United States       Prevention, Pesticides     EPA712-C-98-239
          Environmental Protection    and Toxic Substances     August 1998
          Agency        (7101)
&EPA   Health Effects Test
          Guidelines
          OPPTS 870.6300
          Developmental
          Neurotoxicity Study

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                           INTRODUCTION
     This guideline is one  of a  series  of test  guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental  Protection Agency for use  in the testing of
pesticides and toxic substances, and the  development of test data that must
be submitted to the Agency  for review under Federal regulations.

     The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has  developed this guideline through  a process of harmonization that
blended the testing  guidance  and requirements that  existed in the Office
of Pollution Prevention and  Toxics  (OPPT) and appeared in Title  40,
Chapter I,  Subchapter R of the Code of Federal Regulations  (CFR),  the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical  Information Service (NTIS) and the guidelines pub-
lished by the Organization  for Economic Cooperation and Development
(OECD).

     The purpose of harmonizing these  guidelines  into a single set of
OPPTS guidelines is to minimize  variations among the testing procedures
that must be performed to meet the data  requirements of the U. S. Environ-
mental Protection Agency  under  the Toxic  Substances  Control Act  (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. 136,  etseq. ).

     Final  Guideline Release: This guideline  is available from the U.S.
Government Printing Office,  Washington, DC 20402 on disks or paper
copies: call (202) 512-0132. This  guideline is also available electronically
in PDF (portable document format) from EPA's  World Wide Web  site
(http://www.epa.gov/epahome/research.htm) under the heading "Research-
ers and Scientists/Test Methods and Guidelines/OPPTS  Harmonized Test
Guidelines."

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OPPTS 870.6300 Developmental neurotoxicity study.
     (a) Scope—(1) Applicability. This guideline is intended to meet test-
ing  requirements   of  both  the  Federal  Insecticide,  Fungicide,  and
Rodenticide Act (FIFRA) (7 U.S.C.  136, et seq.) and the Toxic Substances
Control Act (TSCA) (15 U.S.C. 2601).

     (2) Background.  The source material used in developing this har-
monized OPPTS test guideline is OPP 83-6 Developmental Neurotoxicity
Study (Pesticide Assessment Guidelines, Subdivision F~Hazard Evalua-
tion: Human  and Domestic Animals, Addendum 10, EPA report 540/09-
91-123, March 1991).

     (b) Purpose. In the assessment and evaluation of the toxic character-
istics of a  chemical substance or mixture (test substance), determination
of the potential  for developmental neurotoxicity is  important. This  study
is designed to develop  data on the potential functional and morphological
hazards to the nervous system which may arise in the offspring from  expo-
sure of the mother during pregnancy and lactation.

     (c) Principle of the test method.  The test substance is administered
to  several groups of pregnant animals during gestation and early lactation,
one dose level being used per group. Offspring are randomly selected from
within litters for neurotoxicity evaluation.  The evaluation includes observa-
tions to detect gross neurologic  and behavioral abnormalities, determina-
tion of motor activity, response to auditory startle, assessment of learning,
neuropathological evaluation,  and brain  weights. This  protocol may be
used as a separate study, as a followup to a standard  developmental tox-
icity and/or adult neurotoxicity study, or as part of a two-generation repro-
duction study, with assessment of the offspring conducted on the second
(F2) generation.

     (d) Test procedure—(1) Animal selection—(i) Species and strain.
Testing should be performed in the rat. Because of its differences in timing
of developmental events compared to strains that  are more  commonly test-
ed in other developmental and reproductive toxicity  studies, it is preferred
that the Fischer 344 strain not be used.  If a sponsor wishes to use the
Fischer 344 rat or a mammalian species other than the  rat,  ample justifica-
tion/reasoning for this selection must be provided.

     (ii) Age. Young adult (nulliparous females) animals should be  used.

     (iii) Sex. Pregnant female animals should be used at each dose  level.

     (iv) Number of animals. (A) The objective is for a sufficient number
of pregnant rats to be exposed to the test substance  to ensure that an ade-
quate number of offspring are produced  for neurotoxicity evaluation. At
least 20 litters are recommended at each dose level.

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     (B)  On  postnatal day 4, the size of each litter  should  be adjusted
by eliminating extra pups by random selection to yield,  as nearly as pos-
sible, four male and four females per litter. Whenever the number of pups
of either sex  prevents having four of each sex per litter, partial adjustment
(for  example, five males  and three  females)  is permitted. Testing is not
appropriate for litters of less than seven pups. Elimination of runts only
is  not appropriate. Individual  pups  should  be identified uniquely  after
standardization of litters.  A  method that may be used  for identification
can be found under paragraph (f)(l) of this guideline.

     (v) Assignment of animals for  behavioral tests, brain weights, and
neuropathological evaluations. After standardization  of litters, one male
or one female from each litter (total  of 10 males and 10 females per dose
group) should be randomly assigned to one of the following tests: Motor
activity, auditory startle, and learning and memory, in weanling and adult
animals.  On  postnatal day 11,  either 1 male  or  1 female pup from each
litter (total of 10 males and 10 females per  dose group) should be sac-
rificed. Brain weights should be measured in all of  these pups and, of
these pups, six per sex per dose  should be selected  for neuropathological
evaluation. At the termination of the  study, either 1 male or 1 female from
each litter (total of 10  males and 10 females per dose group)  should be
sacrificed and brain weights  should  be measured. An  additional group of
six animals per sex per dose group (one male or one female  per  litter)
should be sacrificed at  the termination of the study  for neuropathological
evaluation.

     (2)  Control group.  A  concurrent control  group is required.  This
group should be a sham-treated group or, if a vehicle is used in administer-
ing the test substance, a vehicle control group. The vehicle should neither
be developmental^ toxic nor  have  effects on  reproduction.  Animals in
the control group should be handled in an identical manner to test  group
animals.

     (3) Dose levels and  dose  selection, (i)  At least three dose levels of
the test substance plus a control group (vehicle control, if a  vehicle is
used) should  be used.

     (ii) If the test substance has  been shown to be developmentally toxic
either in a standard developmental toxicity study or in a pilot  study, the
highest dose  level  should be the maximum dose which will not induce
in utero or neonatal death or malformations sufficient to preclude a mean-
ingful evaluation of neurotoxicity.

     (iii) If a standard developmental  toxicity  study  has not been con-
ducted, the highest dose level,  unless limited by the physicochemical na-
ture  or biological  properties  of the  substance, should induce some overt
maternal toxicity, but should not result in  a reduction in weight gain ex-
ceeding 20 percent during  gestation and lactation.

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     (iv) The lowest dose should not produce any grossly observable evi-
dence of either maternal or developmental neurotoxicity.

     (v)  The intermediate doses should be  equally spaced  between the
highest and lowest doses used.

     (4) Dosing period. Day 0 of gestation is the day on which a vaginal
plug and/or sperm are observed. The dosing period should cover the period
from day 6 of gestation through day- 10 postnatally. Dosing should not
occur on the day of parturition in those animals who have not completely
delivered their offspring.

     (5) Administration of the test substance. The test substance or vehi-
cle should be  administered orally. Other routes of administration may be
acceptable, on a case-by-case basis, with ample justification/reasoning for
this  selection.  The test substance or vehicle should be administered based
on the  most recent weight determination.

     (6) Observation of dams, (i) A gross examination of the dams should
be made at least once each day before daily treatment.

     (ii)  Ten dams per  group  should be observed outside the home cage
at least twice  during  the gestational dosing period (days 6-21) and twice
during the lactational dosing period (days  1-10) for signs of  toxicity. The
animals  should be observed by trained technicians who are unaware of
the animals' treatment,  using  standardized procedures to maximize inter-
observer reliability. Where possible,  it is advisable that  the same observer
be used to evaluate the animals in a given study. If this is  not possible,
some demonstration of interob server reliability is required.

     (iii) During the  treatment and  observation periods under paragraph
(d)(6)(ii), observations should include:

     (A) Assessment of  signs of autonomic  function, including but not lim-
ited to:

     (7) Ranking of the  degree of lacrimation and salivation,  with a range
of severity scores from none to severe.

     (2) Presence or absence of piloerection and exophthalmus.
        Ranking or count of urination and defecation, including polyuria
and diarrhea.

     (4) Pupillary function such as constriction of the pupil in responseto
light or a measure of pupil size.

     (5) Degree of palpebral closure, e.g., ptosis.

     (B) Description, incidence, and severity of any convulsions, tremors,
or abnormal movements.

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     (C) Description and incidence of posture and gait abnormalities.

     (D) Description and incidence of any unusual or abnormal behaviors,
excessive  or  repetitive  actions  (stereotypies), emaciation, dehydration,
hypotonia or  hypertonia, altered fur appearance, red or  crusty deposits
around the eyes, nose, or mouth, and any other observations that may fa-
cilitate interpretation of the data.

     (iv) Signs of toxicity should be recorded as they are observed, includ-
ing the time of onset, degree, and duration.

     (v) Animals should be  weighed at least weekly and  on the  day of
delivery and postnatal  days 11  and 21 (weaning) and such weights should
be recorded.

     (vi) The day of delivery of litters should be recorded and considered
as postnatal day 0.

     (7) Study conduct—(i) Observation of offspring.  (A) All  offspring
should be examined cage-side  at least  daily for gross signs of  mortality
or morbidity.

     (B) A total of  10 male offspring  and  10 female offspring  per dose
group should be examined outside the  cage  for signs of toxicity on days
4, 11,  21, 35, 45, and 60.  The offspring should be observed by trained
technicians, who are unaware of the treatment being used,  using  standard-
ized procedures to maximize interobserver  reliability. Where possible, it
is advisable that the same observer be used to evaluate  the  animals in
a given study. If this is not possible, some demonstration of interobserver
reliability is required. At a minimum, the end points outlined in paragraph
(d)(6)(iii)  of this guideline should be monitored as appropriate for the de-
velopmental stage being observed.

     (C) Any  gross signs of toxicity in the offspring  should be  recorded
as they are  observed,  including the time of onset,  degree, and  duration.

     (ii) Developmental landmarks. Live  pups should be counted and
each pup  within a litter  should be weighed  individually at birth or soon
thereafter, and on postnatal days 4, 11,  17, and 21 and at least once every
2 weeks thereafter. The  age of vaginal opening and preputial separation
should be determined. General procedures for these determinations may
be found in paragraphs (f)(l) and (f)(ll) of this guideline.

     (iii) Motor activity. Motor activity should be monitored specifically
on  postnatal days  13,  17 21, and  60 (±2  days). Motor activity must be
monitored by  an automated activity recording apparatus. The device must
be capable of detecting both increases and decreases  in activity, (i.e., base-
line activity as measured by  the device  must not be  so low as to preclude
detection  of decreases nor so high as  to preclude detection of  increases
in activity). Each device should be tested by standard procedures to ensure,

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to the extent possible, reliability of operation across  devices  and across
days for any one device.  In addition, treatment groups must be balanced
across devices. Each animal should be tested individually. The test session
should be long enough for motor activity to  approach asymptotic levels
by the last 20 percent of the  session for nontreated control animals.  All
sessions  should have  the same duration.  Treatment groups  should be
counter-balanced across test times.  Activity counts should be collected in
equal time periods of no greater than 10 minutes duration. Efforts  should
be made to ensure that variations in the test  conditions are minimal  and
are not systematically related  to treatment.  Among the variables that  can
affect motor activity are sound level, size and shape of the test cage, tem-
perature, relative  humidity, light conditions, odors,  use of home cage or
novel test cage, and environmental distractions. Additional information on
the conduct of a motor activity study may be obtained in OPPTS 870.6200.

     (iv) Auditory startle test. An auditory startle habituation  test  should
be performed on the offspring  around the time of weaning  and around
day 60. Day  of testing should be counterbalanced across treated and con-
trol groups. Details on the conduct of this testing may be obtained under
paragraph (f)(l) of this guideline. In performing the auditory startle task,
the mean response amplitude  on each block of 10 trials  (5 blocks of 10
trials per session on each day of testing) should be made. While  use of
prepulse inhibition is not a requirement, it is highly recommended. Details
on the conduct of this test may be obtained  in paragraph (f)(10)  of  this
guideline

