Registration Dossier
Registration Dossier
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EC number: 947-474-3 | CAS number: -
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:
A repeated insult patch test was conducted to determine by repetitive epidermal contact the potential of the reaction product to induce primary or cumulative irritation and allergic contact sensitization. The test material was prepared as a 50 % dilution, using the supplied diluent, Cetiol CC. The upper back between the scapulae served as the treatment area. The test item was applied under occlusion to the ¾” x ¾” absorbent pad portion of an adhesive dressing. Patches were applied three times per week for a total of nine applications. After approximately 2 weeks a challenge patch was applied to a virgin test site adjacent to the original Induction patch site. With one exception, observation remained negative. Under the conditions of this study, the test material did not indicate a clinically significant potential for dermal irritation or induced allergic contact sensitization. Please refer to IUCLID section 7.10.4.
Migrated from Short description of key information:
A repeated insult human patch test was conducted to determine by repetitive epidermal contact the potential of the test material to induce primary or cumulative irritation and allergic contact sensitization. The insult patch test on 104 human subjects showed no sensitizing potential.
Justification for selection of skin sensitisation endpoint:
Please refer to section 7.10.4
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 1297/2014.
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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