Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data on sensitisation are available for AES (C9-11, 1-2.5 EO) NH4 (CAS 160901-27-9). Therefore this endpoint is covered by read-across to structurally related AES, i.e.AES (C8-10, 1-2.5 EO) Na . The AES reported within the 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 is one study available addressing the skin sensitising properties of AES (C8-10, 1-2.5 EO) Na.

The skin sensitizing potential was assessed in a Guinea Pig Maximisation Test according to OECD Guideline 406 (Schmid, 2013). In this study 10 female guinea pigs were induced by intradermal and epicutaneous application of the test item at concentrations of 2.5% (intradermal induction) and 1.5% (epicutaneous induction). Challenge was performed with 0.5% test item. Vaseline was used as vehicle. The concentrations were chosen on basis of a preliminary range finding test. In the positive control group 5 of 5 animals (100%) showed a positive response at the 24 and 48 h reading. No positive response was observed in animals of the negative control and test item group at any observation time. Thus, the test item showed no sensitising potential within this study.

This lack of sensitising properties of AES is also supported by the evaluation of various AES reported in the HERA report (2003).

 

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.


Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising

Justification for selection of skin sensitisation endpoint:
Reliable OECD Guideline study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation 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.

No data available for respiratory sensitisation.