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:

A Guinea Pig Maximisation Test (GPMT) was performed to determine the sensitising potential of the test substance, in accordance with OECD guideline 406 and under GLP conditions. 30 female Dunkin-Hartley guinea pigs were used. Intradermal induction was done with a 2.5% test substance solution (in propylene glycol), undiluted test article was used for epicutaneous induction. First challenge was done with undiluted test article and 25% and 10% solution, second challenge with 100% test article only (in duplo).

No positive skin reactions were noted after the induction phase in both the test article and control groups. After first challenge, a significant amount of animals were find to have positive skin reactions at the 25% and 10% concentration, but not with the undiluted test article. Therefore, a second challenge with the undiluted test article (100%) was done (in duplo). No clear positive reactions were noted in the test article or control group after the second challenge. It is concluded that RDP is not a skin sensitiser.

Migrated from Short description of key information:
Guinea Pig Maximisation Test (OECD Guideline 406), guinea pig: not sensitising

Justification for classification or non-classification

Based on the available information, RDP does not have to be classified according to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), and outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).