August,  1987

         820K88123


                         2,4,5-TRICHLOROPHENOXYACETIC ACID

                                 Health Advisory
                             Office of Drinking Water
                        U.S.  Environmental Protection Agency
I. INTRODUCTION

        The  Health Advisory  (HA) Program, sponsored by the Office of Drinking
   Water (ODW), provides information on the health effects, analytical method-
   ology and treatment  technology that would be useful in dealing with the
   contamination of drinking water.  Health Advisories describe nonregulatory
   concentrations of drinking water contaminants at which adverse health effects
   would not be anticipated  to occur over specific exposure durations.  Health
   Advisories contain a margin of safety to protect sensitive members of the
   population.

        Health Advisories  serve as informal technical -guidance to assist Federal,
   State and local officials responsible for protecting public health when
   emergency spills or  contamination situations occur.  They are not to be
   construed as legally enforceable Federal standards.  The HAs are subject to
   change as new information becomes available.

        Health Advisories  are developed for one-day, ten-day, longer-term
   (approximately 7 years, or 10% of an individual's lifetime) and  lifetime
   exposures based on data describing noncarcinogenic end points of toxicity.
   Health Advisories do not quantitatively incorporate any potential carcinogenic
   risk  from such exposure.  For those substances that are known or probable
   human carcinogens, according to the Agency classification scheme (Group A or
   B),  Lifetime HAs are not recommended.  The chemical concentration values for
   Group A or B carcinogens  are correlated with carcinogenic risk estimates by
   employing a cancer potency (unit risk) value together with assumptions for
   lifetime  exposure and the consumption of drinking water.  The cancer unit
   risk  is usually derived from the linear multistage model with 95% upper
   confidence limits.   This provides a low-dose estimate of cancer  risk to
   humans that is considered unlikely to pose a carcinogenic risk in excess
   of the stated values.   Excess cancer risk estimates may also be  calculated
   using the One-hit, Weibull, Logit or Probit models.  There is no current
   understanding of the biological mechanisms involved in cancer to suggest that
   any one of these models is able to predict risk more acc-urately  than another.
   Because each model is based on differing assumptions, the estimates that are
   derived can differ by several orders of magnitude.

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    2,4,5-Trichlorophenoxyacetic Acid
                       August,  1987
                                         -2-
II.  GENERAL INFORMATION AND  PROPERTIES

    CAS  No.  93-76-5

    Structural Formula
                                          -CHaCOOH
                         2,4,5-trichlorophenoxyacetic acid
    Synonyms
         0   2,4,5-T; Brush rhap; Brushtox; BCF-Bushkiller; Dacamine; Decamine  4T;
            Ded-Weed; Dinoxol; Envert-T; Estercide t-2 and t-245; Esteron;  Fence
            rider; Forron; Forst U46; Fortex; Fruitone A; Inverton 245; Line
            rider; Phortox; Reddon; Reddox; Spontox; Tippon; Tormona; Transamine;
            Tributon; Trinoxol; Trioxon; Veon 245; Verton 2T; VEON; Weedar;
            Weedone  (Meister, 1983).
    Uses
         0  Salts and esters of 2,4,5-T are widely used to control woody plants
           on industrial sites and rangeland.  Amine formulations are used
           extensively 'for weed control in rice  (Meister, 1983).

    Properties   (BCPC, 1983; Meister, 1983; Windholz et al., 1983; Khan, 1985;
                CHEMLAB, 1985)
           Chemical Formula
           Molecular Weight
           Physical State (25°C)
           Boiling Point
           Melting Point
           Density
           Vapor Pressure (25°C)
           Specific Gravity
           Water Solubility (25°C)
            Log Octanol/Water Partition
             Coefficient
            Taste Threshold
            Odor Threshold
            Conversion Factor
C8H503C13
255.49
Crystals

153°C

6.46 x 10~6 mm Hg

Solubility of acid is 150 g/L; amine
salts are soluble at 189 g/L (20°C);
esters are insoluble
    3.00 (calculated)

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     2,4,5-Trichlorophenoxyacetic Acid                              August,  1987

                                          -3-


     Occurrence

          0   2,4,5-T has  been  found  in  5,009 of  24,516  surface water samples
             analyzed and in 360 of  3,238  ground water  samples (STORET,  1987).
             Samples were collected  at  3,967 surface water  locations and 2,124
             ground water locations, and 2,4,5-T was found  in  45  states.   The 85th
             percentile of all nonzero  samples was  0.1  ug/L in surface water and
             1 ug/L in ground  water  sources.  The maximum concentration  found was
             370 ug/L in  surface water  and 38 ug/L  in ground water.

     Environmental Fate

          0   No information was found in the available  literature on the environ-
             mental fate  of 2,4,5-T.


III. PHARMACOKINETICS

     Absorption

          0   In a  study by Gehring  et al.  (1973), single oral  doses of 5 mg/kg
             2,4,5-T were ingested  by five male  volunteers.  Essentially all
             the 2,4,5-T  was excreted unchanged  via the urine,  indicating that
             gastrointestinal  absorption was nearly complete.

          *   Fang  et al.  (1973) administered single doses of 14C-labeled 2,4,5-T
             in corn oil  by gavage  to pregnant and  nonpregnant female Wistar rats
             at dose levels of 0.17, 4.3 or 41 mg/kg.  Expired air,  urine,  feces,
             internal organs and tissues were analyzed  for  radioactivity.  During
             the first 24 hours, an average of 75 ±7% of the radioactivity was
             excreted in  the urine,  indicating that at  least 75%  of the  dose had
             been  absorbed.

          0   Piper et al. (1973) administered single oral doses of 14C-labeled
             2,4,5-T in corn oil-acetone  (9:1) to adult female Sprague-Dawley rats
             at dose levels of 5, 50, 100  or 20  mg/kg,  and  to  adult female beagle
             dogs  at 5 mg/kg.   Fecal excretion was  3% at the lowest dose (5 mg/kg)
             and increased to  14% at the highest dose (200  mg/kg)  in rats.   In
             dogs  given the 5  mg/kg  dose,  fecal  excretion was  20%.  These data
             indicated that absorption  was somewhat dose dependent,  but  was 80% or
             higher at all doses.

     Distribution

          0   Gehring et al. (1973)  administered  single  oral doses of 5 mg/kg of
             2,4,5-T to five male volunteers.  Essentially  all the 2,4,5-T was
             absorbed in  the body;  65%  of  the absorbed  dose resided  in the plasma
             where 98.7%  was bound  reversibly to protein.   The volume of distribution
             was 0.097 L/kg.   Utilizing the kinetic constants  from the single-dose
             experiment,  the expected concentrations of 2,4,5-T in the plasma
             of individuals receiving repeated doses of 2,4,5-T were calculated.
             From these calculations, it was determined that the  plasma  concentra-
             tions would  essentially reach a plateau value  after  3 days.   If the

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                                     -4-


        daily dose ingested in mg/kg is AQ,  the concentrations in the plasma
        after attaining  plateau would range  from 12.7 AQ to 22.5 AQ ug/mL
        (Gehring et al., 1973).

     9  Fang et al. (1973)  administered single oral doses of 1 4C-labeled
        2,4,5-T to pregnant and nonpregnant  female Wistar rats and internal
        organs and tissues  were analyzed for radioactivity.  Radioactivity
        was detected in  all tissues, with the highest concentration found in
        the kidney.  The maximum concentration in all tissues was generally
        reached between  6 and 12 hours after administration of the~dose
        (0.17, 4.3 or 41 mg/kg) by gavage, and then started to decline rapidly„
        Radioactivity also  was detected in the fetuses and in the milk of the
        pregnant rats.   The average biological half-life of 2,4,5-T in the
        organs was 3.4 hours  for the adult rats and 97 hours for the newborn.

     0  Piper et al. (1973) administered single oral doses of 5, 50, 100 or
        200 mg/kg 2,4,5-T to  Sprague-Dawley  rats, and found that the apparent
        volume of distribution increased with dose, indicating that distribution
        of 2,4,5-T in the body was dose-dependent.

Metabolism

     0  Gehring et al.  (1973) administered  single oral doses of 5 mg/kg •
        2,4,5-T to human volunteers.  Essentially all the chemical was
        excreted in the  urine as parent compound, indicating that there is
        little metabolism of  2,4,5-T in humans.

     0  Grunow et al. (1971)  investigated the metabolism of 2,4,5-T in male
        Wistar (AF/Han)  rats  after receiving single oral doses of 50 mg/kg.
        The 2,4,5-T was  dissolved in peanut  oil and administered by gavage.
        Urine was collected for 7 days after dosing and examined by gas
        chromatography for  2,4,5-T and its  conjugates and metabolites.  From
        45 to 70% of the administered dose  was recovered in urine.  In general,
        about 10 to 30%  of  this was as acid-hydrolyzable conjugates, and the
        remainder was unchanged 2,4,5-T.  Three animals were given doses of
        75 mg/kg, and their urine pooled.  A metabolite isolated from this
        pooled urine was identified as N-(2,4,5-trichlorophenoxy-acetyl)-
        glycine.

     0  Piper et al. (1973) administered single oral doses of 2,4,5-T to
        female Sprague-Dawley rats at dose  levels of 5, 50, 100 or 200 mi./kg.
        A small amount of an  unidentified metabolite was detected in urine at
        the high doses,  but not at the lower doses.  In adult beagle dogs
        given oral doses of 5 mg/kg, three  unidentified metabolites were
        detected in urine,  suggesting a difference in metabolism between rats
        and dogs.

     0  In a  study by Fang  et al. (1973) in  female Wistar rats, urinalysis
        revealed that 90 to 95% of the radioactivity was unchanged 2,4,5-T.
        The authors also found three unidentified minor metabolites, two of
        which were nonpolar,  in the urine.

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                                         -5-


    Excretion

         0   In a study by Gehring et al.  (1973),  single doses of 5 mg/kg 2,4,5-T
            were ingested by  five male  volunteers.   Hie concentrations of  2,4,5-T
            in plasma  and its excretion were  measured at intervals after ingestion.
          •  The clearances from the  plasma, as  well as the body, occurred  via
            apparent first-order  rate processes with half-lives of 23.1  and 29.7
            hours,  respectively.   Essentially all the 2,4,5-T was excreted
            unchanged  via the urine.

         0   In a study by Fang et al.  (1973), 2,4,5-T labeled with 1 4c was orally
            administered  to pregnant and  nonpregnant female Wistar rats  at various
            dosages, and  expired  air, urine and feces were analyzed for  radio-
            activity.   During the first 24 hours, 75 ± 7% of the radioactivity
            was excreted  in the urine and 8.2%  was  excreted in the feces.   No 14C
            was found  in  the  expired air. There was no significant difference in the
            rate of elimination between the pregnant and nonpregnant rats, or
            among the  dosages used (0.17, 4.3 and 41 mg/kg).  The average  biological
            half-life  of  2,4,5-T  in  the organs  was  3.4-hours for the adult rats
            and 97  hours  for  the  newborn.

         0   Grunow  et  al. (1971)  investigated the excretion of 2,4,5-T in  male
            Wistar  (AF/Han) rats  after  single oral  doses of 50 mg/kg.   The 2,4,5-T
            was dissolved in  peanut  oil and administered by gavage.  From  45 to
            70% of  the administered  dose  was  recovered in urine within 7 days.

         0   Clearance  of  14C  activity from the  plasma and its elimination  from
            the body of rats  and  dogs were determined after single oral  doses of
            labeled 2,4,5-T (Piper et al., 1973).  The half-life values  for the
            clearance  of  radioactivity  from the plasma of Sprague-Dawley (Spartan
            strain) rats  given doses of 5, 50,  100 or 200 mg/kg were 4.7,  4.2,
            19.4 and 25.2 hours,  respectively;  half lives for elimination  from
            the body were 13.6, 13.1,  19.3 and  28.9 hours, respectively.  Urinary
            excretion  of  unchanged 2,4,5-T accounted for 68 to 93% of the  radio-
            activity eliminated from the  body of the rats.  Fecal excretion was
            3% at 5 mg/kg, and increased  to 14% at 200 mg/kg.  These results
            indicate that the excretion of 2,4,5-T is altered when large doses
            are administered.  In adult beagle  dogs given doses of 5 mg/kg, the
            half-life  values  for  clearance from plasma and elimination from the
            body were  77.0 and 86.6  hours, respectively.  After 9 days,  11% of
            the dose was  recovered in urine and 20% was recovered in feces.
IV. HEALTH EFFECTS

            Technical 2,4,5-T contains  traces  of  the highly toxic compound
            2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)  as an impurity (NAS,  1977).
            Preparations of 2,4,5-T  formerly contained  TCDD at levels of 1 to 80
            ppm,  a concentration  sufficiently  high to cause toxic effects that
            are characteristic of TCDD.   It has not been feasible to completely
            eliminate TCDD from technical 2,4,5-T, but  NAS (1977) reported it to be
            present in commercial 2,4,5-T at less than  0.1 ppm.   In  the  following
            sections,  the purity  of  2,4,5-T or  the level of TCDD impurity is

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2,4,5-Trichlorophenoxyacetic Acid                             August, 1987

                                     -6-
        given when known.   When the generic term "dioxin" is used, no further
        information was  provided,  and the 2,4,5-T is presumed to contain a
        variety  of dioxin  species  as well as other phenoxy compounds and
        assorted intermediates and breakdown products.
Humans
   Short-term  Exposure

     0  No clinical  effects were observed  in five volunteers who ingested
        single oral  doses of 5 mg/kg of 2,4,5-T (Gehring et al., 1973).

     0  After  an explosion in a chemical plant producing 2,4,5-T in 1949,
        symptoms in  exposed workers included chloracne,  nausea, headache,
        fatigue, and muscular aches and pains (Zack and  Suskind, 1980).

   Long-term Exposure

     0  The mortality experience in a cohort of 1,926 men who had sprayed
        2,4,5-T acid during 1955 to 1971 was followed prospectively from 1972
        to 1980.  Exposure was generally rather low because the duration of
        work had mostly been less than 2 months.  In the period 1972 to 1976,
        mortality from all natural causes in this group  was only 54% of the
        expected value (based on age-specific rates for  the general population),
        and in the next 4-year period, 81% of the expected value.  In the
        assessment of cancer, mortality allowance was made for 10- and 15-year
        periods of latency" between the first exposure and the start of the
        recording of vital status during the followup.  No increase in cancer
        mortality was detected, and the distribution of  cancer types was
        unremarkable.  No cases of death from lymphomas  or soft tissue sarcomas
        were found.   It was noted, however,  that the study results should be
        interpreted with caution due to the small size of the cohort, the low
        past exposure, and the brief followup period (Riihimaki et al., 1982).

     0  An investigation of the rate of birth malformations in the Northland
        region of New Zealand was analyzed with reference to the exposure in
        the area to 2,4,5—T, which was applied as frequently as once a month
        from 1960 to 1977.  The chosen area was divided  into sectors rated as
        high,  intermediate or low, based on the frequency of aerial spraying.
        During this period, there were 37,751 babies born in the hospitals in
        these  sectors.  It was estimated that well over 99% of all births
        occur  in hospitals in this Nortnland area.  The epidemiological
        analysis of the birth data gave no evidence that any malformation of
        the central nervous system, including spina bifida, was associated
        with the spraying of 2,4,5-T.  Heart malformations, hypospadias, and
        epispadias increased with spraying density, but the increases were
        not statistically cignificant  (p >0.05).  The only anomaly that
        increased in a statistically significant (p <0.05) manner with respect
        to the spraying was,talipes (club foot) (Hanify et al., 1981).

     0  The relationship between  the use of 2,4,5-T in Arkansas and the
        concurrent incidence of facial clefts in children was studied retro-
        spectively.  The estimated levels of exposure were determined by

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2,4,5-Trichlorophenoxyacetic Acid                             August, 1987

                                     -7-
        categorizing the 75 counties into high,  medium and low exposure groups
        on the basis of their  rice acreage during 6- to 7-year intervals
        beginning in 1943.   A  total of 1,201  cases of cleft lip and/or cleft
        palate for the 32 years (until 1974)  was detected by screening birth
        certificates and hospital records.  Facial cleft rates, presented by
        sex,  race, time period and exposure group, generally rose over time.
        No significant differences were found for any race or sex combination.
        The investigators concluded that the  general increase seen in facial
        cleft incidence in the high- and low-exposure groups was attributable
        to better case finding rather than maternal exposure to 2,4,5-T
        (Nelson et al., 1979).

        Ott et al. (1980) reported no effects in a survey of 204 workers
        engaged in 2,4,5-T production at estimated airborne levels of 0.2 to
        0.8 mg/m3 for 1 month  to 10 years.

        Numerous epidemiological studies on the  relationship between exposure
        to chlorophenoxyacetic acids and cancer  induction are reviewed in
        U.S.  EPA (1985).  The  conclusion in this review is that there is
        "limited" evidence for the carcinogenicity of chlorinated phenoxyacetic
        herbicides and/or chlorophenols with  chlorinated dibenzodioxin impuri-
        ties, primarily based  on Swedish case-control studies that associated
        induction of soft-tissue sarcomas with exposure to these agents.
Animals
   Short-term Exposure

     0  The acute oral toxicity of 2,4,5-T was determined  in mice,  rats and
        guinea pigs by Rowe and Hymas (1954)  over a 2-week period.   The LD^Q
        values were 500 mg/kg for rats,  389 mg/kg for mice and 381  mg/kg for
        guinea pigs.

     0  Drill and Hiratzka (1953) investigated the acute oral toxicity of
        2,4,5-T in adult mongrel dogs given single oral doses of 50, 100, 250
        or 400 mg/kg by gelatin capsule.   Animals were observed for 14 days,
        at which time survivors were necropsied.   The number of deaths at the
        four dose levels were 0/4, 1/4,  1/1 and 1/1,  respectively.   The LDsg
        value was estimated to be 100 mg/kg or higher.   Marked changes were
        not observed in animals that died, effects being limited to weight
        loss, slight to moderate stiffness in the hind legs and ataxia (at
        the highest doses).

     0  Weanling male Wistar rats were fed diets  containing 2,4,5-T for 3
        weeks to investigate effects on  the immune system  (Vos et al., 1983).
        2,4,5-T (>99% purity, TCDD content not specified)  was fed at levels
        of 200, 1,000 or 2,500 ppm (approximately 20, 100  or 250 mg/kg/day,
        assuming 1  ppm equals 0.1 mg/kg/day in a  younger rat by Lehman, 1959).
        Following the 3-week feeding period,  the  animals were sacrificed and
        the organs of the immune system,  as well  as other  parameters of
        general toxicity,  were examined.   Even at the lowest dose level of
        200 ppm in the diet,  2,4,5-T caused a significant  (p <0.05) decrease
        in relative kidney weight and a  significant (p <0.05) increase in

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                                     -8-
        serum  IgG level,  the most sensitive  indicators  of  its  effects.   In
        this study,  based on general  toxicologic  and  specific  immunologic
        effects  in the  rat,  the  Lowest-Observed-Adverse-Effect-Level  (LOAEL)
        was  20 mg/kg/day.

   Dermal/Ocular Effects

     0   Gehring  and  Betso (1978)  summarized  the effects of 2,4,5-T on the skin
        and  the  eye.  The dry material  is  slightly irritating  to the  skin and
        the  eye.  Highly  concentrated solutions may burn the skin with
        prolonged or repeated contact and  can strongly  irritate the eye and
        possibly cause  corneal damage.   Preparations  of 2,4,5-T formerly
        contained 1  to  80 ppm 2,3,7,8-TCDD,  a concentration high enough to
        cause  chloracne in industrial workers (NAS, 1977).

   Long-term Exposure

     0   Drill  and Hiratzka (1953) investigated the subchronic  toxicity of
        2,4,5-T  in adult mongrel dogs.   One  or two dogs of each sex per group
        were fed capsules in food containing 0, 2, 5,  10 or 20 mg/kg  2,4,5-T,
        5 days per week for 13 weeks.  Animals were weighed twice weekly, and
        blood  was taken on days  0,  30 and  90.  Upon death or completion of
        the  study, animals were  necropsied with histological examination of
        a number of tissues.  No deaths occurred  at doses of 10 mg/kg/day or
        less,  but 4/4 animals receiving 20 mg/kg/day  died.  No effects on
        body weight, hematology  and pathology were seen except in animals
        that died.  The No-Observed-Adverse-Effect-Level (NOAEL) was  identified
        as 10  mg/kg/day.

     0   McCollister and Kociba (1970) examined the effects of  2,4,5-T admini-
        stered in the diet for 90 days  to  male and female Sprague-Dawley rats
        (Spartan strain).  The 2,4,5-T  (99.5% pure, <0.5 ppm dioxin)  was
        included in the diet at  levels  corresponding  to doses  of 0, 3, 10, 30
        or 100 mg/kg/day.  Five  animals of each sex were used  at each dose
        level.  At the  conclusion of the study, necropsy,  urinalyses, blood
        counts and clinical chemistry assays were performed.  There was no
        mortality in any group.   At 100 mg/kg, animals  of both sexes had
        depressed (p <0.05) body weight gain, a slight  but significant
        (p <0.05) decrease in food intake  and elevated  (p <0.05) serum alkaline
        phosphatase (AP)  levels.  Necropsy revealed paleness and an accentuated
        lobular pattern of the liver, with some inconsistent hepatocellular
        swelling.  Males (but not females) had slightly elevated serum glutamic-
        pyruvic transaminase (SGPT) levels,  and slight decreases in red blood
        cell counts and  in hemoglobin.   Males given 100 mg/kg/day had increased
        (p <0.05) kidney/body and liver/body weights.  At the  30 mg/kg/day
        dose level, males exhibited increased (p  <0.05) liver/body, kidney/body,
        and kidney weights.  Females given 30 mg/kg/day had slightly but
        significantly  (p <0.05)  elevated AP and SGPT  levels, but the authors
        felt that the clinical significance of these  latter findings was
        doubtful.  No effects observed  at the 3 or 10 mg/kg dose level were
        considered to be related to the intake of 2,4,5-T.  From this study,
        a NOAEL of 10 mg/kg/day  and a LOAEL of 30 mg/kg/day were identified.

