Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Additional information
Justification for selection of Effect on fertility via oral route:
Study to be conducted ONLY IF warrented by the outcome of a 90-Day Subchronic rat study as per REACH Annex IX, Columan I, Section 8.7.3.

Effects on developmental toxicity

Description of key information
An O.E.C.D. test guideline 414 study in the rat is proiposed.  
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:
An O.E.C.D. test guideline 414Prenatal Developmental study in the rat by the oral gavage route of exposure is proposed. A similar study in the rabbit may be necessary pending the outcome of the rat study.

Justification for classification or non-classification