Registration Dossier
Registration Dossier
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EC number: 679-514-8 | CAS number: 154279-60-4
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:
Local Lymph Node Assay (LLNA)
In a guideline (EPA OPPTS 870.2600) study by Kuhn et al. (2005) with acceptable restrictions (no data on measurements and calculations) 5 female mice per dose received open application of25μLof test substance (trade name Clearlink 1000) solution (2.5, 5 or 10%) to the dorsum of both ears (daily application on 3 consecutive days. 5 female controls were treated in the same manner with vehicle (acetone : olive oil) alone. All test and control animals were given a two day rest period on days 4 and 5. At day 6 lymph nodes were excised 5 h after i.v. injection of 3H labelled Thymidine and lymph nodes from each individual were processed. The test material produced a stimulation index ≥ 3 in all groups of test animals. Based on the study result the test substance is regarded as a skin sensitizer.
Results of this study would lead to the classification of the substance as a skin sensitizer in accordance with the criteria set out in Directive 67/548/EC and Regulation (EC) 1272/2008. This study is classified as acceptable and satisfies the guideline requirements for the skin sensitization study. The result of this study is used as a key value for hazard assessment and classification and labelling.
Migrated from Short description of key information:
Clearlink 1000 was a sentisiser in Local Lymp Node Assay (LLNA) in mice.
Justification for classification or non-classification
Clearlink 1000 is classified R43 according to Annex I of Regulation 67/548/EEC and Skin Sens.1 according to Annex I of Regulation (EC) No 1272/2008.
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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