Registration Dossier
Registration Dossier
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EC number: 413-210-6 | CAS number: 192662-33-2 ORASOL ROT 1988C
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:
In order to assess the cutaneous allergenic potential under GLP conditions, the Maximisation-Test was performed in 30 (20 test and 5 control) Pirbright white guinea pigs, in accordance with OECD Guideline 406 (Ciba-Geigy 1993a). Test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 5 % concentration in 20% aquaeous PEG and epidermally exposed to a 50% concentration in vaseline.Ten control animals were similarly treated, but with vehicle alone. As determined in the range-finder test, the test item causes skin irritation at 50% in vaseline.
Two weeks after the epidermal application all animals were challenged with a non-irritant dose (20 %) and the vehicle.
No skin reactions were observed in response to the 20 % test substance concentration. No skin reactions were evident in the control animals.
Migrated from Short description of key information:
in vivo, Guinea Pig Maximization Test (GPMT), guinea pig: not sensitising (GLP, OECD 406)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No 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 sensitisation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/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 sensitisation under Regulation (EC) No. 1272/2008.
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