Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

A modified EOGRTS (modified OECD TG 443) which will incorporate the data requirements of the 90-day repeat does study, subject to approval of the Test Plan by ECHA


Short description of key information:
In accordance with the ECHA REACH Fact Sheet: Information Requirements for Repeated Dose Toxicity and Reproductive Toxicity – Substances Over 100 (and 1000) Tonnes (Reference: ECHA-09-FS-05-EN), the screening for reproductive/developmental toxicity (required in Annex VIII section 8.7.1 of REACh (Regulation (EC) No 1907/2006)) does not need to be conducted as the dossier contains testing proposals for, a prenatal developmental toxicity study and a 2-generation reproductive toxicity study.

Effects on developmental toxicity

Additional information

OECD Test Guideline 414 Development studies in the rat and rabbit by an appropriate route are proposed by the consortium members as per RIP 3.3. Chapter R.7A, Section R.7.6.6.4. Elements of ITS, subject to approval of the Test Plan by ECHA.

Justification for classification or non-classification

There is no information available concerning reproductive toxicity.