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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Basic Blue 99 was tested in vitro in an Ames test performed according to OECD guideline 471. A biological relevant mutagenic potential was demonstrated in the absence and presence of metabolic activation. Basic Blue 99 was tested in a mouse lymphoma assay performed according to OECD guideline 476. The substance was considered to be non-mutagenic in the study. Basic Blue 99 was tested in an in vitro micronucleus test performed according to OECD guideline 487. Under the conditions of the study a micronuclei inducing potential was detected for the test item.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

Basic Blue 99 was tested in vivo in a micronucleus assay performed according to OECD guideline 474. The test item did not induce a biologically relevant increase in the number of micronucleated polychromatic erythrocytes in bone marrow cells and is considered to be non-mutagenic. Basic Blue 99 was used in an unscheduled DNA synthesis assay performed according to OECD guideline 486. The test item did not induce DNA damage leading to increased repair synthesis and is considered to be non-mutagenic in the in vivo UDS test system. Considering the negative results obtained in the unscheduled DNA synthesis and mouse lymphoma assays, Basic Blue 99 does not possess a mutagenic potential. The aneugenicity/clastogenicity potential of Basic Blue 99 is cleared by the negative result returned in the in vivo micronucleus assay.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification