Registration Dossier
Registration Dossier
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EC number: 272-789-1 | CAS number: 68911-83-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Stitzinger (2013) investigated the sensitising properties of reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde in an LLNA test with female CBA mice. Positive and vehicle controls were included in the study. Test substance concentrations selected for the main study were based on the results of a pre-screen test. In the main study, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 2.5, 5 or 10% w/w on three consecutive days, by open application on the ears. Under the conditions of this study, reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde was observed to be sensitising to the skin.
Migrated from Short description of key information:
In an LLNA test according to OECD Guideline 429, EU Method B.42 and EPA OPPTS870.2600, the substance proved to be sensitising to the skin (Stitzinger, 2013). Under the conditions of this study, reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde was observed to be sensitising to the skin.
Justification for selection of skin sensitisation endpoint:
Only one reliable study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data and according to DSD and CLP, the substance should be classified as skin sensitiser.
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