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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In vitro Gene Mutation study in Bacteria AMES OECD471:

in progress,expected negative

In vitro mammalian cell study

Negative: screening L5178Y tk+/- 3.7.2C cells for the mouse lymphoma assay (MLA) OECD490 screening test.

Negative: HPRT study OECD476 on Similar substance 02.

See the attachement in the Read Across justification on mutagenesis in Section 13.

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

Genetic toxicity in vivo

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

Additional information

Studies on bacteria (AMES)

A test is in progrsss and expected negative.

In vitro mammalian cell study

Similar substance 01 was examined for mutagenic activity by assaying for the induction of 5 trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells after in vitro treatment, in the absence of S9 metabolic activation, using a fluctation method (OECD490), sceening test. The substance does not induce mutation at the TK locus of L5178Y mouse lymphoma cells invitro in the absence of S9 metabolic activation, under the reported experimental conditions.

A study on a similar substance 02 was performed to investigate the potential to induce gene mutations at the HPRT locus in V 79 cells bof the Chinese hamster in vitro.

Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), this result can be considered for the genetic toxicity assessment of the registered substance.

Justification for read-across is detailed in the report attached to the IUCLID section 13.

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.

Substance that are mutagenic in somatic cells may produce heritable effects if they, or their active metabolites, have the ability to interact with the genetic material of germ cells. Conversely, substances that do not induce mutations in somatic cell in vivo would not be expected to be germ cell mutagens.

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.

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 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

An Ames test is in progress and expcted negative.

An OECD 490 is available on similar substance 01 and negative.

In addition, a negative HPRT study on Similar substance 01 was evaluated.

As conclusion, according to the CLP Regulation n.1272/2008 and the ECHA Guidance R.7a, the substance should be classified as non mutagenic.