Registration Dossier
Registration Dossier
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EC number: 941-396-3 | CAS number: -
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:
Sensitization to skin by High oleic sunflower oil, maleated was assessed in a Local Lymph Node Assay performed in accordance with OECD 429 and GLP, where the substance was given to CBA mice at concentrations of 6.25%, 12.5% and 25% (v/v), each diluted with AOO 4:1 (v/v), 4 parts acetone and 1 part olive oil. At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed. The resulting stimulation indices at concentrations of 6.25%, 12.5% and 25% were found to be 0.8, 1.5 and 5.3%, respectively. The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 17.43%.
Thus, the substance was shown to be a skin sensitizer.
In a similar study, Fatty acids, C14-18 and C16-18-unsatd., maleated was also found to be sensitizing when concentrations of 5, 10, 25 and 50% w/v where tested in accordance with OECD 429.
Migrated from Short description of key information:
Skin: sensitizing (OECD 429)
Justification for selection of skin sensitisation endpoint:
GLP-Guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data test substance do meet the criteria for classification according to Regulation (EC) 1272/2008 and is therefore classified as Skin Sens. 1B.
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