Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Data waiving:
other justification
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Additional information

No data are available to evaluate in particular the reprotoxic effect on the target substance or its analogue, but according to the absence of toxicity in acute, repeated, local and systemic tests, and in mutagenicity studies; no effect are expected for the reprotoxicity.

During the 90 days toxicity studies performed on MDBS and Di-methyDBS the repoductive organ for males and females rats were attentively observed (testes, epididymies, prostate, seminal vesicles, uterus+ vagina, ovaries, mammal gland), and no effects were reported, so no effect on reproductive performance could be expect.

The absence of toxicity for the substance tested at the maximum achievable dose according to OECD guidelines did not give any alert to perform further reproductive test, this is in conformtity with the recommandation of the column 2 of the Annex IX of REACh regulation.

Justification for classification or non-classification