All        SEX;
GROUP;                              0.0 HG
NUMBE3  OF WlfWLS!                    20          20          20         20
                                   17.      IX      i    '/.      IX
PROSTATE                      Ex   0     '      0           C           0
EYES                         * ex  20           0           C          2(1
  RETTOl ATROPHY                   1   !5!     0           I          2  (10)
  LYMPH. 1HFIL., WDERIW 8L,        0   CttJ     0           0          1   (5)
OVARY                        K Ex  20           fl           0          1
  CTST                              i   (S3     3           0          0   
-------
              PATHOLOGY  ASSOCIATES,   INC.
                                  PflRA-CRESOL
                                STUDY NO, 522!.03
                              SPKAGUE-iWULEY RA73
                   Project   Summary   Table
    SSMVWY:   Ineidtnc? si NEOPLAST1C and NON-NEOPLASTIC Kicroscapic Findings
PROJECT ID. NO; P.CRESM.             FrtTES: ALL
              DAYS; ALL        SEX: FEHAlE

GROUP:                             0,0 HG       50 HE     -175 MS      ifld HG
NU18EH OF WlfttLSi                   20          Id          20          28
                                   I    7,      IX      
OTHER TISSUES AND LESIONS:

N$ENTEi!C  LN-HEHOSiDESOSIS         1   (5)     d    <0)     0   
HE<3IASTJ?L LN-HB105IDEROSIS         S   <5)     0    <0)     0   (0)      I   (0)
                                       11-14

-------
PATHOLOGY  ASSOCIATES,   INC
                     PARA-CRESOL
                  STUDY  NO. 5221.03
                               RATS
Proj e
c t Surnmar
y Tabl e
SUfWRY: Incidence of NEOPWST1C and NQN-NEOPWSTIC
PROJECT ID. NO: P.CRESOL
DAYS: ALL
GRDUP:
NLM8ER Of mS:

BRAIN
LYMPHOCY11C INFJL. HEN1N6ES
SCIATIC NERVE
SPINU CORD
BCNE
BONE MftRRCU
OLIVARY GLWD
NWDIBULAfi LYMPH MODE
LYMPHOID KYPERPLASIA
THWUS
HEMORRHAGE, ACUTE
PWCREAS
HEflQSIDEROSIS
HSQPK1L1C CELLULAR CTON6E
HYPHIPWSIA, ISLET CELLS
dClifcR ATROPHY
LWHOCYT1C INFILTRATE
PITUITAItt
CYST
WTES! All
SEX: fiL:
Q.O MS
20
1
1 Ex 20
0
I Ex 1?
1 Ex 20
t Ex 20
1 Ex 20
1 Ex 2D
1 Ex 20
7
1 Er 20
17
1 Ex 20
4
0
4"
0
I
1 Ex 13
a


50 MG
20
f
0
0
0
0
0
0
0
0
0
0
0
0
0
o
0
0
0
0
0
Microscopic


175 MG
20
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Findings


609 ft
23
1
28
1
2)
20
20
20
29
20
'
20
13
20
1
3
2
2
1
20
3
                        11-15
                 (Report  Continued)  '

-------
PATHOLOGY  ASSOCIATES,   INC.
                     PftRA-CSESOL
                  STUDY NO, 5221.Di
                 SPRAG1I-WJIEY RATS
Proj e
ct Summary Table
SOWN; Jncidiflce ol NEOPWSTIC and NQN-NEIPLASTIC
PROJECT ID, NO: P.C8ES3L
MYSi ALL
GROUP:
MJ11ES OF flNlWLS;

WR010
EPITHELIAL CYST
PARATHYROID
TRACHEA
LWHDCYTIC 3NFILT1WTE
INFLATION, CHRCNIC-ACTM
EPITHELIAL HETAPLASIA
INFWHWIIN, CHRONIC
ESSTOGUS
6DRBW. 8UHD
ECTfiSIA, MEDULLA
LSWS
LWHOcmc INFIL.,PERIMASC.
WFWH , , INTERSTITIAL , CHRONJ C
PNEU1CNIA, FOREIGN-BODY
ULLULAR THRCHBIB
KfflCRRWSE, ACIHE
tAXT
INFUWKTI*, OiSCNIC
WRTA
COLEW
DUC0EMJN
-

FflTESs ALL
SEX: mil
tt.B H6 3D M6
20 20
1 I
1 Ex 20 0
12 0
i Ex 3? 0
1 Ex 29 20
4 2
0 8
11 0
0 I
1 Ex 20 8
1 Ei 20 1
4 D
1 EJ 28 0
21 0
9 0
0 0
0 0
! 0
t Ex 2D 1!
B D
i Ex 2D 0
i E* 28 0
1 is 20 0
11-16
(Report Continued)
Microscopic


175 MS
20
i
5
0
a
20
2
0
1
2
8
0
0
0
0
0
0
0
e
IT
0
0 '
D
0


Findings


m H6
20
1
28
14
18
20
2
2
1!
0
a
20
1
20
n
u
i
i
g
29
u
28
1
20
531


-------
PATHOLOGY  ASSOCIATES.   INC,
                    PAW-CSESOL
                 STUDY NO. 5221.08
                SPfWGUE-MULET MTS
Project Summary Table
IMWff; iKidtnc* of NEOPLASTIC nd NGN-flEQPLASTIC
fflWHCT ID, NO; P.CRESOL
MYS; ALL
GROUP!
 NU1SEI OF ANIWLS;

FiRESTTOCH
JNFLflHATICN, ACUTE
iUWULftS STWCH
INFLATION, EOS1NOPH1LIC
SKIN
mwm SLANO
SKELETAL MUSCLE
LIVES
INFMHW3W, CHRONIC
NECROSIS
SPLEEN
X10NIY
LYMPHODT1C INFILTRATE
HINEBU.IZAT1W
NEPHRDWIHT, CHRONIC
crsr
WMONEPHROSIS
MffUWWON, CHRCN1C-ACT1VE
mmw IWODER
CALCULUS
IWHOCYTIC INFILTRATE
TESTES
ATRflPKf

flicrosccpic
Findings
FATES! ALL
SEX! KALE
0.8HS
20
I
i Ex 20
1
i Ex 20
1
1 Ex 20
* Ex 10
lEx 20
1 Ex 20
8
0
1 Ex 20
1 Ex 20
8
1
4
I)
3
0
1 Ex 20
i
0
1 Ex 20
2
11-17

50 NS
20
tt
0
0
0
0
0
0
0
0
0
g
0
28
5
g
i;
0
0
s
a
a
0
0
0


175 MS
20
a
0
0
0
0
0
0
0
3
0
0
0
20
7
1
7
0
i
0
tt
0
3
0
0


90 NS
a
i
20
8
20

20
1
20
a
t
i
20
29
1
1
12
1
3
1
20
i
2
21
0
235
(Report CantinuecD

-------
PATHOLOGY  ASSOCIATES,   INC.
                     PARA-CRESOL
                   STUDY NO,  5221,88
                 SPRAGUE-OAULEY RATS
Project Summarx Table
SaHARYs Incitfinci of HEOPLAST1C ind NCN-NEOPLASTIC Microscopic
PROJECT ID. NO: P.CKESCL
DAYS: ALL
GROUP:
NlflBER DF ANWLS:
PSQSTATE
LYMPHOCYTIC INFILTRATE
ftES
(WARY
WERUS
CEWIX
FATES;
SEX! WLE
D.O KG
20
1
1 Ex 20
8
1 Ex 1?
 EJ 0
f Ex 0
1 Ex 0
ALL
SO MS
21
t
0
0
g
0
0
0

175HG
20
1
0
0
0
0
1)
0
Findings

600 (1Q
29
1
20
5
20
0
0
1
                 Oteport Contiwd)
                         11-13
                                                                          6Tl  * f
                                                                          ,'.  *; \>

-------
             PATHOLOGY  ASSOCIATES,  INC.
                                 PRRA-CSE50L
                              STUDY NO.  522!.OS
                                          RATS
                  Project   Summary  Table
             Ineidmet of NEOPWCTIC and NON-NEOPWSTJC Microscopic Findings
PROJECT ID. NO: P.CRESOl            FATES: ALL
             MYS; ftLL       SBCi fttLE

GROUP:                          0.0 KG      SO MS     175 MG      (09 
NUMBER OF WIWLS;                20         20         2D         29
OTHER TISSUES WD LESIWS:

                 , CHS,-ACT.
                                   11-19

-------
PATHOLOGY  ASSOCIATES,   INC.
                    FAM-CRESQL
                  STUSYNO. 5221,08
Projec
SUNWRY: Incidcnci
P8WECT ID. NO: P.CRESOL
DAYS: ALL
680JIP:
NUHBSS OF fiNIMALSi

BRAIN 1
LYMPHCCYTIC JNFIL. MENINGES
SCIATIC HEM 1
SPIWL COfiD 1
BONE 1
8B KARSOU , 1
9MJVARY SIM! 1
IWDIIUIAR LYNPH NODE 1
IYMPHOID HYPERPLASW
THYKUS *
HEKORRfWI, ACUTE
WWCBKS 1
HEMOS1 DOCSIS
MSOPHIL1C CEILUWR CHtflGE
HfPtRPLASW, ISLET CELLS
AC1WR ATROPHY
ITHPHOCrriC INFILTRATE
PSTUlTfllff 1
asi



t Surwnarx Tab! *
oi NCN-EOPWSIIC
MTES: ALL
SEX: mil
D.O HG SO
20 20
1 1
Ex 20 0
0 0
s 19 0
Ex 20 0
Ex 20 0
E* 20 0
It 20 0
Ex 20 0
1 0
Ei 29 0
!? fl
En 28 0
<5 0
g o
4 0
0 0
1 0
EJ IB D
0 0

I! -20
< Report Contimied)
Microscopic Finsjiftgs


ffi 175 HS
20
it
0
g
0
0
9
0
O
0
t
0
a
8
0
fl
0
0
3
0
0






430 KB
21
i
20
I
20
20
20
29
2fl
a1
?
20
13
2J
I
3
2
2
I
23
3
0 M- *R
,C o O


-------
PATHOLOGY  ASSOCIATES,   INC.
                     MRA-CRESCL
                  STUDY NO, 5221.D8
                SPRAGUE-OAULEY SATS
Pro J ec
SJM1ARY; Incidence
PROJECT ID, NO: P.CRISOL
DAYS: ALL
SOT;
NtfiBES DF ANIJWLS:

THYROID i
EPITHELIAL CYST
MRATHYROID 1
TRACHEA II
LYHPHOCYT1C INFILTRATE
INFLAMMATION, CHRSMIC-ACTIUE
B5!lHEL]ftL HETAPLASIA
INFLATION, CHRCNIC
ESQPHASUS i
AOBBW. BLAND i
. . . ECTASIA, MEDULLA
LUNG 1
LYWHQCYTIC 1NFII.,PERWASC.
INFLAH . , INTEISTITIAL , CHRONIC
WEiWCNM, FORE16N-POY
CELLULAR THRQNEUS
KMORRHA6E, ACUTE
mm i
WFWfWTISN, CHRONIC
ADITA I
COLIN 1
DUODENUM I




t Summary
o* MW-*EEPLA5TIC
FATES: ALL
SEX: MALE
0,0 Hf> S3
20 20
f 1
Ex 28 0
12 t
Ex I? II
Ex 20 20
4 2
S 0
0 0
0 1
Ex 20 0
Ex 20 J
4 0
Ex 20 0
20 0
f 0
0 0
0 0
1 G
ix 20 0
8 0
Ex 20 0
Ex 20 0
Ex 211 0


II-Z1
 Q
,' 
-------
PATHOLOGY  ASSOCIATES,   INC,
                      fftRfr-CHESQl
                   STUDY NO. 5221.08
                  S?fM6(i-DAUlEY RATS
Proj e c
SUfttRY: Incidence
PROJECT 18. NO: P.C8ESQL
DflYS; ALL
GROUP-.
NUMBER OF (WlHALSi

FWESTffttCH 1
.IHFltffWTION, AOfTE
SUWBULAR STOWCH 1
INFLiWtfKH, EOS1NOPH1L1C
SKIN 1
mwm SUM) i
SKaETftL KUSCLE 1
LIVES 1
INFLATION, CHRONIC
tCtOSlS
SPLEEH 1
flMO 1
LWHQCYFIC INFILTRATE
NMW.I2ATIGN
ffiPHIOPATHf, CHRONIC
CYST
KfDRCNEPHTOSlS
INFUWATIIW, CHRONIC-ACTIVE
URIWRY BLADDER t
CALCULUS
LWHOcrnc [NFILTRAII
liSTES 1
ATROPfff


t Summarx
of NGN-flEDPLASTIC
WTEi: ALL
SEX: ME
a. a ME SB
n n
t i
1% 20 0
1 0
Ex 20 0
i 0
Ex 2(1 0
Ex 10 3
Ex 20 1!
Ex 2J 0
8 0
0 1
Ex 20 t
En 20 20
a 5
i g
4 11
0 8
Q 0
0 i
E* 20 0
5 0
0 0
E 20 t
2 0
11-22
(Report tont
-------
             PATHOLOGY  ASSOCIATES,   INC.
                                 WRA-CXESOl
                              STUDY NO, 5221.38
                             SPRrtSH-WULEY RrtTS
                  Project   Sunvnarx  Table
           SUtttlTf:  Incidence of  NON-NEOPLAST1C Microscopic Finding*
PROJECT ID. NO:  P.CRESOL            WTES:PLL
             DAYS: ALL       SEX: WLE

GROUP:                           D.I G      50 ME
NUMBER Of (WIHALS:                 20         20
                                                     175 KG
                                                      20
                                                                WO M6
                                                                 20
PROSTATE                      Ex 20
             INFILTRATE           8
                                                                  t
                                                                 20
                                                                  5
EYES
                            I Ex  17
(WARY
                            1 Ex  0
UTERUS


CRfW
                            1 Ex  0
                            1 Ex  0
                             (Report Continued)
                                    11-23

-------
              PATHOLOGY  ASSOCIATES,   INC.
                                  PAfeKRESQL
                               STUDY NO.  5221.08
                              SPRflGUE-OAULEY WT5
                   Project  Summary  Table
            SUMWW;  Incident? of NCN-NEOPLASTIC Microscopic Findings
PROJECT ID. NO: P.CRESDL             FATES: ALL
              MYS: ALL       SEX: fttLE

GROUP:                           0.0 H6      50 6      175 MS     iOO KS
NU1BER OF (WIMALS:                 20         20          2D         29
                                   t
OTHER TISSUES WD LESIONS:

TONSUE-INFLATION, CHR.-^CT.       0
                              (Report  Continued]
                                    11-24

-------
PATHOLOGY ASSOCIATES,   INC,
                  MRA-CRESQL
                JTUOYNO, 5221.03
               SPftj-fl.EY TS
Project Summar
SMWSY! Incidinei of NEOPLASTSC
PRCtfECJ ]D. NO: P.CRESflL FATES: ALL
DAfS: ALL SEX: MALE
BROUP: 0.3 MS
HUHBE8 OF rWNALS; 2(1
I
BRAIN 1 Ex 20
SCIATIC NEJWE i Ex If
Wimi CORD 1 Ex 20
IKE i EX n
SCNI ttRRQU 1 Ex 29
SALWfiRY GWND 1 E* 20
WNBISUWf? LYMPH NODE 1 Ex 2fl
THWUS I Ex 20
RWCREAS 1 Ex 2fl
PITUITAfTf 1 Ex 18
TffTOID 1 Ex 20
PAfWTHYROlO 1 Ex 1?
ITWCHIA 1 Ex 20
ES3PWGUS i Es 28
11-25
X Tab! e
Microscopic Findings

50 MS 175 m m MS
20 21 29
i I 1
0 0 20
0 1 29
0 0 20
0 0 29
i tt 20
0 0 2!
D  20
0 0 25
0 0 20
0 0 21
0 B 20
1 0 IS
2B 20 23
0 8 1
TS / rt,
.  4 0
(itjoct Can(inued>

-------
PATHOLOGY  ASSOCIATES,   INC.
                     PftRA-CJESOL
                  STUDY NO.  5221.38
                 SPRflGUE-MULEY RATS
Project Summary Tab!
SUtttRY: Incidence of NEOPLAST1C Microscopic
PROJECT ID. NO: P.CRESUL
DAYS: ALL
GROUP:
WISER OF ANIMALS:
ADRENAL GLAND
LUNG
HEART
AORTA
COLIN
DUODEMH
FORESTWCH
SJWULAR STOMACH
SKIN
MAMWRY GLAND
SKELETAL MUSCLE
LMR
SPLEEN
e
Findings
FATES: ALL
SEX; NM.E
0.0 MG SONG 175 KG
20 20 20
1 1
1 Ex 20 1
1 Ex 20 0
1 Ex 20 0
1 Ei 20 0
1 Ex 20 0
1 Ex 20 0
1 Ex 20 0
1 Ex 20 0
1 Ex 20 0
1 Ex 10 0
1 Ei 20 0
1 Ex 20 0
8 Ex 20 0
deport Continued)
11-26
a
0
0
9
1)
0
0
tt
0
0
0
0
0
0

605 M6
20
1
21
20
20
20
20
20
2t
20
29
7
2J
20
73
244

-------
PATHOLOGY  ASSOCIATES,   INC.
                    FftRA-CSESOL
                 STUDY NO. 5221.08
                S?MGUE-MULFT RATS
Project Surrtmar
SIMBRT: Incifcnct of NEOPWSTJC
PROJECT 10. NO: P.CRESOL
DAYS! ALL
BROUP:
ftHBER OF dNIttftLS:
KIDNEY
URIMItt BLAMES
TESTES
PROSTATE
EYES
QVfiirr O
IrtERUS
CEWIX
y Tabl
Microscopic
s
Findings
MTES: ALL
SEX: W.I
0.0 (1G
20
1
I Ex 20
f Ei 20
 Ix 20
1 It 20
1 Ex 1?
1 Ex 0
* Ex O
I Ex 11
50 MS 175 H6 40 J H8
20 20 20
(t
20
tt
0
0
0
D
0
0
f 1
20 211
0 20
0 211
0 20
0 29
0 0
0 6
0 0
                (Report Continued]
                       11-27
                                                                  245

-------
             PATHOLOGY  ASSOCIATES,   INC.
                               MWKRESQL
                                 NO. 5221.88
                                        HATS
                 Project  Summary Table
            SUIWTf:  Incidence of N1BPWSI1C Microscopic Findings
PROJECT 3D. NO: P.CSESDL             FATES; ALL
             DAYS: W.       SH: (W.H

5JDDP:                         0,3 MB      50 H5      175 tie     M NS
NUHBEI OF W3WLS:                20        2D        20         23
UTHER TISSUES (M LESIONS:
                            (Sliport Continued)
                                                                             .16'

                                  11-28

-------
TABULATED ANIMAL DATA

-------

-------
                          PATHOLOGY ASSOCIATES,   INC.
                                          STUDY NO. 5221.08
                                         SPRAGtI-WUlEY RATS
                               Tabulated  Animal   Data
                  PROJECT  ID: P.CRESOL    GROUP: 0.0 MS     SEX:  FEWLE     DAYS: ALL
                  PAGE 1                 FATES: ALL
         AN1WL ID. NO:              3801   3802   3803   3804   3805   3804  3897   3803   380?   3310

BRAIN                                NNNNNNNNNN


SCIATIC NERVE                         NNNNNNNNNH


SPINAL CCRO                           NNNNNNNNNN


BCME                                 NNNNNNNNNN


BONEWRROU                           NNNNNNNNNN


        5LANO                        NNNNMNNNNN
IWD1BUWR LYMPH NODE                  N     N                  N      N     N      N
  LWHOID KIPESPWSIA                              1      1     -      -     -      -     1      2
TKlflUS                                                   N
  HB10RRW6E, ACUTE                   <1)    <1>    
-------
                           PATHOLOGY  ASSOCIATES,   INC
                                               PARA-CRESOL
                                            STUDY NO.  5221.18
                                           SPRflBUE-WULEY  RATS
                                Tabulated  Animal   Data
                   PROJECT ID:  P.CRESOL    GROUP:  0.0 MG      SEX: FBttLE     DAYS: All
                   PAGE 2                 FATES!  AIL
                ID. NO:
WROID
  EPITHELIAL CYST
2801    3802   3803   3804   3005   2804   3807   3808   3807   3813
 N     N
             (I)    CD          (1)    (2!
PARATHYROID
 NNNNNUNNNN
TRACHEA
  INFLmtVTION, CHRONIC-ACTIVE
       NHNNNNNNN
ESOIW6US
 NNNNNNNNNN
ADSBWL GLAND
 NNNNNNNNNN
im
  LWHODTIC INF!L.,PER]ASC.
  INFIAM. ,INTERSTITlAL,CHR(NIt;
                           (3)
                                                     (1)
HEART
 KNH'NNNNNNN
AORTA
 NNNNNNNNNN
COLCK
 NHHNNNNHNN
DUODEN1W
 NNNNNNNNNN
                                  (Report Continued)
                                                   III-2
                                                                              24Q

-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                             PARA-C8E50L
                                          STUDY NO. 5221.Q8
                                                       RATS
                               Tabulated Animal  Data
                   PROJECT 10:  P.CRESOL    GROUP: 0.0 MS      SEX: FEfttlE     MYS: ALL
                   M6E 3                 FATES: ALL
         WML ID. NO:

FOREST CmCH
3801   3302   3903   ]E04   3805   3806   3907  3809   380$   3S10

 NNNNNNNNNN
ELflNDUWS STOWCH
 N     N     N      N      N     N      N     N      N      N
SKIN
 NNNNNNNNNN
       BLWD
 NNUNNNHNNN
SKELETAL MUSCLE
 NNNNNNNNNN
L1UES
  L1FOIDOS1S
             ,  CHRCN1C
       H     N
                                                         (13
SPLEEN
 NNNNNNNNNN
KIDNEY
  LWHOCYT1C INFILTRATE
  CYST
 N      N
                   (U
                                      (2)
                                                                                  N     N      N
URINARY BLADDER
 NNNNNNNNNN
TISTE5
                                (Rpport Continjd)
                                                1II-3
                                                                                 250

-------
                           PATHOLOGY  ASSOCIATES,   INC.
                                               WRft-CRESOL
                                           STUDY NO. 5221.08
                                                        WTS
                                Tabulated  Animal   Data
                   PROJECT  ID: P.CRESOL    GROUP: 0.0 HG     SEX: F0WLE     MYS: ALL
                   PAGE 4                 FATES: ALL
                ID. NO:                3801   38D2   3803  3304   3805   380J   3307   3BQ8   380?   3B1D

PROSTATE                               *           *     *                 i            t      i


EYES                                   NNNNNNNNNH
OVARY                                  N     N      N     N      N     N      N
  CYST                                 	
l/TERUS                                  NNNNNN.NNNH


CEWIX                                  NNNNNNNNNH
                                 (Report  Continued)
                                                                                          ^  1^% -1


                                                  III-4

-------
                                    PATHOLOGY  ASSOCIATES,   INC.
                                                       RftRft-OJEBOL
                                                    STUDY NO,  5221.08
                                                   SPRASlf-WWIEY RATS
                                         Tabulated  Animal   Data
                            BKJJECT It5i P.CRESOL    6ROUP: 1.0 6      SEX: FtmLE     M^Ss W.L
                                 5                 WTESsAU.
                   ANIWL ID. KO:                3801   3SD2   3EQ3   3804   3805   380-5   3807   3BG8   391?   3310

OTHES TISSUES W LESItMSi

         HESMEHC LN-HEHOS1BEROS1S                                        1	
         MEDMST1NAL IM-UB10SIOEROS1S                                       1	
                                                           III-5

-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                             PftfM-CRESOL
                                          STUDY NO. 5221.08
                                          SPRAGCE-MULEY RATS
                               Tabulated  Animal  Data
                  PROJECT ID: P.CRESOL   SROUP1. 3.0 MS      SEX: FEMALE     DAYS: ALL
                  PAGE 4                FATES: ALL
                ID. NO;               3B11   3312  3313   3314   3315  3316   3817   3B18   361?   3820

BRAIN                                 NNNNNNNNNN


SCIATIC NEWE                          NNNNNNNNNN


SPm CORD                            NNNNNNNNNN


6QNE                                  NNNNNNNNNN


EWE MftRROU                            NNNNHNNNNN


SALIVARY 6LAW                         HNNNNNNHN-H
NWJIBULAR LYMPH NODE                         N           N      N                        H     N
  LYMPH01D HYPERPWS1A                 1      -     1     -      -     1     2      1      -     -
TKYMUS                                             N     N      N
  H91QRRJWSE,  ACUTE                    <1)    (15           -           (1)     <1>    <2>
PtfOEAS                              NNNNNN            UN
  AClHfiR ATROPHY                       	
  LYMPHOCYTIC INFILTRATE               -      -     -     -      -            (1)
PITUITARY                             N                  N            N            N     N     N
  CYST                                -     (3)    (1)    -     (2)     -(!)---
                                (Report Continued)
                                                rn-6

-------
                           PATHOLOGY  ASSOCIATES,  INC.
                                              PftKA-CRISOL
                                           STUDY NO. 3221.08
                                          SPRABUi-EAHLET HATS
                                Tabulated  Animal   Data
                   PSQJECT  IDs P.CRESQL    GSQIff:  8.0 US      SEXi FENfilE    MYS: All
                   WGE  7                 FA1ES:  ALL
                IP. NO:               3811   3812   3813   3814   381S   3Sli   381?   3818  3319   3820

THYROID                                                  N      N     N                          H
  EPITHaiAL CYST                              2                        (1)    CD    (1>
PftWTWROI!)                            UUUNHNNNNH
                                                         N      N     N      N     N      N     N
  LWHflCYTJC INFILTRATE               <1)    CD    <1>	
ESOPHASUS                              KNNHHNNNNN
flOREL  5U*ID                                 NNHNNNNKH
  ECTASIA, MEDtlLA                     1	
urn
  LWWflCYTIC INFIL..PERIVASC.             <2).        <1>    <1>    <3>    <1)    <2>
  lNFlAM.,IHTERSTniAL,CHRQNIC         >----     (1)     -     (I)     -
HEAfT                                 NNNHNMNHHH


AORTfl                                 NNHNNNNNNN


COLIW                                 HNNNKHNHNN


DUOOfflUI                               NNNNNHNNNN
                                 (Rescrt Continued)
                                                 III-7

-------
                           PATHOLOGY  ASSOCIATES,   INC.
                                               PftRfr-CRESOL
                                            STUDY NO. 5221.08
                                           SPRAGUE-OAULEY RATS
                                 Tabulated  Animal   Data
                   PROJECT ID:  P.CRESOL    GROUP:  0.0 M6      SEX: FEfttLE     DAYS: ALL
                   PAGE 8                 FATES: ALL
          ANIML  ID. NO:               3811   3812   3613   3814   3315   3814   3817   3813   3319   3820

 FORESTOTCCH                            NNNNNNNNNN


 GLANDULAR STGTCCH                       NNNNNNNNNN


 SKIN                                   NNNNNNNNNN


 htffttRY GLWD                           NNNNNNNNNN


 SKELETAL MUSCLE                         NNNNNNNNHN


 LIVEH                                  N            H                                N      N
  INFLAtWTICN, CHRCNIC                 -     <1>     -     <1>    (1)    <1>    <1)    -      -     


 SPLEB4                                 NNNNNNNNNN
KICNCf                                 N                   N            N            N      N      N
  LYHPHOCYTIC INFILTWTE                -      -      -      -      -            (1)
  MINERALIZATION                        	(1)     -
  NEPHROPATHY,-CHRONIC                                             1	
  CYST                                       (1)     	
  HYDRtflEPHRCSIS                        -      -      1	-
URINARY BLADDER                         NNNNNNNNNN
TEJTES                                 tttttiiit*
                                  (Report Continued)
                                                                                                61  K
                                                   111 -8                                       '-  'J

-------
                         PATHOLOGY  ASSOCIATES,   INC.
                                            PflRft-KESOL
                                         STUDY NO. 5221.D9
                                        STRAGJE-MULEY RATS
                              Tabulated  Animal  Data
                  PROJECT ID:  P.CRE50L    6ROUP: 0.0 HG      SEX: FEMIE     DAYS: ALL
                  PA6E 9                FflTES: ALL
               ID. NDi               3811   3312   3813   3814   3815  3814   3817   3913   381?   3320

PROSTATE                                   i      J           I     i      i      I      1     i
EYES                                 NNNNN           NNNN
         flTROPHY                     	2
                                    NNNNNNNNNN


UTERUS                               NNNNNNNNNN


CEW1X                               MNNNNNNNNK
                               [Report Continued)
                                                III-9

-------
                                   PATHOLOGY  ASSOCIATES,   INC.
                                                      PftRfr-QESQL
                                                   STUDY HO. 5221,08
                                                  SPIW6UE-D(W.Fr RATS
                                        Tabulated  Animal   Data
                           PSOJECT IDs P.CRESOL   6RDUP:  0,11 M6      SDS; FBttLE     MYSt ALL
                           FA6E ID               FATES:  ALL
                  MIHAL  10. NOs               38tl   3812   3813   3814   3815   38ii   3817   38!8  381?   3820

OTHER TISSUES m LESHNSi
                                         find  of Report)
                                                         III-IO

-------
                         PATHOLOGY  ASSOCIATES,  INC.
                                            BftM-CSESOL
                                         STUDY NO. 5221.OB
                                        SPRftGU-OAULEY RATS
                               Tabulated  Animal   Data
                  PROJECT ID: P.CSESOL   6ROUP:  50 MS      SEX:  FETOLE    DAYS: ALL
                  PAGE 1                FATES:  ALL
         ANWL  IB. NO:               3831   3832   3833  3934   3835   3834   3937  3838  3639   3840

ESAIN                                iiiiiiliii


SCIATIC NERVE                               *      *     *                 *          *      


SPIWL CORD                           i      i      i     *     i      i      i     i     *      i
BEHE  fttfWCW                           i      i           *     *      i           i          i


WLUJARY SUM)                         i      J      1     i     i            i     i          i


[WD1BUWR LWHNODE                  i      <      i     J     i            i     1     1     1


TKfflUS                                ittti*t*i


PANCREAS                              i      j      *     i     i      i      i     i          


PITUITARY                             *!**


TKYRDID                               *      i      *                                     *


PARATHYROID                           ****!*
                               (Report Continjrd)                                  '/r\  p  p
                                                                                  ci  O  O
                                               III-ll

-------
                           PATHOLOGY  ASSOCIATES,  INC
                                            CTUOT NO, 5221.03
                                           5FRAGUE-UULEY RATS
                                Tabulated  Animal   Data.
                   PROJECT ID: P.CRESOL    6ROUP: 50 116       SEX: FEWLE     DATS: All
                   PAGE 2                 FATES: ALL
          (WIHU 10. NO:               3831   3B32   3933   3334   3835   3834   3837   3838   3837   334Q

TRACHEA                                NNH            NNNNNN
  EPITHELIAL hETflPLASIA                                    (1)	
E5CPMEUS
ADRE>ttL GLAND
HEART                                  J      t      *     J      i      I      I           *      *



AORTA                                  *      i      *           *            *      i     *      i


COIN                                        i      i     i            t            i           



OUODENIH                                                                   >                 *


FORE5TOTOCH                             <      t      *           i      i            *           *


6LWDULAR STOttCH                             i      i                 i      i           i      



SKIM                                   *      *                 *            *      *     *      *
                                 (Rpport  Continued)
                                                                                          *) ^ Q
                                                                                          /> o O
                                                  TII-12

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                       STUDY NO. 5221.08
                                                   IW7S
                             Tabulated  Animal   Data.
                 PROJECT ]&: P.C8ESOL   6ROUP; 5fl HB      SEXi FBWi     MYS: ALL
                 MfiE 3               FATES: flU
              ID. NO:              3S3J   3832   3833  3834  3835  383,5   3837   3838   3839   3849

       6U*ffl                        *      t     t     i     i     i     i     1     1     I


SKELETAL MUSCLE                      *tiiii.tii


LMR                               ittttttttt
EYES
(WRY
                                   *      *                i     i     *     i     i      i
                                   ---(!!    ------
URlfWW SLAOOES                      i      i     I     i     i     i     i     i     i      i
                                   *      *     *     *     *     *     *.     *     *
                              (Report Continutd)
                                                                                    260
                                             ni-13

-------
                                    PATHOLOGY  ASSOCIATES,   INC.
                                                        WiW-CSESOL
                                                     STUDY NO.  5221.08
                                                    SPMGUE-DAULEY RATS
                                          Tabulated  Animal   Data.
                            PROJECT ID: ?.CRESOL    GflOUP: SO  HG       SEX: F&WLE    DAYS: ALL
                            PAGE <                 FATES: ALL
                          ID. NO:               3631   3832   3833   3834   3B35   3836   3837   3838   3837   2840

OTHER TISSUES tfID LESIiNS:
                                           (R?port Continued)
                                                            111-14

-------
                          PATHOLOGY  ASSOCIATES,   INC
                                             WRft-CRESOL
                                          STUDY NO. 5221.03
                                         SPfWfiUE-MULEY IWTS
                               Tabula-ted  Animal  Data
                   PROJECT ID: P.CRESDL    GROUP:  50 MS       SEX: FEttlLE     DAYS:  ALL
                   PftGE 5                FATES:  ALL
         W1WL ID. NOi               3841   3842   3843   3844   3845  3844   3847   3848   3849   3850

HWIN                                 *      *     i      i      i                i     i      i


SCIATIC NEM                          *      *     *      i      i     f      *          *      i


SPIfttL CORD                            *      i     i      I      i     I      I     1     I      J


BGNE                                  i*iiiiit*i


BONE IttRROU                            i      i     i      i      i     i      e     *     i      *


                                      *iiittti


          LYMPH NODE                   t      t     t      i      t     t      t     t     t      t


THtNUS                                *           I      I      *     1      I     1     I      I


FWOEAS                               *      i           i      i     i      i     i           i


PITUITARY                              *           *      *      *     *           *     *      *


TKTROID                                                       *     *      *     *           


PARATHYROID                            j      i     I      I           *      *     i     *      *
                                (Report Continued)
                                               rn-15

-------
                          PATHOLOGY ASSOCIATES,  INC.
                                             WRA-CSEStJL
                                          STUDY NO.  5221.03
                                         SPRAGUE-DAUIEY IWTS
                               Tabulated  Animal   Data
                   PROJECT  ID: P.CSESOL    6RBUP; 35 N6       SEX: FBttLE    DAYS: ALL
                  PAGE 6                FATES: ALL
         AN1MUO. NO:              3641   3842   3843   3344   3845   3B   3847  3348   384?   3950

TRACHEA                               NNNNNNNNNN


ESCPWGUS                             ttttttttti


ftDRENU SLAND                         1     I     i      I      i     I      f     1     1      1


LING                                 ii*aiiiii


HEART                                iiiiiitiii


AORTA                                >iii*}iii]


COLON                                *iiiiiifi{


DUDDENIM                              iiiiitiiii


FORESTCWDH                                i     i      i      i     i      i     t     i      i


ELANDUWR JTWCH                           **     i     i      i


SX1N                                 *                *      *                *           *


       GLAND                         t          i            i     *      *     i     *      
                                (Report  Continued)
                                                 111-16

-------
                        PATHOLOGY  ASSOCIATES,   INC
                                          MfW-CSESOL
                                       STUDY NO. 5221.33
                                       SPRAGUE-DAULEY RftTS
                             Tabulated Animal  Data
                 PROJECT ID;  P.CRESOL    BROUP: 50 KG      SEX: FEWLE     DAYS: ALL
                 PAGE 7                FATES: ALL
         ANIWL ID. NO:              3841  3842  3843  3844   3845   3846   384?   3848   384?   3859

SKELETAL MUSCLE                           t     i     i     i     *     i     i     i     i


LIVER                               ti***tii


SPLEEN                              iiti*"iiii
KICNEY                              i     *     t     i           i     *     *     i     i
  WDRONEPHROSIS                     ---->	
URINftRY BWODE8                      *     *          *     *     *     *          *     *
EYES                                i*i*ii
                                        *     *     *     *     *     *     *     *     
ICTERUS
CEtWIX                              *     *     *     *     *     *          *          *
                              (Report Continued)
                                              IIT-17
                                                                                    264

-------
                               PATHOLOGY  ASSOCIATES,  INC.
                                                 WRA-RESOL
                                              STUDY NO. 5221,08
                                             SPM6UE-MULEY SATS
                                    Tabulated Animal   Data
                         PROJECT 10: P.CtfSOL   6ROUP: 50 KG      SEX: FEWLE    DAYS: ALL
                         PAGES               FATES: All
                      ID. NO:             3841   3842  3843   3844   3845  3844  3847   3848   384?  3BSQ

OTHER TISSUES WO LESlftS:
                                     (End (rf Report)
                                                                                       2G5
                                                    111-18

-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                             WBKRESOL
                                          STUDY NO, 5221.D8
                                         SPfW6UE-MWLEt WTS
                               Tabulated  Animal   Data
                  PROJECT  ID: P.CRESOl    6ROUP:  175 MS     SEX: FEMLE     DOTS: ALL
                  W5E 1                 FATES i  ALL
                ID. NO:               3841   3862   3943   38,54   3845   3844   3347   38 i8  3849   3370

BIM1N                                 i      *     *     *      i           i                 I


SCIATIC NEBJE                         i      i     t     *      i     i      *      i     f      i


SPIWL CORD                           i      i     i     i           i      *      i           i
B1HE hKRRGU                           *iiiiii
        GIWB                        ^1      S           I           I      I      I           


(WOIBUWR LWH NOOE                  *      *           *                            *      


THWS                                *            *     *           *      *      *           i


                                     *      *                 i     i      *           *      *
PITUITARY                             i      N     *     i      i     i      i
                                                       *           *            *     *      
WW1HYROID                           i      i      i      i      i     i      i      i     i      i
                                (Riport Continued)                                              2 6 6


                                                  111-19

-------
                          PATHOLOGY ASSOCIATES,  INC
                                             PARA-CSE3DL
                                          STUDY HO. 5221.09
                                         SPHA61JE-MULEY RATS
                               Tabulated  Animal   Data
                  PROJECT ID: P.CSESQL    GROUP: 175 MS      SEX: F0WI    DAYS: ALL
                  PA6E 2                FATES: ALL
         AUWL  ID. NO:

TRACHEA
  LWPHQCYTIC INFILTRATE
  EPITHELIAL METAPLASIA
ESOPfttSUS


ADRENAL ELAND


LINE


HEART


AORTA


COLON


DUCDEN1H


FQRESTtWCH


Sl/NOULAR


SKIN
                                     3841   3842   3843  3844   3845   3844   3847   3848   384?   3870

                                     UN            N            N      N     H      N      N
                                     illlllliil



                                     III*11I1



                                     IfilllSllI

















                                     t     1      1      <     I     I      1      I     1      I
                                     ttittttttt
                                (Report
                                                 111-20

-------
                          PATHOLOGY  ASSOCIATES,   INC
                                             PMtt-CRESOL
                                          STUDY NO. 5221.08
                                         SPBWUE-MULEY RftTS
                               Tabulated  Animal   Data
                   PROJECT ID: P.C8ESOL    6RQUP: 175 HG     SEX:  FTOLE     DAYS: ALL
                   PA6E 3                FATES: ALL
         ANIMAL ID. NO:              3841   3342   3863   3844   3845   3344   3847   3948   384?   3870

KWfcRY SUM)                               i      i      i     *                       i      


SKELETAL MUSCLE                             t      t                            t      i      I


LMR                                ittiititti


SPLEEN                                iii*ift


K1WFY                                1      1      1      t     I      1      t     I      t      I


URINARY BLAOOE3                                         1     1            t     i      i      j


EYES                                  iiiiiiiiii


(WARY                                 ******


UTEKUS                                iiiiiiitit


CEJWIX                                *            *      *     *            i           *      
                                (Report  Continued)
                                                                                             268

                                                 111-21

-------
                                   PATHOLOGY  ASSOCIATES,  INC.
                                                     PftRft-CRESCL
                                                  STUDY NO. 5221,08
                                                  SPRA6UE-Wfl.EY WTS
                                        Tabulated  Animal  Data
                           PROJECT ID: P.CRESCL    GROUP: 175 MS      SEX: FEMLE     DAYS: ALL
                           MfiE 4                 FttTES: ALL
                        ID. NO:               3841   3842   3B43   3844   38^5   38^   3Bi7   33,53   384?  3370

OTHER T1SSUESMD LES1IHS:
                                        (Rtport Contirufd)
                                                          HI-22

-------
                          PATHOLOGY  ASSOCIATES,   INC
                                              WRA-CRESOL
                                           STUDY HO, 5221.08
                                          SPRAGUE-MULEY WTS
                                Tabulated  Animal   Data
                   FKOJECT ID: P.CSESDL    5SOUP: 173 H6     SEX: FEHUE     DAYS! ALL
                   PAGE 5                 FATES: ALL
         AN1ML ID. HO:               3871    3872   3873  3874   3875   3874  3877   3878   387?   388D

 mw                                 i     f      i     *      i      i     t      i     i      i


 SCIATIC NRWE                          i                *      t      t     t      i     t      i


 SPINAL CORO                            i     *      f     i      i      i     i      i     i      i


 8(HE                                  fitiiiitti


 BBNE (WRROU                                 i           f            I                      i


 SAL1WRY GLAND                         itif**ii


MftWIEULAR LWH NODE                        i      i     i      j      t           i     i      i


THWUS                                     i      I     i                 I      i     t      


PANCREAS                                   i      i     t      i      i                i      


PITUITARY                              *i**tt.itft


THYROID                                *iiiiii


PARATHYROID                            itiiittii*
                                       Continued)

                                                                                             O <*> A
                                                                                             A    V


                                                  111-23

-------
                         PATHOLOGY  ASSOCIATES,  JNC.
                                           PftRft-CSSSQi.
                                        STUDY NO. 5221.08
                                        SPBWOi-WWLEY MIS
                              Tabulated  Animal   Data
                  PROJECT IDs P.CSESQl    SROUP: 175 MS     SEXs FBW.E    MYS: ALL
                  6E 4                FATES: ALL
               15. NO!              3S7S   3872  3873  3374  3S75  387(5   3877   3878   3879   S88J

                                    N           H           M     N                 H    N
  LWPHGCfTIC INFILTfWTE               ...    ^)    -----    -
  INFljWATISW, CURWIC                -)----     
-------
                         PATHOLOGY  ASSOCIATES,  INC.
                                           MBhCSESQL
                                        STUDY NO. 5221.08
                                        SH6UE-WJLEr MS
                              Tabulated  Animal   Data
                  PROJECT IDs P.CSESOL    BMUPi 175 N6     SEX: F0W.E    DAYS: ALL
                  CASE 7                FATES; All
         fNWl IB. HO:              3B7I   S872  3873  3874  3875  3874  3177   3fl78   387?   3881

       SUM)                        tttttttttt


SKELETAL WJSaE                       i     *     i     i          i     i          i     i


LIVER                               1     1     I     I     *     1     I     1     f     I


SPIHN                               i*iiifiii
KlQNfY                               1            i     i     I     1     i     1     i     i
                                         (23	-
       SLAODER                       fi      i      i      i     i     i     *     i     i
EYES
[WARY                                iliiiiifii
IfTEBUS
CSWIX                               i      i      i      i      i      i     i     i     i     i
                              deport Continatd)
                                                ni-25

-------
                                    PATHOLOGY  ASSOCIATES,   INC.
                                                       PARft-CRESOL
                                                    SIUBYNO. 5221.08
                                                   SPRAGUE-DflULfY RflTS
                                         Tabulated  Animal   Data
                            PROJECT IDs P.CRESOL    GROUP:  175 MS      SEX: FBW.E     CAYS: ALL
                            PAGE 8                 FATES:  ALL
                         ID. NO:               38?i   3872   3873   3874   3875   3874   3877   3878   387?   388D

OTHER TISSUES AND LESIONS:
                                          (End of Report)
                                                            TII-26

-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                            PflRA-CRESQL
                                         STUDY NO. 5221,08
                                        SPRAGUE-WULEY PATS
                               Tabulated  Animal   Data
                  PROJECT  JO: P.CRESOL    GROUP: 400 MG     SEX:  FEKALE     DAYS: ALL
                  PAGE I                 FATES: ALL
                ID. NO:               389!   38*2  3893   3894   38?5   3894  3897   3898   3899   3903

BRAIN                                NNNNNNNNNN


SCIATIC NERVE                         NNNNNNNNNN


SPINAL Cm                           NNNNNNNNNN


BONE                                 NNNNNNNNNN


BONE MARRGU                           N      N     N     N  >  N      N.N     N     N      N


SflLiWRY GLAND                         NNNNNNNNNN
HANDIEULAR LWPH NODE                                          N     N            N     N
  HEMORRHAGE, ACltfE                    	1
  LWPHQIO hfTPERPLASIS                 1      1   ~   1     2     -     -      2
THWUS                                      N                 N                        N     N
  HB1QRRMGE. ACUTE                    -      -    <1>    <1)     -     <1>    (1)    CD
  EMBRYGWL REJtWT                   (2)	
                                           NNNNNNNNN
        ATROPHY                      (!)	
PITUITARY                            N            NNNNN           NN
  CYST                               -CD     -----    (i)
                                                                                    274
                                            111-27

-------
                           PATHOLOGY  ASSOCIATES,   INC
                                              PAto-EEESOL
                                           STUDY m, 5221.08
                                          SPRA6UE-MULEY iWTS
                                Tabulated  Animal   Data
                   PSQJECT ID: P.CRESQL   6ROUP:      <2>    <2>    <2>    <2>    -      -    <1)    <1>


 PARATHYROID                           NNNNUNNNNN
                                                                                                                  i

 TiMC'dEA                               N      H           N                   N           N
   EPITHELIAL HETAPLASW                .-2-12-2-1


 ESCPWCU5                             NNNNNNNNNN


 ADREWL fll^D                         NNNNN            NNNH
   ECTASM, MEDULU                     	!


'UHS
   LYMPHOCYTIC INF!L.,PE3!WSC.          <3>        <2>    <2>    <1>    <3>    <3>    <1)    <2)    <2>
   !NRj*I,,MEiSTlTWL,CHRONIC          <2)     -    <1>   ' -      -     <2)    <2>    (1)
   OTGESTICN                          	<2)
   OIL OROPLETS                        	     (23     -
   E2EMA                               	<1>


 HEART                                 NNNNNHNNNN


 AORTA                                 NNNNNNNNNN


 COLCN                                 HNNNNNNNNN
                                 !S*port Continued)
                                              111-28

-------
                          PATHOLOGY  ASSOCIATES,   IMC
                                             PftfW-CRESQt
                                          STUDY NO.  5221.08
                                          SPRA8UE-MUlEY RATS
                               Tabulated  Animal   Data
                   PROJECT ID: P.CRESOL    6ROUP; 400 MS      SEX; FBWLE     DAYS: ALL
                   PAEE 3                 FATIS; All
          AMIWt 30,  NO:               3891   3892   38?3   3S94  38?S   38?d   3897   3898   389?   3?00

 DUOOENW                              NNHNHNNMNH


 FQRE3TWCH                            NNNNNNNNNN


 iUWDULAt  STOMCH                      NNNNNHNNNN


SKIN                                  NNNNNNNNHN


MMHWW  iUWD                          NHNNNNNNNN


SKELETAL HUSCLE                        NNNNNNNNNN
LIVER                                        N           H
  INFLfiUWTlOK,  CHROMIC                <     -        -         (i)    <    -
  NECROSIS                            	
-------
                          PATHOLOGY  ASSOCIATES,   INC
                                             PARA-CSESOL
                                          STUDY NQ. 5221.08
                                         SPfWGUE-WWLEY FATS
                               Tabulated  Animal   Data
                  PROJECT  ID! P.CRESGL    GSCUP: 400 HG     SEX: FEMALE    DAYS; ALL
                  PAGE 4                FATES: ALL
                IB. NO:              3891   3892   3893   3894  3895   3894   389?  3393   3899   3903

TES7ES                                *      i            *     i      *      i     j      ]      i


PROSTATE                              *i*****si


EYES                                  N      N      N      N     N      N                   N      N
  RETIWL ATROPHY                      	2
  LWH.INFIL., tWRDERIAN  GL.           	(2)


OWRY                                 NNNNNNNHNH


UTERUS                                NNNNNNNNNN


CEW1X                                NNNNNNNKNH
                                (Resort Continutd)
                                                                                              >
                                            III-3Q

-------
                                     PATHOLOGY  ASSOCIATES,   INC
                                                         PftRA-CXESOL
                                                      STUDY NO.  5221.08
                                                     SPRAGUE-DAW.EY RATS
                                          Tabulated  Animal   Data
                             PROJECT ID:  P.CRESOL    SROUP: 400 MG      SEX: FEMALE     MYS:  ALL
                             PAGE 5                 FATES) ALL
                   ANIMAL ID. NO:               3891   3892   3893   3394   3895   3894   3697   3B98   3S99   3900

OTHER TISSUES AND LESI04S:
                                            (Report Continued)
                                                                                                          ":-J  V  &


                                                         111-31

-------
        PATHOLOGY  ASSOCIATES,   INC,
                            PftfM-CaESCL
                        STUDY NO. 5221.08
                        SPKAGUE-MULEY RATS
             Tabulated  Animal  Data.
PROJECT  10: P.CRESOL    GROUP: 400 MG      SEX: FEfWLE     DAYS: ALL
PAGE 4                  FATES! ALL
                 ID. NO:
 BRAIN


 SCIATIC


 SPIfWL CORD


 BCNE


 3WE ttRRQU
                   3?01   3902   3903   3904   3905   3FQ4    3907   3508   390?   3910

                    NNNNNNNNNN


                    NNHNNNHNNN


                    NNNNNNNNNN


                    NNNNNNNNNN


                    NNNNNNNNNN
SAL1WRY GUiND
                   NNNNNNNN            H
                   ........     a)     -
           LYMPH NCDE
  LYHPH01D  HYPERPLASIA
                                N      N      N     N             N     N
                                 -      -      -     -      ]
TKYHU5
  HEMORRHAGE, ACITTE
                                                          CD    
PANCREAS
                   NNNNNNNNNN
PITUITARY
  CYST
                   NNNNNNNNN
                                                                              <2)
              (Report Continued)
                           111-32
                                                                                 Q

-------
                           PATHOLOGY  ASSOCIATES,  INC.
                                               PARfl-CteSOL
                                            STUDY NO. 5221.08
                                           S?RA6UE-OfiREY RATS
                                Tabulated  Animal  Data
                   PROJECT 10:  P.CRESOL    GROUP: 400 HG      SEX: FETCLE     DAYS: ALL
                   PAGE 7                 FATES: ALL
          ANIMAL  ID, NO:

 THYSCID
  EPITHELIAL CYST
  LWHCCYTIC INFILTRATE
39B1    2502   3903   3?04   3705   390i   3907   39S3   390?   39!0

 N     N                   N     N      N                   N
             (2)     (2)     -     -      -     (1)    <2)
                    (i)	
PARATHYROID
 NNUNUUNNNH
TRACHEA
  LWPHOCYTIC  INFILTRATE
  INFLAmATlGN, CHRONIC-^CTIUE
  EPITHELIAL METAPLASIA
       (1)
       1
                    N      N     N
ESOPHAGUS
 NNNNNNNNNN
ACRBttL OLANO
NNNNNN.NNHN
LLNG
  LYMPHOCYTIC W!L,,PERIVASC.
  INFLAM., INTERSTITWL,CHR!]C
  CBNSESTItN
  HISTIOCTTCSIS
  OIL DROPLETS
(3)        
-------
        PATHOLOGY  ASSOCIATES,   INC
                            WRA-CRESOL
                         STUDY NO. 5221.08
                        SPRAGUE-OAULEY RATS
             Tabulated  Animal   Data.
PROJECT  ID: P.CSESOL    GROUP:  dOO KG      SEX;  FEMALE     MYS: ALL
PAGE a                 FATES:  ALL
 COLON
                 ID. NO:
                   3701    3902   3903   3904   3905   3914   3907   3?03   390?   3910

                    NNNMNNNNNN
DUQDENlfl
                    NNNMNNNNNN
FORESTTOCH
                    HNNNHKNNNN
GLANDULAR STCWCH


S:.  O

-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                             WRA-CSESOL
                                          STUDY NO. 5221.03
                                         SPMGUE-MULEY RATS
                               Tabulated  Animal   Data
                   PROJECT 10: P.CSESOL    GROUP;  400 M     SEX: FETCLE     DATS: flLL
                   PAGE 9      .          FATES: All
         ANIML ID. NO:              3901   3902   3903  390+   3905   39d,S   3?D7   3908   3909   39!Q

