Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames test:

In an ames test according to OECD and EC test guidelines, Radiagreen RA was tested in the Salmonella typhimurium reverse mutation assay with four histidine requiring strains (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan requiring strain (WP2uvrA) in presence and absence of S9 mix. The substance was tested up to 3330 microgram/plate in the absence and presence of S9 mix, and showed precipitation at the highest dose and in addition toxicity was seen in some of the strains. Radiagreen RA did not induce a significant increase in the number of revertant colonies in all strains tested in the absence and presence of S9 metabolic activation. Therefore, the substance is considered to be not mutagenic in this study.

Chromosome aberration test:

In a chromosome aberration study according to OECD and EC test guidelines, Radiagreen RA was tested in cultured peripheral human lymphocytes in the presence and absence of metabolic activation for chromosome aberrations and clastogenicity. Radiagreen was tested up to 600 microgram/ml showing toxicity and/or precipitation under the different test conditions. The substance did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9 mix. No effects on polyploid cells and cells with endoreduplicated chromosomes were observed. Therefore, the substance is considered not to disturb the mitotic processes and cell cycle progression, it does not induce numerical chromosome aberrations and it is not clastogenic.

MLA test:

In a mammalian cell gene mutation test with L5178Y mouse lymphoma cells according to OECD and EC test guideline, Radia 7838 was tested on the induction of forward mutations at the TK locus in L5178Y mouse lymphoma cells in the presence and absence of metabolic activation. Radia 7838 was tested up to 1000 microgram/ml showing precipitation and/or cytotoxicity. The substance did not induce a significant increase in the mutation frequency in the presence and absence of S9 -mix. Therefore, Radia 7838 is considered to be not mutagenic.


Short description of key information:
The Ames study was performed according to OECD Guideline 471 and GLP principles. The chromosome aberration study was performed according to OECD Guideline 473 and GLP principles. The TK mutation test was performed according to OECD Guideline 476 and GLP principles. All tests were considered negative with regard to genotoxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

It can be concluded that Radia 7838 is not considered mutagenic/clastogenic according to CLP Regulation (EC) No. 1272/2008.