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EC number: 216-721-0
CAS number: 1653-19-6
A single generation fertility and early embryonic developmental study
was conducted with 2,3-dichloro-1,3- butadiene (DCBD). Groups of
Crl:CD®(SD)IGS BR rats (24/sex/concentration) were exposed by inhalation
(whole body) at mean vapour concentrations of 0, 1, 5, or 50 ppm. Rats
were exposed for 6 hours/day during premating (8 weeks; 5 days/week),
during cohabitation of mating pairs (up to 2 weeks, 7 days/week), and
then post-cohabitation for males and nonpregnant females (approximately
7 days, 7 days/week). The pregnant dams were exposed from conception to
implantation (days 0-7 of gestation).
Clinical observations, body weight, and food consumption were determined
at weekly intervals through premating and gestation. Following at least
50 days of exposure (premating), males and females (P1 parental
generation) were cohoused within their respective treatment groups until
evidence of copulation was observed or 2 weeks had elapsed with no
evidence of mating.
Oestrous cycle parameters (percent days in dioestruos, proestruos, and
oestruos) and oestrous cycle length were evaluated prior to and during
the cohabitation period (for at least 3 weeks) in P1 rats. Necropsy of
the P1 females was conducted on GD 21 and the following parameters
-gross pathological examination, number and status of implantation
sites, and foetal assessments (viability, location, sex, foetal weight,
external alterations). All P1 male rats were given a gross pathological
examination at the end of the cohabitation period. Epididymal sperm
motility, morphology and counts, and testicular spermatid counts were
determined in all P1 male rats. Reproductive organs and other selected
organs, including potential target organs, were weighed and collected
for all P1 rats. Potential target organs (liver, spleen, thymus,
kidneys, urinary bladder, lungs, trachea, nose, larynx, pharynx,
pituitary gland) and gross lesions from P1 rats in the control and 50
ppm groups (10/sex/group) were examined microscopically; tissues in the
low and intermediate groups were subsequently evaluated as needed to
determine a no-adverse-effect level.
The parameters assessed but showing no effects of treatment or no
adverse effects of exposure to DCBD included:
mortality and clinical observations in P1 males and females
oestrous cycle and sperm parameters in P1 rats
mating, precoital interval and fertility in P1 rats
number of corpora lutea; implantation sites, resorptions, live foetuses;
pre- and postimplantation loss
foetal weight, sex ratio, and external alterations
gross observations in P1 male and females
organ weights in P1 females
Effects considered to be related to DCBD exposure were evident in the
high concentration group - 50 ppm:
decreased body weight, weight gain, food consumption, and food
efficiency in P1 males and females
degeneration of the nasal olfactory epithelium in P1 rats
Under the conditions of this study, the no-observed-effect level (NOEL)
for reproductive and developmental toxicity was 50 ppm, the highest
concentration tested. The NOEL for effects in P1 rats was 5 ppm based on
adverse effects on body weight and food consumption parameters, and
nasal olfactory epithelial toxicity at 50 ppm.
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