Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Study reports addressing gene mutation and cytogenicity in mammalian cells in vitro are available.

Gene mutation in bacteria was investigated with the reverse mutation assay (Ames test) in the Salmonella typhimurium strains TA 98, 100, 1535, 1537 and 1538, and in the E. coli strain WP2 uvrA with and without metabolic activation by Aroclor 1254-induced rat liver S9 (Mueller, 1988). The test substance was not mutagenic in S. typhimurium up to the highest concentration of 10000 µg/plate, with cytotoxicity starting at 500 µg/plate without S9 and 2500 µg/plate with S9.

 

Cytogenicity in mammalian cells in vitro was investigated with the chromosomal aberration assay performed in V79 cells, with as well as without metabolic activation by Aroclor 1254-induced rat liver S9 (Mueller, 1989). In this assay cytotoxicity was observed starting at 250 µg/ml up to the limit of solubility; therefore, the test substance was tested up to 75 µg/ml without S9 and 200 µg/ml with S9. The test substance did not demonstrate any cytogenic activity up to the highest tested concentration with or without metabolic activation.

 

The information provided by these tests is further supported by literature which was reviewed in a widely cited article by Greim et al. (1994).

 

No data is available on mutagenicity in mammalian cells in vitro, but sufficient peer-reviewed information from in vivo assays in mammals is available, therefore testing is not required according to Annex VIII, section 8.4.3, column 2 of Regulation (EC) No 1907/2006.

 

In vivo data is available from two non-published industry studies and an article by Oba and Takei (1992) that had been reviewed by Nair in 1998. All of these data sources have been peer-reviewed in the Arthur D. Little report on Alpha Olefin Sulfonates, prepared for 'The Soap and Detergent Association' in 1993. Each of them considered separately might not reveal enough information to justify their use for regulatory purposes, but all three sources considered in a weight of evidence approach demonstrate that Alpha Olefin Sulfonates, including Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts, are not mutagenic in the Host Mediated Assay in mice and rats with Salmonella typhimurium, strains TA1530, 1534 and 1535, and Saccharomyces cerevisiae D3 as indicator cells. Although one test showed a positive result in rats with S. typhimurium TA1530 as indicator cells (Little, 1993, unpublished data by Procter & Gamble), this effect could be unequivocally ascribed to pH-effects as well as impurities upon repetition: After adjustment of pH or ether extraction of the test substance and testing of the aqueous phase, the effect could be either abrogated or at least significantly diminished. The Alpha Olefin Sulfonates, if not produced under proper manufacturing practices, on accasion can contain impurities in form of sultones, i.e. cyclic sulfonate esters of hydroxy sulfonic acids which slowly hydrolize in the presence of water to their respective hydroxy sulfonic acids. Sultones are shown to be mutagenic in vitro and in vivo, further to be toxic, carcinogenic and teratogenic.

 

In conclusion, the test substance Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts is not genotoxic, neither in vitro nor in vivo.

Justification for selection of genetic toxicity endpoint

No study was selected, since all available in vivo and in vitro genetic toxicity data refer to different endpoints and were all negative.

Short description of key information:

Gene mutation in bacteria in vitro (Ames test): negative with and without metabolic activation in all strains tested (OECD 471/472).

Cytogenicity in mammalian cells in vitro (Chromosomal aberration): negative with and without metabolic activation in V79 CHL cells (OECD 473).

Gene mutation in mammalian cells in vitro: No sufficient data available.

Mutagenicity in vivo (Host Mediated Assay): negative in rat and mouse, weight of evidence approach.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test material does not demonstrate mutagenic or clastogenic effects in bacteria and mammalian cells in vitro or in mammals in vivo. Therefore, Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts does not have to be classifed for genetic toxicity according to the criteria of EU Directive 67/548/EEC or Regulation (EC) No 1272/2008.