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EC number: 203-458-1 | CAS number: 107-06-2
In a developmental toxicity study, 1,2 -dichloroethane (> 99 %) was administered to 26 female Sprague-Dawley rats/dose in corn oil by gavage at dose levels of 0, 1.2, 1.6, 2.0 or 2.4 mmol/kg bw/d (= 0, 118, 158, 198 or 238 mg/kg bw/d) from days 6 through 20 of gestation. 26 female rats were used per group with 23 to 16 litters delivered. No deaths occurred. Maternal toxicity was indicated by decreased absolute body weight gain at the two highest oral dose levels. Pregnancy rates were similar in all groups. The maternal LOAEL was 198 mg/kg bw/d, based on changes in body weight. The maternal NOAEL was 158 mg/kg bw/d.
At 238 mg/kg bw/d, 3 dams delivered pre-term on day 20. All fetuses of these litters were dead and were excluded from further final analysis of reproductive parameters due to the possibility of cannibalism. No significant effect was noted on the mean number of implantation sites and live fetuses, fetal sex ratio, and fetal body weights. No embryo- or fetotoxicity, changes in fetal growth or teratological effects were induced at any dose. All malformations and variations seen were scattered among all groups with no indication of treatment-related effect. There was only some embryolethal effects (increase in non- viable implants and resorption sites per litter), significant at 198 mg/kg bw/d and higher (p<0.05). The developmental LOAEL was 198 mg/kg bw/d, based on embryotoxicity. The developmental NOAEL was 158 mg/kg bw/d.
The developmental toxicity study in the rat was classified acceptable and was conducted equivalent or similar to the guideline requirement for a developmental toxicity study (OECD 414) in rats.
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