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     0  Groups  of  Sprague-Dawley  rats  (50/sex/level)  were maintained on diets
        supplying  3,  10 or  30 mg/kg/day of  2,4,5-T  for  2  years  (Kociba et al.,
        1979).   The  2,4,5-T was approximately  99% pure, containing 1.3% (w/w)
        other phenoxy acid  impurities.   Dioxins  were  not  detected, the limit
        of detection for TCDD being  0.33 ppb.  An interim sacrifice was
        performed  on an additionally included  group of  10 animals  of each sex
        at 118  to  119 days.  Control groups included  86 animals of each sex.
        The highest  dose level was associated  with  some degree  of  toxicity,
        including  a  decrease in body weight gain (p <0.05 in  females)  and an
        increase in  relative kidney  weight  (p  <0.05 in  males).   Increases
        (p <0.05)  in the volume of urine excreted and in  the  urinary excretion
        of coproporphyrin and uroporphyrin  were  also  observed at this dose
        level.   Increased  (p <0.05)  morphological changes were  observed in the
        kidney,  liver and lungs of animals  administered 30 mg/kg/day.   The
        kidney  changes involved primarily the  presence  (p <0.05) of mineralized
        deposits in  the renal pelvis in females. Effects noted at the 10 mg/kg
        dose level were primarily an increased (p <0.05)  incidence of miner-
        alized  deposits in  the renal pelvis in females.   During the early
        phase of the study  there  was an increase (p' <0.05) in urinary excretion
        of coproporphyrin in males.  At the lowest  dose level (3 mg/kg),
        there were no changes that were considered  to be  related to treatment
        throughout the 2-year period.   From this study  in rats, a  NOAEL of
        3 mg/kg/day  was identified.

   Reproductive Effects

     0  Male and female Sprague-Dawley  rats (FQ) were fed lab chow containing
        2,4,5-T (<0.03 ppb  TCDD)  to  provide dose levels of 0, 3, 10 or 30
        nig/kg/day  for 90 days and then  were bred (Smith et al., 1981).  At
        day 21  of  lactation, pups were  randomly  selected  for  the following
        generation (F-j) and the rest were necropsied.  Subsequent matings were
        conducted  to produce F2,  F3a and F3D litters, successive generations
        being fed  from weaning on the  appropriate test  or control  diet.
        Fertility  was decreased  (p <0.05) in the matings  of the F^b litters  in
        the group  given 10  mg/kg/day.   Postnatal survival was significantly
        (p <0.05)  decreased in the F2  litters  of the  10 mg/kg group and in the
        F1, F2  and F3 litters of  the 30 mg/kg  group.  A significant decrease
        (p <0.05)  in relative thymus weight was  seen  only in  the F3t> generation
        of the  30  mg/kg group, but the  relative  liver weights of weanlings
        was significantly  (p <0.05)  increased  in the  F2»  F3a  and F^b litters
        of this dosage group.  Smith et al. concluded t^at dose levels of
        2,4,5-T that were sufficiently  high to cause  signs of toxicity in
        neonates had no effect on the reproductive  capacity of  the rats,
        except  for a tendency toward a  reduction of postnatal survival at a
        dose of 30 mg/kg.   Reproduction was not  impaired  at the lowest dose
        of 3 mg/kg.   The apparent NOAEL with respect  to reproductive capacity
        and fetotoxic effects in  this  study is 3 mg/kg/day.   Smith et al.
        (1978)  noted a significant (p <0.05) decrease in  FT (10 and 30 mg/kg
        on days  14 and 21)  and F3 (3 mg/kg  on  day 14, and 10  and 30 mg/kg on
        day 21)  litters, and they concluded that there  was no effect of
        2,4,5-T on rat reproduction  except  for a tendency toward a reduction
        in neonatal  survival at 10 and  30 mg/kg.

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                                     -10-


   Developmental Effects

     0  Sparschu et al.  (1971)  tested 2,4,5-T (commercial grade,  0.5 ppm TCDD)
        at levels of 50  or 100  mg/kg/day in pregnant rats (strain not specified)
        on either days 6 to 1 5  (50 mg/kg)  or days 6 to 10 (100 mg/kg) of
        gestation.   The  2,4,5-T was administered by oral  intubation in a
        solution of Methocel, and  controls were given an  appropriate volume
        of Methocel. At the  50 mg/kg dose,  there was a slightly  higher
        incidence of delayed  ossification of the skull bones,  but this was
        not considered a teratogenic response.   The 100 mg/kg  dose (administered
        on days 6 to 10) was  toxic to the dams  and caused a high  incidence of
        maternal deaths  (only 4 of the 25 pregnant rats survived).  Of these,
        three had complete early resorptions, and one had a litter of 13
        viable fetuses that showed toxic effects (not further  described) but
        no terata.   From these  data for maternal effects, a NOAEL of 50 mg/kg
        and a LOAEL of 100 mg/kg were identified.  Also identified were a
        NOAEL of 100 mg/kg for  teratogenicity and a LOAEL of 50 mg/kg for
        fetotoxicity.

     0  A sample of 2,4,5-T (technical grade) containing  0.5 ppm  TCDD as well
        as other phenoxy compounds was administered to CD-1 rats  by oral
        intubation on days 6  through 15 of gestation at dose levels of 10,
        21.5, 46.4 or 80 mg/kg/day (Courtney and Moore, 1971).  Examination
        of offspring revealed that the sample was not teratogenic at these
        dose levels. There was a  significant (p <0.05) increase  in fetal
        mortality at the 80 mg/kg/day dose levels (the maternal LD4Q).  In
        two 2,4,5-T-treated fetuses, mild gastrointestinal hemorrhages were
        observed as a fetotoxic effect.  Kidney anomalies were also slightly
        increased with  the effect  most pronounced at the  80 mg/kg level, but
        the number of litters examined was too small to evaluate  this observa-
        tion.  In a separate  study, rats were administered 50  mg/kg/day in an
        identical protocol, but in this case they were allowed to litter, and
        the neonates were examined and weighed on day 1 and followed for 21
        days.  Postnatal growth and development were comparable to that of
        the control animals.  A NOAEL of 46.4 mg/kg/day for both  fetotoxicity
        and teratogenicity in the  CD-1 rat was  identified from these data.

     0  Sprague-Dawley  rats (50/group) and New Zealand White rabbits (20/group)
        were given oral  doses (gavage for rats, capsules  for rabbits) of
        2,4,5-T (containing 0.5 ppm TCDD) during gestation (Emerson et al.,
        1971).  The rats received  daily doses of 1, 3, 6, 12 or 24 mg/kg on
        days 6 through  15, while the raobits were administered 10, 20 or 40
        mg/kg on days 6  through 18 of gestation.  In both species, animals
        were observed daily,  weighed periodically and subjected to Cesarean
        section prior to parturition.  Rabbit pups were kept for  observation
        for 24 hours and then sacrificed.  There were no observable adverse
        effects in dams  of either  species treated with the 2,4,5-T.  Litter
        size, number of  fetal resorptions, birth weights  and sex  ratios all
        appeared to be  unaffected  in the treated groups.   Detailed visceral
        and skeletal examinations  were performed on the control and high-dose
        groups for each  species, and no embryotoxic or teratogenic effects
        were revealed.   A NOAEL for fetotoxic 'and maternal effects identified
        from this study  was 24  mg/kg/day for the rat and  40 mg/kg/day for the
        rabbit.

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                                     -11-
     0   Several  different samples  of  2,4,5-T (containing  <0.5 ppm TCDD)  were
        tested in  pregnant Wistar  rats  by  daily oral  administration on days
        6  through  15 of  gestation  at  dose  levels between  25 and 150 mg/kg/day
        (Khera and McKinley,  1972).   In some cases,  fetuses were removed by
        Cesarean section for  examination;  some animals  were allowed to litter,
        and  the  offspring were  observed for  up to 12  weeks.  At doses  of
        100  rag/kg, there was  an increase (p  <0.05)  in fetal mortality  and an
        increase (p <0.05) in skeletal  anomalies;  a visceral anomaly was noted
        (dilatation of the renal pelvis),  which was slightly increased over
        the  control level, but  was not  statistically  significant (p >0.05).
        The  survival of  the progeny was not  affected  up to doses of 100  mg/kg,
        and  in only one  trial was  there a  low average litter size and  viability.
        This effect was  not duplicated  in  a  repeat test with the same  sample.
        At the 25  and 50 mg/kg  dose levels,  significant (p <0.05) differences
        from controls were not  apparent.   With respect  to fetotoxicity,  this
        study identified a NOAEL of 50  mg/kg/day in the rat.

     0   The  teratogenic  effects of 2,4,5-T were examined  in golden Syrian
        hamsters after oral dosing (by  gavage)  on days  6  through 10 of gestation
        at dose  levels of 20, 40,  80  or 100  mg/kg/day (Collins et al.,  1971).
        Four samples of  2,4,5-T with  dioxin  levels  of 45, 2.9, 0.5 or  0.1 ppm
        were administered. Three  samples, which had  no detectable dioxin
        (based on  TCDD),  were also tested.   The 2,4,5-T samples induced  fetal
        death and  terata.   The  incidence of  effects increased with increasing
        content  of the TCDD impurity.   2,4,5-T with no  detectable dioxin
        produced no malformations  below the  100 mg/kg dose level.  Using the
        data from  the 2,4,5-T samples with no detectable  dioxin, a NOAEL of
        80 mg/kg/day for the  hamster  was identified.

     0   Behavioral effects resulting  from  in utero  exposure to 2,4,5-T were
        examined in Long-Evans  rats after  single oral doses were administered
        during gestation (Crampton and  Rogers,  1983).   The sample of 2,4,5-T
        contained  <0.03  ppm TCDD.  Novelty response abnormalities were
        detected after single doses as  low as 6 mg/kg were administered  on
        day  8 of gestation.   Examination of  the brain in  the affected  offspring
        failed to  reveal any  changes  of a  qualitative or  quantitative  structural
        nature in  various areas of the  brain.  With respect to behavioral
        effects,  the LOAEL for  this study  is 6 mg/kg.

     0   The  teratogenic  effects of technical 2,4,5-T  (TCDD content 0.1 ppm)
        were studied using large numbers of  pregnant  mice of C57BL/6,  C3H/He,
        BALB/c and A/JAX inbred strains and  CD-1  stock  (Gaines et al.,  1975).
        Dose-response curves  were  determined for the  incidence of cleft
        palate,  embryo lethality and  fetal growth retardation.  These  deter-
        minations  were replicated  6 to  1 0  times for each  inbred strain and
        35 times for the CD-1.   The number of litters studied ranged from 2J6
        for  BALB/c mice  to 1,485 for  CD-1  mice.   Treatment was by gavage on
        days 6 to  14 of  pregnancy, and  dose  levels  of 2,4,5-T ranged from 15
        to 120 mg/kg/day.   The  lowest dose tested  in  the  A/JAX was 15  mg/kg,
        and  this dose was  teratogenic.   The  other strains and CD-1  demonstrated
        teratogenicity at 30  mg/kg, the lowest dose tested.   There were
        significant (p <0.05) differences  in sensitivities among the strains
        for  the  parameters measured.  Based  on this study in the mouse,  the

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                                     -12-
        LOAEL for teratogenic effects is 15 mg/kg/day  for  the A/JAX strain
        and 30 mg/kg/day for the other strains.

     0  Neubert and  Dillmann (1972)  studied the  effects  of  2,4,5-T in pregnant
        NMRI mice.   Three samples of 2,4,5-T were  utilized:   one had <0.02 ppm
        dioxin,  and  was  considered "dioxin-free";  a_second  sample had a dioxin
        content of 0.05  i 0.02 ppm;  and the third  sample had  an undetermined
        dioxin content.   The 2,4,5-T was administered  by gavage on days 6
        through 15 of  gestation at dose levels from  8  to 120  mg/kg/day.
        Fetuses  were removed on day 18 and  examined.   Cleft palate frequency
        exceeding (p <0.05)  that of  the controls was observed with doses
        higher than  30 mg/kg with all samples.   Reductions  (p <0.05) in fetal
        weight were  observed with all samples tested at  doses as low as 10 to
        15 mg/kg.  There was no clear increase in  embryo lethality over that
        of controls  at these lower doses.   With  the  purest  sample of 2,4,5-T,
        single oral  doses of 150 to 300 mg/kg were capable  of producing
        significant  (p <0.05) incidences of cleft  palate.   The maximal terato-
        genic effect was seen when the 2,4,5-T was administered on days 12 to
        13 of gestation.  Based on the data obtained with  the purest sample
        of 2,4,5-T,  the  teratogenic NOAEL is 15  mg/kg/day  and the fetotoxic
        NOAEL is 8 mg/kg/day.

     0  Roll (1971)  examined the teratogenic effects of  2,4,5-T in NMRI-Han
        mice after oral  administration on days 6 to  15 of  gestation at dose
        levels of 0, 20, 35, 60, 90 or 130 mg/kg/day.  The  2,4,5-T sample had
        a purity of  99.6%,  with a dioxin content of  <0.01 ppm (measured by
        the DOW method), or  0.05 ± 0.02 ppm (measured  by the  U.S. Food and
        Drug Administration  (FDA) method).   Peanut oil was  used as the vehicle.
        Animals were sacrificed on day 18 and examined for  defects.  Fetal
        weight was  significantly (p <0.05)  lower than  control at all doses.
        Resorptions  were significantly (p <0.05) increased  at 60 mg/kg and
        above.  The  incidence of cleft palates was significantly (p <0.05)
        higher at 35 mg/kg and higher, but there was no  effect at 20 mg/kg.
        There were also  dose-dependent increases in ossification defects of
        sternum and  various  other bones.  The authors  concluded that 2,4,5-T
        alone (independent of TCDD contamination)  was  teratogenic in mice,
        and that the teratogenic NOAEL in this strain  was  20  mg/kg/day.  In
        view of the  significantly (p <0.05) lower  fetal  weight at 20 mg/kg/day,
        this level may also be considered the LOAEL for  fetotoxicity.

