Registration Dossier
Registration Dossier
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EC number: 216-032-5 | CAS number: 1477-55-0
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:
A pre-GLP study (Upman, 1973) found no evidence that the test substance produced skin hypersensitivity in guinea pigs. However, under the conditions of the experiment, the formulation appears to produce primary skin irritation. More reliable GLP studies (Grundler, 1981 and Allen, 1998) have shown the substance to be a sensitiser in contact with guinea pig skin. A local lymph node assay conducted to GLP standards in the mouse (Sanders, 2004) also showed the test substance to be a sensitiser.
Migrated from Short description of key information:
Sensitising to guinea pig skin (OECD 406)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No data
Justification for classification or non-classification
Two GLP studies have shown that it is appropriate to classify the test substance as R43: may cause sensitisation
by skin contact under the criteria of Directive 67/548/EEC and Skin sensitizer Category 1 under GHS as
reflected by Regulation (EC) 1272/2008. Following the second amendment of the CLP Regulation as published
in Commission Regulation (EU) No 286/2011, the results from the local lymph node assay with MXDA can be
used to classify the substance into sub-category 1B, as the EC3 value is greater than 2% for this substance (the
stimulation index was 1.63 with a test concentration of 2.5% and 5.21 with a concentration of 5%).
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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