UR1WRY  BLADDER                       NNNNNNNNNN


TESTE5                               *            *           *      *            *      i     


FfiOJTATE                             i*iiii*j
EYES                                 N            NNNNNNNH
  RETINAL ATROPHY                      -      1	-     -
                                     NNNNNNNNKH
UTESUS                             'NNNNNNNNHN
CEiWIX                                NNNNNNNNNN
                                       Continued)
                                                                                                9
                                                                                           /. O

                                             111-35

-------
                                     PATHOLOGY  ASSOCIATES,    INC
                                                         PflW-CSESOL
                                                      STUDY NO.  5221.03
                                                     SPfWGUE-DAULEY RATS
                                          Tabulated  Animal   Data.
                             PROJECT  ID:  P.CRESOL    GROUP: iOB MS     SEX; FEMALE     DAYS;  ALL
                             PAGE ID                 FATES; ALL
                   ANIMAL ID.  NO:                3901   3902   3703   3904   3905   390
-------
                         PATHOLOGY  ASSOCIATES,  INC.
                                            PftRA-CRESOL
                                         STUDY NO. 5221.08
                                        SPRA6UE-WULEY SA7S
                              Tabulated  Animal   Data
                  PROJECT ID:  P.CRESOL    GROUP: 0.0 M6     SEX: MLE      DAYS: ALL
                  WEE  1                FATES: ALL
         ANIWL ID. NO:
BMIN
3471   3472  3473  3474   3475   3474   3477  347S   3477   34BO

 NNNNNNNNNN
SCIATIC NERVE
 NNNNNNNNNII
SPINAL CORD


BtNE
NNNNNNNNNN
 NNNNNKNNNH
GONE WRROU
NH'HNNNHNNH
SALIWRY GLAND
NNNNNNNNNN
          LYMPH NODE
  LWPHOID HYPERPWSIA
       N     N     N     N     N      N     N
 1	22
THfflUS
           , ACUTE
(1)    (J)
                                            N     N
                                     
-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                             Pftffe-CRESOL
                                          STUDY NO. 5221.08
                                          SPRAGUE-WULEY WTS
                               Tabula-ted  Animal   Data
                  PROJECT ID:  P.CSESOL    GROUP: 0.0 HS     SEX: MLE       DAYS: ALL
                  PAGE 2                 FATES: ALL
         tHWL ID. NO;               3471   3472   3473   3474   3475   3674   3477   3478  347?   3480

7HYMID                               'N            N     K            N     N            N      H
  EPITHELIAL CYST                           <2)           -     (1)     -     -     (I)     -
WWTHYRD1D                            NNNKNNMNNN
TRACHEA                                NNNNNN            NNN
  LYHPHOCYT1C INFILTRATE                	     <1>     -
ESOPWGUS                              NNNNNNNNNN
ACRENAL 5LAND                          MNNNN                   HHN
  ECTASIA, MEDULLA                      	I.I---.
LING
  L
  INFlAM.,]MTERSTniAL,CKR[MC                                   U)    <1)     -     <1>   <1)


HEART                                 NNNNNN
  INFlrttttTIDN, CHRONIC                 -     -     <2>    -     (1)


AORTA                                 NNNHNKNHNN


COLON                                 NNNNNNNNNN


0UOOENU1                               NN'NNNNNNNH
                                 (Report Continued)
                                                                                                    285
                                                 111-38

-------
                          PATHOLOGY ASSOCIATES,  INC
                                            PARA-CRESOL
                                          STUDY NO. 5221.08
                                         SPRAGUE-MULEY RATS
                               Tabulated  Animal  Data
                  PROJECT  ID: P.CKE50L    GROUP: O.Q HE      SEX: fttLE      DAYS:
                  WEE 3                FATES: ALL
                ID. NO:              3471   3472   3473   3474   3475   3474   3477   3673   347?   3480

FORE5TOWCH                           N     N      N            N     N      N     N     N      N   
  WFUWWTION, ACOTE                                    <2>	
GLtfWltf R STEWCH                      N            NNHNNNNH
  IHFL^MATICN,  EOS1HOPHILIC            -     <1>	


SKIN                                 NNNNHNNNNN


NVWRY 5U0                         U     N      U      U     H     U      N     N     U      U


SKELETAL MUSCLE                        NHNNNNNNHN
LMR                                 N            N      N           N      N     N
        &Tim, CHRONIC                -     {!>     -    -  -    <])    -      -     -
SPLEEN                                NHNNNNNNNN
KIDNEY                                                   H     K     N      N     N            H
  LWPHDCYTIC 1NFILTWTE              	-     <2)     -
  NEPHRDWTHY, CHRONIC                 -21	
URIWfTf BLADDER                              N      N     N     N     N            N
  CALCULUS                            1	I      -     <2)     2
TESTES                                HHHNNNMNNH
                                (Report Continued)

                                                                                                  286
                                               111-39

-------
                         PATHOLOGY ASSOCIATES,   INC.
                                          MtW-CRESQL
                                        STUFf NO.  5221.08
                                       SPBtfUEHMULEY RATS
                             Tabulated  Animal  Data
                 PROJECT IBi P.CSEiOL    GROUP: 0.0 H8      SSXs MLE       BAYS: All
                 PftK 4                FATES; ALL
               ID. HO:              &?1   3i?2   3i73   3474   3475   3474  3477  3d78  347?  3480

PROSTATE                            N     K     N      N                       N     N
  LWPHDCYT1C INFILTRATE              ----   )    -     -    <2>
EYES                                NNNNHNHNNN
                                    f      i      i      I     i     i     I     I
UTESUS
                              {Report ContinwcD
                                                                                           *? 8 '/'
                                                                                           ^ ij  /
                                             111-40

-------
                                    PATHOLOGY  ASSOCIATES,   INC
                                                        PARA-CRESOL
                                                     STUDY NO,  5221.03
                                                    SPRA6UE-MUI.EY IWTS
                                          Tabulated  Animal   Data
                            PROJECT ID: P.CRESOL    GROUP:  1.0 MS      SEX: M.E      DOTS: ALL
                            PAGE 5                 FATES:  ALL
                          ID. N3:               3471   3472   3473   3474   3475   3474   3477   3478   3477   3480

OTHER TISSUES WD LESICNS:
                                           (Report Continued}
                                                                                                                  n  o
                                                                                                                  G  d

-------
                          PATHOLOGY ASSOCIATES,   INC
                                              PftRft-CXESOL
                                           STUDY NO. 5221,08
                                          SPRAGUE-MULEY RATS
                                Tabulated  Animal   Data
                   PROJECT ID: P.CRESOL    GROUP: 0.1 MS     SEX: WLE       DAYS: AIL
                   PA6E 4                 FATES: All
         (MVAL ID. NO:               3481    3m   3m   3m   34i5   3484   3487   3488   348?   3490

BRAIN                                 NSUNNNNNNN


SCIATIC NEWE                          NHNHNNNNNH


SPlfWL CORD                            NNNNNNNNNN


ICNE                                  NNNNNNNNNN


BONE WRROU                            NNNNNNNKNN


SALIVARY GUttD                         NNNNNHHNNH
1WOIKJLAR LYHPH NODE                               N      N            N     N      N            N
  LYKPHDIO HYPERPLASIA                  1      1     -      -      1      -     -      -     1      -
THYNUS                 .                                         N
  HEMDRRWSE, ACUTE                    <2>        (2)    <2)    
PANCREAS                               N     N     N      N                         N            N
  HEMOSIDEROSIS                        -     -     -      -      -     (1)     <1)     -    <1>
  HTPERPIAS1A,  1SLH CELLS              	(1)     <2>
  LYHPHOCY71C INFILTRATE                -     -     -      -     (t)     	
PITUITARY                              NNUUNNNNNN
                                (Report  Continued)
                                               111-42
                                                                                             89

-------
                            PATHOLOGY  ASSOCIATES,   INC,
                                                PARA-CRESOL
                                             STUDYNO. 5221.08
                                            SPRAGUE-OAULEY RATS
                                 Tabulated  Animal   Data
                    PROJECT ID: P.CRESOL    GROUP: 0.0 KG      SEX: MLE       DAYS: ALL
                    PAGE 7                 FATES: ALL
                 ID.  NO:                3681   3482   3683   3B4    34B5   3486   3687   3688   3687   3670

THYROID                                                                            '                   N
  EPITHELIAL CYST                      <1)    <1)    <1>    <2)     C2)    <1>    <1)    <1>    (1)
PARATHYROID                             NHNNUNNNNH
TRACHEA                                        N      N     N      N      N      N             N
  LYMPHOCYTE INFILTRATE               (1)     	          <2>    <2>    <1)    <3>
  1NFLAH.I1HTERSTITWL,CHRCNIC          <1>        <1>     -     <1>


AORTA                                   NNNHNNNHNN


COLON                                   NNNNNNNNNN
                                  (Report Continu(d)
                                                                                                      ? O
                                                   111-43

-------
                         PATHOLOGY  ASSOCIATES,   INC
                                            PAKA-CRE50L
                                         STUDY HO. 5221.08
                                        SPRAGUE-OAULEY RATS
                              Tabulated  Animal   Data
                  PROJECT IS: P.CRESOL    GROUP: 0.0 MS     SEX:  HALE      DAYS: All
                  PAGE 3                FATES: ALL
DUODENlfl
               ID.  NO:
3691   3682  3483   3484   34E5   3484  3(597   3488   348?   3tf

 NNNNNNNNNN
FORES7CWCH


GLANDULAR STCWCH
                                    NNNNNNNNNN
 NNNNNNNNNN
SKIN
                                    NNNNNNNNHN
       GLWD
                                     U      N     N     N      U
                                      N     N      N      U
SKELETAL MUSCLE
                                    NNSNNNNNNN
L1UER
  INFUWttllON, CHRCNIC
                                                                          N     N
SPLEEN
                                    NKNNNNNNNN
KICNEY
  LYMPHQCYT1C  INFILTRATE
  MINERALIZATION
  NEPHRDPATHt, CHRONIC
             (1)
       BLADDER
  CALCULUS
                                           NNNNNNNNN
                                (Report Continutd)
                                              111-44
                                                                                       291

-------
                           PATHOLOGY  ASSOCIATES,   INC
                                              PftRft-CRESOL
                                           STUDY NO, 5221.08
                                           SPRAGUE-OWLFf RATS
                                Tabulated  Animal   Data
                   PRWECT  IDs P.CRESDL    GROUP: 0.0 H6     SIX: MLE      DBYS: ALL
                   PAGE 9                  FATES: ALL
                ID. NO:                3431   3.J82   3^83   3dS4   3685   3m   3487   3483   343?   3470

TE5TES                                       NNNNNN            NN
  ATROPHY                              [41	[3]
PROSTATE                              H                   N            N      N     N      N
  LYHPHOCYTIC INFILTRATE                -     <2)    <2)           <3>            -     -      -     <3>
EfE5                                  NNNNNNNUNH


CWARY                                 *ff***i


UTERUS                                      i      *                  i      *                *


CEIWIX                                ti*t*f*i
                                 (Report Continued)
                                                                                                  9 Q 9
                                                                                                  . i^ ({/
                                                in-45

-------
                              PATHOLOGY ASSOCIATES,   INC.
                                              FBRA-CSESCL
                                            STUDY NO, 5221.08
                                           SPRAGUE-WJLFf RATS  '
                                   Tabulated  Animal  Data
                        PROJECT ID: P.CRESOL   6ROUP: 0.0 KB    SEX: IW.E      DAYS: ALL
                        WGE 10             FATES: All
                     ID. NO;             3^81   3682  3433   3484  3685   34B4  3487   3688  348?   3490


(TTKER TISSUES m LESIWS:
                                   (End erf Report)
                                                                                      293
                                                111-46

-------
                         PATHOLOGY  ASSOCIATES,  INC.
                                            PftRA-CRESOL
                                         STUDY NO. 5221.09
                                        SPJM6UE-MULEY
                              Tabulated  Anjma.1   Data
                  PROJECT ID: P.CRESOl   GROUP: 53 KB      SEX: WLE      DAYS: ALL
                  PAGE  1                FATES: All
         ANIlttL ID. NO:               3701   37112   3703   3704  3705   3704   3707   370S  3709  3711

 BRAIN                                I      1      I     i     t      *      *     i     i     i


 SCIATIC NERVE                               i      i     f     *      *      i          }     i


 SPINAL CORD                           *            *     *     t      t      i     i     i     i


 BONE                                 **i<)i}iii


 BONE NflRROU                           t      t      t     i     i                 i     i     


 SALIWRY SUWD                         liit***ti


fWfllBUWR LYHPHNOOE                  1      t      i     1     i      *      I     i          i


THYHUS                                *Jiii*


PANCREAS                                    t      i     t     t      t      i     i          t


 PITUITARY                                         *     *     J      i      *     i          *


THYROID                               iiiiiiii**


PARATHYROID                           i      t           *     i      i      i     i     i     i
                               (Report Continjfd]

                                              111-47
294

-------
                          PATHOLOGY  ASSOCIATES,   INC
                                             WRA-CSESCL
                                          STUDY NO. 5221.08
                                          EPMGUE-DAULEY RATS
                               Tabulated Animal  Data
                   PROJECT ID: P.CREStJL   GROUP: 50 MB       SEX: MLE      DAYS: ALL
                   PAGE 2                FATES: ALL
         AN1ML ID. NO:               3701   3702   3703   3704   3705   3704   3707   3708   370?   3710

TRACHEA                               NHNNNNNNNN


ESOPtHGUS                                   *           i      t     t      t     i      i      i


ADRENAL  SLAND                         *      t     *            *           *     N            i
HEART                                *      *     *            t     t      *     i            i


AORTA                                *      *     *      *      *     *      i           *      *


C3LQN                                iiiiiiiiit


CUOD&IK                              iiiiiiiiii


FORESTOHACH                           *      *           *      *     *           *      t      


6LWOUWR STOttCH                      **!***


SKIN                                 iiiiiiiiii


       SLAND                         I      1           *                 i     i      *      
                                (Report Continued)
                                                                                             29
                                               111-48

-------
                           PATHOLOGY  ASSOCIATES,   INC.
                                              RftRft-OtESOL
                                           STUDY HO.  5221.08
                                          SPRAGUE-MULEY RATS
                                Tabulated  Animal   Data
                   PROJECT  ID: P.CRESCL    GROUP:  50  H6       SEX: hWLE       MYS: ALL
                   PAGE 3                 FATES:  ALL
                ID. ND:                37D1   3702   3703   3704   3705   370,5   3707   3708  370?   3710

SXELETAL MUSCLE                        1111*11111


LIVER                                 iiti**ti


SPLiEN                                llll'Jlfill
KIDNEY                                                          N                                N
  tPHROPATHY, TRONIC                 I      I      1      2     -      1      I      -     1
  INFLfftttTIN, CHRNIC-ACTIVE          	<1)     -      -
URllttRY BLADDER                        i      i     i      i      i      i      t      i     i      i


TESTES                                i      *     *      i            i      *      i     ti


PROSTATE                                    I     5      I            i      1      i     1      I


EYES                                  i           *      i      i      i      i      i     t      *
                                 (Report Continued)
                                                                                             296
                                                111-49

-------
                                    PATHOLOGY  ASSOCIATES,   INC
                                                     STUDY NO.  5221.08
                                                    SPRAGUE-MM.EY RATS
                                          Tabulated  Animal   Data
                             PROJECT ID: P.CRESOL    GROUP:  50 MS       SEX: MALE      DAYS: ALL
                             PAGE 4                 FATES:  A11
                   ANIMAL ID. NO:               37111   3702   3703   3704   3705   3704   3707   3708   3709   3710

OTHER TISSUES AND LESIWS:

                            , CHR.-dCT.          	(2)     -     -      -




                                           (Report Continatd)
                                                                                                      f>  Q  ^
                                                            II1-50                                   '"  tj  '

-------
                       PATHOLOGY  ASSOCIATES,  INC.
                                        MRA-CHESQL
                                     STOYNO. 5221.08
                                    SPMGUE-mEY IWTS
                           Tabulated Animal  Data
                PROJECT ID; P.CRISfll   GROUP: SO S      SEX: mil      BWS: ALL
                PA6I 5              FATES: AIL
        mmi. IB. HOs             3711   3712   3713  3711   3711  3714  3717   3718  3719   3720

                                 fliiliiiit


SCIATIC mm                           i     *                    i     t     i     i


mmi CMC                        i     *     i          *     *          *     *     


BCNE                              iliiiiifii


SIMEHARROU                        I*ilft<*i


ML1UARY SUV
-------
                         PATHOLOGY  ASSOCIATES,   INC.
                                           PAIW-CRESOL
                                         STUDY HO. 5221.08
                                        SPfWGUE-MULEY W7S
                              Tabulated Animal   Data
                  PROJECT ID: P.CRESOL    GROUP: SO NB      SEX: WLE      MYS: ALL
                  PAGE J                FATES: ALL
               ID. NO:
TRACHEA
  LWHOCYTIC 1NF1L7MTE
             , CHRONIC
                                   3711   3712  3713   3714   371S   3714   3717   3718   371?   3720
                                                            CD
                                                                  N      N     N     N
ESO?MSUS
       GLAND
HEART
                                    *          *
                                                                         *      *      t
AORTA
COLON


DUDDENLh


FOHE5TITOCH


BLWDULAft


SKIN
                                    i     I     1     J     
                                          i     i
                                                            i      i      i      
                                                                                     j      *
                                    ***j*tit*
                               (Report  Continued}
                                             111-52
                                                                                       *?     -

-------
                          PATHOLOGY ASSOCIATES,  INC.
                                          STUDY NO. 5221. fl8
                                                      NTS
                               Tabulated  Animal   Data.
                  PROJECT  ID: P.CRISOL    GROUP: 30 HE      SEX: NUE      WYSi ALL
                  WGE 7                FATES: AU
         (WML ID. NO:              3711    3712   3713   3714   3715   3716   3717   3718  371?   3721

IttttiRY  6UWD                         4     i      1      i     i      i      i     i      i      t


