Registration Dossier
Registration Dossier
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EC number: 401-540-3 | CAS number: 84632-65-5
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:
Pigment Red 254 (CAS# 84632-65-5) was tested in the Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman to determine its sensitizing potential (OECD 406). Adult male and female guinea pigs (Pirbright White strain; 20 test animalsin test group, 10 animals in control group) were induced by epicutaneous applications of the test substance, 10% (w/w) in Vaseline (epidermal application) and 1% in sesame oil and adjuvant mixture (intradermal application). After being challenged with 0.3% in Vaseline, animals were observed for a response at 24h and 48h. No positive response was observed to the concentrations tested in any of the animals. These results indicate a sensitization rate of 0%. The substance can be classified to the lowest grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs according to the grading of Magnusson & Kligman.
Migrated from Short description of key information:
Skin sensitisation: Not sensitising (OECD 406 , Guinea pig maximisation test)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
This information is not available.
Justification for classification or non-classification
Skin Sensitisation
Based on the available information in the dossier, the substance Pigment Red 254 (CAS# 84632-65-5) does not need to be classified for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC are applied.
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