Registration Dossier

Administrative data

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
At this time it is expected that isooctanol will not be a reproductive toxicant. A one-generation study in rats (Hansen, 1992) was performed with the analog substance 1-dodecanol (CAS RN 112-53-8) using the Combined Repeat Dose and Reproductive/Developmental Toxicity Screening Test protoc ol. Male and female rats were administered 1-dodecanol orally via the feed at doses of 100, 500 and 2000 mg/kg/day for a period of 14 days. No effects were seen on reproductive or developmental parameters up to doses of 2000 mg/kg/day. 1-Dodecanol at the dose administered had no influence on body weight, weight gain, food consumption and reproductive efficiency in the parental generation. Pregnancy rates were not statistically altered and there were no differences in the lengths of the gestation periods. No organ toxicity was observed in the females, and there was no effect on the number of pups per litter, weight, sex ratio, or mortality rate from Days 1 to 5 after birth. Test data that will be collected as part of the integrated testing strategy outlined in the assessment reports will be used to inform the justification for this endpoint.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion