Registration Dossier

Diss Factsheets

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.