Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Type of information:
experimental study planned
Study period:
Annex X, Sec. 8.7.3. two-generation reproductive toxicity study: 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.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: modified EOGRTS without extension of Cohort 1B, without Cohorts 2A and 2B, and without Cohort 3
Principles of method if other than guideline:
There is no indication of endocrine disruption, developmental neurotoxicity or developmental immunotoxicity which may have triggered the need for expansion of the basic EOGRTS test design.

Specifically pertaining to the proposal of using a modified EOGRTS (modified OECD TG 443) to ensure the study meets the endpoint needs of both the EOGRTS and a 90-day toxicity study, the registrant proposes the following EOGRTS study modifications for the testing:
1) Extending the pre-mating interval from 10 weeks to 13 weeks.
2) Collecting full haematology and clinical chemistry at the end of the extended pre-mating period.
3) Conducting neurobehavioral functional testing at the end of the extended pre-mating period.

Further explanation and justification is provided as an attachment below.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion