Registration Dossier
Registration Dossier
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EC number: 416-730-1 | CAS number: 154946-66-4
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:
Procedure and results
To evaluate the allergic potential of the test substance, a skin maximisation test in guinea-pig was perfomed. Ten test and five control guinea-pigs were used in this study. For induction of animals, three pairs of intradermal injection were made. 6d later, topical induction in the same area was perfomed after treatment with sodium lauryl sulphate in petrolatum. Control and test animals were challenged topically two weeks after the topical induction application using the test substance, 70 and 35% w/v in distilled water.
There were no skin reactions or signs of toxicity recorded, other than staining of the dose site, seen in any of the test animals.
Discussion
The test substance did not induce any dermal reactions in test animals unless yellow staining of the application site. Thus, the test substance is considered to be as a non-sensitizer.
Migrated from Short description of key information:
To evaluate the allergic potential of the test substance, a skin maximisation test in ten test and five control guinea-pig was perfomed. The test substance did not induce any dermal reactions in test animals unless yellow staining of the application site. Thus, the test substance is considered to be as non-sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No experimental data is available regarding respiratory sensitization.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC,as amended for the 30th time in Directive 2008/58/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
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