Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Additional information

Although just one study is available to assess the reproduction toxicity of the substance, the data available suggests that the substance presents no potential of reproduction toxicity.


Short description of key information:
One study is available to assess the reproduction toxicity of the substance by oral exposure.

Justification for selection of Effect on fertility via oral route:
The data from one study is available. No effects were observed at the maximum dose concentration assessed.

Effects on developmental toxicity

Additional information

Based upon the toxicological data available, including the reproduction toxicity study available, and taking account of animal welfare consideration, there is no evidence that the substance is likely to have any developmental toxicity effect. It is therefore considered not scientifically justified to undertake a development toxicity study in animals.

Toxicity to reproduction: other studies

Additional information

Based upon the toxicological data available, including the reproduction toxicity study available, and taking account of animal welfare consideration, there is no evidence that the substance is likely to have any reproduction toxicity effect. It is therefore considered not scientifically justified to undertake any further reproductive toxicity study in animals.

Justification for classification or non-classification

Based on the data available and considering the complete absence of response in that study, the substance is considered to be not classifed as a reproductive toxin