      0  No teratogenic effects were observed in  the offspring of female
        rhesus monkeys that  were given oral doses  of 0.05,  1.0 or 10.0 mg
        2,4,5-T (containing  0.05 ppm TCDD)/kg/day  in capsules during gestation
        days 22 through  38.   Neither was toxicity  evident  in  the mothers
        (Dougherty et  al., 1976).

   Mutagenicity

      0  At 250 and 1,000 ppm 2,4,5-T (with no detectable TCDD), mutation
        rate was significantly (p <0.05) increased at  the  higher dose in the
        sex-linked recessive lethal test in Drosophila as  carried out by
        Majumdar and Golia  (1974).  The sex-linked test  was not affected by
        920 or 1,804 ppm of the sodium salt of  2,4,5-T at  pH  6.8 in a study

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                                     -13-
        carried  out by  Vogel  and Chandler  (1974).   Although  they found no
        cytogenetic effects in  Drosophila,  Magnusson  et  al.  (1977)  concluded
        that 1,000  ppm  2,4,5-T  (<0.1 ppm TCDD)  did  cause an  increase (p <0.05)
        in  the number of  recessive  lethals  compared to the controls.   Rasmusson
        and Svahlin (1978) treated  Drosophila  larvae  to  food containing 100
        and 200  ppm 2,4,5-T;  survival  was  low  at 200  ppm, but 2,4,5-T had
        no  observable effect  on somatic mutational  activity.

     0  Anderson et al.  (1972)  found that  neither  2,4,5-T nor its butyric
        acid form showed  any  mutagenic action  when  tested on histidine—
        requiring mutants of  Salmonella typhimurium.

     0  Buselmaier  et al. (1972) found that intraperitoneal  injection of
        2,4,5-T  (dioxin levels  not  given)  had  no effect  in the host-mediated
        assay (500  mg/kg) or  in the dominant lethal test (100 mg/kg)  with
        NMRI mice.   Styles  (1973),  likewise,  found  no increase in back mutation
        rates with  the  serum  of rats treated orally with 2,4,5-T in the
        host-mediated assay with Salmonella typhimurium  (dosages and purity
        of  the samples  not given).

     0  Shirasu  et  al.  (1976) found that 2,4,5-T did  not induce mitotic gene
        conversion  in a diploid strain of  Saccharomyces  cerevisiae.   When the
        pH  of the treatment solution was less  than  4.5,  Zetterberg  (1978)
        found that  2,4,5-T was  mutagenic in haploid,  DNA-repair-defective
        .§.•  cerevisiae.

     0  Jenssen  and Renberg (1976)  investigated the cytogenetic effects of
        2,4,5-T  in  mice by examining the ability of the  herbicide to induce
        micronuclei formation in the erythrocytes  of  mouse bone marrow.  CBA
        mice were treated at  8  to 1 0 weeks  of  age  (20 to 30  g)  with a single
        intraperitoneal injection of 100 mg/kg of  2,4,5-T (<1  ppm TCDD) dis-
        solved in Tween 80 and  physiological saline.  Cytogenetic examination
        at  24 hours and 7 days  after treatment showed no detectable increase
        in  micronuclei  in the erythrocytes  compared to controls.  A weak
        toxic effect on the mitotic activity was indicated,  as judged by a
        decrease in the percentage  of  polychromatic erythrocytes.

   Carcinogenicity

     0  Innes et al.  (1969) investigated the potential carcinogenic effects
        of  2,4,5-T  in two hybrid strains of mice derived by  breeding SPF
        C57BL/6  female  mice to  either  C3H/Anf  or AKR  males.   Beginning at
        6 days of age,  2,4,5-T  was  administered by  gavage in 0.5% gelatin to
        a group  of  72 mice at a dose level  of  21.5  mg/kg/day.   This was
        reported to be  the maximum  tolerated dose.  At 28 days  of age,  the
        2,4,5-T  was added to  the diet  at a  level of 60 ppm,  corresponding to
        a dose of about 9 mg/kg/day (assuming  that  1  ppm equals 0.15 mg/kg/day
        in  the diet from  Lehman, 1959).  This  dose  was fed for  18 months, at
        which time  the  study  was terminated.   All animals were necropsied and
        the tissues were  examined both grossly and  microscopically.   There
        were no  significant (p  >0.05)  increases in  tumors in either strain of
        treated  mice.

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                                       -14-


        *   A  lifetime study using oral administration  of  2,4,5-T  in  both  sexes
           of two strains of mice, C3Hf and XVII/G, was performed by Muranyi-
           Kovacs et al.  (1976).  The 2,4,5-T, which contained  less  than  0.05
           ppm of dioxins, was administered in the water  (1,000 mg/L)  for 2
           months beginning at 6 weeks of age, and thereafter in  the diet at
           80 ppm (12 mg/kg/day) until death or when the  mice were sacrificed in
           extremis.  In  the treated C3Hf mice there was  a  significant (p <0.03)
           increase in  the incidence of total tumors found  in female mice and a
           significant  (p <0.001) increase in total nonincidental tumors  in each
           sex, which the authors interpreted as  life-threatening.   No signifi-
           cant (p >0.05) difference was found in the  XVII/G strain  between the
           treated and  control mice.  The authors felt that 2,4,5-T  demonstrated
           carcinogenic potential in the C3Hf strain,  but that  additional studies
           in other strains and in other species  of animals needed to be  performed
           before a reliable conclusion with respect to carcinogenicity could be
           made.

        0   Groups of Sprague-Dawley rats (50 each of males  and  females) were
           maintained on diets supplying 3, 10 or 30 mg/kg/day  of 2,4,5-T for 2
           years  (Kociba et al., 1979).  The 2,4,5-T was  approximately 99% pure,
           containing 1.3%  (w/w) other phenoxy acid impurities.   Dioxins  were
           not detected,  the limit of detection for TCDD  being  0.33  ppb.   An
           interim sacrifice was performed on an  additionally included group of
           10 animals of  each sex at 118 to 119 days.  Control  groups included
           86 animals of  each sex.  At the end of the  2-year period,  there was
           no significant  (p >0.05) increase in tumor  incidence in any treated
           group compared to the control for either male  or female animals.


V. QUANTIFICATION OF TOXICOLOGICAL EFFECTS

        Health Advisories  (HAs) are generally determined  for one-day,  ten-day,
   longer-term (approximately 7 years) and lifetime exposures if  adequate data
   are available  that identify a sensitive noncarcinogenic  end  point of toxicity.
   The HAs for noncarcinogenic toxicants are derived using  the  following  formula:

                 HA =  (NOAEL or LOAEL) X  (BW) = 	    /L  (	   /L)
                        (UF) x  {    L/day)
   where:
           NOAEL or  LOAEL = No-  or Lowest-Observed-Adverse-Effect-Level
                            in mg/kg  bw/day.

                       BW = assumed body weight of  a  child  (10 kg)  or
                            an adult  (70 kg).

                       UF = uncertainty factor  (10,  100 or  1,000),  in
                            accordance with NAS/ODW guidelines.

                	 L/day = assumed daily water consumption of a child
                            (1 L/day)  or an adult (2  L/day).

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2,4%5-Trichlorophenoxyacetic Acid                             August, 1987
   '                                                      ?
                                     -15-


One-day Health Advisory

     No information was found in the available literature that was suitable
for determination of the One-day HA value for 2,4,5-T.  The study in humans
by Gehring et al. (1973) was not selected because observations of the subjects
were reported simply as clinical effects without further details.  The
behavioral study in rats by Crampton and Rogers (1983) was not selected
because the interpretation of altered novelty response behavior in the absence
of other toxic signs needs further investigation before definitive conclusions
can be made.  It is therefore recommended that the Ten-day HA value for a
10-kg child (0.8 mg/L,  calculated below) be used at this time as a conservative
estimate of the One-day HA value.

Ten-day Health Advisory

     The study by Neubert and Dillman (1972) has been selected to serve as
the basis for determination of the Ten-day HA value for 2,4,5-T.  This
developmental study in rats identified a NOAEL of 8 mg/kg/day and a LOAEL
of 15 mg/kg/day, based on reduced body weights in pups from dams exposed on
days 6 to 15 of gestation.  This LOAEL is supported by a number of other
developmental studies in rodents that identified LOAELs ranging from 15 to
100tmg/kg/day (Roll, 1971; Sparschu et al., 1971; Khera and McKinley, 1972;
Gaines et al., 1975).  In the 21-day feeding study in rats by Vos et al.
(1983), a LOAEL of 20 mg/kg/day was identified based on effects on kidney
weight and the immune system.  The 8 mg/kg/day NOAEL for fetal effects selected
from the Neubert and Dillman (1972) study may not be applicable to a 10-kg
child; however, the assumptions for a 10-kg child are used with this NOAEL
in this case since, although a NOAEL was not found in the 21-day study by
Vos et al. (1983) where the observed effects are applicable to a 10-kg child,
the LOAEL of 20 mg/kg/day is 2.5 times higher than the NOAEL used for the
Ten-day HA.

     Using a NOAEL of 8 mg/kg/day, the Ten-day HA for a 10-kg child is
calculated as follows:

           Ten-day HA = <8 mg/kg/day) (10 kg) = 0>8   /L (80Q   /L)
                           (100) (1 L/day)

where:

        8 mg/kg/day = NOAEL,  based on absence of maternal or fetal effects in
                      rats exposed by gavage on days 6 to 15 of gestation.

              10 kg = assumed body weight of a child.

                100 = uncertainty factor, chosen in accordance with NAS/ODW
                      guidelines for use with a NOAEL from an animal study.

            1 L/day = assumed daily water consumption of a child.

Longer-term Health Advisory

     The reproduction study by Smith et al. (1981, 1978)  has been selected
to serve as the basis for the Longer-term HA value for 2,4,5-T because the

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                                     -16-
reduction in neonatal survival over multiple generations is concluded to be
relevant to the Longer-term HA for a 10-kg child.  The NOAEL identified was
3 mg/kg/day, and the LOAEL was 10 mg/kg/day.  Other possible selections have
a higher NOAEL [10 mg/kg/day in the 90-day feeding study in rats by McCollister
and Kociba (1970) and the 90-day oral treatment study in dogs by Drill and
Hiratzka (1953)].

     Using a NOAEL of 3 mg/kg/day, the Longer-term HA for a 10-kg child is
calculated as follows:

         Longer-term HA * (3 mg/kg/day) (10 kg) = 0.3 mg/L (300 ug/L)
                             (100) (1  L/day)
where:
        3 mg/kg/day = NOAEL,  based on absence of adverse effects in neonatal rats
                      in the  three-generation reproduction study in rats given
                      2,4,5-T in the diet.

              10 kg = assumed body weight of a child.

                100 = uncertainty factor, chosen in accordance with NAS/ODW
                      guidelines for use with a NOAEL from an animal study.

            1 L/day = assumed daily water consumption of a child.

     The Longer-term HA for a 70-kg adult is calculated as follows:

       Longer-term HA = (3 mg/kg/day) (70 kg) -LOS mg/L (1,050 ug/L)
                           (100) (2 L/day)

where:

        3 mg/kg/day = NOAEL,  based on absence of adverse effects in neonatal rats
                      in a three-generation reproduction study in rats given
                      2,4,5-T in the diet.

              70 kg = assumed body weight of an adult.

                100 = uncertainty factor, chosen in accordance with NAS/ODW
                      guidelines for use with a NOAEL from an animal sf.dy.

            2 L/day = assumed daily water consumption of an adult.

Lifetime Health Advisory

     The Lifetime HA represents that portion of an individual's total exposure
that is attributed to drinking water and is considered protective of noncar-
cinogenic adverse health effects over a lifetime exposure.  The Lifetime HA
is derived in a three-step process.  Step 1 determines the Reference Dose
(RfD), formerly called the Acceptable Daily intake (ADI).  The RfD is an esti-
mate of a daily exposure to the human population that is likely to be without
appreciable risk of deleterious effects over a lifetime, and is derived from

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2,4,5-Trichlorophenoxyacetic Acid    «                        August, 1987

                                     -17-
the NOAEL (or LOAEL), identified from a chronic (or subchronic) study, divided
by an uncertainty factor(s).  From the RfD, a Drinking Water Equivalent Level
(DWEL) can be determined (Step 2).  A DWEL is a medium-specific (i.e., drinking
water) lifetime exposure level, assuming 100% exposure from that medium, at
which adverse, noncarcinogenic health effects would not be expected to occur.
The DWEL is derived from the multiplication of the RfD by the assumed body
weight of an adult and divided by the assumed daily water consumption of an
adult.  The Lifetime HA is determined in Step 3 by factoring in other sources
of exposure, the relative source contribution (RSC).  The RSC from drinking
water is based on actual exposure data or, if data are not available, a
value of 20% is assumed for synthetic organic chemicals and a value of 10%
is assumed for inorganic chemicals.   If the contaminant is classified as a
Group A or B carcinogen, according to the Agency's classification scheme of
carcinogenic potential (U.S. EPA, 1986), then caution should be exercised in
assessing the risks associated with lifetime exposure to this chemical.

     The study by Kociba et al.  (1979) has been selected to serve as the
basis for the Lifetime HA value for 2,4,5-T.  In this study, rats were fed
2,4,5-T in the diet for 2 years.  Based on observations of effects of 2,4,5-T
on various biochemical parameters in addition to gross and microscopic obser-
vations related to general toxicity in the rats, this study identified a
NOAEL of 3 mg/kg/day and a LOAEL of 10 mg/kg/day.   This study is supported by
the three-generation rat study (Smith et al., 1981, 1978) that identified a
NOAEL of 3 mg/kg/day.

     Using this study, the Lifetime HA is calculated as follows:

Step 1:  Determination of the Reference Dose (RfD)

                   RfD = j.3.0 mg/kg/day) = 0>003 mg/kg/day
                           (100) (10)

where:

        3.0 mg/kg/day = NOAEL, based on absence of adverse effects on the
                        kidneys, liver and lungs of rats exposed to 2,4,5-T
                        in the diet for 2 years.

                  100 = uncertainty factor, chosen in accordance with NAS/ODW
                        guidelines for use with a  NOAEL from an animal study.

