Registration Dossier

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:

The key study was a human Repeated Insult Patch Test. The study has a proper design and results are reported well. This test was performed on the skin of 50 human volunteers (21 males and 29 females). 15 induction exposures were applied, 3 times/week, for 24 hours. After 14 days of no contact with the test material, 1 challenge exposure was applied for 24 hours. Evaluation after challenge occurred at 0, 24 and 48 hours after removal of the patch. Under the conditions of this study, IDDPP was found not to induce any positive reaction in human skin after challenge.

A Two Application Patch Test was available as a supporting study. 100 males and 100 female volunteer subjects were exposed twice to IDDPP (15 days rest period between treatments) for 48 hours on the upper arm using an occluded patch (impregnated paper). Skin reactions were scored at 0, 24 and 48 hours after removal of the patch to determine the sensitising potential of the test substance. Under the conditions of this study, IDDPP was found not to induce any positive reaction in human skin after challenge.


Migrated from Short description of key information:
Human Repeated Insult Patch Test (no guideline available): not sensitising.

Justification for classification or non-classification

Based on the results of both skin sensitisation studies IDDPP does not need to be classified as a skin sensitiser when considering the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.