Registration Dossier
Registration Dossier
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EC number: 251-717-2 | CAS number: 33885-51-7
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: skin sensitiser (1B) based on testing in OECD TG OECD 429
Respiratory sensitisation: The substance is not a respiratory sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Animal
The skin sensitisation potential of the test substance has been tested according to OECD TG 429 (Local Lymph Node Assay). At 2.5, 5, 10, 25 and 50% the substance showed SI values of 1.8, 1.1, 1.7, 3.0 and 4.5, respectively. An EC3 value of 25% was derived. The substance did not cause skin irritation on the mouse ear. The substance was found to be a skin sensitiser under the conditions of this test.
Human
In a repeat insult patch test on 38 human subjects (IFF, 1972, Klimisch 2), 2.5% test material in alcohol SDA 39C induced little or no primary irritation and no sensitization in the subjects tested. In view of the limited number of subjects the study will not be used for DNEL derivation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance is not a respiratory sensitiser in absence of human data indicating such effects. In addition, the respiratory sensitisation is assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-4, 2017).
1) The substance is a skin sensitiser;
2) The substance does not belong to the di-isocyanates;
3) the substance has no structural alerts or is structurally related to chemicals causing respiratory sensitisation as presented in Table R.7.3-1 in the ECHA guidance of 2008 or those provided in the following document:http://ec.europa.eu/health/scientific_committees/docs/annex6_respiratory.pdf. Therefore, the substance is not considered to be a respiratory sensitiser.
Justification for classification or non-classification
The substance does not need to be classified for respiratory sensitization but has to be classified as Skin Sens 1B and shall be labelled with H317: May cause an allergic reaction according to EU CLP (EC No. 1272/2008 and its amendments).
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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