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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

 - Genetic toxicity in vitro: Bacterial reverse mutation assay:

Key study: OECD guideline and EU method . GLP study.

The test item had no mutagenic activity on the growth of the applied bacterium tester strains under the test conditions used in this study.

 

- Genetic toxicity in vitro: Chromosome aberrations in mammalian cells:

Key study: OECD guideline. GLP study.

The test item did not cause chromosomal aberrations in this in vitro cytogenetic test using cultured human lymphocytes.

 

- Genetic toxicity in vitro: Gene mutation in mammalian cells:

Key study: OECD guideline and EU method. GLP study.

No mutagenic effect was observed either in the presence or in the absence of metabolic activation system under the conditions of this Mouse Lymphoma Assay.


Justification for selection of genetic toxicity endpoint
No study was selected, since the results obtained in the in vitro studies (Ames test, Chromosome aberration test and Mammalian cell gene mutation assay) were negative.

Short description of key information:
 - Genetic toxicity in vitro: Bacterial reverse mutation assay:
Key study: OECD guideline and EU method . GLP study.
The test item had no mutagenic activity on the growth of the applied bacterium tester strains under the test conditions used in this study.
 
- Genetic toxicity in vitro: Chromosome aberrations in mammalian cells:
Key study: OECD guideline. GLP study.
The test item did not cause chromosomal aberrations in this in vitro cytogenetic test using cultured human lymphocytes.
 
- Genetic toxicity in vitro: Gene mutation in mammalian cells:
Key study: OECD guideline and EU method. GLP study.
No mutagenic effect was observed either in the presence or in the absence of metabolic activation system under the conditions of this Mouse Lymphoma Assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results obtained from the in vitro studies, the substance is not classified for mutagenicity.