Registration Dossier

Administrative data

Description of key information

Non-skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitisation potential of the substance was evaluated by taking into consideration experimental data on Similar Substance 01. Justification for Read Across is given in Section 13 of IUCLID.

Similar Substance 01 was evaluated for its skin sensitisation potential in the Maurer optimisation test according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), of the US Association of Food and Drug Officials (AFDO). During the induction period (days 0 -19) ten male and ten female guinea pigs were subjected to intradermal injections with 0.1 % of substance in polyethylene glycol:saline (70:30). After one week the animals were subjected to intradermal injections with 0.1 % of substance with adjuvant (ratio 1:1) for two weeks. The animals were later challenged with intradermal injections of 0.1 % of substance in polyethylene glycol:saline (70:30). After 24 hrs the skin reactions were assessed and the skin-fold thickness of the erythemateous reaction and the individual "reaction volume was determined. Skin sensitization was defined to occur of the challenge reaction whenever the reaction volume exceeded the mean value + one SD of the pre-sensitization responses. Only 2 out of 20 test group animals presented skin reactions while one out of 20 animals in the negative control group had a positive reaction.

The analogue substance is considered as a non-skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No criteria for the classification or non-classification are mentioned in the CLP Regulation regarding the Maurer optimisation test. However, the results of the test group are comparable to the results of the negative/control group. Two out of 20 and one out of 20 animals in the test and negative control group respectively presented positive skin reactions.

The substance is not classified for skin sensitisation according to the CLP Regulation (EC) No.1272/2008.