Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Based on read across approach, the study results are conflicting: considering the progression in the category, the extreme components of the category are mutagen and not mutagen, respectively. Results of Modified Ames Test on FLL TDA sample indicate that the substance of interest is more similar to mutagen component of the category.

Short description of key information:
The extracts of the substance tested with metabolic activation induced a significant increase in the number of reversions in TA 98 Salmonella typhimurium strain.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

According to Regulation 1272/2008 the substance has to be classified as category 2 mutagen H341.

According to Directive 67/548/EEC the substance has to be classified as category 3 mutagen R68.