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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In the  in vitro gene mutation study in bacteria, S.TYPHIMURIUM REVERSE MUTATION ASSAY, duplicate test (Ames test). STR AINS N. TA1535, 1537, 1538, 98 and 100-bacteria,
in the concentration range investigated, (15-1500 mcg/plate) the test article did not show any mutagenic activity with or without the addition of S9 liver homogenate fractions.

From the in vitro mammalian cytogenicity study, in neither chromosome aberration tests, the test item induced a biologically relevant and statistically significant increase in the percentage of cells with structural chromosome aberrations at any of the concentrations and time points analysed, when compared with the vehicle control value.
In the IN VITRO MAMMALIAN CELL GENE MUTATION TEST at the thymidine kinase locus of L5 1 7 8 Y mouselymphoma cells, in the presence or absence of exogenous metabolic activation (β-naphthoflavone and phenobarbital induced rat liver S9), Mutation frequency ( MF) of each concentration is calculated and there is no concentration related response among test item groups in each test condition. Compared with the concurrent negative control, the increase of MF was less than Global Evaluation Factor (GEF, 126×10-6) at any concentration in all test conditions. The test item did not cause gene mutation in L51 7 8 Y TK+/-clone (3.7.2C) cell line.

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

Additional information

Justification for classification or non-classification

The results from the three in vitro studies are all negative, the substance is not classified for germ cell mutagenicity.