Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

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

Two studies according to OECD guideline 406 were available. Both available studies indicate that test substance is a strong sensitiser by inducing skin hypersensitvity in 80 to 100 % of the treated animals, responding to an intrademal induction of 5 % in water or physiological saline.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP regulation (EC 1272/2008), based on a Guinea pig maximisation test, classification in category 1A applies if:

≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose

and classification in category 1B applies if:

≥ 30 % to < 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.

Based on a positive response in 80 to 100 % animals responding to an intradermal induction at 5%, classification in category 1B applies.