Registration Dossier
Registration Dossier
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EC number: 449-360-4 | CAS number: 647828-16-8
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: the substance is a skin sensitiser (1B): EC3 is 43.44% and NOAEC is 25% (LLNA, OECD TG 429, GLP).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitisation - LLNA
A Local Lymph Node Assay (LLNA) was performed in accordance with OECD TG 429 and under GLP conditions to assess the skin sensitisation potential of the test substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the undiluted test substance (100 %) and the test substance as a solution in acetone/olive oil 4:1 at concentrations of 50 % and 25 % v/v. A further group of 5 animals was treated with acetone/olive oil 4:1 alone. The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group were 1.35, 3.18, and 6.32 for the 25 %, 50 %, and 100 % exposure groups, respectively. Based on these results, the test substance was considered to be a sensitiser under the conditions of the test. The calculated EC3 value is 43.44 % and the NOAEL is 25 %.
HRIPT - human
In addition to the LLNA test, a Human Repeated Insult Patch Test is available in which 101 human subjects were treated with 4 % of the test substance. No dermal irritation or sensitisation was observed. As the results of this study do not add value for the derivation of the DNEL, no study summary was prepared.
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 needs to be classified for skin sensitisation category 1B 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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