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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro mutagenicity testing in bacteria on C12 TMAC and C16 TMAC

In vitro chromosome aberation test in mammalian cells on C16 TMAC

In vitro mutation test in mammalian cells on C12 TMAC

See attached read-across justification to tetradonium bromide attached in section 13

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

Additional information

From read-across to genotoxicity data on structurally closely related substances there is no concern for mutagenic effects in relation to tetradonium bromide. No in vivo testing is warranted.


Justification for selection of genetic toxicity endpoint
In a weight of evidence approach, data on both C12 and C16 alkyltrimethylammonium chloride are used for prediction of the genetic toxicity of the C14 alkyltrimethylammonium bromide.

Short description of key information:
Data on cetrimonium (C16) chloride from testing in salmonelle typhimurium with and without S9 was negative.
Data on dodecyl(C12)trimethylammonium chloride from testing in salmonelle typhimurium with and without S9 was negative.
Data on cetrimonium (C16) chloride from testing in in vitro chromosome aberration test (OECD 473) was negative.
Data on dodecyl(C12)trimethylammonium chloride from testing in an in vitro mouse lymphoma assay (comparable to OECD 476) with and without S9 was negative.
Data on dodecyl(C12)trimethylammonium chloride from testing in an in vitro rat hepatocytes UDS assay (comparable to OECD 482) was negative.

In vivo test with dodecyl(C12)trimethylammonium chloride in rats in a bone marrow chromosome aberration test (comparable to OECD 475) was negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Tetradonium bromide should not be classified in relation to mutagenicity.