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Key value for chemical safety assessment

Additional information

A substantial database of reliable studies exists on the bacterial in vitro genetic toxicity of alkyl sulphates. Results in the reverse mutation assay were consistently negative with or without metabolic activation. No evidence of mutagenic activity was observed, irrespective of carbon chain length, unsaturation, or the nature of the countervalent moiety that neutralized the anionic surfactant.

C12ASO4Na was not genotoxic in mammalian cell cultures with and without metabolic activation and tested up to and including cytotoxic concentrations (Mouse lymphoma assay, McGregor et al., 1988).

The lack of mutagenic activity for this chemical class is predictable based on structural and mechanistic considerations. Mutagens are chemicals that either 1) contain highly reactive electrophilic centers capable of interacting with nucleophilic sites on DNA (direct acting agents) or 2) can be metabolized to highly reactive electrophiles. The chemical structures represented by this chemical class do not contain electrophilic functional groups or functional groups capable of being metabolized to electrophiles. Alkyl sulphates with fully saturated carbon chains are not metabolized to reactive electrophiles. The consistent lack of mutagenic activity with AS is consistent with these mechanistic predictions.

Several alkyl sulphates have been evaluated in in vivo rodent studies for chromosomal aberrations which gave negative results. According to the Regulation EC No. 1907/2006 (REACH) VIII 8.4.2, column 2, an in vitro cytogenicity study in mammalian cells does not need to be conducted if adequate data from an in vivo cytogenicity test are available.

Based on the outcome of these tests, AS can be considered as non-genotoxic.

Short description of key information:
Several studies investigating the genetic toxicity of AS in-vitro and in-vivo have shown that AS are not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification criteria according to 67/548/EEC and (EC)1272/2008 are not fulfilled.