     (v) Learning and  memory tests. A test of associative learning  and
memory should be conducted  around the time of weaning and around  day
60. Day of testing should be  counterbalanced across  treated  and control
groups. The  same or separate tests may be used at these two stages of
development. Some flexibility is allowed in  the choice  of tests for learning
and memory in weanling and adult rats. However,  the tests must  be  de-
signed to fulfill two criteria. First, learning must be assessed  either as  a
change across several repeated learning  trials or sessions, or, in tests in-
volving a single trial, with reference to a condition  that controls for non-
associative effects of the training experience.  Second,  the tests should in-
clude some measure of memory (short-term or long-term) in addition to
original learning (acquisition). If the tests of learning  and memory reveal
an effect of the test compound, it may be in  the best interest of the sponsor
to conduct additional tests to  rule out alternative interpretations based on
alterations in sensory,  motivational, and/or motor capacities. In addition
to the  above two criteria, it is recommended that the test of learning  and
memory be chosen on the basis  of its demonstrated sensitivity to the class
of compound under investigation, if such information is  available in  the
literature. In the absence of such information,  examples of tests that could
be made to meet the above criteria include:  Delayed-matching-to-position,
as described  for the  adult  rat  (see paragraph (f)(3) of this guideline)  and

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for the infant rat (see paragraph (f)(9) of this guideline); olfactory condi-
tioning, as described in paragraph (f)(13) of this guideline; and acquisition
and retention of schedule-controlled  behavior  (see paragraphs (f)(4) and
(f)(5) of this guideline). Additional tests for weanling rats are described
under paragraphs (f)(20) and (f)(12)  of this guideline, and for adult rats
under paragraph (f)(16) of this guideline.

     (vi) Neuropathology. Neuropathological  evaluation should be con-
ducted on animals on postnatal day 11 and at the termination of the study.
At  11 days of age, one male or female pup should be  removed from each
litter such that  equal numbers  of male and female offspring are removed
from all litters combined. Of these, six male and six female pups per dose
group will be sacrificed for neuropathological  analysis.  The pups will be
killed by exposure to carbon dioxide and immediately thereafter the brains
should be removed,  weighed, and  immersion-fixed in  an appropriate
aldehyde  fixative. The remaining  animals will be sacrificed  in a similar
manner and immediately thereafter their brains removed and weighed. At
the termination of the study, one male or one female from each litter will
be  killed  by exposure to carbon dioxide and  immediately thereafter  the
brain should be removed and  weighed.  In addition, six animals per  sex
per dose group (one male or female per litter)  should be sacrificed at the
termination   of   the   study    for   neuropathological    evaluation.
Neuropathological analysis of animals sacrificed at the termination of the
study  should  be  performed  in  accordance  with  OPPTS 870.6200.
Neuropathological evaluation of animals sacrificed on postnatal day 11 and
at termination  of the study  should  include  a  qualitative  analysis  and
semiquantitative analysis as well as simple morphometrics.

     (A)  Fixation and processing of tissue samples for postnatal  day
11  animals. Immediately following removal, the brain should be weighed
and immersion fixed in an appropriate aldehyde fixative. The brains should
be  postfixed and processed according to  standardized published histo-
logical protocols under paragraphs (f)(6), (f)(14), (f)(17), and (f)(21)  of
this guideline. Paraffin embedding  is acceptable but plastic embedding is
preferred  and recommended. Tissue  blocks and slides  should be appro-
priately identified when stored. Histological sections should be stained for
hematoxylin  and eosin, or a  similar stain according to standard published
protocols  under paragraphs (f)(2),  (f)(18),  and (f)(23) of this guideline.
For animals sacrificed at the termination of the  study, methods for fixation
and processing of tissue samples are provided in paragraph (e)(4)(iv)(A)
of OPPTS  870.6200.

     (B) Qualitative analysis. The purposes of the qualitative  examination
are threefold—to identify regions within the nervous system exhibiting evi-
dence of neuropathological  alterations, to identify types of neuropatholo-
gical alterations resulting from exposure to the test substance, and to deter-
mine the range of severity of the neuropathological alterations. Representa-
tive histological sections from the tissue samples should be examined mi-

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croscopically  by  an appropriately trained  pathologist  for  evidence of
neuropathological alterations. The following stepwise procedure is  rec-
ommended for the qualitative analysis. First, sections from the high dose
group  are compared with those of the  control group. If no evidence of
neuropathological alterations is  found in animals of the high dose group,
no further analysis is required. If evidence of neuropathological alterations
are found in the high dose group, then animals from the  intermediate and
low dose group are examined.  Subject  to professional judgment and the
kind of neuropathological alterations observed, it is recommended that ad-
ditional methods such as Bodian's or Bielchowsky's  silver methods and/
or immunohistochemistry for glial fibrillary acid protein be used in con-
junction with  more  standard stains to determine the lowest dose level at
which neuropathological alterations are observed. Evaluations of postnatal
day 11 pups is described in paragraphs (d)(7)(vi)(B)(7) and (d)(7)(vi)(B)(2)
of this  guideline.  For animals sacrificed at  the termination of the  study,
the regions to be examined and the  types  of alterations that should be
assessed are identified in paragraph (e)(4)(iv)(B) of OPPTS 870.6200.

     (7) Regions to be examined. The brains should be examined for any
evidence of treatment-related neuropathological alterations and adequate
samples should be taken from all major brain regions (e.g., olfactory bulbs,
cerebral cortex,  hippocampus,  basal  ganglia, thalamus, hypothalamus,
midbrain (tectum, tegmentum, and cerebral peduncles), brainstem and cer-
ebellum) to ensure a thorough examination.

     (2) Types of alterations. Guidance for neuropathological examination
for indications of developmental insult to the brain  can be found in para-
graphs (f)(8) and (f)(22) of this guideline. In  addition to more typical kinds
of cellular alterations (e.g., neuronal vacuolation, degeneration, necrosis)
and tissue changes (e.g., astrocytic proliferation, leukocytic infiltration, and
cystic formation) particular emphasis should be paid to structural changes
indicative of developmental insult including but not restricted to:

     (/) Gross changes in the size or shape of brain regions such as alter-
ations  in the  size of the cerebral hemispheres or the normal pattern of
foliation of the cerebellum.

     (//) The death of neuronal  precursors, abnormal  proliferation,  or ab-
normal migration,  as indicated  by pyknotic cells or  ectopic neurons, or
gross alterations in regions with active proliferative and  migratory  zones,
alterations in transient developmental structures (e.g., the external germinal
zone of the cerebellum, see paragraph (f)(15) of this guideline).

     (///) Abnormal  differentiation,  while  more apparent  with  special
stains, may also be indicated by  shrunken and malformed cell bodies.

     (iv) Evidence of hydrocephalus, in particular enlargement of the ven-
tricles,  stenosis of the cerebral aqueduct and general thinning of the cere-
bral hemispheres.

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     (C) Subjective diagnosis. If any evidence of neuropathological alter-
ations is found in the qualitative examination, then a subjective diagnosis
will  be performed for the purpose of evaluating dose-response relation-
ships.  All  regions  of  the  brain  exhibiting   any   evidence   of
neuropathological changes should be included  in this  analysis. Sections
of each region from  all dose groups will be coded as to  treatment and
examined in randomized order. The frequency of each type  and the sever-
ity of each lesion will be recorded. After all sections from all dose groups
including  all regions have been rated, the code  will be  broken and statis-
tical analyses performed to evaluate dose-response relationships. For each
type of dose related lesion observed, examples of different ranges of sever-
ity should be described. The examples will serve to illustrate a rating  scale,
such as 1+, 2+, and 3+ for the degree of severity ranging from very  slight
to very extensive.

     (D)  Simple  morphometric analysis.  Since the disruption of devel-
opmental processes is sometimes more clearly reflected in the rate or ex-
tent  of growth of particular brain regions, some form of  morphometric
analysis should be performed on postnatal day  11 and  at the termination
of the study to assess the structural development of the brain.  At a  mini-
mum, this  would consist  of a reliable estimate  of the thickness of major
layers at representative locations within the neocortex,  hippocampus, and
cerebellum. For guidance on such measurements see Rodier and Gramann
under paragraph (f)(19) of this guideline.

     (e) Data  collection,  reporting, and evaluation. The  following spe-
cific information should be reported:

     (1) Description  of test system and test methods. A  description of
the general design of the  experiment  should be  provided. This  should in-
clude:

     (i) A detailed description of the procedures  used to standardize obser-
vations and procedures as well as operational definitions for  scoring obser-
vations.

     (ii) Positive  control data from the laboratory performing the test that
demonstrate the sensitivity of the procedures being used.  These data do
not have to be from studies using prenatal exposures. However, the labora-
tory must  demonstrate competence in evaluation effects in neonatal ani-
mals perinatally exposed to chemicals and establish test norms for the ap-
propriate age group.

     (iii)  Procedures for calibrating and ensuring the equivalence of de-
vices and the balancing of treatment groups in testing procedures.

     (iv)  A short justification explaining any  decisions involving profes-
sional judgement.

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     (2) Results. The  following information must be arranged by each
treatment and control group:

     (i) In tabular form, data for each animal must be provided showing:

     (A) Its identification number and the litter from which it came.

     (B) Its  body weight and score on each developmental landmark at
each observation time.

     (C) Total session activity counts and intrasession subtotals on each
day measured.

     (D) Auditory startle response  amplitude per session and intrasession
amplitudes on each day measured.

     (E) Appropriate data for each repeated trial (or session) showing ac-
quisition and retention  scores on the tests of learning and memory on each
day measured.

     (F) Time and cause of death (if appropriate);  any neurological signs
observed;  a  list  of  structures examined as well as the locations, nature,
frequency, and extent of lesions; and brain weights.

     (ii) The following data should also be provided, as appropriate:

     (A) Inclusion of photomicrographs demonstrating typical examples of
the type and extent of the neuropathological alterations observed is rec-
ommended.

     (B) Any diagnoses derived from neurological signs and lesions, in-
cluding naturally occurring diseases or conditions, should also be recorded.

     (iii) Summary data for each treatment  and control group must include:

     (A) The number of animals at the  start of the test.

     (B) The body weight of the dams during gestation and lactation.

     (C) Litter size and mean weight at birth.

     (D) The number of animals showing each abnormal  sign at each ob-
servation time.

     (E) The percentage  of animals showing each  abnormal sign at each
observation time.

     (F) The mean  and standard deviation for  each continuous  endpoint
at each observation time.  These will include body weight,  motor activity
counts, auditory startle responses,  performance in  learning and memory
tests, regional brain weights and whole brain weights (both absolute and
relative).

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     (G) The number of animals in which any lesion was found.

     (H) The number of animals affected by each different type of lesion,
the location,  frequency and average grade of each type  of lesion for each
animal.

     (I) The values of all morphometric measurements made for each ani-
mal listed by treatment group.

     (3) Evaluation of data. An evaluation of test results must be made.
The evaluation should include the relationship between the doses of the
test substance and the presence  or absence, incidence, and extent of any
neurotoxic effect. The  evaluation should  include appropriate statistical
analyses.  The choice  of analyses should consider  tests appropriate to the
experimental design and needed adjustments for multiple comparisons. The
evaluation should  include the  relationship,  if any,  between observed
neuropathological and behavioral alterations.

     (f) References. The following references  should be consulted for ad-
ditional background material on this test guideline.

     (1) Adams,  J., Buelke-Sam, J.,  Kimmel,  C.A., Nelson,  C.J., Reiter,
L.W., Sobotka, T.J., Tilson, H. A., and Nelson, B.K. Collaborative behav-
ioral   teratolgy   study:  Protocol   design   and testing   procedures.
Neurobehavioral  Toxicology and Teratology 7:579-586 (1985).

     (2) Bennett,  H.S., Wyrick, A.D., Lee, S.W., and McNeil,  J.H.  Science
and art in preparing tissues embedded in plastic for light microscopy, with
special reference  to glycol methacrylate, glass knives and simple stains.
Stain Technology 51:71-97 (1976).

     (3) Bushnell, P.J. Effects of delay, intertrial interval, delay behavior
and trimethyltin on spatial delayed response in rats. Neurotoxicology and
Teratology 10:237-244 (1988).

     (4) Campbell,  B.A. and Haroutunian, V. Effects of age on long-term
memory:Retention  of fixed  interval  responding. Journal  of  Gerontology
36:338-341 (1981).

     (5) Cory-Slechta, D.A., Weiss,  B., and Cox, C.  Delayed behavioral
toxicity of lead with increasing exposure  concentration. Toxicology and
Applied Pharmacology 71:342-352 (1983).

     (6) Di Sant Agnese, P. A. and De Mesy Jensen, K.L. Dibasic  staining
of large epoxy tissue sections and application to surgical pathology. Amer-
ican Journal  of Clinical  Pathology 81:25-29 (1984).

     (7) U.S.  Environmental Protection Agency. Neurotoxicity Screening
Battery. In: Pesticide Assessment Guidelines, Subdivision F, Addendum
10. EPA 540/09-91-123. NTIS PB 91-154617. (1991).

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     (8) Friede,  R.  L. Developmental Neuropathology.  Springer-Verlag,
New York. pp. 1-23, 297-313, 326-351. (1975).

     (9) Green, R.J.  and Stanton, M.E. Differential ontogeny of working
memory  and  reference memory in the  rat.  Behavioral Neuroscience
103:98-105 (1989).

     (10) Ison, J.R.  Reflex modification as an objective test for sensory
processing  following toxicant exposure. Neurobehavioral Toxicology and
Teratology 6:437-445 (1984).

     (11) Korenbrot, C.C., Huhtaniemi,  I.T.,  and Weiner, R.I. Preputial
separation  as an external  sign of pubertal development in the male  rat.
Biology of Reproduction 17:298-303 (1977).

     (12) Krasnegor, N.A., Blass, E.M., Hofer, M.A.,  and Smotherman,
W.P. (eds.) Perinatal Development: A Psychobiological Perspective. Aca-
demic Press, Orlando, pp. 11-37, 145-167. (1987).

     (13) Kucharski, D. and Spear,  N.E.  Conditioning  of  aversion to  an
odor paired with peripheral shock in the developing rat. Developmental
Psychobiology 17:465-479 (1984).

     (14) Luna, L. G. (editor). Manual of Histologic Staining Methods of
the Armed Forces Institute of Pathology. (Third Edition).  McGraw-Hill,
New York. pp. 1-31. (1968).

     (15) Miale,  I.  L. and Sidman, R.L. An autoradiographic analysis of
histogenesis in the mouse cerebellum. Experimental Neurology. 4:277-296
(1961).

     (16) Miller, D.B. and Eckerman,  D.A. Learning and memory meas-
ures. In: Neurobehavioral Toxicology , Z. Annau (ed). Johns Hopkins Uni-
versity Press, Baltimore, pp. 94-149 (1986).

     (17) Pender, M.P. A simple method for high resolution light micros-
copy of nervous tissue. Journal of Neuroscience Methods.  15:213-218
(1985).

     (18)  Ralis,  H.M.,  Beesley,  R.A.,  and Ralis,  Z.A.  Techniques  in
Neurohistology. Butterworths, London, pp. 57-145. (1973).

     (19) Rodier, P.M. and Gramann, W.J.  Morphologic effects of inter-
ference with cell proliferation in the early fetal period.  Neurobehavioral
Toxicology 1:129-135 (1979).

     (20) Spear,  N.E. and Campbell, B.A.  (eds.) Ontogeny of Learning
and Memory. Erlbaum, New Jersey, pp. 101-133,  157-224. (1979).

     (21)   Spencer,   P.S.,  Bischoff,  M.C.,  and   Schaumburg,  H.H.
Neuropathological methods for the detection of neurotoxic disease. In: Ex-

                                 11

-------
perimental and Clinical Neurotoxicology. Spencer, P.S. and Schaumburg,
H.H. (eds.). Williams and Wilkins, Baltimore, pp. 743-757. (1980)

    (22) Suzuki, K. Special vulnerabilities of the developing nervous sys-
tem to toxic  substances.  In: Experimental and Clinical Neurotoxicology.
Spencer, P.S. and Schaumburg, H.H. (eds.). Williams and Wilkins, Balti-
more, pp. 48-61 (1980).

    (23) Luna, L.G. (Editor).  Manual of Histologic Staining Methods of
the Armed Forces Institute of Pathology.  (Third Edition). McGraw-Hill,
New York. pp. 32-46. (1968).
                                 12

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