Registration Dossier

Administrative data

toxicity to reproduction
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Justification for type of information:
Two repeated dose toxicity studies are available, a 28-day and a 90-day dietary study in rats at dose levels up to the limit dose of 1000 mg/kg body weight per day. No treatment related adverse effects were observed in both studies up to the highest dose tested. The NOAEL is consequently > 1000 mg/kg bw. The studies confirm the low bioavailability of the substance as also demonstrated in the toxicokinetic study. Due to the low water and anticipated low lipid solubility it can reasonably assumed that the substance is unlikely to exert adverse effects by other routes of exposure or studies of longer duration. The substance is unlikely to have any local irritation effects as no indications of irritation were observed neither in the skin and eye irritation studies nor in the repeated dose studies.
Due to the absence of effects at the limit dose of 1000 mg/kg bw in both repeated dose and developmental toxicity studies, futher studies on reproductive toxicity are not warranted.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion