Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Based on the document "Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance" (Version 6.0-July 2017), page 566, since the substance shares structural characteristics with known mutagens (harmonised CLP classification of analogue CAS 52234-82-9: Mutagen Category 2) it is possible to make a conclusive hazard assessment in accordance with Annex I of REACH without additional testing on the basis of structure-activity relationship alone. Furthermore, a justification is provided below on the basis of point 1.5 of Annex XI for adaptation of the standard testing regime in order to demonstrate that the information used is adequate for the purpose of classification and labelling.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion