United States
                                 Environmental Protection
                                 Agency
                                 Health Effects Research
                                 Laboratory
                                 Research Triangle Park NC 27711
v-xEPA
                                 Research and Development
                                 EPA-600/S1-81-034 June 1981
Project  Summary
                                 Skeletal Variants  as  an
                                 Indicator of  Biological
                                 Effects  of  Environmental
                                 Contaminants
                                 Sidney L Beck
                                  The project consisted of an attempt
                                 at developing a Skeletal Variant Assay
                                 System (SVAS)  for mice whereby it
                                 might be possible to detect subtle bio-
                                 logical effects of in utero exposure to
                                 noxious  substances even  in  the
                                 absence of gross malformations, by an
                                 examination of a series of variations in
                                 development in adult skeletons.
                                  The compounds  tested  included
                                 several  pesticides and a number of
                                 known teratogens. Animals were CD-1
                                 mice. Doses were chosen to include
                                 potentially teratogenic and no effect
                                 levels; they were administered by the
                                 most appropriate route and at appro-
                                 priate times; choices were culled from
                                 published protocols wherever these
                                 were available.  Toxicity tests were
                                 performed when necessary.  Vehicle
                                 controls and untreated controls were
                                 included in each  series.
                                  Eighty-eight variants were selected
                                 for study. They were all qualitative in
                                 nature to increase  ease of typing,
                                 objectivity, and reliability. Most were
                                 polymorphic in CD-1 mice and thus
                                 what was measured was change in
                                 frequency of occurrence in response
                                to treatment.
                                  In many cases a prenatal study was
                                also performed  in  order to provide
                                comparability  with traditional tera-
                                togen studies. A series of fetal skeletal
                                parameters  was included  in  the
                                prenatal studies.
                                  A series of adult skeletons of four-
                                 way outcross mice which had been
                                 selected for susceptibility and resist-
                                 ance to the teratogen trypan blue were
                                 available and were also examined for
                                 the SVAS variants as a separate con-
                                 firming study.
                                  This Project Summary was develop-
                                 ed by EPA's Health Effects Research
                                 Laboratory. Research Triangle Park.
                                 NC.  to announce key findings of the
                                 research project  that is  fully docu-
                                 mented in a separate report of the
                                 same title (see Project Report ordering
                                 information at back).

                                 Introduction
                                  The experimental design was very
                                 similar for all compounds. Mice were
                                 purchased as needed and maintained
                                 for, usually, three to six weeks before
                                 the start of the experiments, in shoebox-
                                 type cages, five animals of one sex per
                                 cage, at 72 ± 2°F, relative humidity at
                                 50 ± 5%, on  light:dark regime  of
                                 18hr:6hr, with Purina Mouse Chowand
                                 tap water available ad libitum Groups of
                                 five females were  mated with a single
                                 male at  4:00 p.m. and checked for
                                 vaginal  plugs the following morning
                                 Mated females were isolated to experi-
                                 mental pens, with five females per pen,
                                 each from a different mating, receiving
                                 the same treatment. Each male contri-
                                 buted to different experimental groups

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The order of the experimental pens was
randomized on the shelves.
  Females were isolated after their last
treatment and  bore and  raised their
litters in isolation. Litters were counted
and weighed within one day of birth and
examined for gross abnormalities. They
were  again  examined,   sexed,  and
weighed  -at weaning  and allowed to
remain together until sacrifice at 62 ±2
days of age. Litters were killed, identi-
fied  with unique  numbers, processed
for   alizarin  staining  of  articulated
skeletons, examined for a battery of 44
variants,  reprocessed for  study of an
additional  battery of 44  variants in
papain-digested,  disarticulated
skeletons, and stored.
  Frequencies of  each variant  m each
experimental group were calculated
and  each experimental was compared
with  Untreated and Vehicle  Control
values for each variant. Of interest were
the number of variants which differed in
the experimental groups, the magnitude
and direction of the differences, and the
specific variants which were affected.
  Statistical analysis initially involved
both Mann-Whitney U tests on mean
litter percent derived frequencies  with
significance being defined as P-C05 and
t-tests on  arcsin square-root trans-
formed frequencies with  significance
being defined at P<.01 to compensate
forType I errors  It was subsequently felt
that  the Mann-Whitney test discarded
potentially  useful  data and the t-test
became the standard test of  signifi-
cance for the preliminary analyses.
  In  the prenatal  studies fetuses were
dissected on the 1 8th day  of gestation,
examined  for  gross malformations,
weighed, and preserved in alcohol or
formalin  for alizarin staining  Fetal
skeletons were  studied for ossification
of cervical   centra, caudal vertebrae,
number of metatarsals  and metacar-
pals, number of phalangeal rows, and
number of ribs and sternebrae.
  All of the variants which occurred in
these experiments were photographed
as   were  additional  representative
specimens  of interest, thus providing a
permanent   record. Some specimens
were photographed through a  dissect-
ing microscope. A photographic atlas of
variants  is  presented  in  the  project
report.

Conclusions
  Skeletons of CD-1 mice were exam-
ined in a systematic way at 62 + 2  days
postnatal for a series of  88 normally
occurring variations. Subjects had been
exposed in utero, by treatment of their
dams, to one of a group of pesticides—
Trifluralin  (TFL),  2,4,5-T (245-T),
Captan, Maneb, Dicamethrin (DMT); or
known teratogens—Thahdomide,
trypan blue (TB), acetazolamide(ACZM),
bromodeoxyundine (BUDR),  diphenyl-
hydantoin  (DPH),  cortisone  (CORT), at
both high and no-effect levels. Frequen-
cies of occurrence of each variant in
each treatment group were contrasted
with  vehicle  (VEH)   control   and
untreated  (UNTD) values. Sixty-eight of
the skeletal variants  were  useful in
these  studies;  the  others occurred
rarely or not at all.
  Prenatal exposure to  2,4,5-T,  TFL,
DMT, TB, ACZM, and BUDR could be de-
tected  by  the  existence of  substantial
numbers  of skeletal variants the fre-
quencies  of which were significantly
different from  VEH and UNTD controls,
at  the  higher dose  levels.  Prenatal
exposure to Captan, Thahdomide, corti-
sone, diphenylhydantoin, and probably
Maneb, could  not be detected by this
criterion. This suggests that the SVAS is
a  sensitive,  yet  not  indiscriminate,
method for detecting prenatal exposure
to a variety of noxious substances, even
in the absence of gross malformations.
Considering  the  particular  variants
which  were affected, it would appear
that a smaller subgroup could serve as a
reasonable screen for detecting subtle
biological   effects, by virtue of their
having responded in a large number of
the experimental  series. These include
the presence of an interfrontal bone, the
existence  of parted f rentals and preoptic
sutures in the skull, imperfect trans-
verse  foramina  (F.T.I.)  of the  atlas,
reduction  of articular processes of the
thoracic vertebrae, occurrence of 27
rather  than the usual  26 presacral
vertebrae, sacral  fusions  in the
vertebral   column,  possible   carpal
fusions in the appendicular skeleton,
and the occurrence of 14 ribs.
  Some variants were only affected by
teratogenic or high dose levels. These
included malformations of the ribs, and
fusions in the  lumbar vertebrae and  in
the transverse processes of the sacral
vertebrae. Some of these might be con-
sidered cryptic malformations. In most
of the series there were variants which
were enormously affected only by one
or  two compounds.  These  included
Interfrontal and Carpal  Fusions  in TB
and BUDR experiments, F.T.I,  of the
atlas by TB, Accessory Parietal and 27
presacral  vertebrae (on  day 8  only) by
ACZM, fusions of dorsal processes  of
sacral vertebrae by 2,4,5-T and ACZM,
fusions of the vertebral body in sacral
vertebrae  by ACZM (especially  in the
days 9-11  treatment) and by TB, the
occurrence of fewer than  30 caudal
vertebrae in the 245-T, TFL and perhaps
ACZM  treated  groups,  and  caudal
fusions by ACZM and TB. Most of the
treatment effects on the important vari-
ants in all studies resulted in increases
in frequencies of occurrence.
  In many of the experiments  there
were also variants which were uniquely
affected.   These   included:   Fused
Frontals, Frontal Foramen Double and a
really major increase  in absence  of
prominent  dorsal spine of the second
thoracic vertebra in 245-T, doubling of
the  posterior  foramen minus  in the
palatal bone by TFL,  F.T.I of C3-C6  by
DMT, dyssymphysis of the atlas, malfor-
mations  and  dyssymphyses  of the
cervical vertebrae by TB (also in Captan
treated  animals).  Accessory Parietal
and Abnormal Metoptic Roots by ACZM
on day 8, lumbar fusions and malforma-
tions in both ACZM  regimes  and  in
BUDR treatments on day  9.
  Replication of  experiments with TB,
ACZM, and BUDR resulted in good  to
excellent agreement between the two
series. Considerations of spectrum and
magnitude of response as well  as idio-
syncratic  or specific responses add
strength to the ability of  the SVAS  to
detect prenatal exposure to 245-T, TFL,
DMT, TB, ACZM, and BUDR.
  Prenatal  studies  with  most  of the
compounds were  in essential  agree-
ment with  published results; DPH was
neither  teratogenic  nor  fetotoxic  in
these studies and was also negative in
the SVAS; cortisone, although it had  no
effect on the skeletons of survivors, was
a potent cleft palate producer. From the
prenatal studies there was also the sug-
gestion that ossification of the centra of
the  cervical vertebrae and of  caudal
vertebrae  might  be indicative of expo-
sure to high doses of all or nearly all of
the compounds.
  Finally,   examination   of  available
skeletons  from adult mice in  several
generations of  a four-way outcross
mouse population selected for suscep-
tibility or resistance to trypan blue tera-
togenesis as well as an unselected line
revealed better agreement across gen-
erations for each line that was seen in
different batches  of CD-1  mice. The
variability of different "batches" of CD-1
mice require  an examination  of un-
treated  animals  in  each  group  of
animals purchased.

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Sidney L Beck is with the Biology Department,  Wheaton College, Norton, MA
  02766.
Neil Chernoff is the EPA Project Officer (see below).
The complete report, entitled "Skeletal Variants as an Indicator of Biological
  Effects on Environmental Contaminants." (Order No. PB 81-186 025; Cost:
  $17.00, subject to change) will be available only from:
        National Technical Information Service
        5285 Port Royal Road
        Springfield,  VA  22161
        Telephone: 703-487-4650
The EPA Project Officer can be contacted at:
        Health Effects Research Laboratory
        U.S. Environmental Protection Agency
        Research Triangle Park, NC 27711
                                                                                      1 US GOVERNMENT PRINTING OFFICE 1981 -757-012/7126

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