Registration Dossier

Administrative data

Description of key information

Buehler test (OECD 406): not sensitising

Key value for chemical safety assessment

Skin sensitisation

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

To cover the endpoint skin sensitization of substance C16AE (52609-19-5), a study from a similar substance was taken for read-across. Read-across is justified because a substantial amount of skin sensitisation studies in guinea pigs following either the Magnusson Kligman maximization or the Buehler testing protocol are available to evaluate the skin sensitisation potential of alcohol ethoxylates (AE). Although a mild skin sensitization reaction was observed in a study following the Magnusson Kligman protocol, the weight of evidence clearly supports the assessment that AE should not be considered as skin sensitisers. This is further supported by clinical data that demonstrate the absence skin sensitisation responses to AE when tested under the conditions of the HRIPT (HERA, 2009).

 

The skin sensitising potential was assessed with C16-18AE (CAS 68439-49-6) in a Buehler Test according to OECD Guideline 406. In this study 20 female guinea pigs were induced by an epicutaneous occlusive dressing with 100% test substance (in maize oil) for 6 h on Day 0, 7 and 14. Two weeks after the last induction animals were challenged by epicutaneous occlusive exposure for 6 h to 100% test substance (in maize oil). 24 and 48 h after patch removal the application site was assessed for signs of local irritation. No dermal reactions were observed in any test animal at any time point.


Justification for selection of skin sensitisation endpoint:
Reliable Guideline study chosen.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP) the substance does not need to be classified for skin sensitisation. No data is available for respiratory sensitization.