Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro-test (Bacterial Reverse Mutation Test/Ames Test), OECD 471:

Five genetically manipulated strains of Salmonella were exposed to the test item both in the presence and in the absence of a metabolic activation system for 48 hours, using the plate incorporation method.None of the concentrations caused an increase in the number of revertant colonies in the tested strains.The test item neither showed any mutagenic effects nor any cytotoxicity in the Ames Test.

 

In vitro-test (Mammalian Cell Gene Mutation Assay), OECD 476:

The test item was assessed for its potential to induce mutations at mice cell genes. Two experiments at different concentrations with and without metabolic activation showed positive results at the higher concentrations. In conclusion the test item is considered to be clastogenic according to the Mammalian Cell Gene Mutation test.

 

In vivo test (Mouse micronucleus test), OECD 474:

The genotoxic effect on erythrocytes in bone marrow was examined in the Micronucleus Test in mice.

Male and female animal groups were tested at concentration up to 2000 mg/kg. All animals showed no abnormalities after dosing. The test item induced a statistically significant increase in the mean number of micro-nucleated polychromatic erythrocytes. The observed increase is assessed as biologically relevant and the test item is considered to be clastogenic in the Mouse Micronucleus test.

Overall view

The test item showed a negative and a positive result in in-vitro tests and a positive result in one in-vivo test. Therefore, a classification as mutagenic, category 2 according to CLP regulation 3.5.2.2 is proposed. The criteria for a classification as mutagenic, category 1 B are not given.


Short description of key information:
The substance showed positive results in the Mammalian Cell Gene Mutation and the Mouse Micronucleus Test, a negative result in the Bacterial Reverse Mutation Test. The substance is considered to be classified as mutagenic, category 2 according to CLP regulation.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

The test item showed a negative and a positive result in in-vitro tests and a positive result in one in-vivo test. Therefore, a classification as mutagenic, category 2 according to CLP regulation 3.5.2.2 is proposed. Criteria for a classification as mutagenic, category 1 B will not be met.

The administration of the substance in the micronucleus test as an intraperitoneal injection is not an intake that is relevant compared to the most likely human exposure. On the other hand, based on the test results, it cannot be excluded that the substance may induce heritable mutations of germ cells. Therefore it is proposed to classify the substance as mutagenic category 2.