Registration Dossier

Administrative data

Description of key information

skin sensitization (OECD 406): not sensitizing

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 from structurally related AES, i.e. AES (C8-10, 1-2.5 EO) Na and AES (C12) Na (CAS 9004-82-4). 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.

 

The skin sensitizing potential of AES (C8-10, 1-2.5 EO) Na was assessed in a Guinea Pig Maximisation Test according to OECD Guideline 406 (Z&S, 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.

The skin sensitizing potential of AES (C12) Na (CAS 9004-82-4) was assessed in a Guinea Pig Maximisation Test similar to OECD Guideline 406 (Unilever, 1989a). In this study 10 guinea pigs were induced by intradermal and epicutaneous application of the test item at concentrations of 0.1% (intradermal induction) and 5% (epicutaneous induction). Challenge was performed with 0.5% test item. Re-challenge was done 1 week after challenge. Physiological saline was used as vehicle. In the negative control group 0 of 4 animals showed a positive response at the 24 and 48 h reading upon challenge and re-challenge. In the test group 1 of 10 animals showed a positive response at the 24 and 48 h reading upon challenge. Upon re-challenge 1 of 9 animals showed a positive response at 24 h reading and 0 of 9 animals at 48 h reading. One animal was sacrificed due to a broken leg. 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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

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

No data available for respiratory sensitisation.