Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short description of key information:
Negative for mutagenicity on bacterial cultures in non-GLP short term in vitro tests (equivalent to OECD 471)
Negative for induction of structural and numerical chromosome aberrations (OECD 473)
Negative for gene mutation in mouse lymphoma cells (OECD 476)


 


 

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

Genetic toxicity in vivo

Description of key information

Negative for clastogenicity or aneugenicity in the in vivo mammalian erythrocyte micronucleus test (OECD 474) which was conducted for a non-EU notification. 

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

Additional information

Test substance formulations were not found to be mutagenic in bacteria, and did not induce gene conversion in yeast, chromosome damage in rat liver cells, or gene mutation in mouse lymphoma cells. The test item is not clastogenic or aneugenic in the bone marrow micronucleus test of male rats up to a dose of 2000 mg/kg (required for a non-EU authority notification). All results for genotoxic potential were negative.



Short description of key information:
Negative for mutagenicity on bacterial cultures in non-GLP short term in vitro tests (equivalent to OECD 471)
Negative for induction of structural and numerical chromosome aberrations (OECD 473)
Negative for gene mutation in mouse lymphoma cells (OECD 476)


Negative for clastogenicity or aneugenicity in the in vivo mammalian erythrocyte micronucleus test (OECD 474)


 


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Test substance formulations were not found to be mutagenic in bacteria, and did not induce gene conversion in yeast, chromosome damage in rat liver cells, or gene mutation in mouse lymphoma cells. The test item is not clastogenic or aneugenic in the bone marrow micronucleus test of male rats up to a dose of 2000 mg/kg. All results for genotoxic potential, in prokaryotic and eukaryotic (including mammalian) species were negative. Therefore, in accordance with Directive 67/548/EEC and EC Regulation 1272/2008, no classification is required.