SKELETAL MUSCLE                                  *           *      *      *     *            I


LIVER                                }iiiiiiii


SPLEEN                                *tt*!tii
HCWFf                                     N
  LWPHOmiC INFILTRATE              <1>    -     <1)    
-------
                               PATHOLOGY ASSOCIATES,   INC
                                                FflRft-CSESOL
                                              STUDY HO. 5221.OS
                                             S?RftGUE-MW.EY RflTS
                                    Tabulated Animal  Data
                         PROJECT ID: P.CKSCL   6ROUP: 50 MB      SEX: MALE      MYS: ALL
                         PAGE 8               FATES: ALL
                (WML ID. NO:             3711   3712  3713  3714   3715   3714  3717  3713   3717   372(1

OTHER TISSUES  LESItNS:
                                     (End (rf Re per O
                                                                                        301
                                                   111-54

-------
                         PATHOLOGY  ASSOCIATES,  INC
                                         STUDY NO. 5221. fl
                                                     MS
                              Tabulated  Animal   Data
                  fRWECT 10:  P.CRESDl   SBOUPs  175 R6     SEX: mil      MYS: ALL
                  W6E 1                FATES! All
         ANJNflL 10. NO:               3731   3732   3733   3734  3735   3734   3737   3738   373?   3740

 BRAIN                                ii*iiij*
SCIATIC

      
SPIM CURD
BGNE HARiOU                          *      i      i     t     f     t     t      i      i


   IWRY 6UWO                        liitiitit


          IWPN NODE                 iiififiii


THYMUS                               liitlffii


mmm                                   *                     i     *      t      


PlTUTOiY                                  i                t     i     i      I      i


THYROID                              f      i      *     *     i     i     i      i      *


PARATHYROID                          *ii**ii
                               (Report Continued)

                                              111-55

-------
                          PATHOLOGY  ASSOCIATES,   INC
                                             IftRA-CRESDL
                                          STUDY NO.  5221.QB
                                          SPRAGUE-DAULEY ftttS
                               Tabulated  Animal   Data
                   PROTECT ID:  P.CRESOL    GROUP: 175 .13      SEX: WILE       DAYS: ALL
                   PA6E 2                 FATES: ALL
                ID. NO:               3731   3732   3733   3734   373S   3734  3737   3738   373?   3740

                                            N            NHNNKNN
  LWHOCYT1C INFILTRATE               <1)     -     (1)'	
  EPITHELIAL METAPLASIA                             U)	
ESOPHAGUS                                    *      *           *                 *     '      


ADRENAL  GLAND                          1      I      *      I     1      I     1      I     I      1


LLNS                                              *      *           *     i           i      
AORTA                                 i      *      *      *           *           *     *      


COLCN                                 it*t


DUODENUM                               iiiii*ii


FORESTGMCH                                        *      *                      *     *      *


GLWDUWR STOmCH                      *            *      *           *                      


SK3H                                  *      i      i      I     i      I     i      I     i"     I
                                (Report  Continued)
                                                111-56

-------
                            PATHOLOGY  ASSOCIATES,   INC.
                                               PARA-CRESOL
                                             STUDY NO. 5221.08
                                            SPRAGUE-OAULEY
                                 Tabulated  Animal   Data
                    PROJECT ID: P.CRESOL    GROUP: 175 MG      SEX: MLE       DAYS: ALL
                    PAGE 3                  FATES: ALL
                 10. NO:                3731   3712   3733   3734   3735   3734   3737   3738   3739   370

MAMMARY ELAND                           t      t      t      t      i      i      t      t            t


SKELETAL MUSCLE                          i      *      *      i      t      i      t      t      t      i


LIVER                                   *i*itff*i


SPLEEN                                  fiiiiii'ffi
K1CNEY                                 N      N                                       H
  LYMPHOCYTIC  INFILTIWTE                	>>---
  MINERALIZATION                        	      --(!)-
  hPHROPATmr,  CHRONIC                                I       I      1      -      -     -      -      1
URINARY GLADDER
TES7ES
PROSTATE
EYES
                                  (Report Continued)
                                                  111-57

-------
                                    PATHOLOGY  ASSOCIATES,   INC
                                                       PARA-CRE50L
                                                     STUDY NO. 5221.08
                                                    SPRAGUE-MULEY
                                         Tabulated  Animal   Data
                            PROJECT ID: P.CRESOL    GROUP! 175 MG     SEXi tttLE      DAYS: AO.
                            W6E 4                 FATES: ALL
                   tfllttL IB. NO:               3731   3732   3733   3734   3735   3734   3737   3738   373?   3740

OTHER TISSUES WO IESIMS:
                                          (Report  Continued)
                                                          111-58

-------
                        PATHOLOGY  ASSOCIATES,  INC,
                                         !fc-CRESOl
                                      STUDY NO. 5221.OS
                            Tabulated  Animal   Data
                 P8WICT ID; P.CRESOL    6RQUP:  175 HS     SBC: mil     DAYS: ALL
                 PAGES               FATES: ALL
ANimL 10. NO!
CPT&tir JJtSUS:
SPINAL cam
Bint
eUic HHKXIJU
' ~''"v
Si 1U6SY GUWB
3741 3742 3743 3744 3745 374<5 3747 3748 37 375J

iliflilllf


MWB1BULAR LWKHDDE                 tttttttttt


THYHUS                             tiii****


PANCREAS                           i           *     l     *     *      *     it     i


PITUITARY                           **iii


THYROID      .                      i     i      i     i          i      i     i     i     i


PARATHYROID                              *           i          *           *     *     
                                    Contintd)
                                                                                306
                                           111-59

-------
                          PATHOLOGY  ASSOCIATES,  INC
                                             WW-CSESQL
                                         STUDY NO.  5221.08
                                         SPftttUE-MULEY RATS
                               Tabulated  Animal   Data
                  PROJECT  ID: P.CKSOL    6RDUP: 175 MS      SEX: HALE
                  PAGE 6                 FATES: All
                                                                       DAYS: flLL
TRACHEA
                ID. NO:
CHRCWIC
                                    3741   3742   3743   3744  3745   374i   3747  3743   374?   3750
                      N      N     N     H
                                                             <1)
                                                                     N      N
                                                                                       N      N
                                                                                 (1)
AORBWL
HWffT
AORTA
1 I
Itffftlt
DUODENU1


FOHESTWCH


         STWCH
SKIN
                                (Report Continued)
                                               111-60
                                                                                     30

-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                          STUDY NO. 3221.08
                                         S?MU-WW.iY RATS
                               Tabulated  Animal   Data
                   HMUECT 10; P.OTSM.    EROUPi  173 HS     SEXs LE      DAYS: flU.
                   TOE 7                OTES: ftU
                ID. NO:
        suw


 SKELETAL MUSCLE


 LIVER


 SPLEBi
 HONEY
  LWHOCYTIC 1NF1LTFWTE
  fiPHRDPAM, CHRCNIC
  WDRflNEPHROSlS
URINARY ILADDIR
TESTIS
PICSTflTi
_EYES
3741   3742   3743   3744   3745  374(5   3747   374S   374?   375(1

 flliiliftl








 1      i     I      *{*!*      I


             N
      (i)     -     CD    
-------
                               PATHOLOGY  ASSOCIATES,   INC.
                                                MW-CRESOL
                                             OTYNO, 5221,08
                                             SPfWBil-MULCT RATS
                                   Tabulated  Animal   Data
                        fSftJECI  10: P.CRESBL    6ROUP;  ITS MS     SEX: fLE      DAYS: ALL
                        M6E 8               FATEa: ALL
                     ID. NOs             374!   37   3743   3744   3745   37   3747   374i  374?  3750

HER TISSUES m LESIINS;
                                    (End H Rtport)
                                                  111-62
                                                                                      309

-------
                         PATHQLOeY  ASSOCIATES,   INC
                         ~                  Pftfift-CSESDL
                                        mm m. 5221.DB
                                       SPIMGUE-tftULElf RATS
                              Tabulated  Animal  Data
                  HGJECT l!h P.CRISOL   iRQUP; 609 MS     SEX: Hftll      DfttS: ALL
                  WSE I                WTES: ALL
               IB. NO:              3741   3762   37i3   3744   37   37M   3767   3741  3769   377J

BRAIN                              NNNNNNNNNN


SCIATIC NEFWE                        NNNNNNNNNM


SPZWL CORD                          NNNNNNNHNN


BCNE                               NNHNHHKNNH


                                   NKHHHNNKHN


                                   NNNNNNNKNN
(WffllilMR LWH NODE                       N      N      H      N           N     K
  LYHPHOiO IffPERPlASM                2----I--21
iirmus                              N                  N      N      H
  KB1flRfl*SE ACUTE                   -     (15    ---    <1>        (1)
WWC8EAS                            N           H     N                  N           N      N
  BftSIPHILIC KLUJLAR OW6E                 <15	
  KfPERPWSIA, ISLET KLIS             -     -     -     -     <2)     -      -    
-------
                         PATHOLOGY  ASSOCIATES,   INC.
                                            PABKRESQL
                                         STUDY HO. 5221,08
                                        SPIWGUE-OAULEY  f&TS
                              Tabulated  Animal   Data.
                  PROJECT ID!  P.CRESOL   GROUP!  400 KB     SEX: WLE       WYS: ALL
                  W6E 2                FATES;  ALL
               ID. KD:
PITUITARY
  cirsT
3741   3762   3743   3744   3745   3744   3747   3748   374?   377B

 NN           N      N     N     N     N      N      N
THYROID
  EPITHELIAL  CYST
 N           N                              N
      (1)    -     (1)    (1)    (25   (13    -     <2>    (1)
PARATHYROID
 N'HNNNNNNNN
TWCHSI
  LYMPHOCTT1C  INFllTi^TE
  EFITHILML METAPLASIA
                   (2)
                                                                   (15
                                            (1)
ESQFKASJS
 NNNNNNNNNK
                                    NNNNNNNNNN
  IWPHOCfTIC INFIL.,P!RlWiSC,
  lHFLAH.,IMTERSTniAL,CH8(MC
  WEUflHIA,  FOREI6H-BOOY
                                                        (1)
HEART
  WUffWTIOK, CHRW1C
 N           N      N      N
      (2)           -      -
                                                                                N     N
                                                                         
-------
                           PATHOLOGY  ASSOCIATES,  INC.
                                           STUDY NO. 5221.08
                                          SPMGUE-MUIEY MIS
                                Tabulated  Animal  Data
PROJECT  ID: P.CRESOl    GROUP:  
-------
                         PATHOLOGY  ASSOCIATES,   INC.
                                             PARft-CSESDL
                                         STUDY NO.  5221.03
                                         SPRAGUE-MM.EY RATS
                               Tabulated  Animal   Data
                  PROJECT ID: P.CRESOL    BROUP: 400 MS     SEX: MLE       CAYS: ALL
                  PAGE 4                 FATES: ALL
         ftNIML  10. NO:
TESTES
3741   37S2   3763   3744   3745   3744   3747   3748   3749   3770

 NNNNNNNNNN
PROSTATE
  LYMPHOmiC INFILTRATE
       N      N      N     N      N      N
                                                                                        N
ETES
 HNNNNNNNNN
OWRY
UTERUS
CWIX
                                (Report Continued}
                                                111-66
                                                     31
                                                                                               
-------
                                  PATHOLOGY  ASSOCIATES,   INC
                                                    MW-CRESOL
                                                  STUDY HO.  5221.08
                                                 SPRAGUE-WULEY RATS
                                       Tabulated  Animal  Data
                           PROJECT ID: P.CRESDL    GROUP: 400 MG      SEX: WLE      DAYS: All
                           PftGE 5                FATES: ALL
                        ID. HO:              3761   37i2   3743   3744   3745   3744  3747   3748   374?   3770

OM8 TISSUES WD LESNNS;
                                        (Report Continued)
                                                       rn-67

-------
                          PATHOLOGY  ASSOCIATES,   INC
                                              PftRA-CRESOL
                                          STUDY NO. 5221.08
                                          SPRAGUE-iWJLEY RATS
                               Tabulated  Animal   Data
                   PROJECT ID:  P.CRESOL    GROUP: m MS      SEX: WLE       DAYS: ALL
                   PAGE i                 FATES: All
         ANJML ID. NO:

 BRAIN
  LWHQCTTIC INF1L. MENINGES
                                     3771   3772   3773   3774   3775   377i   3777   3778   3779   37BO

                                      N     N            N     N      N      N      N     N      N
                                                  U>     .......
SCIATIC NEWE
                                      NNHNHMUHNN
SPItoL CCRD
                                      NNNNNNNNNN
BM
                                      NNNNNHHNNH
BONEttiRROU
                                      NNNNNNNNNN
SALIVARY SLAND
                                      NNNNNN.HNNN
IWDIBULAR LYMPH NODE
  M1PHOIO HYPERPLASIA
                                      N            K      N                               N      N
                                      -      i     -      -     3      2      1      1
TKTOUS
  HEMJRRJW6E, ACUTE
                                           <15
PANCREAS
  KHOS1DERDS1S
  BASCPHILIE CaLULAR CttWGE
  ACIfW? ATROPHY
N                  N      N     N
-      -     (!)
-      -.     -     -      -
      <1>
                                                                            <2)
                                                                                         (2)
                                (Report  Continued)
                                                111-68
                                                                                              o 1 O

-------
                           PATHOLOGY  ASSOCIATES,  INC,
                                              PAHA-CHESOL
                                           STUDY NO. 5221.08
                                           SPRAGUE-DAULEY MIS
                                Tabulated  Animal  Data
                   PROJECT 10: P.CRESOL   GROUP: 4DD KG      SEX: WLE       DAYS: All
                   PAGE 7                FATES: ALL
                ID. NO:               3771   3772   3773   3774   3775   3774   3777   3778   377?   37EO

PITUITARY                              N     N      N     N      N            H            N      H
  CTST                                 	(I)            1
THYROID                                                          N      N      H
  EPITHELIAL CYST                      <2>    <1>    (1)     (1)            -      -     <2>    (2)    <2>
PARATHYROID                             U     N      N     N      N      U      N      N     N      H
TRACHEA                                N                  N      N            N            N
  INFUHMTION, CHRONIC-ACTIVE           -    U)	<1)
  EPITHELIAL METAPLASIA                 -                            <2)     -     <2>
ESOPHAGUS                               NNNNNKNNNH
ADRB. BLAND                           N      N      N     N      N      N      K            NN
  EUASIA, HEDULLA                      	             I
LUNG
  LYM?HOCYTICINfIL.)PERlVASC.          <3)    <2>    (1)     <2)        <3>        <1>    <2>     -     <2>
  CELLULAR THROHBUS                     	<1)
HEART                                                     N      N      H
  iNFwmvncN, CHRONIC                    tn     (i)    
-------
                          PATHOLOGY ASSOCIATES,  INC.
                                            BHW-CSE50L
                                          STUBY NO.  5221.08
                                         SPMGUE-MUIET RATS
                               Tabulated  Animal   Data
                  PROJECT  ID: P.CRESOl    SROUPi m Ml      SEd WLE      WYSf ALL
                  WGI 8                 FATES: ALL
                ID, NOi     -        3771   3772   3773   3774   3775   377i   3777   3778  3779   3781

 COLIN                                HHHMNHNNNH


 OUODENU1                              HNNNNNNNNN


 FORiSICmCH                           HNNNNNNHNH


 SUWDUIAR STOCH                     NHNNNNNNNH


 UN                                 NNNNNNHNNK


mVAm BiflNO                         yHNUNNUHUfl


 SCSLiTtt HUSCII                        NNNNNNHHNN
LIVES                                 N     N     N            N                        N     H
  WFWHW10N, OffiSNIC                -     -           (I)           (I?    <1)    <1>
  NECROSIS                            	     
-------
                          PATHOLOGY  ASSOCIATES,   INC.
                                             Mftt-CHESOl
                                          STUB? NO, 5221.08
                                                       SATS
                               Tabulated  Animal   Data
                   PROJECT IDs P.CREiOL    6RDUP; m HG     SEXi WLE       DAYS: ALL
                   PftSS ?                 MT1S: ALL
                IB. NO;               3771   3772   3773   3774   3775   3774  3777   3773  377?   37SB

W1WM UDDER                              M     N     H     N                               N
  fflLCULUS                             1      .....      i     -      2
  LWHCCfTlC INFILTRATE                	(IJ     -    U)
1ESTES                                NHHHNNMNNH
PROSTATI                                     NNNNHNH
  LWHOGYtlC INFILTRATE               <2)            -      -     -      -     -      -
                                     NNN'NKNNNNN


AMY                                 siiiiiiiii


UTERUS                                >lSijtiti


CEW1X                                *iijii**ii
                                (Repert Continued!
                                                111-71

-------
                                  PATHOLOGY  ASSOCIATES,   INC.
                                                    WIW-CRESQL
                                                 SIU6Y NO. 5221,08
                                                 SPHAGUE-WWLEY WTS
                                       Tabulated  Animal   Data
                           PRWiCT I5i P.CSESQL    6MUP: iOfl H6     SEX: NM.E       MYS: AU.
                           WGI Sfl               FA7IS; ALL
                  MIHAL ID. NO:              3771   3772  3773   3774   1775   3774   3777  377S  3779   378B

UTffii TISSUES AND LEil^S:
                                        
-------
IV. GROSS VS. MICROSCOPIC FINDINGS
                                        320

-------
Page Intentionally Blank

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY NO.  5221.03
                               SPRAGUE-DAULEY RATS
                Correlation o-f  Gross & Micro  Findings
 ROJECT ID: P.CRESOL    GROUP:  0.0 MG       SEX:  FEMALE     DAYS: ALL
 AGE 1                   FATES!  ALL


 NIMAL NO: 3801            PATHOLOGY ID. NO:  353801             PATHOLOGIST- DSC
 NIMAL FATE: SCHEDULED SACRIFICE
 ROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: ?Q

 EFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

 NGL
 NIMAL NO: 3802            PATHOLOGY  ID. NO: 853S02             PATHOLOGIST: DSC
 NIMAL FATE: SCHEDULED SACRIFICE
 ROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90
          TD NECROPSY RECORD:           RELATED  HI STOPATHOLOGY :

 NGL
.NIMAL NO:  3803            PATHOLOGY  ID. NO: 8S3803             PATHOLOGIST: DSC
iNIMAL FATE:  SCHEDULED SACRIFICE
'ROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

NGL
.NIMAL NO:  3304            PATHOLOGY  ID. NO: S53304             PATHOLOGIST: DSC
.NIMAL FATE:  SCHEDULED SACRIFICE
'ROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: ?1

REFERENCE TO  NECROPSY RECORD:           RELATED  HI3TOPATHOLOGY:

>NGL
                                                                      - 9 1
                                                                      aj:* -w -1
                              ^Report Continued)
                                      IV-1

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY NO.  5221 .OS
                               SPRAGUE-DAWLEY  RATS
                Correlation o-f  Gross & Micro  Findings
PROJECT  IDs  P.CRESOL     GROUP:  0,0 MG       SEX:  FEMALE      DAYS: ALL
PAGE 2                   FATES:  ALL


ANIMAL NO: 3S05             PATHOLOGY ID. NO;  853805             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST:  90

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIHAL NOs 3806            PATHOLOGY  ID. NO: 853806            PATHOL06IST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:
ANIMAL NO: 3807            PATHOLOGY ID. NO: 853807            PATHOLOGIST: DSC
ANIMAL- FATE: SCHEDULED SACRIFICE
PROBABLE'.CAUSE OF DEATH;                                       DAYS ON TEST i 91

REFERENCE TO NECROPSY RECORD:           RELATED HI3TOPATHOLOGY:

>NGL
ANIMAL NO: 3808            PATHOLOGY ID. NO: 853803            PATHOLOGIST: DSC
ANIMAL FATE! SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                              (Report Continued)               c',22

                                      IV-2

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross &  Micro Findings
 PROJECT  ID:  P.CRESOL    GROUP:  0.0 MG      SEX:  FEMALE     DAYS: ALL
 PAGE  3                   FATES:  ALL


 ANIMAL NO:  3809             PATHOLOGY ID.  NO:  853309            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF  DEATH:                               .         DAYS ON TEST: ?0

 REFERENCE TO  NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

 >NGL
ANIMAL NO:  3810             PATHOLOGY  ID.  NO:  853B10             PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE  CAUSE  OF  DEATH:                                        DAYS DN TEST: 90

REFERENCE TO  NECROPSY RECORD:            RELATED HISTDPATHOLOGY:
ANIMAL'NO: '3811            PATHOLOGY  ID. NO:  853811             PATHOLOGIST:  DSC
ANIMAL FATE; fe^H^ULED "SACRIFICE
PROBABLE CAUSE; OF DEATH:                                        DAYS ON TEST;  90

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3812            PATHOLOGY  ID. NO: 853S12             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
                              (Report Continued)

                                      IV-3

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                   PARA-CRE50L
                                STUDY NO. 5221.03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross & Micro Findings'
 PROJECT ID:  P.CRESOL    GROUP; 0.0 MG      SEX: FEMALE     DAYS: ALL
 PAGE 4                  FATES: ALL


 ANIMAL NO:  3B13            PATHOLOGY ID. NO: 353813            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATHs                                        DAYS ON TEST: 92

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 >NGL
 ANIMAL  NO;  3814             PATHOLOGY ID.  NO: 353314            PATHOLOGIST: DSC
 ANIMAL  FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

 REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO:  3815             PATHOLOGY ID.  NO:  853315            PATHOLOGIST: DSC
.ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGYs

>NGL
ANIMAL NO: 3816             PATHOLOGY  ID.  NO:  853816            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORDS            RELATED HISTOPATHOLOGY:

>NGL
                               (Report  Continued)

                                                                  - '* 4

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO.  5221.08
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross & Micro  Findings
 PROJECT  ID:  P.CRESOL    GROUP:  0.0  MG      SEX:  FEMALE     DAYS: ALL
 PAGE  5                   FATES:  ALL


 ANIMAL NO: 3317             PATHOLOGY  ID.  NO:  853817            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF  DEATH:                        '                DAYS ON TEST: 92

 REFERENCE TO  NECROPSY  RECORD:            RELATED  HISTOPATHOLQGY:

 >NGL
ANIMAL NO: 3818             PATHOLOGY  ID. NO:  853818             PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:
ANIMAL NO: 3319            PATHOLOGY  ID. NO:  853819             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                 .       DAYS ON TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3820            PATHOLOGY  ID. NO; S5382Q             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON  TEST:  90

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>PITUITARY GLAND-SLIGHTLY ENLARGED       NO COROLLARY  CHANGE  DETECTED
                              < End o-f Repor t)

                                      IV-5                          -} 9
                                                                   " *'

-------
                        PATHOLOGY ASSOCIATES, INC.
                                    PARA-CRESOL
                                STUDY NO. 5221 .08
                               SPRAGUE-DAULEY RATS
                 Correlation o-f  Gross  & Micro Findings
 PROJECT ID: P.CRESOL    GROUP: 50 MG       SEX:  FEMALE      DAYS: ALL
 PAGE 1                  FATES: ALL


 ANIMAL NO: 3831            PATHOLOGY ID. NO: 85333L             PATHOLOGIST!  DSC
 ANIMAL FATE: SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  90

 REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

 >NGL
 ANIMAL MO:  3832            PATHOLOGY ID. NO: 853832            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 90

" "  ~ERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >MGL
 ANIMAL NO:  3833            PATHOLOGY ID. NO: 853S33            PATHOLOGIST! DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 90

 REFERENCE.TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 >NGL
ANIMAL  NO:  3834            PATHOLOGY ID.  NO: 853834            PATHOLOGIST: DSC
ANIMAL  FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF DEATH:                                        DAYS ON TEST: ?1

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEY3-SLIGHTLY MOTTLED                NO COROLLARY CHANGE DETECTED
                               (Report Continued)               3 2 6
                                       IV-6

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY  NO.  5221,08
                               SPRAGUE-DAyLEY RATS
                Correlation o-f  Gross & Micro  Findings
 PROJECT  ID;  P.CRESOL     GROUP!  50 MG        SEX:  FEMALE      DAYS: ALL
 PAGE  2    '               FATES:  ALL


 ANIMAL NO: 3835            PATHOLOGY  ID. NO:  853335            PATHOLOGIST: DSC
 ANIMAL FATE; SCHEDULED SACRIFICE
 PROBABLE  CAUSE OF  DEATH:                                       DAYS ON TEST; 91

 REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY;

 >NGL
ANIMAL NO: 3836            PATHOLOGY ID. NO: 853834            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:
ANIMAL NO: 3837            PATHOLOGY ID. NO; 853337            PATHOLOGIST: DSC
ANIMAL FATEs SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLQGY:

>NQL
ANIMAL NO: 3838            PATHOLOGY ID. NO: 853838            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATHi                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                              (Report Continued)

                                      IV-7

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                    PARA-CRESCL
                                STUDY NO. 5221 .03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f  Gross & Micro Findings
 PROJECT ID:  P.CRESOL    GROUP: 50 MG       SEX: FEMALE     DAYS: ALL
 PAGE 3                  FATES: ALL


 ANIMAL NO:  3839            PATHOLOGY ID. NO: 853839            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATHs                                        DAYS ON TEST: 90

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 >NGL
ANIMAL NO:  3840             PATHOLOGY ID.  NO:  853340            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE  OF DEATH:                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:
-1- '- >
  'GL
ANIMAL NO:  3841             PATHOLOGY ID.  NO:  853341             PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE  OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3S42             PATHOLOGY  ID.  NO:  853342             PATHOLOGIST: DSC
ANIMAL FATE'. SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
                               
-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                   PARA-CRESCL
                                STUDY NO. 5221 .OS
                               SPRAGUE-DAULEY RATS
                Correlation  o-f Gross & Micro Findings
PROJECT  ID:  P.CRESOL    GROUP: 50 MG       SEX: FEMALE     DAYS: ALL
PAGE  4                   FATES: ALL
ANIMAL  NO:  3343             PATHOLOGY ID. NOi  853843            PATHOLOGIST: DSC
ANIMAL  FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF DEATH:                                        DAYS ON TEST:  92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO:  3344             PATHOLOGY ID.  NO: 853S44            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

  GL
ANIMAL NO; 3843             PATHOLOGY ID.  NO:  S5384S            PATHOLOGIST: DSC
ANIMAL FATf:: SCKi-,L>ULfcD  SACRIFICE
PROBABLE  CAUSE Or  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEYS-BOTH,PELVIS SLIGHTLY  DILATED    KIDNEY- HYDRONEPHROSIS
ANIMAL NO: 384^             PATHOLOGY  ID.  NO:  353S46            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               (Report  Continued)

                                       IV-9

-------
                        PATHOLOGY  ASSOCIATES, INC.
                                   PARA-CRESOL
                                STUDY NO. 5221 .03
                               SPRAGUE-DAUILEY RATS
                Correlation  o-f Gross  & Micro Findings
 PROJECT  ID:  P.CRESOL    GROUP: 50 MG       SEX: FEMALE     DAYS: ALL
 PAGE  5                   FATES: ALL


 ANIMAL NO:  3847            PATHOLOGY ID. NO: 853837            PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  91

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 >NGL
ANIMAL NO:  3348             PATHOLOGY ID. NO: 853348            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST:  90

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3849             PATHOLOGY ID.  NO: S5384?            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3850             PATHOLOGY  ID.  NO:  853850             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               ( End  o-f  Repor O
                                                                 '-1 3
                                      IV-10

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO.  5221 .'OS
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross &  Micro Findings
PROJECT  ID:  P.CRESOL     GROUP:  175 MG      SEX:  FEMALE     DAYS: ALL
PAGE  1                   FATES:  ALL


ANIMAL NO: 3861             PATHOLOGY ID.  NO:  853841             PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE  OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3862             PATHOLOGY  ID.  NO:  853862            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 91

  "ERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>PITUITARY GLAND-SL1GHTLY  ENLARGED        HISTOLOGICALLY NORMAL
ANIMAL NO: 3863             PATHOLOGY  ID.  NO:  853363            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLDGY:

>NGL
ANIMAL NO: 3864            PATHOLOGY  ID. NO:  853864             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:           RELATED  HISTCPATHOLOGY:

>MGL
                               
-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.08
                               SPRAGUE-DAULEY RATS
                Correlation  o-f Gross &  Micro  Findings
 PROJECT  ID:  P.CRESOL    GROUP:  175 MG      SEX: FEMALE     DAYS: ALL
 PAGE  2                   FATES:  ALL


 ANIMAL NO: 3S65             PATHOLOGY ID.  NO:  353845            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 90

 REFERENCE TO  NECROPSY  RECORD:            RELATED HISTCPATHOLOGY:

 >NGL
ANIMAL NO: 3S66             PATHOLOGY  ID.  NO:  853866            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY RECORD:           RELATED  HISTQPATHOLOGY:
ANIMAL NO: 3867             PATHOLOGY  ID. NO:  853867             PATHOLOGIST:  DSC
ANIMAL FATE; SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3S63            PATHOLOGY  ID. NO: 853068             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
                               (Report Continued)

                                      IV-12

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY NO. 5221.OS
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross &  Micro Findings
PROJECT  ID:  P.CRESOL    GROUP:  175 MG      SEX: FEMALE     DAYS: ALL
PAGE  3                   FATES:  ALL


ANIMAL NO: 3869             PATHOLOGY ID.  NO: 853349            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO:  3370             PATHOLOGY ID.  NO:  8S3S70            PATHOLOGIST: DSC
ANIMAL FATEi  SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3871            PATHOLOGY  ID.  NO:  SS3S71             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                      .  DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHCLOGY:

>NGL
ANIMAL MO: 3372            PATHOLOGY  ID. NO:  853372             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>KIDNEY3-RIGHT PELVIS DILATED.           KIDNEY- HYDRONEPHROSIS
                               O

                                      IV-13

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO.  5221.03
                               SPRAGUE-DALJLEY RATS
                Correlation o-f  Gross & Micro  Findings
PROJECT  ID:  P.CRESOL     GROUP:  175  MG      SEX:  FEMALE     DAYS:  ALL
PAGE  4                   FATES:  ALL


ANIMAL NO: 3873             PATHOLOGY  ID.  NO:  853873            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3374            PATHOLOGY  ID.  NO:  853374             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:
ANIMAL NO: 3375            PATHOLOGY  ID. NO: 853875             PATHOLOGIST:  DSC
ANIMAL'FATE:''SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON  TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3876            PATHOLOGY  ID. NO: S53876             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON  TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHCLOGY:

>NGL
                              (Report Continued)
                                      iv-u

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY NO. 5221 .OS
                               SPRAGUE-DAULEY RATS
                Correlation  o-f Gross &  Micro Findings
PROJECT  ID:  P.CRESOL     GROUP:  175 MG      SEX: FEMALE     DAYS: ALL
PAGE  5                   FATES:  ALL


ANIMAL NO: 3377             PATHOLOGY ID. NOs  853877            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3878             PATHOLOGY ID.  NO:  853878            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3S79             PATHOLOGY ID.  NO:  853379            PATHOLOGIST: DSC
ANIMAL FATE: SCHErTHfl'.KD  SACRIFICE
PROBABLE CAUSE OF- DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3880             PATHOLOGY ID,  NO:  853330             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               (End  o-F  Report) 
                                                                  O O fi
                                       IV-15                          J

-------
                        PATHOLOGY  ASSOCIATES,  INC
                                   PARA-CRESOL
                                STUDY NO. 5221.OS
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f  Gross   Micro Findings
 PROJECT  ID;  P.CRESOL    GROUP: 600 MG      SEX: FEMALE      DAYS: ALL
 PAGE  1                   FATES: ALL  -


 ANIMAL NOs  3891             PATHOLOGY ID. NO: 853391             PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                         DAYS ON  TEST:  91

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHQLOGY:

 >NGL
ANIMAL  NO:  3892            PATHOLOGY ID. NO: 853392            PATHOLOGIST:  DSC
ANIMAL  FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE  OF DEATH:                                        DAYS  ON  TEST:  91

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3393             PATHOLOGY ID.  NO: 853393            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 9:

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3394             PATHOLOGY  ID.  NO:  853394            PATHOLOGIST: DSi
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 9'

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               (Report Continued)
                                    IV-16

-------
                       PATHOLOGY ASSOCIATES,  INC,
                                   PARA-CRESOL
                                STUDY NO.  5221 .OS
                               S P R AGUE-DAWL EY  RAT3
                Correlation'  o-f Gross &. Micro  Findings
PROJECT  10: P.CRESOL     GROUP:  600  MG       SEX:  FEMALE     DAYS:  ALL
PAGE  2                   FATES:  ALL


ANIMAL NO: 3895             PATHOLOGY  ID.  MO;  853895             PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST:  PC

REFERENCE TO  NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3396             PATHOLOGY  ID, NO:  353896             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE ,OF DEATH:                                        DAYS ON TEST:  PI

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3S?7            PATHOLOGY  ID.. NO: 333897             PATHOLOGIST:  DS:
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON  TEST .=  

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
ANIMAL MO: 389S            PATHOLOGY ID. NO: 353898             PATHOLOGIST:  DS
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON  TEST:  9

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                              (Report Continued^              83?

                                    IV-17

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                    PARA-CRE50L
                                 STUDY  NO.  3221.03
                               SFRASUE-DAWLEY  RATS
                 Correlation o-f  Gross, fii Micro  Findings
 PROJECT ID:  F.CRESOL    GROUP:  600 MG       SEX:  FEMALE     DAYS: ALL
 PAGE 3                  FATES:  ALL


 ANIMAL NO:  3B99            PATHOLOGY  ID, NO:  853399            PATHOLOGIST: DSC
 ANIMAL FATE:  FOUND DEAD
 PROBABLE CAUSE OF DEATH:                                         DAYS ON TEST:  1

 REFERENCE TO  NECROPSY RECORD:            RELATED  HISTOPATHOLQGY:

 >LUNGS-RED AND MOTTLED AMD FAILED TO     LUNG- CONGESTION
  COMPLETELY COLLAPSE

 >                                         ALL  TISSUES MILDLY AUTOLYTIC
 ANIMAL NO:  3900            PATHOLOGY  ID. NO:  853700             PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 9!

"REFERENCE TO  NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

 >NGL
ANIMAL  NO:  3901             PATHOLOGY ID. MO: 353901             PATHOLOGIST: DS<
ANIMAL  FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: ?\

REFERENCE TO  NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
                               
-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                   FARA-CRESQL
                                STUDY NO. 322! .08 .
                               SFRAGUE-DAULEY RATS
                Corr-ela^ion  o-f Gross  &t Micro Findings
PROJECT  ID:  P.CRESOL    GROUP: &00 MG      SEX: FEMALE      DAYS:  ALL
PAGE  4                   FATES: ALL


ANIMAL NO:  3902             PATHOLOGY ID. NO: 353902             PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST:  92

REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLQGY:

>NGL
ANIMAL NO:  3903             PATHOLOGY ID. NO: 53903'             PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                         DAYS  ON TEST:  ?2

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGYs

>NGL
ANIMAL NO: 3904          -   PATHOLOGY ID.  NO: 353904            PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS  ON TEST:  ?:

REFERENCE TO NECROPSY RECORD:           -RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3905             PATHOLOGY ID.  MO: 353905            PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  ?i

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY\

>NGL
                               (Report  Con t i nu*d)

                                    IV-19

-------
                        PATHOLOGY  ASSOCIATES,  INC
                                   PARA-CRESOL
                                STUDY NO. 5221 .OS'
                               SPRAGUE-DAUILEY RATS
                Correlation  o-f  Gross  & Micro  Findings
PROJECT  IDs  P.CRE3GL    GROUP: 600 MG    '  SEX:  FEMALE     DAYS: ALL
PAGE  5                   FATES: ALL


ANIMAL NO:  3906            PATHOLOGY ID. NO: 35390,=,             PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:           RELATED  HISTOPATHQLOGY:

>NGL
ANIMAL NO:  3907             PATHOLOGY ID. NO: 853907             PATHOLOGIST; DSC
ANIMAL FATEt  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF DEATH:                                         DAYS ON TEST: 90

REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:
ANIMAL NO:  3903             PATHOLOGY ID. NO: S5390S             PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                         DAYS ON TEST: 90

REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3?09             PATHOLOGY ID. NO: 853909             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                          .               DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               (Report Continued)

                                    IV-20

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                    PARA-CRESOL
                                STUDY NO.  5221.OS
                               SPRAGUE-DAl-JLEY RATS
                Correlation  o-F  Gros-s & Micro  Findings
PROJECT  ID: F.CRESOL    GROUP: 600 MG       SEX:  FEMALE     DAYS: ALL
PAGE *                   FATES: ALL


ANIMAL NO: 3910             PATHOLOGY ID.  MO:  853910            PATHOLOGIST:  DSC
ANIMAL FATE:  FOUND  DEAD
PROBABLE CAUSE  OF  DEATH:                                          DAYS ON TEST 1  1

REFERENCE TO  NECROPSY RECORD:            RELATED  HISTQPATHOLOGY:

>OIL AROUND NOSE AND MOUTH                (TISSUE UNAVAILABLE)

>OIL IN TRACHEA                            LUNG- OIL  DROPLETS
                               (End o-F Report)
                                                                   <> A -i
                                      IV-21                          ^ -1

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                    PARA-CRESOL
                                STUDY NO. 5221.08
                               SPRAGUE-DAULEY RATS
                 Correlation  o-f  Gross  & Micro Findings
 PROJECT ID: P.CRESOL    GROUPs 0.0 MG      SEX: MALE       DAYS: ALL
 PAGE 1                   FATES: ALL


 ANIMAL  MO: 3-671            PATHOLOGY ID. NO: 853671            PATHOLOGIST: DSC
 ANIMAL  FATE: SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 91

 REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >NGL
 ANIMAL NO:  3472            PATHOLOGY ID. NO: 853672            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 90

          TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:
 ANIMAL  NO:  3673            PATHOLOGY ID. NO: 853473            PATHOLOGIST: DSC
 ANIMAL  FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 90

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGYs

 >KIDNYS-SLIGHTLY MOTTLED                KIDNEY- NEFHROPATHY,  CHRONIC
ANIMAL NO:  3674             PATHOLOGY ID.  NO:  853674            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE  OF DEATH:                                        DAYS ON TEST: 91
REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:
>KIDNEYS-SLIGHTLY MOTTLED                NO COROLLARY CHANGE DETECTED
'- :YER-SLIGHTLY  ENLARGED  AND PALE        NO COROLLARY CHANGE DETECTED
                                       IV-22
                               (Report  Continued)

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY NO. 5221.08
                               SPRAGUE-DAULEY RATS
                Correlation  o-f Gross &  Micro Findings
PROJECT  ID:  P.CRESQL    GROUP:  0.0 MG      SEX: MALE       DAYS: ALL
PAGE  2                   FATES:  ALL


ANIMAL NO: 3675             PATHOLOGY ID.  NO: 853675            PATHOLOGIST: DSC
ANIMAL FATE;  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEYS-SLIGHTLY  MOTTLED                NO COROLLARY CHANGE DETECTED
ANIMAL NO:  3676             PATHOLOGY ID.  NO:  853676            PATHOLOGIST; DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3677             PATHOLOGY  ID.  NO:  853677            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3673            PATHOLOGY  ID. NO:  853673             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>KIDNEYS-SLIGHTLY MOTTLED                NO  COROLLARY CHANGE DETECTED
                               (Report  Continued)


                                       IV-23

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross &  Micro Findings
   JJECT  ID:  P.CRESOL     GROUP:  0.0 MG      SEX: MALE       DAYS: ALL
   5E 3                   FATES:  ALL


   1MAL NO: 3679             PATHOLOGY ID. NO 5  853479            PATHOLOGIST: DSC
   IMAL FATE:  SCHEDULED SACRIFICE
   OBABLE  CAUSE GF  DEATH:                                        DAYS ON TEST:  90

   FERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

   IDNEYS-SLIGHTLY  MOTTLED                KIDNEY- LYMPHOCYTIC INFILTRATE
  JlfWL NO: 3660             PATHOLOGY ID.  NO: 853680            PATHOLOGIST: DSC
  JIMAL FATE: SCHEDULED  SACRIFICE
  50BABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

 EFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 T\    -BOTH KIDNEYS-PELVIS  SLIGHTLY       NO COROLLARY CHANGE DETECTED
 DILrtTED.

 KIDNEYS-SLIGHTLY MOTTLED                 NO COROLLARY CHANGE DETECTED
 .NIMAL NO: 3<8i             PATHOLOGY  ID.  NO:  853481             PATHOLOGIST: DSC
 .NIMAL FATE: SCHEDULED SACRIFICE
=ROBABLE CAUSE OF DEATH:                      '                  DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD;           RELATED  HISTQPATHOLOGY!

>NGL

>                                         TESTICULAR  ATROPHY IS UNILATERAL
                               (Report  Continued)
                                      IV-24
                                                                  >  A .f.
                                                                  o-  i '^

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO.  5221.03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross &  Micro  Findings
 PROJECT  ID: P.CRESOL     GROUP:  0.0 MS      SEX:  MALE       DAYS: ALL
 PAGE 4                   FATES:  ALL


 ANIMAL NO: 3632             PATHOLOGY ID.  NO:  853682            PATHOLOGIST:  DSC
 ANIMAL FATE: SCHEDULED  SACRIFICE
 PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 90

 REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

 >NGL
ANIMAL NO: 3633             PATHOLOGY  ID. NO:  853633             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORDS           RELATED  HISTOPATHOLOGY:
ANIMAL NO: 3694            PATHOLOGY  ID. NO: 853684             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

)NGL
ANIMAL NO: 3685            PATHOLOGY  ID. NO: 853635             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                              < Report Continued)                   t> ,<
                                                                   ,> Li
                                      IV-25

-------
                        PATHOLOGY  ASSOCIATES, INC
                                   PARA-CRE3QL
                                STUDY NO. 5221.08
                               SPRAGUE-DAUILEY RATS
                Correlation  o-f Gross & Micro Findings
PROJECT  ID:  P.CRESOL    GROUP: 0.0 MG      SEX: MALE        DAYS:  ALL
PAGE  5                   FATES: ALL


ANIMAL NO:  3636            PATHOLOGY ID. NO: 353686             PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                         DAYS ON  TEST:  92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO:  36S7             PATHOLOGY ID.  NO: S53687            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST;  91

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3698             PATHOLOGY ID.  NO:  853688            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST; 90

REFERENCE TO NECROPSY RECORD:            RELATED HI STOPATHOLOGY:

>NGL

>                                         TESTICULAR ATROPHY IS UNILATERAL
ANIMAL NO: 3639             PATHOLOGY  ID.  NO:  85363?            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST; 92

REFERENCE TO NECROPSY RECORD:       ,    RELATED HISTOPATHOLOGY:

>NGL
                               (Report  Continued)                    "->. A 1
                                                                    t.--' A ^J

                                       IV-25

-------
                       PATHOLOGY  ASSOCIATES,  INC.
                                  PARA-CRESOL
                               STUDY NO. 5221.OS
                              SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross & Micro Findings
PROJECT ID: P.CRESOL    GROUP: 0.0 MG      SEX: MALE       DAYS:  ALL
PAGE 6                  FATES: ALL


ANIMAL NO: 3690            PATHOLOGY ID. NO: 853690            PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH;                                       DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                              
-------
                        PATHOLOGY ASSOCIATES,  INC
                                    PARA-CRESOL
f                                STUDY MO.  5221.OS
                                SPRAGUF_-DAtJLF_Y RATS
                 Correlation o-f  Gross & Micro  Findings
 PROJECT ID: P.CRESOL     QROUP:  50  MG       SEX:  MALE       DAYS: ALL
 PAGE 1                   FATES:  ALL


 ANIMAL NO: 3701             PATHOLOGY ID.  NO:  853701             PATHOLOGIST: DSC
 ANIMAL FATE: SCHEDULED  SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

 REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

 >NGL
 ANIMAL NO: 3702            PATHOLOGY  ID.  NO:  853702            PATHOLOGIST: DSC
 ANIMAL FATE: SCHEDULED SACRIFICE
 PROBABLE CAUSE QF DEATH:                                        DAYS ON TEST: 91

/"""-ERENCE TO NECROPSY RECORD:           RELATED  HI STOPATHOLOGY :

 >NGL
 ANIMAL NO:  3703            PATHOLOGY  ID. NO:  853703             PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >NGL
 ANIMAL NO:  3704            PATHOLOGY ID. NO: 853704             PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >KIDNEY3-SL!GHTLY MOTTLED.               KIDNEY- NEPHROPATHY,  CHROMIC
                                                                    O A V
                                                                    .i Ll Q
                               
-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.OS
                               SPRAGUE-OAWLEY RATS
                Correlation  o-f Gross. &  Micro Findings.
PROJECT  ID:  P.CRESOL    GROUP:  50 MG       SEX: MALE       DAYS: ALL
PAGE 2                   FATES:  ALL


ANIMAL NO: 3705             PATHOLOGY ID. NO: 95370S            PATHOLOGIST:  DSC
ANIMAL FATEs SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO! 3704             PATHOLOGY ID.  NO: 853706            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST:  91

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO; 3707             PATHOLOGY  ID.  NO:  853707            PATHOLOGIST! DSC
ANIMAl  FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TESTi 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>TONGUE-3 X 3MM, WHITE,  CIRCLE  ON         TONGUE-INFLAMMATION, CHR.-ACT.
 UNDERSIDE
ANIMAL NO: 3703             PATHOLOGY ID.  NO:  S53708            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>RT. ADRENAL-UERY  SMALL                  HISTOLOGICALLY NORMAL.
                                                                    3-43
                               (Report  Continued)

                                       IV-29

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                    PARA-CRESOL
                                STUDY NO.  5221.03
                               SPRAGUE-DAWLEY RATS
                 Correlation o-f  Gross & Micro  Findings
 PROJECT ID: P.CRESOL    GROUP: 50 MG        SEX:  MALE       DAYS: ALL
 PAGE 3                  FATES: ALL


 ANIMAL NO 8  3709            PATHOLOGY  ID. NO:  853709             PATHOLOGIST: DSC
 ANIMAL FATE: SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

 REFERENCE TO NECROPSY RECORD:           RELATED  HISTQPATHOLOGY:

 >MGL
 ANIMAL NO:  3710   '         PATHOLOGY  ID. NO: 853710             PATHOLOGIST;  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

I-"' "QL
 ANIMAL NO:  3711             PATHOLOGY ID. NO: 853711             PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >NGL
 ANIMAL NO:  3712            PATHOLOGY ID. NO: 853712             PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS  ON TEST: 92

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >NGL
                               < Re port Continued)                   <> ^ rt,


                                      IV-30

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.OS
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross &  Micro  Findings
PROJECT  ID: P.CRESOL     GROUP:  50 MG       SEX:  MALE       DAYS: ALL
PAGE  4                   FATES:  ALL


ANIMAL NO! 3713             PATHOLOGY ID.  NO:  853713            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:           RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3714             PATHOLOGY  ID.  NOi  853714             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:
ANIMAL NO; 3715            PATHOLOGY  ID. NO:  853715             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3716            PATHOLOGY  ID. NO: S537I6             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                               (Report Continued)
                                                                    '6 5 1
                                      IV-31

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.03
                               SPRAGUE-DAULEY RATS
                Correlation  o-f Gross &  Micro Findings
PROJECT  ID:  P.CRESOL    GROUP:  50 MG       SEX: MALE       DAYS: ALL
PAGE  5                   FATES:  ALL


ANIMAL NO: 3717             PATHOLOGY ID.  NO:  853717            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLCGY:

>NGL
ANIMAL NO: 3718         '    PATHOLOGY  ID.  NO:  653718            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS CM TEST: 92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3719             PATHOLOGY  ID.  NO:  853719            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>MGL
ANIMAL NO: 3720            PATHOLOGY  ID. NO:  853720             PATHOLOGIST; DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
                                                                I r f)
                               (End  o-f Repor t)                   *-- ^ -^
                                      IV-32

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                   PARA-CRE30L
                                STUDY NO. 5221.08
                               SPRAGUE-DAULEY RATS
                Correlation  o-f  Gross. & Micro Findings
 PROJECT ID:  P.CRESOL    GROUP: 175 MG      SEX: MALE       DAYS: ALL
 PAGE 1                   FATES: ALL


 ANIMAL  NO:  3731             PATHOLOGY ID. NO: 853731            PATHOLOGIST: DSC
 ANIMAL  FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 90

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 >NGL
 ANIMAL NO:  3732            PATHOLOGY ID. NO: 853732            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

""'FERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

 >NGL
ANIMAL NO:  3733             PATHOLOGY ID. MO: 853733            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE  OF DEATHs                                        DAYS ON TEST: 90

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO:  3734             PATHOLOGY ID.  NO:  853734            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH;                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               (Report Continued)

                                       IV-33

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.08
                               SPRAGUE-DAULEY RATS
                Correlation  o-f Gross &  Micro Findings
PROJECT  ID:  P.CRESOL    GROUP:  175 MG      SEX: MALE       DAYS: ALL
PAGE  2                   FATES:  ALL


ANIMAL NO:  3735             PATHOLOGY ID. NO:  853735            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEYS-SLIGHTLY  MOTTLED                KIDNEY- NEPHROPATHY,  CHRONIC
ANIMAL NO:  3736             PATHOLOGY ID.  NO:  853736            PATHOLOGIST! DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:
ANIMAL NO: 3737             PATHOLOGY  ID.  NO:  853737            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3733             PATHOLOGY  ID.  NO:  853733            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
                               < Report  Continued)                   '.J E. /?
                                                                   *.'. J E

                                       IV-34

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO.  5221 .03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross & Micro  Findings
PROJECT  ID:  P.CRESOL     GROUP:  175 MG      SEX:  MALE       DAYS: ALL
PAGE  3'                  FATES:  ALL


ANIMAL NO:  3739             PATHOLOGY ID.  NO:  853739            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 90

REFERENCE TO  NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

)NGL
ANIMAL NO: 3740             PATHOLOGY  ID. NO;  853740             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 90

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:
ANIMAL NO: 3741            PATHOLOGY  ID. NO:  853741             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3742            PATHOLOGY  ID. NO: 953742             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

>NGL
                                                                   ' J K
                                                                   v* ij
                              (Report Continued)

                                      IV-35

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                    PARA-CRE3QL
                                STUDY NO. 5221.08
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f  Gross & Micro Findings
 PROJECT ID:  P.CRESOL    GROUP: 175 MG      SEX: MALE       DAYS: ALL
 PAGE 4                  FATES; ALL


 ANIMAL NO:  3743            PATHOLOGY ID. NO: 853743            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST: 91

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLQGY:

 >NGL
 ANIMAL NO:  3744            PATHOLOGY ID.  NO: S53744            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

 REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

:' " <3L
ANIMAL  NO:  3745             PATHOLOGY ID.  NO:  853745            PATHOLOGIST: DSC
ANIMAL  FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>MGL
ANIMAL NO:  3744             PATHOLOGY ID.  NO:  853746            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 92

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               (Report  Continued)
                                                               *^ ^ r*
                                                               .L'.- o b
                                      IV-36

-------
                        PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO. 5221.03
                               SPRAGUE-DAUILEY RATS
                Correlation  o-f Gross &  Micro Findings
 PROJECT  ID:  P.CRESQL     GROUP:  175 MG      SEXr  MALE       DAYS: ALL
 PAGE  5                   FATES:  ALL


 ANIMAL NO: 3747             PATHOLOGY ID.  NO:  853747            PATHOLOGIST: DSC
 ANIMAL FATE:  SCHEDULED  SACRIFICE
 PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 92

 REFERENCE TO  NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

 >NGL
ANIMAL NO: 3743             PATHOLOGY  ID.  NO:  853743            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TESTs 92

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

  3L
ANIMAL NO: 3749             PATHOLOGY  ID.  NO:  853749             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: ??.

