Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

One key study is available for this endpoint. In a developmental toxicity study according to OECD testing guideline 414, the test item was administered to female rats by gavage from days 6 through 19 of gestation. On the basis of the effects observed in this study, the LOEL for maternal toxicity was determined at 10 mg/kg/day (effects on maternal body weight) and the NOAEL for fetal and developmental toxicity at 30 mg/kg/day (growth retardation at 100 mg/kg bw/day).

Based on this data, no classification is required for the test item concerning the developmental toxicity endpoint according to the CLP criteria.