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EC number: 216-721-0
CAS number: 1653-19-6
Analytical measurements of purity, stability and dimer concentrations
confirmed the suitability of the test material for use in inhalation
exposure. The analysed chamber concentrations were virtually
indistinguishable from nominal values. The analytically determined
overall mean concentrations ± S.E.M. of DCBD in the exposure chambers
targeted to 1, 10, or 50 ppm were 1.0 ± 0.0072, 10 ± 0.050, or 50 ±
0.070, respectively. The daily mean chamber concentrations for 6 hours
of exposure were consistent throughout the study.
Groups of 22 time-mated pregnant female Crl:CD®(SD)IGS BR rats were
exposed (whole body) to the test substance at atmospheric concentrations
of 1, 10, or 50 ppm (whole body exposure) for 6 hours per day during
gestation days 6-20 (days 6-20G). Control group females were exposed to
conditioned air alone according to the same exposure regimen. During the
in-life portion of the study, maternal body weights, food consumption,
and clinical signs data were collected. On day 21G, dams were euthanized
and subjected to a gross external and internal examination. Uterine
contents were described; all fetuses were removed and individually
weighed, sexed, and examined for external alterations. Approximately
one-half of the fetuses were subjected to visceral and head evaluations;
all fetuses were examined for skeletal alterations. There was no test
substance-related maternal mortality, nor were there any test
substance-related maternal gross post-mortem findings. Maternal toxicity
was observed at 50 ppm which was characterized by statistically
significant, test substance-related reductions in maternal body weight,
weight gain, and food consumption. Gasping was observed during the first
exposure period in 50 ppm females, and laboured breathing was observed
during the third exposure period for 50 ppm females. Subsequently, there
were no test substance-related clinical signs of toxicity either during
exposure or following the daily exposure periods. Fetuses in the 50 ppm
group had a test substance-related reduction (6.2% lower than the
control mean) in mean fetal weight. There were no test substance-related
malformations or variations observed at any exposure concentration.
Fetal viability, resorptions, sex ratio, and litter size were comparable
across all groups. Under the conditions of the study, maternal toxicity
occurred at an exposure concentration of 50 ppm based on decreased
maternal body weight, weight gain, food consumption, and clinical signs
of toxicity during exposure. Developmental toxicity occurred at 50 ppm,
evident as decreased fetal weight. Therefore, the maternal and fetal
no-observed-effect levels (NOEL)a were both considered to be 10 ppm.
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