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EC number: 204-640-3
CAS number: 123-66-0
In the key Combined Repeated Dose Toxicity
28-day / Reproduction/Developmental Toxicity Screening Test in rats
(OECD 422), the No Observed Adverse Effect Level (NOAEL) for the test
item was 1000 mg/kg bw/day (top dose). These data were supported by the
dose range finder study conducted in rats.
In the key study, a test item-related
increase in throid hormone (T4) was observed in adult males and pups at
1000 mg/kg. However, it was not considered to have toxicological
relevance since there were no correlated changes in other parameters
including microscopic findings of thyroids (with parathyroids). At the
top dose an increase in prothrombin time (both sexes) and increased
kidney weight (females) were observed; however, these effects were not
considered to have toxicologically relevance as no correlated
microscopic findings were observed. Additionally, decreased gamma
glutamyl transpeptidase was identified in males in all test item-treated
groups; however, it was not considered to have toxicological relevance
since there were no correlated microscopic findings.
No adverse effects were observed in the key combined
repeated dose with the reproduction/developmental toxicity screening
test in rats (OECD 422) in rats or in the dose range finder study;
therefore, the test substance is not classificable as STOT RE according
to CLP (Regulation EC No 1272/2008).
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