Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The justification for read-across is attached in Section 13 of the IUCLID

Gene Mutation Assay

A Bacterial Reverse mutation Assay (Ames test) was performed on the read-across substance EC 255 -485 -3 according to the OECD 471 test guideline on a read-across substance. The study (2008) was selected as a key study. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains in both experiments, with any dose of the test material, either with or without metabolic activation. The study results indicate that the substance does not induce gene mutations in bacteria, whereas all positive control chemicals (with and without metabolic activation) induced a significant increase in the number of colonies.The substance is therefore considered as non-mutagenic according in the Ames test.

Short description of key information:
- Ames Test: non mutagenic up to 5000 µg/plate in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 & WP2uvrA-pKm101

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including the ATP2.

Self classification:

Based on the available data, no additional classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) .