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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

BTN/A was tested for mutation in histidine requiring strains of Salmonella typhimurium both in the absence and presence of metabolic activation by an Aroclor 1254 induced rat liver post-mitochondrial fraction (S9) according to OECD guideline 471. The substance failed to induce a significant increase in revertant numbers with any tester strain either in the absence or presence of S9, so was considered non-mutagenic in this assy.

The substance was assayed for the ability to cause chromosomal damage in cultured human lymphocytes, following in vitro treatment in the absence and presence of S9 metabolic activation according to EC test method B.10 and OECD Guideline No. 473. No statistically significant increase in the incidence of cells bearing aberrations was observed. It was concluded that the substance did not induce chromosomal aberrations in human lymphocytes after in vitro treatment, under the reported experimental conditions.

An in-vivo assessment of clastogenic action has been undertaken by the performance of a bone marrow erythrocyt micronucleus test in the mice follwing methods described by OECD TG 474 / EC B12. There was no evidence of induced chromosomal or other damage leading to micronucleus formation in polychromatic erythrocytes of treated mice 24, 48 or 72 hours after oral administration of the substance.

All available data clearly demonstrate the lack of genotoxic effects.


Short description of key information:
No evidence of genetic toxicity was seen in two in-vitro tests, one a bacterial reverse mutation assay (Ames test) and the second a cytogenicity assay for chromosome aberrations in cultuted human lymphocytes. There was also no evidence of activity in an in-vivo assessment of clastogencity using the mammalian cell erythrocyte micronucleus test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Data from various tests clearly demonstrate that the material is not genotoxic.