Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
A screening study for reproductive/developmental toxicity does not need to be conducted because there is no evidence from available information (e.g. (Q)SAR) that the substance may be a developmental toxicant.
The acute oral toxicity of the test item is very low (LD50: > 5 mL/kg). Also in a study with repeated oral dosing over 28 consecutive days no adverse clinical effects or histopathological findings were seen in rats dosed with up to 1000 mg/kg (NOAEL: > 1000 mg/kg). As also reported in the attached (Q)SAR predicted profile, the test item does not suggest a specific alert for a teratogenic potential in humans. Therefore, at present there is no need to perform a screening study for reproductive/developmental toxicity in experimental animals.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloctane-1,7-diol
EC Number:
203-517-1
EC Name:
3,7-dimethyloctane-1,7-diol
Cas Number:
107-74-4
Molecular formula:
C10H22O2
IUPAC Name:
3,7-dimethyloctane-1,7-diol
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion