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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Non mutagenic in bacterial reverse mutation assay (Ames test).

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Bacterial reverse mutation test (AMES test) was conducted with five different strains, namely TA 1535, TA 1537, TA98 and TA100 of Salmonella typhimurium and WP2 uvrA of Escherichia coli, according to OECD guideline 471 (1997), using standard plate and preincubation methods.

No genotoxic effects, evident as substantial increase in revertant colony numbers of any of the tester strains, were seen following treatment with substance at any dose level, neither in presence nor in absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations.

Cytotoxic effects, evident as a reduction in the number of revertants, were seen at high concentrations (3000 - 5000 µg/plate onward in standard plate test and 1000 µg/plate onward in preincubation test) with and without metabolic activation, depending on the strain.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), a mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known.

The more general terms ‘genotoxic’ and ‘genotoxicity’ apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non- physiological manner (temporarily) alter its replication.

For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories:

 

Category 1: substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.

Category 1A: based on positive evidence from human epidemiological studies.

Category 1B: based on:

- positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or

- positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells.

- positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.

 

Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans, based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

- somatic cell mutagenicity tests in vivo, in mammals; or

- other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays

 

Based on negative result in the available study, a mutagenic potential to bacteria for Basic Red 014 acetate was excluded.

Accordingly, the substance is not classified under the CLP Regulation (EC 1272/2008).