Registration Dossier
Registration Dossier
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EC number: 614-482-0 | CAS number: 68439-46-3
Endpoint summary
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:
To cover the endpoint skin sensitization of substance C9-11AE (CAS 68439-46-3), a study from a similar substance (C6-12AE; CAS 68439-45-2) was taken for read-across. Read-across is justified because a substantial amount of skin sensitization studies in guinea pigs following either the Magnusson Kligman maximization or the Buehler testing protocol are available to evaluate the skin sensitization potential of alcohol ethoxylates (AE). Although a mild skin sensitization reaction was observed in a study with C7-9AE following the Magnusson Kligman protocol, the weight of evidence clearly supports the assessment that AE should not be considered as skin sensitizers. This is further supported by clinical data that demonstrate the absence skin sensitization responses to AE when tested under the conditions of the HRIPT (HERA, 2009).
The skin sensitizing potential was assessed with C6-12AE (CAS 68439-45-2) in a Guinea Pig Maximization Test according to OECD Guideline 406. In this study ten guinea pigs per sex were induced intradermally with 0.1% test substance (w/v, in corn oil), followed by epicutaneous occlusive induction for 48 hours with 50% test substance (w/v, in corn oil) seven days later. Two weeks later animals were challenged by epicutaneous occlusive exposure for 24 h to 25% test substance (w/v, in corn oil). 24 and 48 hours 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.
Migrated from Short description of key information:
GPMT (OECD 406): not sensitising
Justification for selection of skin sensitisation endpoint:
Reliable OECD Guideline study chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
No data available.
Justification for classification or non-classification
According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the substance does not need to be classified for skin sensitization. No data is available for respiratory sensitization.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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