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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:
Twenty female guinea-pigs were given induction doses by intradermal injection. Test organisms were also given an injection of Freund's complete adjuvant diluted water into the same area. The same area was clipped and shaved one week after exposure. Topical application of the test substance in acetone was placed on the same area under a semiocclusive dressing and left for 48 hours. After 14 days, the test organisms were challenged topically the test substance in acetone, in place for 24 hours. Challenge sites were evaluated at 24, 48, and 72 hours after removal. A vehicle control group of 10 female guinea-pigs was given the same treatments with acetone vehicle.

 

Reactions were scored on a scale from 0 to 4 for erythema, eschar formation and oedema formation. All test sites were scored 0 for both the test and control animals. The test substance did not produce evidence of contact sensitivity.


Migrated from Short description of key information:
The study assessed the skin sensitisation potential of the test substance.The test substance did not produce any contact sensitivity during the observation in any test organism.

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for sensitisation.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for skin sensitisation.