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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not mutagenic

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

IN VITRO GENOTOXICITY

The test item was evaluated for its potential to induce mutagenic effects in an in vitro bacterial cell inverse mutation assay (Ames test), according to a method similar to the OECD 471 guideline. Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were exposed to test item concentrations ranging from 1.0 to 10,000 µg/plate both in the presence and absence of S9 metabolic activation. The test item showed no toxicity to the TA-100 indicator strain during a preliminary test, which determined the appropriate test item concentrations.

The test item showed no genetic activity in any of the concentrations or replicates conducted, with or without metabolic activation. Therefore, the test item can be considered non-mutagenic in these test conditions. The higher concentrations used counterbalance the shortcomings that could result from the use of a test item with a low purity used suggest that the use of the experimental results for the evaluation of mutagenicity is acceptable.

Justification for classification or non-classification

Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. These changes may involve a single gene or gene segment, a block of genes or chromosomes.

According to the CLP Regulation (EC 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:

-substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans (Category 1); or

-substances, which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans (Category 2).

Based on results of the in vitro bacterial gene mutation study (Ames test) performed, it can be concluded that the test item does not induce gene mutations in reverse mutation in Salmonella typhimurium strains tested either in the absence or the presence of S9 metabolism.

According to the REACH Regulation EC no. 1907/2006, Annex VII, Column 2, further mutagenicity studies are not necessary and are not considered in the case of a negative result. Therefore, it is possible to conclude that the test item is considered not genotoxic.