REFERENCE TO NECROPSY RECORD:            RELATED  HISTQPATHOLCGY:

>NGL
ANIMAL NO: 3750            PATHOLOGY  ID. NO:  853750             PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  92

REFERENCE TO NECROPSY RECORD:           RELATED  HISTOPATHQLOGY:

>KIDNEY-RIGHT PELUIS DILATED.            KIDNEY- HYDRONEPHROSIS
                               
-------
                        PATHOLOGY  ASSOCIATES,  INC
                                    PARA-CRESOL
                                STUDY NO. 5221 .03
                               SPRAGUE-DAULEY RATS
                 Correlation  o-f  Gross.  & Micro Findings
 PROJECT ID:  P.CRESOL    GROUP: 600 MG      SEX: MALE       DAYS:  ALL
 PAGE 1                   FATES: ALL


 ANIMAL  NO:  3761             PATHOLOGY ID. NO: 853761             PATHOLOGIST:  DSC
 ANIMAL  FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST:  91

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

 >NGL
 ANIMAL NO:  3762            PATHOLOGY ID. NO: 853762            PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:                                       DAYS  ON TEST: 91

.-"""""BERENICE TO  NECROPSY RECORD:           RELATED HI STOPATHOLOGY :

 >NGL
ANIMAL MO:  3763             PATHOLOGY ID.  NO: 853763            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEYS-SLIGHTLY  MOTTLED                KIDNEY- NEFHROPATHY, CHRONIC
ANIMAL NO!  3764             PATHOLOGY ID.  NO: 853764            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TESTi 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                                                                   358
                                Repor t  Con t inued)

                                       IV-38

-------
                        PATHOLOGY  ASSOCIATES,  INC.
                                   PARA-CRESQL
                                STUDY NO. 5221 .03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f Gross & Micro Findings
PROJECT  ID:  P.CRESQL    GROUP:  600 MG      SEX: MALE       DAYS: ALL
PAGE  2                   FATES:  ALL


ANIMAL NO:  3765             PATHOLOGY ID. NO: S53765            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE CAUSE  OF  DEATH:                                        DAYS ON  TEST:  91

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLQGY:

)NGL
ANIMAL NO:  3766             PATHOLOGY ID.  NO: 853746            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

   3L
ANIMAL NO: 3767             PATHOLOGY ID.  NO:  853747            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEYS-MOTTLED SLIGHTLY                 KIDNEY- NEPHROPATHY, CHRONIC
ANIMAL NO: 3763             PATHOLOGY ID.  NO:  853763            PATHOLOGIST:  DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST:  90

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>MGL
                                                                     *> f" Q
                               (Report  Continued)                     i.s J t>
                                       IV-39

-------
                       PATHOLOGY  ASSOCIATES,  INC.
                                  PARA-CRESQL
                               STUDY NO. 5221.03
                              SPRAGUE-DAWLEY RATS
                Correlation  o-f  Gross &  Micro  Findings
PROJECT  10: P.CRESOL    GROUP: 600 MG      SEX: MALE       DAYS:  ALL
PAGE 3                  FATES: ALL


ANIMAL NO: 3769            PATHOLOGY ID. -NO!  833769            PATHOLOGIST:  DSC
ANIMAL FATE; SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                       DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:           RELATED HISTOPATHOLQGY:

>NGL
ANIMAL NO: 3770            PATHOLOGY ID.  NO:  853770             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS  ON TEST:  91

REFERENCE TO NECROPSY RECORD:            RELATED HISTQPATHOLQGY:

    L
ANIMAL MO: 3771             PATHOLOGY ID.  NO:  S53771             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                       DAYS  ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL

>       .                                 LUNG-IS INFLAMMATION  INCLUDES A
                                         HISTIOCYTOSIS  COMPONENT
                              (Report  Continued^
                                                                360
                                      IV-40

-------
                        PATHOLOGY  ASSOCIATES, INC.
                                    PARA-CRESOL
                                STUDY NO.  5221 .03
                               SPRAGUE-DAWLEY RATS
                Correlation  o-f  Gross  & Micro Findings
 PROJECT ID:  P.CRESOL    GROUP: 600 MG      SEX; MALE        DAYS:  ALL
 PAGE A                  FATES! ALL


 ANIMAL NO:  3772            PATHOLOGY ID. NO: 853772             PATHOLOGIST:  DSC
 ANIMAL FATE:  SCHEDULED SACRIFICE
 PROBABLE CAUSE OF DEATH:            '                            DAYS  ON TEST:  92

 REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGYs

 >NGL
ANIMAL  NO:  3773            PATHOLOGY ID. NO: S53773             PATHOLOGIST:  DSC
ANIMAL  FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE  OF DEATH:                                         DAYS  ON  TEST:  90

REFERENCE TO  NECROPSY RECORD:           RELATED HISTOPATHOLOGY:

""""GL
ANIMAL NO:  3774             PATHOLOGY ID. NO: 853774            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS  ON  TEST:  92

REFERENCE TO  NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
ANIMAL NO: 3775             PATHOLOGY ID. NO: 853775            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS  ON TEST:  92

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHCLOGY:

>NGL
                               (Report Continued)

                                       IV-41

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                        PATHOLOGY  ASSOCIATES, INC.
                                   PARA-CRESOL
                                STUDY NO. 5221 .OS
                               SPRAGUE-DAWLEY RATS
                Correlation  o-F  Gross & Micro Findings
PROJECT  ID:  P.CRESOL    GROUP: 600 MG      SEX: MALE        DAYS: ALL
PAGE  5                   FATES: ALL


ANIMAL MO: 3776             PATHOLOGY ID. NO: 853774            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS ON  TEST:  90

REFERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:

>HISTQ.-  1 (1 X  IMM)  CYST IN CORTEX      KIDNEY- CYST
 OF RIGHT KIDNEY
ANIMAL NO:  3777             PATHOLOGY ID.  NO: 853777            PATHOLOGIST:  DSC
ANIMAL FATE:  SCHEDULED SACRIFICE
PROBABLE  CAUSE OF  DEATH:                                        DAYS  ON TEST:  91
DF.FERENCE TO  NECROPSY  RECORD:            RELATED HISTOPATHOLOGY:
-..JGL
ANIMAL NO: 3778             PATHOLOGY ID.  NO:  353778            PATHOLOGIST: DSC
ANIMAL FATE:  SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST:  91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>KIDNEYS-BOTH MOTTLED SLIGHTLY           KIDNEY- NEPHROPATHY, CHRONIC
ANIMAL NO: 377?             PATHOLOGY ID.  NO:  85377?            PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED  SACRIFICE
PROBABLE CAUSE OF  DEATH:                                        DAYS ON TEST: 91

REFERENCE TO NECROPSY RECORD:            RELATED HISTOPATHOLOGY:

>NGL
                               < Rep or t  Con t i nu           3 6 C


                                       IV-42

-------
                       PATHOLOGY ASSOCIATES,  INC.
                                   PARA-CRESOL
                                STUDY NO.  5221.OS
                               SPRAGUE-DAWLEY  RATS
                Correlation o-f  Gross. & Micra  Findings
PROJECT ID: P.CRESOL    GROUP:  600  MG       SEX:  MALE       DAYS:  ALL
PAGE 6                  FATES:  ALL


ANIMAL NO: 3730            PATHOLOGY  ID.  NO:  853730             PATHOLOGIST: DSC
ANIMAL FATE: SCHEDULED SACRIFICE
PROBABLE CAUSE OF DEATH:                                        DAYS ON TEST: 92

REFERENCE TO NECROPSY RECORD:            RELATED  HISTOPATHOLOGY:

>NGL
                               (End o-f  Report)
                                       iv-43                364

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Animal No.

3794
3882


3886

3887
                      GROSS  AND MICROSCOPIC  FINDINGS
                                     P-CRESOL
                                45 DAY  SACRIFICE
                 Qp. 1
3800
3822
3826
3827
3851
3854
3858
3859
3882
Gp. 1
Gp. 2
Qp. 2
Gp. 2
Gp. 3
Gp. 3
Gp. 3
Gp. 3
Gp. 4
Qp. 4



Gp. 4

Op. 4
                     FEMALES

            Qross Observation

            Kidney-slightly mottled
              (red and brown)

            Kidne/-slightly mottled

            Kidne/-slightly mottled

            Kidney-slightly mottled

            Kidney-slightly mottled
            (brown and red)
                                                       Microscoic^
                                                       No corresponding lesion

                                                       No corresponding lesion

                                                       No corresponding lesion

                                                       No corresponding lesion

                                                       No corresponding lesion
                            Kidney-si ightly mottled      No corresponding lesion
                            Kidney-slightly mottled
                            (red and brown)

                            Kidney-slightly mottled

                            Kidney-slightly mottled

                            Kidney-mottled
                            (brown and red)

                            Kidney-MOL


                            Kidney-slightly mottled

                            Klflney-slightly mottled
No corresponding lesion

No corresponding lesion

No corresponding lesion


No corresponding lesion

Lymphocytic infiltrate, focal,
minimal

No corresponding lesion

Cyst, focal, minimal
                                                                          5
                                        IV-44

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                    GROSS AND MICROSCOPIC  FINDINGS
                                   P-CRESOL
                              45 DAY  SACRIFICE
AnfmaL No.
3661
3663'
3664
3665
3666
3666
3667
3667
3667
3668
3668
3669
3670
3670
3693
3693
3694
3695
3696
Dose Gp.
Gp. 1
Op, 1
Op. 1
Qp. 1
GP. i
Qp. 1
Op. 1
Op, 1
Op, !
Qp. 1
Gp. I
Op. 1
Gp. 1
Op. 1
GP. 2
Gp. 2
flp. 2
Op. 2
Gp. 2
                                     MALES
                                 Observation
3696
Gp.  2
Kidney-slightly mottled
Kidney-si ightly mottled
Kidney- slightly pale
Kidney-slightly mottled
Kidney-slightly mottled
 (brown end red)
Kidney- NGL
Kidney-slightly mottled
Kidney- NOL
Kidney-NGL
Kidney-slightly mottled
Kidney-NGL
Kidney-slightly mottled
 (red and brown)
Kidney-slightly mottled
Kidney- NGL
Kidney- mottled
Liver-si ightly pale
Kidney-slighty mottled
Kidney-slightly mottled
Kidney- mottled
(brown and red)
Kidney-NGL
 Hicroscopic  QhsRrvntinn
 No corresponding lesion
 Nephropathy, chronic, minimal
 Nephropathy, chronic, minimal
 No corresponding lesion

 No corresponding lesion
 Lymphocytic infiltrate, focal, minimal
 No corresponding lesion
 Lymphocytic infiltrate, focal, minimal
 Inferct, focal, minimal
 No corresponding lesion
 Cyst, focal, minimal

 Nephropathy, chronic, minimal
 No corresponding lesion
Cyst,focal, minimal
 Nephropathy, chronic, minimal
 No corresponding lesion
Nephropathy, chronic, minimal
Nephropathy, chronic, minimal

No corresponding lesion
Lymphocytic infiltrate, multifocal,
minimal
                    fiN  /"& ypS
                         o
                                      IV-45

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  3698
                     GROSS AND MICROSCOPIC  FINDINGS
                                    P-CRESOL
                               45 DAY SACRIFICE
                               MALES CONTINUED
Animal  No.    Dose Sp,

   3696         Op, 2

   3696         Gp. 2
Gp.  2
           Gross Observation

           Liver-slightly pale

           Liver-NOL
Kidney-si ightly mottled
 (red and brown)
3699
3700
3721
3721
3721
3723
3723
3723
3723
3721
3724
3727
Gp. 2
Bp. 2
Gp. 3
Op. 3
Gp. 3
ep. 3
Op. 3
Gp. 3
Gp. 3
Op. 3
Gp. 3
eP.3
Liver-slightly pale
Kidney- si ightly mottled
Kidney-slightly mottled
and pitted
Liver-slightly pale
Liver-NCL
Kidney- mottled
( brown and red)
Kidney- NQL
Liver-slightly pale
Liver-NGL
Kidney- mottled
(brown and red)
Kidney-NGL
Kidney- pale
 Microscopic  Observation

 No cor responding lesion

 Inflammation, chronic, multifocal,
 minimal


 Nephropathy, chronic, minimal

 No corresponding lesion

 Nephropathy, chronic, minimal


 No corresponding lesion

 No corresponding lesion

 Lnflemmation, chronic, multtfocal,
 minimal


 No corresponding lesion

 Lymphocytic infiltrate, fecal .minimal

 No corresponding lesion

 Inflammation, chronic, multifocal,
 minimal


No corresponding lesion

Lymphocytic infiltrate, multifocal,
minimal

Nephropathy, chronic, mild
                                      IV-46
                                                    o  / *i
                                                    O  b  t

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                     GROSS  AND MICROSCOPIC  FINDINGS
                                    P-CRESOL
                               45 DAY  SACRIFICE
Animal  Np.    Dose 6p.

   3728         Gp. 3

   3730         Op. 3
3730
3751
3751
3752
3752
3753
3754
3757
3757
3757
3758
3760
Gp. 3
Op. 4
GP.
Op. 4
Qp. 4,
Op. 4
Op. 4
Op. 4
Gp, 4
Gp. 4
Gp. 4
Op, 4
    MALES CONTINUED

Brnsa Observation

Kidney-si ightly mottled

Kidney-mottled
 (brown and red)

Kidney-NGl

Kidney-si ightly mottled

Kidney-NOL
                           Kldney-sligMly mottled
                            (brown and red)

                           Kidney-NQL
                           Kidney-slightly mottled
                            (brown and red)

                           Kidney-mottled

                           Kidney-mottled
                            (brown and red)

                           Kidney-NGL

                           Kidney-NGL

                           Kidney-slightly mottled

                           Kidney-slightly mottled
flieroscnpic  observation

Nephropathy, chronic, mild


Nephropathy, chronic, minimal

Mineralization, focal, minimal

No corresponding lesion

Lympnocytlc Infiltrate, focal,
minimal


No corresponding lesion

Lymphocytic infiltrate, multifocal
minimal


Nephropathy, chronic, minimal

No corresponding lesion


Nephropathy, chronic, mild

Mineralization, focal, minimal

Hydronephrosis, multifocal .minimal

No corresponding lesion

No corresponding lesion
                                                                               8
                                      IV-47

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V.  INTERIM SACRIFICE-EARLY DEATH
                                        *>. r r-;
                                          b ^

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Page Intentionally Blank

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                  INTERIM  SACRIFICE  - EARLY  DEATH
                               P-CRE50L
Animal No. 3883
Sex: Female
Dose: 600 mg
Gross  Findings:
                I.  Left lung lobes mildly mottled
                2.  Liver dark red - NCL
Microscopic  Findings:
                I.  Thymus
                2.  Trachea
                3.  Lung
      - Hemorrhage, acute, focal, minimal
      - Inflammation, chronic-active, multifocal,
         severe
      - Epithelial metaplasia, mild
      - Oil droplets, multifocal, mild
      - Congestion, multifocal, minimal TGL-1
Comment:  Large focus of tracheal exudate (in lumen)

Tissues  Within Normal Histological  Limits:  Brain, Sciatic Nerve,
Spinal Cord, Bone, Bone Marrow, Salivary Gland, Mandibular Lymph Node,
Pancreas., Pituitary, Thyroid, Parathyroid, Esophagus, Adrenal Gland, Heart,
Aorta, Colon, Duodenum, Forestomach, Glandular Stomach,  Skin, Mammary
Gland, Skeletal Muscle, Liver, Spleen, Kidney, Urinary Bladder, Ovaries,
Uterus, Cervix, Eyes.
                              V-l

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                    THIS PAC-E SEViS!3
                                                Date
VI. QUALITY ASSURANCE STATEMENT
                                        I

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                   QUALITY ASSURANCE STATEMENT

   This histopathology project has been conducted in compliance with Good
   Laboratory Practice regulations promulgated  by  the U. 5. Food and Drug
   Administration and the U. 5. Environmental Protection Agency. Pathology
   Associates,  Incorporated  has  a  functioning  and  responsive  quality
   assurance unit which has conducted appropriate inspections and reported
   all findings to management.  The following is a record of those inspections
   and reports:

                                                Date  Findings Reported
     Date of                                        to Management
   Inspection*        Phase  Inspected         and Study  Pathologist
  **01-15-86          Necropsy                          01-17-86
  * 01-07-86          Tissue Trimming                     01-09-86
  * 01-09-86          Processing                         01-14-86
  * 01-09-86          Embedding                         01-14-86
  **02-19-36          Microtomy                         02-19-86
  * 02-19-86          Staining                           02-19-86
  * 02-19-86          Coverslipping                       02-19-86
  * 02-10-86          Labeling                           02-10-86
  **04-28-86          Individual Animal Data                 05-15-86
  **04-28-86          Data Entry                         05-15-86
  **05-02-86          Computer Validation                  05-15-86
  **05-15-86          Draft Pathology Report                 05-15-66
  **06-09-86          Final Pathology Report                 06-09-86
  **09-22-86          Revised Final Pathology Report           09-22-56
  * General monthly phese inspection
  ** Inspection specific for Study Number

  Tln accordance with the PAI Quality Assurance Division's Standard Operating
  Procedures, phase inspections are routinely conducted on a random basis at a
  minimum of monthly.   Dates  of inspection are  reported  for each study
  according to the most recent phase inspection conducted during that period.
                                                 September 23, 1986
                                                             *
//V/.1  Director, Quality Assurance Unit                   Date


   Study Number 5221.08: "Subchronic Toxicity of Para-Cresol in Sprague
   Dawley Rats".


                                                          (-1 7 9
                                                          O 8 t~J

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APPENDIX
               o r*)
               o 7

-------


-------
                                          Apoendix 1
   PATHOLOGY ASSOCIATES,  INC
              PARA-CRESOL
           STUDY NO. 5221.08
          SPRAGUE-DAWLEY RATS
     Reports.  Code Table
N    Tissues within normal  histological limits

A    Autolxsis precluding adequate evaluation

U    Tissues unavailable/unsuitable for evaluation

S    Tissues not applicable to animal

*    Tissues not examined/not required bx protocol
1    mi n imal

2    mild

3    moderate

4    severe

)    -focal

]    di-ffuse

>    mult i focal

P    Present

B    Neoplasm, Benign

M    Neoplasm, Malignant without Metastasis

C    Neoplasm, Malignant with Metastasis

X    Metastatic Si te ( + )


          (End of Report)
                            374

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APPENDIX 2

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Intentionally Blank

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                                                          Appendix 2
                           ABBREVIATIONS LIST


                              PARA-CRESOL


Infil.-lnflltrate


Peri.Vas.-Perivascular


Perivasc.-Perivascular


Inflam.-lnflammation


Lymph.-Lymphocytic


Chr.-Chronic


Act.-Active :  -if
                                         * !*) /Ti
                                         o 7 o

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