Registration Dossier
Registration Dossier
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EC number: 201-857-5 | CAS number: 88-75-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No data available.
Effects on developmental toxicity
Description of key information
In the available developmental toxicity / teratogenicity study (International Programme on Chemical Safety (IPCS)) developmental effects were observed at doses that also produced maternal toxicity and the foetuses were not examined for malformations. Hence, the data is insufficient for the deduction of a reliable effect level.
Additional information
Developmental toxicity / teratogenicity
Data on developmental toxicity / teratogenicity of the test substance is available only as secondary source (International Programme on Chemical Safety (IPCS)):
In the available study the developmental toxicity / teratogenicity of the test substance was determined in rats. The study was conducted as a range finding study. Charles River COBS CD (5 dams per group) were administered the test material in doses of 50, 125, 250, 500, and 1000 mg/kg bw via gavage from day 5 to day 15 of gestation. Control animals were included in the study, but no further details are given. Uterine examination was conducted on day 20. One high-dose animal died, but no cause of death could be determined. Other clinical findings included darkly coloured urine at > 250 mg/kg body weight and yellow staining of haircoat (at the nose, mouth, anogenital area) at > 125 mg/kg body weight; the necropsy findings gave no biologically meaningful differences in surviving dams. At the highest dose level of 1000 mg/kg body weight, a slight but statistically significant (also compared with historical controls) increase in group mean post-implantation losses (13.8 % versus 8.2 % in controls) and mean early resorptions (2.3 versus 1.2 in controls) was seen.
Developmental effects were only observed at doses that also produced maternal toxicity. Furthermore, the foetuses were not examined for malformations. Hence, the data is insufficient for the deduction of a reliable effect level.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC) and Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
Based on the available data of a range-finding teratology study in rats, developmental effects of the test substance can not be excluded. Hence, classification for developmental toxicity is inconclusive under Directive (67/548/EEC) and Regulation (EC) No. 1272/2008. Data on effects concerning fertility are lacking.
Additional information
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