Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Short description of key information:
An O.E.C.D. test guideline no. 414, "Prenatal Developmental Toxicity Study" in the rat by the oral route of exposure is proposed. A second O.E.C.D. 414 developmental toxicity study may be conducted in the rabbit as needed.

An O.E.C.D. test guideline 416, "Two-Generation Reproduction Toxicity Study" in the rat by the oral route of exposure may be conducted pending the outcome of the proposed O.E.C.D. test guideline no. 408, "Repeated Dose 90-Day Oral Toxicity Study in Rodents" with the rat.

Effects on developmental toxicity

Description of key information

An OECD test guideline no. 414 "Pre-natal Developmental Toxicity Study in Rodents" has been conducted in order to assess potential systemic toxicity. All data has been collected and processed and is currently in the report writing phase. The draft report is expected to be received on 06 October 2017. After review of the draft report and finalization the the updated dossier will be submitted before 31 October 2017.

Justification for classification or non-classification