Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.