Registration Dossier

Administrative data

Description of key information

Pigment Red 221 was found to be non irritating to rabbit skin and eyes as tested in 1974 and 1983/84.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Pigment Red 221 (CAS 71566-54-6, 926 g/mol)

Pigment Red 221 was tested in two studies in rabbits (Ciba-Geigy Ltd 1974, Ciba 1983/84) for both skin and eye irritation. The eye irritation study procedures were comparable to OECD testing guideline 405. Six animals instead of 3 were used. For 3 animals substance was washed out after 30 seconds, whereas for the remaining animals eyes were not washed. The study showed adverse no effects on iris, cornea or conjunctivae.

The skin irritation procedure involved 24h exposure with occlusive wrapping and a three-day observation period. A shaved, but intact site and an abraded site were treated. The duration is longer than required by the OECD guideline 404, but the observation period is shorter. The study was not performed under GLP, but is reported with sufficient detail for evaluation. Polyethylene glycol was used as vehicle. No indication of erythema or edema was observed.

 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.