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Administrative data

Key value for chemical safety assessment

Additional information

Ames test

The mutagenic activity of the substance was evaluated in accordance with OECD 471 (1987), EU Method B.13/14 (2000) and according to GLP principles. The test was performed in two independent experiments, at first a direct plate assay was performed and secondly a preincubation assay, both in the absence and presence of S9-mix. Adequate negative and positive controls were included. The 5 strains tested were S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102.

In both experiments, the substance did not induce a significant increase in the number of revertant colonies in any of the 5 strains at any concentration, up to 5000 µg/plate, neither in the presence nor in the absence of metabolic activation. Based on the results of this study it is concluded that the substance is not mutagenic in the Bacterial Reverse Mutation Assay.

Chromosome aberration test (in vitro)

In accordance with OECD 473 (1998) and according to GLP principles, a chromosome aberration study with the substance was performed in cultured peripheral human lymphocytes in two independent experiments with and without metabolic activation. Adequate solvent and positive controls were included. The substance was tested up to and above precipitating concentrations.

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, in either of the two independently repeated experiments. No effects of the substance on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Based on the results of this study, it is concluded that the substance does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations. The substance is not clastogenic in human lymphocytes under the experimental conditions of the study.

Mouse lymphoma assay

The mouse lymphoma assay with L 130 was conducted according to OECD 476 guideline and GLP principles.

No toxicity was observed up to and including the highest tested precipitated dose levels in both experiments in the absence and presence of S9-mix. In the absence of S9-mix, L 130 did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the duration of treatment time. In the presence of S9-mix, L 130 did not induce a significant increase in the mutation frequency in one experiment. Positive control chemicals, methyl methane sulfonate and cyclophosphamide induced appropriate responses. It is concluded that L 130 is not mutagenic in the TK mutation test system under the experimental conditions described in the absence and presence of S9 -mix.


Justification for selection of genetic toxicity endpoint
No single study was selected as key study, as the endpoint conclusion is derived by weight-of-evidence using three in vitro studies.

Short description of key information:
Three in vitro studies are available with the substance. In all studies, the substance was negative with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information, the substance does not need to be classified for genetic toxicity in accordance with the CLP Regulation.