Registration Dossier
Registration Dossier
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EC number: 482-100-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Read-across to properties of an analog is applicable based on the similarity in structure and physico-chemical properties.The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.
In a key study performed in accordance with OECD Guideline No. 429 and EC Method B42 (LLNA) the skin sensitization potential of the test material was assesd. Female CBA/Ca mice were used for both the preliminary and the official study. The preliminary test used 3 animals at concentrations of 100%, 50%, and 25% test material v/v acetone/olive oil 4:1 as the vehicle. A concentration of 25% was the highest concentration that was predicted to not produce systemic toxicity or excessive local irritation and therefore, this was the highest concentration used in the study.
Following the preliminary screening test, four groups of 5 animals were treated with 50 uL (25 uL per ear) of either the vehicle (acetone/olive oil 4:1) alone or at concentrations of 25%, 10%, and 5% of the test material v/v in the vehicle.
The Stimulation Index (SI) was calculated for each test group and was 1.00 (5%), 1.28 (10%), and 2.64 (25%).
The test material was considered to be a non-sensitizer under the conditions of the test.
Migrated from Short description of key information:
The key study was performed according to OECD Guideline 429 and EC Method B42, Local Lymph Node Assay (LLNA). Following the preliminary screening test, four groups of 5 animals were treated with 50 uL (25 uL per ear) of either the vehicle (acetone/olive oil 4:1) alone or at concentrations of 25%, 10%, and 5% of the test material v/v in the vehicle.
The Stimulation Index (SI) was calculated for each test group and was 1.00 (5%), 1.28 (10%), and 2.64 (25%).
The test material was considered to be a non-sensitizer under the conditions of the test.
Justification for selection of skin sensitisation endpoint:
This study was performed according to OECD Guideline 429 and EU Method B.42. The Stimulation Index (SI) was calculated for each test group and was 1.00 (5%), 1.28 (10%), and 2.64 (25%). The test material was considered to be a non-sensitizer under the conditions of the test.
Justification for classification or non-classification
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin sensitisation.
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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