Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis([1,1'-biphenyl]-4-yl)-2,5-dihydro-

Endpoint summary

Description of key information

The pigment showed no indication of skin irritation in rabbits as tested in a GLP compliant study performed according to OECD testing guideline 404. It caused transient mild irritation of conjunctivae in rabbits as tested in a GLP compliant study performed according to OECD testing guideline 405.

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)

Additional information

A GLP conform in vivo study was performed to assess the acute dermal irritation or corrosion potential of the test substance in White New Zealand rabbits according to the OECD guideline 404 (Notox 1993c). Three rabbits were exposed to 0.5 grams of the test substance that was applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

Exposure to the test substance resulted in neither erythema nor edema in the treated skin-areas of the rabbits.

Red staining of the treated skin by the test substance was observed between days 1 and 3 on all animals which did not hamper the scoring of the skin reactions.

 

To assess the acute eye irritation or corrosion potential of the test substance in vivo a GLP conform eye irritation test in White New Zealand rabbits was performed according to the method described in OECD guideline 405 (Notox 1993d). Single samples of approximately 21 mg of the test substance (a volume of 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test substance resulted in effects on the conjunctivae. Irritation of the conjunctivae was seen as slight redness and discharge, which had completely resolved within 48 hours in all animals. No corneal opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals. Mean scores of the 24 - 72 h readings were 0.0 for both corneal opacity and iris, 0.33 for conjunctivae redness.

 

No data is available on respiratory irritation.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin and eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, 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 and eye irritation under Regulation (EC) No. 1272/2008.