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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

non-mutagenic with and without metabolic activation.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance was tested for its mutagenic potential based on the ability to induce point mutations in the strains of Salmonella typhimuium and Escherichia coli, in a reverse mutation assay according to the Guidelines OECD 471 and EU Method B.13/14.

In this assay on Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2 uvrA , no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material (26 - 6500 μg/plate) both in the presence and the absence of a metabolic activation system. Positive and negative controls that were carried out parallel to the experiment confirmed the validity of the test.

Since, there was no dose-related and reproducible increase in the number of revertant colonies and the number of revertants for all tester strains were within the historical negative control range the substance is considered as non-mutagenic.

Justification for classification or non-classification

Germ Cell Mutagenicity

According to the CLP Regulation (EC) No. 1272/2008:

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories:

Category 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.

Category 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests, preferably as described in Regulation (EC) No. 440/2008 adopted in accordance with Article 13(3) of Regulation (EC) No 1907/2006 (‘Test Method Regulation’) such as those listed below:

- in-vitro mammalian chromosome aberration test;

- in-vitro mammalian cell gene mutation test;

- bacterial reverse mutation tests

The substance did not induce gene mutations in the strains of Salmonella typhimurium and Escherichia coli, under the performed test, therefore according to section 3.5. of the CLP Regulation (EC) No. 1272/2008, it is not classified as mutagenic for germ cells.