Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation study in bacteria (Ames test)

Not mutagenic

In vitro gene mutation study in mammalian cells (Mouse  Lymphoma Assay)

Not mutagenic

in vitro cytogenicity / micronucleus study (Human Lymphocytes test)

Not clastogenic

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is no complete information about the genetic toxicity of Direct Violet 051, therefore, the available data on structural analogous Similar Substance 01 have been taken into account. The read across approach can be considered as reliable and adequate for the purpose; details and explanations are detailed in the report attached to the IUCLID section 13.

In vitro gene mutation study in bacteria (Ames test)

In an Ames test the salified form of the Target substance (sodium salt) was tested in Salmonella typhimurium strains TA1535, TA1537, TA98, TA102 and TA100 in presence and absence of metabolic activation. As the substance is an azo-dye the Prival Mitchell modification was included in the test design. No increase in mutant frequency was reported in any of the strains tested both in presence and absence of metabolic activation. The substance is considered to be non-mutagenic under the conditions of this test.

Negative results were also obtained in a test carried out on Similar Substance 01, were no increase in mutant frequency was reported in any of the strains tested both in presence and absence of metabolic activation.

In vitro gene mutation study in mammalian cells (Mouse  Lymphoma Assay)

Similar Substance 01 was tested in the L5178Y TK +/- Mouse  Lymphoma Assay according to OECD 490 up to precipitation level. Exposure was either 4 hours (with and without metabolic activation) or 24 hours (without metabolic activation). No increase in the mutant frequency at the TK +/- locus was reported (evaluation with the Global Evaluation Factor (GEF) of 126 E-06). Therefore it is concluded that the substance is non-mutagenic in this assay.

in vitro cytogenicity / micronucleus study (Human Lymphocytes test)

Similar Substance 01 was tested in an in vitro micronucleus test (OECD 487). Human lymphocytes were exposed for 4 hours (with and without metabolic activation) or 24 hours (without metabolic activation). After the exposure cytokinesis was inhibited by treatment with Cytochalasin B. There was no inhibition of the CBPI and the concentrations to be evaluated were limited by precipitate at 128 ug/mL. No increase in the percentage of micronucleated binuclear cells was observed in any of the treatments. Therefore it can be concluded that the substance is not clastogenic.

Justification for classification or non-classification

Based on the outcome of the available in vitro tests, the substance does not need to be classified for mutagenicity according to Regulation (EC) No 1272/2008 (CLP).