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Key value for chemical safety assessment

Additional information

No data on genetic toxicity are available for AES (C12-14, 1-2.5 EO) NH4 (CAS 125301-88-4). Therefore this endpoint is covered by read across to structurally related AES, i.e. AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3). 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.

There are three key studies available addressing genetic toxicity for the read-across substance AES (C12-14; 1-2.5EO) Na (CAS 68891-38-3).

Mutagenicity in bacteria was assessed in a key study performed similar to OECD Guideline 471. Tester strain TA 102 or E.coli were not used during the conduct of the study (Schöberl, 1994). In the study with AES (C12-14; EO2)Na (CAS 68891-38-3, analytical purity 71.5%) Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 1538 and TA 100 were treated using the plate incorporation method with and without the addition of a rat liver S9-mix. The dose range for the plate incorporation test was 11, 56, 280, 1400 and 7000 µg/plate. Results achieved with vehicle (distilled water) and positive controls were valid. Cytotoxicity was seen in presence and absence of metabolic activation while no genotoxicity was observed under both circumstances for AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3).

The mutagenicity of AES (C12-14) Na (CAS 68891-38-3, analytical purity 27.6%, no data on grade of ethoxylation) in a mammalian cell line was investigated according to OECD guideline 476 using the mouse lymphoma L5178Y cells with and without metabolic activation (Falezza, 1995). The test concentrations were 2.44, 4.88, 9.76, 19.5, 39.1 and 58.6 µg/mL without metabolic activation as well as 2.44, 4.88, 9.76, 19.5, 39.1, 78.1 and 117 µg/mL with metabolic activation. Results achieved with the negative (distilled water) and positive controls were valid. Cytotoxicity was seen in presence and absence of metabolic activation while no genotoxicity was observed under both circumstances for Na AES (C12-14, 1-2.5 EO) (CAS 68891-38-3).

The in vivo clastogenic potential of AES (C12-14) Na (CAS 68891-38-3, analytical purity 27-29%, no data on grade of ethoxylation) was assessed in a mammalian bone marrow chromosomal aberration test with CD-1 mouse according to OECD Guideline 475 (Ciliutti, 1995). The test substance was administered via gavage at doses of 1000 and 2000 mg/kg bw to five animals per sex per dose. Distilled water was used as vehicle. The post exposure period were 10, 24 and 48 h for the test group including the vehicle control and 26 h for the positive control group. Results achieved with the negative (distilled water) and positive controls were valid. No signs of toxicity and no increased number of chromosome aberration were seen at 1000 and 2000 mg/kg bw. Thus the test substance did not show clastogenicity at 1000 and 2000 mg/kg bw based on the test material and 270 to 290 and 540 to 580 mg/kg bw based on the active ingredient.

 

In conclusion, the test substance did not show any genotoxic potential. This is supported by the conclusions of the HERA report for AES were it is stated that: “In all available in vitro and in vivo genotoxicity assays, there is no indication of genetic toxicity of AES.”

 

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 selection of genetic toxicity endpoint
No study selected as all three studies were negative.

Short description of key information:
In vitro gene mutation:
Bacterial reverse mutation assay (Ames test / OECD guideline 471): negative
In vitro mammalian cell gene mutation assay (MLA / OECD guideline 476): negative
In vivo:
Mammalian Bone Marrow Chromosome Aberration Test (OECD 475): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.