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Toxicological information

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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The test item did not cause mutagenic effects in bacteria as well in mammalian cells in vitro as well as in vivo.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

It can be stated that in the bacterial reverse mutation assay (Ames test) the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.

Therefore, Genamin 3920 is considered to be non-mutagenic in this bacterial reverse mutation assay.

In an in vitro cell gene mutagenicity test the test item is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.

In a micronucleus assay in the mouse the test item did not induce structural and/or numerical chromosomal damage in the immature erythrocytes of the mouse.

Therefore, the test item is considered to be non-mutagenic with respect to clastogenicity and/or aneugenicity in the Mammalian Erythrocyte Micronucleus Test.


Justification for selection of genetic toxicity endpoint
The study in mammalian cells in vitro was selected

Justification for classification or non-classification

No classification

The test item did not cause mutagenic effects in bacteria as well in mammalian cells in vitro as well as in vivo.