Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
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

Justification for selection of Effect on fertility via oral route:
A reproduction study will be proposed pending results of an OECD 414 and OECD 408 which will include evaluation of extra reproductive parameters such as sperm analysis, estrus cycle and sperm staging.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Additional information

Justification for selection of Effect on developmental toxicity: via oral route:
Propose OECD 414 in rat via oral administration.

Justification for classification or non-classification