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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay (Ames / OECD 471): negative
In vitro mammalian cell gene mutation assay (MLA / OECD 476): negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information
Mammalian Bone Marrow Chromosome Aberration Test (CA / OECD 475): negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

The genetic toxicity of alcohol ethoxysulfates (AES) was evaluated in several in vitro and in vivo genotoxicity tests. The AES reported within the AES category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read across approach between structurally related AES. For details please refer to the category justification attached in IUCLID section 13.

Studies which were undertaken in vitro using a number of test systems have resulted in negative findings. The Ames tests conducted with AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) u

sing strains of S. typhimurium showed negative results. Testing for mammalian genotoxicity with AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) revealed a negative outcome as well. The result of in vivo testing revealed that the substance AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) has no clastogenic potential. 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 also AES (C12-13, 1-2.5 EO) Na (CAS 161074-79-9) can be considered as non-genotoxic.

 

References:

Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28

HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject.com.

Justification for classification or non-classification

The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.