Registration Dossier
Registration Dossier
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EC number: 932-051-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The key study with the reaction product is a 1994 Ames assay following GLP guidelines. The test substance was not mutagenic at up to 4997 ug a.i./plate, the highest concentration tested.
There are 3 different in vitro genetic toxicity assays and 3 different in vivo genetic toxicity assays conducted with the linear alkylbenzenesulfonate substances. The assays are Ames Test, mouse lymphoma mammalian gene mutation, Chinese hamster ovary mammalian chromosome aberration, in vivo mouse micronucleus bone marrow chromosome analysis, mammalian germ cell cytogenetic assay, and dominant lethal assay (9 months). All studies were negative.
There are 4 different in vitro genetic toxicity assays and 2 different in vivo genetic toxicity assays conducted with hydrotrope substances. The assays are Ames Test, mouse lymphoma mammalian gene mutation, Chinese hamster sister chromatid exchange, Chinese hamster ovary mammalian chromosome aberration, in vivo mouse micronucleus bone marrow chromosome analysis, and in vivo mammalian erythrocye micronucleus. All are guideline studies, conducted according to GLP requirements and fully documented.
The conclusion from the battery of 6 different validated assays is the test substances are not mutagenic, not genotoxic.
Short description of key information:
There is an GLP Guideline Ames assay with the reaction product and a number of in vitro and in vivo studies with substances closely related to the two substances that comprise the reaction product (i.e., the hydrotropes, and linear alkybenzenesulfonates). The conclusion from the AMES assay and the entire battery of assays is these substances are not mutagenic and not genotoxic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The conclusion from the battery of 6 different validated assays is the test substances are not mutagenic, not genotoxic. The substance is not classified according to EU CLP guideline.
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