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Key value for chemical safety assessment

Additional information

The absence of point mutation-inducing activities was demonstrated by the negative outcome in a Bacerial Reverse Mutation Test and a Mammalian Cell Mutation assay. The absence of chromosome aberration-inducing activities was demonstrated by the negative outcome in a Mammalian Chromosome Aberration Test. In conclusion testing of Manganese oxalate, dihydrate revealed no evidence of mutagenic activity in bacteria and mammalian cells. Therefore the test item as well as the submission substance were not considered to be mutagenic.


Justification for selection of genetic toxicity endpoint
Due to the available studies and its outcome, selection of a single reference in order to cover genetic toxicity is not sufficient. Therefore the availbale set of in vitro studies (AMES, HPRT, CA) was selected.

Short description of key information:
Bacerial Reverse Mutation Test
In this Bacerial Reverse Mutation Test (AMES-Test), with and without metabolic activation, the test item did not induce genmutation in the genom of the tester strains used. Therefore the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli Reverse Mutation Assay.

Mammalian Chromosome Aberration Test
In this In Vitro Mammalian Chromosome Aberration Test, with and without metabolic activation, the test item did not induce an increase of the number of structural chromosome aberrations or numerical aberrations. In conclusion, it can be stated that the test item is considered not to be clastogenic or aneugenic in this Chromosome Aberration Test in Chinese Hamster V79 Cells.

Mammalian Cell Mutation assay
In this In Vitro Mammalian Cell Mutation assay, with and without metabolic activation, the test item did not induce an increase of the mutant frequency. Therefore the test item is considered to be non-mutagenic in this In Vitro Mammalian Cell Mutation assay (HPRT-Test).


In conclusion, it can be stated that the test item did not induce point or genmutations , chromosomal mutations (structural aberrations) or genomic mutations (numerical aberrations) in this battery of in vitro genetic toxicity tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In the absence of any mutagenic activity, findings do not meet criteria for classification according to the rules laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008. Therefore classification is not warrantable.