Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: dermal
Type of information:
experimental study planned
Study period:
Annex IX, Sec. 8.6.2. 90-day rat subchronic: Propose to incorporate the data requirements of the 90-day repeat does study into the pre-mating internal of a modified EOGRTS (modified OECD TG 443), subject to approval of the Test Plan by ECHA

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Incorporate the data requirements of the 90-day repeat dose study into the pre-mating interval of a modified EOGRTS (modified OECD TG 443)
Principles of method if other than guideline:
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

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion