Registration Dossier
Registration Dossier
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EC number: 700-497-0 | CAS number: 1335202-82-8
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:
Introduction: The study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The method was designed to meet the requirements of the following:
- OECD Guidelines for the testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17th of July 1992)
- Method B6 Acute Toxicity (Skin Sensitisation) of Commission Directive 96/54/EC
Method: Ten test and five control animals were used for the main study. Two phases were involved in the main test; an induction of a response by intradermal injection and a topical challenge of that response.
Based on the results of sighting tests, the concentrations of test material for the topical induction and topical challenge phases were selected as:
Intradermal Induction: 100%
Topical Induction: 100%
Topical challenge: 12.5% and 6.25% in liquid paraffin
Conclusion: Under the conditions of the test, the test material produced a 0% sensitisation rate and was classified as a non sensitiser to the guinea pig skin . The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrases are required.
Migrated from Short description of key information:
The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrases are required.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
Study not required
Justification for classification or non-classification
The substance Enordet 0241 does not meet the classification criteria according to DSD or the CLP regulations for skin sensitisation and is therefore not classified.
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