Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity
Justification for type of information:
No maternal or fetal toxicity has been observed in a developmental toxicity study in rats, treated orally with the test material up to the highest dose of 1000 mg/kg bw/day. In addition, no indication of any toxicity was observed in a subchronic oral toxicity study in rats. Histological examinations did not indicate toxic effects on reproductive organs of the test animals treated up to 1000 mg/kg bw/day for 90 days. The substance was shown to be neither genotoxic nor carcinogenic in rats after dermal treatment. In addition, the substance is physiologically available: Its phosphorylated form takes part in glycolysis, and it is an intermediate product of fructose metabolism.
The absence of any toxic effects suggests that at present there is no need for further information and/or testing on reproduction toxicity beyond those which are being applied already.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion