Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the dermal route (required in section 8.6.1 of Annex VIII) does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements. Furthermore, dermal exposure of the substance is considered unlikely.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion