2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters

Endpoint summary

Additional information

The data set for the test substance genetic toxicity is robust and provides a thorough evaluation of in vitro gene mutations and clastogenicity/aneugenicity.

The mutagenic effects of the test item were determined in a reverse mutation assay with Salmonella typhimurium. The test was performed in the four salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537 and in E. coli WP2 uvrA in concentrations from 100 to 5000 µL/plate with (+) and without (-) metabolic activation system. Result: not mutagen.

The potential of the test item to induce chromosome aberrations was investigated in human peripheral blood lymphocytes in vitro. For each experiment duplicate cell cultures were used for each concentration. The test compound was tested at concentrations of 125 to 3000 µg/mL including solvent controls with (+) and without (-) metabolic activation system from Aroclor induced Spraque Dawley-rat liver. Result: not clastogenic.

The test item Fluowet AC812 solid was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster. The study was performed in two independent experiments, using identical experimental procedures and concentrations of 312.5 up to 5000 µg/mL. In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. No relevant and reproducible increase in mutant colony numbers/10⁶cells was observed in the main experiments up to the maximum concentration with and without metabolic activation. The induction factor did not reach or exceed the threshold of 3 times the mutation frequency of the corresponding solvent control. The mutation frequency did not exceed the historical range of solvent controls. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.

Result: non-mutagenic.

Therefore, the overall conclusion, based on the results from the robust data set, is that there is no genotoxic concern associated with the test material.

Short description of key information:
The test item was tested for its genetic toxicity potential in three in vitro testing systems (i.e. Ames test , Chromosome Aberration test and HPRT test).
1. The Ames-test was performed with test item in the four salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537 and in E. coli WP2uvrA in concentrations from 100 to 5000 µL/plate with (+) and without (-) metabolic activation system. Result: negative.
2. The potential of the test item to induce chromosome aberrations was investigated in human peripheral blood lymphocytes in vitro. For each experiment duplicate cell cultures were used for each concentration. The test compound was tested at concentrations of 125 to 3000µg/mL including solvent controls with (+) and without (-) metabolic activation system from Aroclor induced Spraque Dawley-rat liver. Result: the test item is not clastogenic in this test system.
3. The test item was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster. The study was performed in two independent experiments, using identical experimental procedures. In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test item is considered to be non-mutagenic in this HPRT assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test item was examined for its mutagenic/genotoxic potential in three independent in vitro test systems, i.e. Ames test, Chromosome aberration test and HPRT test. Result: all three tests are negative under the test conditions described.

According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS Global Harmonized System for classification, labeling and packaging) Annex 1, the test substance has not to be classified.