Registration Dossier
Registration Dossier
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EC number: 947-381-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
skin sensitisation: sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a GLP study according OECD TG 406 the skin sensitization potential of the test item was examined in the Guinea Pig Maximization test (GPMT). The test concentrations for the main test were determined according to the results of a pre-test. For first induction in the main study, 2.5% test item in the vehicle aqua dest. and in an adjuvant solution was intradermal injected into the scapular area of 10 guinea pigs. Animals of the control group were injected only with the vehicle or a 50% concentration of the vehicle in the adjuvant solution. All animals got a third pair of intradermal injections consisting of the adjuvant solution as a 1:1-mixture of adjuvant solution and 0.9% NaCl. One week after first induction, 100% test item was applied under occlusive conditions on the skin of the scapular area for 48 hours. In the control group, dermal induction was accomplished with the vehicle aqua dest. Following induction, all animals displayed graduated skin reactions in form of erythema (grade 1 to 3) or no reactions (grade 0) on the injection sides. Three weeks after first induction, animals underwent challenge treatment comprising a 24-hour occlusive application of the 100% test item onto the skin of the caudal right flank. Skin reactions were assessed 24 and 48 hours after patch removal. In the main test, 8 of 10 animals of the test group responded with skin reactions of grade 1 and 2 (discrete or patchy erythema or moderate and confluent erythema) 24 and 48 hours after application. In the control group, none of the animals responded to the challenge treatment. Based on the results the test item has a skin sensitizing potential (BASF SE 30H0178/16X167; 2017).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on these information the test item is considered to be classified for skin sensitisation Cat.1A (H317 "May cause an allergic skin reaction") under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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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