Registration Dossier

Administrative data

Description of key information

Skin Sens 1B

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

To assess the allergenic potential of test item in albino guinea pigs the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. The study was conducted according to internationally accepted guidelines (OECD 406).

In the study it was found that 70 and 60 % of the animals gave a positive response at the 24 and 48 hour time points respectively following challenge with the highest non-irritating concentration of 25 % test item.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In this study it was found that 70 and 60 % of the animals gave a positive response at the 24 and 48 hour time points respectively followlng challenge wlth an induction perfomed at 5 % of test article in bi-distrilled water.

According to CLP Regulation (EC 1272/2008) section 3.4.2, the test substance shall be classified as skin sensitisers sub-category 1B, in Guinea pig maximisation test positive responses have been recorded in more than 30 % of population, responding an intradermal induction dose higher than 1 %.