Registration Dossier
Registration Dossier
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EC number: 939-525-3 | CAS number: 1471313-03-7
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:
Magnusson & Kligman maximisation studies were performed according to OECD guideline 406; this is a widely recognised test to assess skin sensitisation therefore the results are applicable to humans. The negative response with the structurally-related substance CAS 28219-61-6 was observed with the maximum number of animals recommended by the OECD guideline (20 animals).
Migrated from Short description of key information:
In a Magnusson & Kligman maximisation study with the structurally-related substance CAS 28219-61-6: no positive response in 20 guinea pigs.
In a Magnusson & Kligman maximisation study with the substance: almost no positive response in 10 guinea pigs (1/10 during the 2nd challenge).
Justification for selection of skin sensitisation endpoint:
GLP study conducted in compliance with OECD guideline 406 with the appropriate number of animals tested.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In 2 Magnusson & Kligman studies, one with the structurally-related substance CAS 28219-61-6 and one with the substance, no more than 10% positive responses were observed in guinea pigs. Therefore the substance is not classified as a sensitiser according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.
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