                   10 = modifying factor used by U.S. EPA Office of Pesticide
                        Programs to account for data gaps (chronic feeding
                        study in dogs) which does  not make it possible to
                        establish the most sensitive end point for 2,4,5-T.

Step 2:  Determination of the Drinking Water Equivalent Level (DWEL)

           DWEL = (0-003 mg/kg/day)  (70 kg) = 0.., 05 mg/L {, Q
                         (2 L/day)

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    2,4,5-Trichlorqphenoxyacetic Acid                              August,  1987

                                         -18-


    where:

            0.003 mg/kg/day = RfD.

                      70 kg » assumed body weight  of an adult.

                    2  L/day * assumed daily water  consumption of an adult.

    Step 3:   Determination of the Lifetime Health  Advisory

              Lifetime HA =  (0.105 mg/L)  (20%)  =  0.021 mg/L  (21 ug/L)

    where:

            0.105 mg/L = DWEL.

                   20% = assumed relative source contribution from water,

    Evaluation of Carcinogenic Potential

         0   Chronic  feeding studies with  2,4,5-T in Sprague-Dawley rats  (Kociba
            et al.,  1979) and C57BL/6 x C3H/Anf, C57BL/6 x AKR and XVII/G  strains
            of mice  (Innes et al., 1969;  Muranyi-Kovacs, et al; 1976) were
            negative for carcinogenic effects.   A  chronic feeding  study  with
            2,4,5-T  in C3Hf mice was inconclusive  (Muranyi-Kovacs  et al.,  1976).

         '•  IARC  (1982) concluded that the carcinogenic!ty of 2,4,5-T is indeter-
            minant  (Group 3, inadequate evidence in animals and humans).

         0   Applying the criteria described in EPA's guidelines for assessment
            of carcinogenic risk  (U.S. EPA, 1986), 2,4,5-T may be  classified  in
            Group D:   not classified.  This category is for agents with  inadequate
            animal  evidence of carcinogenicity.

         0   The Carcinogen Assessment Group (CAG)  of the U.S. EPA  classified
            chlorophenoxyacetic acids and/or chlorophenols containing 2,3,7,8-TCDD
            in IARC category  2A  (probably carcinogenic in humans on the  basis
            of limited evidence in humans), but  a  quantitative cancer risk estimate
            only  for 2,3,7,8-TCDD itself  was made.  The CAG considered the human
            evidence for  the  carcinogenicity of  2,3,7,8-TCDD alone to be "inadequate"
            because of the difficulty in  attributing observed effects solely  to
            the presence  of 2,3,7,8-TCDD,  which  occurs as an  impurity in the
            phenoxyacetic acids and chlorophenols  (U.S. EPA,  1985).


VI. OTHER CRITERIA,  GUIDANCE  AND  STANDARDS

         0  The U.S.- EPA/Office of Pesticide Programs has calculated a Provisional
            Acceptable Daily  Intake (PADI) value of 0.003 mg/kg/day, based on the
            results  of a  rat  chronic oral NOAEL  of 3 mg/kg/day with an uncertainty
            factor  of  1,000 (used because of data  gaps).

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      2,4,5-Trichlorophenoxyacetic Acid                             August, 1987

                                           -19-
           0  The National Academy of Sciences (NAS, 1977) has calculated an ADI
              of 0.1 mg/kg/day, using a NOAEL of 10 mg/kg/day (identified in a
              90-day feeding study in dogs) and an uncertainty factor of 100.  A
              chronic Suggested-No-Adverse-Effeet-Level (SNARL) of 0.7 mg/L was
              calculated based on the ADI of 0.1 mg/kg/day.

           0  The American Conference of Governmental Industrial Hygienists (ACGIH,
              1981) has recommended a Threshold Limit Value-Time-Weighted Average
              (TLV-TWA) of 10 mg/m3 and a Threshold Limit Value-Short-Term Exposure
              Limit (TLV-STEL) of 20 mg/m3.

           0  The ADI recommended by the World Health Organization is 0 to
              0.03 mg/kg (Vettorazzi and van den Hurk,  1983).


 VII. ANALYTICAL METHODS

           0  Determination of 2,4,5-T is by a liquid-liquid extraction gas
              chromatographic procedure (U.S.  EPA, 1978;  -Standard Methods,  1985).
              Specifically, the procedure involves the  extraction of chlorophanoxy
              acids and their esters from an acidified  water sample with ethyl
              ether.  The esters are hydrolyzed to acids,  and extraneous organic
              material is removed by a solvent wash.  The acids are converted  to
              methyl esters that are extracted from the aqueous phase.   Separation
              and identification of the esters is made  by gas chromatography.
              Detection and measurement are accomplished  by an electron-capture,
              microcoulometric or electrolytic conductivity detector.   Identifica-
              tion may be corroborated through the use  of  two unlike columns.   The
              detection limit is dependent on  the sample  size and instrumentation
              used.   Typically,  using a 1-L sample and  a  gas chromatograph  with
              an electron-capture detector results in an  approximate detection
              limit of 10 ng/L for 2,4,5-T.


VIII. TREATMENT  TECHNOLOGIES

              Available data indicate that granular-activated carbon (GAC)  and
              powdered-activated  carbon (PAC)  adsorption will effectively remove
              2,4,5-T  from  water.

           0   Robeck et al.  (1965)  experimentally  determined adsorption  isotherms
              for  the  butoxy  ethanol  ester  of  2,4,5-T on PAC.   Based on  these
              results,  it was calculated  that  14  mg/L PAC  would be  required to
              remove 90%  of  2,4,5-T,  while 44  mg/L  PAC would  be required to remove
              99%  of 2,4,5-T  (Pershe  and  Goss,  1979;  Robeck  et al.,  1965).

           0   Robeck et al.  (1965)  reported  the results of a  GAC column operating
              under pilot plant conditions.  At a  flow rate of 0.5 gpm/ft3, 99+%
              of 2,4,5-T  was  removed.   By  comparison, treatment with 5 to 20 mg/L
              PAC  removed 80  to 95% of  the same concentration of  2,4,5-T.

           0   in a laboratory  study conducted with an exchange resin, Rees and Au
              (1979) reported  89±2% removal efficiency of  2,4,5-T from contaminated
              water by  adsorption onto  synthetic resins.

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2,4,5-Trichlorophenoxyacetic Acid                              August,  1987

                                     -20-
        Conventional  water  treatment technique of  coagulation with alum,
        sedimentation and sand  filtration removed  63% of the 2,4,5-T ester
        present in  spiked river water (Robeck et al.,  1965).

        Treatment technologies  for  the removal of  2,4,5-T from water are
        available and have  been reported  to be effective.   However,  selection
        of individual or combinations of  technologies to attempt 2,4,5-T
        removal from   water must be based on a case-by-case technical evaluation,
        and an assessment of the economics involved.

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    2,4,5-Trichlorophenoxyacetic Acid                             August, 1987

                                         -21-


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  2,4,5-Trichlorophenoxyacetic Acid        ,..,,-,                August, 1987

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2,4,5-Trichlorophenoxyacetic Acid                              August, 1987

                                   '   -23-


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    T2j*,r5TTEicMorophenoxyacetic AcigJ         t-". >  -  -^-^.y-      August,  1987
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         2,4,5-Trichlorophenoxyacetic Acid          jl                    August-,
»


+

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                                                                 •.'- '„..-_:•   i   , r.  r

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