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 skin sensitisation 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) and AES (C12-14; 1-2.5 EO) TIPA (CAS 174450-50-1). 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 two studies available addressing skin sensitisation for the read-across substances AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3) and AES (C12-14; 1-2.5 EO) TIPA (CAS 174450-50-1).

The skin sensitizing potential was assessed with AES (C12-14; 2 EO) Na (CAS 68891-38-3) in a Guinea Pig Maximisation Test according to OECD Guideline 406 without positive control (Kynoch, 1986). In this study 20 female guinea pigs were induced by intradermal and epicutaneous application of the test item at concentrations of 0.05% (intradermal induction) and 2.5% (epicutaneous induction). Challenge was performed with 0.1 and 0.5%. Water was used as vehicle. At a dose level of 0.1% 1/20 (5%) animals treated with the test item and 1/10 (10%) animals of the control group showed a positive reaction at reading 24 and 48 h after challenge. At the dose level of 0.5% 6/20 animals (30%) after 24 h and 5/20 animals (25%) after 48 h showed a positive response. In the control group 2 of 10 animals (20%) showed a positive response at the 24 and 48 h reading. Thus, the test item showed no significant sensitising potential within this study.

A second study on skin sensitisation was performed with AES (C12-14; 2 EO) TIPA (CAS 174450-50-1) in a Buehler Test on 20 Dunkin-Hartley guinea pigs according to OECD guideline 406 without positive controls (Krueger, 1997c). The induction was performed with 50% of the test substance and the challenge with 25% of the test substance. Both applications were conducted under occlusive conditions and water was used as vehicle. At both readings (24 and 48 h after challenge) 0/20 animals of the test group and 0/10 animals of the control group showed a positive response. Thus, the test item showed no significant sensitising potential within this study.

 

No sensitising potential of the substance is expected based on the above mentioned data. This 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.