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Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro

HPRT

A mammalian cell gene mutation assay (HPRT) was performed to test for mutagenicity of the test substance. The study was conducted according to OECD TG 476. Chinese hamster ovary cells were exposed to the test substance with and without metabolic activation. No genotoxic effects were observed. Cytotoxicity was detected from 62.6 µg/mL (with metabolic activation) and 300 µg/mL (without metabolic activation) upwards. Due to these results the test substance was considered non mutagenic in mammalian cell culture.

 

Ames

The study tested the mutagenicity of the test substance. The study was conducted according to OECD TG 471. The standard plate and preincubation tests were performed. Both were done with and without the addition of a metabolizing system obtained from rat liver (S-9 mix) using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA. Cytotoxicity was observed dependent on strain and experimental conditions from 333 µg/plate onwards. All tests and strains showed a negative effect for genotoxicity. Therefore the test substance was considered non mutagenic in this study under the corresponding conditions.

 

Micronucleus

The test substance was tested for its potential to induce micronuclei in Chinese hamster lung fibroblasts (V79) according to OECD TG 487.Two independent experiments were carried out, both with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). A sample of at least 1000 cells for each culture was analyzed for micronuclei. All controls (negative, positive and vehicle) were determined to be valid. Cytotoxicity was observed at the highest test substance concentration in all experiments. No increase in the number of cells with micronuclei was detected. Therefore it was concluded that the test substance did not show chromosome damaging and chromosomal aberrations effects in mammalian cells in vitro.

 


Justification for selection of genetic toxicity endpoint
An Ames, HPRT and micronucleus test were considered to evaluate mutagenicity of the test substance.

Short description of key information:
HPRT: No mutagenic effect was observed.
Ames: No mutagenic effect was detected.
Micronuclei: No mutagenic effec was observed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Genetic toxicity

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221. As a result the substance is considered to be not classified as mutagenic.