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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Non mutagenic

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No information on "genetic toxicity" is available for the Target Substance. However an in-vitro bacterial reverse mutation test is available on Similar Substance 02, that has been taken into account for the assessment. More details about the similarity between the two substances are reported in section 13.

The substance was tested for mutagenicity potential following OECD 471 (Ames test and Prival modification). Salmonella T. strains ( TA1535, TA 100, TA 1537, TA 98) and E. Coli strain (WP2 uvrA) were chosen and tested with and without S9 mix (rat and hamster livers). Negative and positive control were concurrent during the experiment. Under the experimental conditions the substance did not show any potetial to be a mutagenic agent.

Justification for classification or non-classification


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.

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.

Categoty 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 as In vitro mutagenicity tests such as these indicated in

- in vitro mammalian chromosome aberration test;

- in vitro mammalian cell gene mutation test;

- bacterial reverse mutation tests

The substance did not create gene mutations in the strains of Salmonella typhimurium and E.Coli under the performed test, therefore according to the CLP Regulation EC n.1272/2008, it cannot be classified as mutagenic for germ cells.