Registration Dossier
Registration Dossier
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EC number: 434-850-2 | CAS number: 1680-31-5
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:
Key study:
In accordance with OECD guideline 406 a Buehler test with the test item was performed in order to assess the potential of the test item to induce delayed contact hypersensitivity in the guinea pig. The undiluted test article was used for the inductions. A 75% test item concentration was used for the challenge. Under the experimental conditions described the test item caused no evidence of delayed contact hypersensitivity.
Supporting study:
After repeated topical application of the test item the evaluation of samples of SSB (Skin Surface Biopsy) using ethyl cyanoacrylate does not reveal qualitatively changes of the skin surface and the impaired openings of the hair follicles. No horny comedonal plugs could be observed nor any quantitatively assessed change of the openings of the hair follicles. No indications of skin sensitisations were obvious from microscopic evaluation of the test substance treated human skin (patch test).
Supporting study:
The myeloid U937 skin sensitization test is a dendritic cell activation test to predict skin sensitizing potential. The test is performed using the human pro-monocytic cell line U937 as surrogate fer dendritic cells. As readout, the change in the expression of the cell membrane marker CD 86 measured by flow cytometry after 48 hours of test substance exposure is determined. A test substance is predicted to activate dendritic cells when CD86 cell surface expression exceeds the threshold in relation to vehicle control in at least two independent experiments.
After 48 hours of exposure to test item CD 86 expression was induced in U937 cells at concentration 690.60 µg/mL affording at least 70 % viability. From this it has to be concluded that test item does induce dendritic cell activation .
Migrated from Short description of key information:
Key study:
In accordance with OECD guideline 406 a Buehler test with the test item was performed in order to assess the potential of the test item to induce delayed contact hypersensitivity in the guinea pig. Under the experimental conditions described the test item caused no evidence of delayed contact hypersensitivity.
Justification for classification or non-classification
Based on the results of the skin sensitization study, the test item is not subjected to classification according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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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