Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[4-(1,1-dimethylethyl)phenyl]-2,5-dihydro-

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A sensitisation test in albino guinea pigs was performed to determine the contact allergenic potency in albino guinea pigs (Ciba-Geigy Ltd 1993d). This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group. The induction was a two-stage operation. First , intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. The application site was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. The concentration for injections were 5% (arachis oil) and for epidermal exposure 50% (vaseline).Twenty four and forty eight hours after reraoving the dressings, the challenge reactions were graded according to the Draize scoring scale. After the first challenge application 10 and 40% of the animals of the test and control group showed skin reactions 24 and 48 hours after removal of the dressings, respectively.

After a second challenge application, using a lower test article concentration, none of the animals of the test group was sensitised and none of the animals of the control group showed skin reactions 24 and 48 hours after removing the dressings.

The pigment is, therefore, not considered as a skin sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.

Migrated from Short description of key information:
The substanc was not sensitizing in a GLP-compliant study in guinea pigs (OECD 406) ( Ciba-Geigy Ltd 1993d).

Respiratory sensitisation

Endpoint conclusion

Additional information:

There is no information available on the potential for the test substance to produce respiratory sensitization in animals or humans.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

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 sensitization under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.