Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

There are two studies available and one study is in progress addressing genetic toxicity of AES (C8-10, 1-2.5 EO) Na.

The mutagenicity of AES (C8-10, 2 EO) Na in bacteria was assessed in a study performed according to OECD Guideline 471 with Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 102 and TA 100 (Wallner, 2012). The tester strains were treated using the plate incorporation and the pre incubation method both with and without S9-mix. The concentrations for both testing methods was 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 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 (C8-10, 1-2.5 EO) Na.

The mutagenicity of AES (C8-10, 2 EO) Na in a mammalian cell line was investigated according to OECD guideline 476 using the mouse lymphoma L5178Y cells with and without metabolic activation (Trenz, 2012). The test concentrations were 0.01, 0.02, 0.05, 0.10, 0.20, 0.24, 0.28, 0.32 mM without metabolic activation as well as 0.01, 0.05, 0.24, 0.28, 0.32, 0.36, 0.40, 0.44, 0.48 mM with metabolic activation in the first experiment (4 h incubation). In the second experiment the cells were incubated with concentrations of 0.15, 0.35, 0.39, 0.43, 0.45, 0.47, 0.49, 0.53 mM in the presence of metabolic activation for 4 h and at concentrations of 0.0005, 0.001, 0.005, 0.01, 0.05, 0.10, 0.15, 0.20, 0.25 mM in the absence of metabolic activation for 24 h. Results achieved with the vehicle (RPMI medium) and positive controls were valid. Cytotoxicity was seen in presence and absence of metabolic activation. No genotoxicity was observed for AES (C8-10, 2 EO) Na, except for the highest dose level in experiment I with metabolic activation where a significantly increased number of mutants and a dose dependency were seen at 0.48 mM. In addition the Global Evaluation Factor of 126 was exceeded by the induced mutant frequency. This effect was only seen in the highly cytotoxic range (relative total growth below 10%) and was not seen in the verification experiment (experiment II with metabolic activation). Therefore this effect was considered to be of no biological relevance.

According to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.4, Column 1, in addition to the bacterial and mammalian mutagenicity test an in vitro cytogenicity study in mammalian cells needs to be performed. This study, i.e. a chromosomal aberration study in Chinese hamster cells with AES C8-10Na, is still on-going. The dossier will be updated as soon as possible and the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of this study.

In conclusion, AES (C8-10, 2 EO) Na did not show any mutagenic 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.”

(HERA report, 2003);

Justification for selection of genetic toxicity endpoint
No study selected as outcome is 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 muatation assay (MLA / OECD guideline 476): negative
In vitro mammalian chromosome aberration assay (CA / OECD guideline 473): Study in progress

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification