Registration Dossier
Registration Dossier
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EC number: 442-080-3 | 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:
The sensitising potential of the test article was assessed in guinea pigs according to the OECD guideline 406. No animals treated with the test article showed a positive reaction at the challenge.
Migrated from Short description of key information:
Non sensitizing
Justification for selection of skin sensitisation endpoint:
Test conducted according to internationally accepted testing procedures and according to the GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
The criteria to classify a substance as skin sensitizer, on the basis of results from test animals, are reported into the second adaptation to technical progress*: a substance in considered a skin sensitizer when:
- an adjuvant type test method for skin sensitisation is used and a response of at least 30 % of the animals is considered as positive;
- for a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive;
- a stimulation index of three or more is considered a positive response in the local lymph node assay.
In the Guinea Pig Maximization Test, 0 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
In conclusion, the substance does not meet the criteria for classification as skin sensitizer, according to the CLP Regulation (EC 1272/2008).
*Commission Regulation (EU) No 286/2011 of 10 March 2011, amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.
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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