Registration Dossier
Registration Dossier
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EC number: 456-880-5 | CAS number: 439685-79-7
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:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, groups of 20 Hartley Crl: (HA) BR guinea pigs (10/sex) were induced with three pairs of intradermal injections of 0.1 mL of FCA (50 % v/v in 0.9 % NaCl), test item at 10 % w/w in 0.9 % NaCl and test item at 10 % w/w in mixture of FCA/0.9 % NaCl (50/50) on Day 1 on three different sites on each side of interscapular region. Control group of 10 animals (5/sex) was intradermally induced with FCA (50 % v/v in 0.9 % NaCl), 0.9 % NaCl and vehicle at 50 % w/v in a mixture of FCA/0.9 % NaCl (50/50). After one week the same area was topically induced with test item at 25 % w/w via occluded filter paper patch for 48 h for the treated group. Control group was patched with filter paper saturated with vehicle alone. After 2 weeks of rest period, a challenge filter paper patch of vehicle and test item at 25 % w/w was applied to posterior left and right flank of all animals, respectively. No deaths and no systemic clinical signs were noted during the study. No cutaneous reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. Mexoryl SBF produced a 0 % (0/20) sensitisation rate and was considered to be a non-sensitizer to guinea pig skin.
Migrated from Short description of key information:
In a GLP skin sensitization test in guinea pigs conducted according to OECD guideline 406, MEXORYL SBF at 25% w/w did not elicite positive response in the 20 animals tested.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data
Migrated from Short description of key information:
No data
Justification for classification or non-classification
As none of the tested animals had positive response in a maximisation test, it is concluded that MEXORYL SBF does not need to be classified as skin sensitiser according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008).
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