Registration Dossier
Registration Dossier
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EC number: 203-972-6 | CAS number: 112-44-7
Endpoint summary
Administrative data
Description of key information
N-Undecanal did not induce skin sensitisation in volunteers in a human maximisation test.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
25 healthy male black american inmates completed this human maximization test using the undiluted test item (name in the report:71-5-15 - aldehyde C-11 undecylic, liquid, purity: not stated). The 15 days induction phase (48 h treatment with test material, repeated 5 times under occlusive conditions) was followed by a 10 days rest period and a final challenging phase (48 h treatment with test material under occlusive conditions). Scoring was made after the patch was removed and 24 h thereafter. None of the subjects revealed any reaction following this treatment, therefore the test item is considered to have no skin sensitisation potential (Kligman, 1971).
Disregarded studies:
A human repeated insult patch test was carried out on 40 volunteers. The material (purity: not stated) was tested at a concentration of 0.5% in ethanol under semi-occlusive conditions. The test item did not produce any sensitisation reactions in this assay (Hill Top Research Inst., 1964). Due to the low concentration applied, this study was jugded to be not reliable (RL3).
Migrated from Short description of key information:
No skin sensitisation potential was observed in studies on humans.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No reliable studies are available referring to respiratory sensitisation potential of the test material.
Justification for classification or non-classification
Based on information gathered in humans no classification for skin sensitisation is required according to Regulation (EC) No 1272/2008.
No reliable data are available, which allows for a reliable classification on respiratory sensitisation.
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