Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test substance did not induce an increase in gene-mutation in the Ames/Salmonella bacterial mutation test when tested up to a dose level of 5000 ug/plate with and without a rat liver S9 metabolic activation preparation.

The test substance induced a statistically significant, dose related increase in the chromosomes aberration frequency in CHO cells treated 3 -hour with metabolic activation. No statistically significant, dose related increase in the chromosomes aberration frequency in CHO cells treated 3 -hour without metabolic activation was noted.

In the LY5178Y mouse lymphoma cell gene-mutation assay, a significant, dose related increase of the TK -/- mutant frequency was noted when a 3 -hour treatment with metabolic activation or a prolonged 24 -hour treatment withh or without metabolic activation was employeed. In the study there was an increase in the frequency of small colony mutants in the test substance treated cultures that suggest a chromosome aberration mechanism.This findings in the mouse lymphoma cell mutation assay supports the positive chromosomes aberration response in CHO cell study . An OECD 489 Mammalian alkaline comet assay test is proposed to assess the ability of the test substance to induce chromosomes aberration in vivo.


Short description of key information:
The test substance was evaluated for genotoxicity potential in the following assays: OECD 471 Bacterial (ames) mutation test, OECD 473 In vitro chromosomes aberration Test and OECD 476 In vitro Mammalian Cell Gene Mutation test.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Data are insufficient to Classify and Label at this time. There are no positive in vivo findings available.