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 Buehler epicutaneous patch test was conducted on male guinea pigs according to OECD guideline 406 with a test item containing 75 % active ingredient. A 50 % test substance formulation was used for first to third induction and a 25 % test substance formulation for challenge, based on previously performed range finding tests (highest dose to cause mild irritation for induction, highest non-irritating dose for challenge). 24 and 48 hours after challenge exposure (30 and 54 hours after the beginning of the challenge) the treated sites were assessed.

The challenge with the 25 % test item formulation led to slight skin effects (grade 1) in the test item group in 1/20 animals after 24 hours and in 1/20 animals after 48 hours. Slight skin effects (grade 1) were also seen in 1/10 of the animals in the control group after 24 and 48 hours. The total number of reacting animals was 1/10 (10 %) in the control group and 2/20 (10 %) of the animals in the test item group.

In summary, by comparing the effects in the test item group and the control group it can be concluded that under the conditions used the test item exhibits no skin-sensitization potential.


Migrated from Short description of key information:
Buehler test, Guinea pig: negative

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification on skin sensitisation is warranted according to Regulation (EC) No 1272/2008, Annex I.

Although a commercial product with a 75 % concentration of active ingredient was used in the available assay on sensitisation (Buehler), the negative test result should also be valid for the pure substance, as the test item was tested at a concentration that was the highest to cause mild irritation for induction and at a concentration that was the highest non-irritating concentration for challenge. Higher concentrations would not have been appropriate.