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EC number: 287-476-5
CAS number: 85535-84-8
In a well conducted GLP study, similar to
OECD Guideline 414, groups of 25 mated female COBS CD rats were given 0,
100, 500 or 2000 mg/kg bw/day of a C10 -12 chlorinated paraffin (58%
chlorination) in corn oil by oral gavage on days 6 to 19 of gestation.
Animal were killed on day 20 and the numbers and location of viable and
non-viable foetuses, resorption sites and the total number of
implantations and corpera lutea were determined. Appearance and body
weight gain of dams was monitored and all foetuses were examined for
external malformations. Approximately one half of the foetuses from each
litter were examined for visceral malformations and the other half for
Clinical signs of maternal toxicity were
seen in both 500 and 2000 mg/kg bw/day groups, comprising yellow or
brown matting and staining of the coat in the anogenital region, red or
brown staining in the nasal region, excessive salivation, lethary and
emaciation. The effects were at an increased frequency in the top dose
animals. A decrease in body weight gain from days 9 to 16 and 8/25
animals died between gestation days 16 and 20 in the top dose group.
Significant increases in the numbers of post-implantation losses, due to
both early and late resorptions, and a decrease in the numbers of viable
foetuses was seen in the top dose group only. Foetal malformations
(adactyly and/or shortened digits) were seen in 19 foetuses from 3/15
litters examined from the top dose animals.
Overall, no developmental toxicity was seen
in animals in the 500 mg/kg bw/day group, and no adverse effects were
seen in dams or foetuses in the control or 100 mg/kg bw/day groups. Therefore,
the no-observed-adverse-effect level (NOAEL) for developmental toxicity
in the rat in this study was 500 mg/kg bw/day.
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