Registration Dossier
Registration Dossier
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EC number: 213-888-1 | CAS number: 1052-38-6
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:
The analogue substance 2 was tested for skin sensitisation following EU Method B42 (REACH&Colours Kft, 2012). The substance showed a tendency to increase the ear weight in the highest dose level but without lymphocyte proliferation and skin irritation. Residues of the test substance on the ears caused this weight increase. The result of skin irritation effect was considered as negative
Comparison of Stimulation Indexes between all treated groups and control vehicle group revealed that the test substance did not cause significant increase in radioisotope incorporation into the DNA of dividing lymphocytes and the Stimulation Index (SI) <3.
Based on the read across justification the same result can be applied to Solvent Brown 41.
Migrated from Short description of key information:
LLNA, mice, not sensitizing
Justification for selection of skin sensitisation endpoint:
This is a new study performed on a pure and analytically well identified substance, in GLP, fully reliable
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to CLP Regulation, For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay. Since the SI in the performed tests is < 3, no classification for skin sensitisation is warranted under Regulation 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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