4-bromo-3,3,4,4-tetrafluorobut-1-ene

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Description of relevant studies: 

Negative - Bacterial reverse mutation test in vitro - Lawrence & Gladnick (2000).

Negative - Salmonella/Mictrosome assay in vitro - Russel (1977).

Non-mutagenic - Mutagenicity in chinese hamster ovary assay in vitro - Fitzpatrick (1979).

Non-clastogenic - Chromosome Aberration test in vitro - Curry (2000).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Mode of Action Analysis / Human Relevance Framework

Not relevant, no mutagenic activity was observed in any of the submitted studies.

Additional information

In vitro Mutagenicity data: 

 

1. Lawrence & Gladnick (2000): Bacterial reverse mutation test in vitro

The study was performed to OECD TG 471 and U.S. EPA 40 CFR Part 870.5100 to assess the mutagenic potential of the test substance to Salmonella typhimurium strains TA97a, TA98, TA100 and TA1535 and in Escherichia coli  strain WP2 uvrA (pKM101). In tester strains TA97a, TA98, TA100, and E.coli WP2 uvrA (pKm101) there were no test substance concentrations with a mean number of revertants that were 2 times greater than the mean of the concurrent vehicle control. In tester strain TA1535, there were no test substance concentrations with a mean number of revertants that were 3 times greater than the mean of the concurrent vehicle control. No test related precipitate was observed in any of the assays at any concentration levels. Under the conditions of the study, the test substance showed no evidence of mutagenic activity and it was concluded that the test substance was negative for the induction of mutagenicity in the bacterial reverse mutation test in Salmonella typhimurium and Escherichia coli.

 

2. Russel (1977): Salmonella/Mictrosome assay in vitro

The study was performed to assess the mutagenic potential of the test iem to Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 in the presence and absence of a liver microsomal system (S.9). Under the conditions of this study, the test item is considered not mutagenic in concentrations up to 1000 µg/plate in either the presence or absence of a liver microsomal system on Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100. 

 

3. Fitzpatrick (1979): Mutagenicity in chinese hamster ovary assay in vitro

A Chinese hamster ovary (CHO) assay was conducted to establish the capability of the test item to induce forward mutations in cultured CHO cells in vitro. The cytotoxic and mutagenic activities of the test material were evaluated in the presence and absence of a metabolic activation system composed of rat-liver homogenate and cofactors. An initial cytotoxicity was conducted to establish the dose range for testing. The test item was found to be non-mutagenic to cultured Chinese hamster ovary cells. The statistical analyses showed no significant increase in the mutation frequency of any of the tested doses over that of the control.

 

4. Curry (2000): Chromosome Aberration test in vitro

The test item was evaluated for in vitro clastogenic (chromosome-damaging) potential in human peripheral blood lymphocytes in the absence and presence of an exogenous metabolic activation system (Aroclor^® -induced rat liver S9).  An initial cytotoxicity/chromosome aberration assay was conducted to establish the dose range for testing.

No statistically significant increases in the percent of aberrant cells were observed at any concentrations in any of the testing conditions. The negative and positive control substances met the requirements for a valid test.

Under the conditions of this study, the test item was concluded to be negative for the induction of structural and numerical chromosome aberrations in the non-activated and S9 activated in vitro mammalian chromosome aberration test in human blood peripheral lymphocytes. 

 

 

Justification for classification or non-classification

Two bacterial assays, a mutagenicity assay (Chinese Hamster Ovary) and a chromosome abberation assay were conducted in line with the requirements of the Intelligent Testing Strategy (ITS) for mutagenicity under REACH (Guidance document R7a, v6 2017). 

None of the assays produced a positive result. A weight-of-evidence review of the outcomes of these studies confirms that the requirements of the ITS are satisfied and the test item would not be classified as a genetic toxicant (germ cell mutagenicity), in accordance with CLP Regulation No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.