Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-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:

There are valid in vivo data available for the assessment of the skin sensitisation potential of

3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione (CAS No. 84632-65-5).

  

In a first Guinea pig maximisation test, the test substance commercial grade pigment, was tested for the assessment of skin allergic effects using albino guinea pigs. The test was performed under GLP according to the OECD Test Guideline No. 406. The test was conducted on Dunkin-Hartley albino guinea pigs using 20 animals (10 males and 10 females). The experiment proceeded in three phases: two induction phases (intradermal injection [1 % dilution of test article in sesame oil, 0.1 mL/site] and topical application [10 % test article in Vaseline as a paste of 0.4 g.]) one week after intradermal injection (occlusive conditions, 48 hours) and the challenge phase (topical application of 0.3 % test article in Vaseline as paste of 0.2 g, 24 hours). Potential skin reactions were evaluated approximately 24 and 48 hours after challenge. The exposed animals showed no allergic skin reactions and no other negative clinical symptoms throughout the experiment. The test substance was not shown to be a contact allergen.

In a second Guinea pig maximisation test, the test substance (commercial grade) was tested at higher doses under the same conditions. The test was performed under GLP according to the OECD Test Guideline No. 406 (1981). In a range finding test, the concentration of test compound for induction and challenge periods were determined on four separate animals with concentrations of 1 %, 3 % and 10 % in Vaseline.

In the main test, 20 (10 males and 10 females) Dunkin-Hartley albino guinea pigs were used. The experiment proceeded in three phases: two induction phases (intradermal injection [1 % dilution of test article in sesame oil, 0.1 mL/site] and topical occlusive application [10 % test article in Vaseline as a paste of 0.4 g]) one week after intradermal injection (48 hours) and the challenge phase (topical application of 3 % test article in Vaseline as paste of 0.2 g, 24 hours). Thereby, on the day before epidermal induction the application sites were pretreated with 10 % sodium lauryl sulfate under open conditions.

Potential skin reactions were evaluated approximately 24 and 48 hours after challenge. The exposed animals showed no allergic skin reactions and no other negative clinical symptoms throughout the experiment.

 

Conclusion: The substance, 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione (CAS No. 84632-65-5), was not sensitizing to the skin of guinea pigs.

Migrated from Short description of key information:
Guinea pig maximisation test: not sensitising (OECD 406/GLP study, CIBA-GEIGY 1986)

Respiratory sensitisation

Endpoint conclusion

Additional information:

Migrated from Short description of key information:
There are no data available concerning the respiratory sensitisation.

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 sensitization under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

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.