Registration Dossier

Diss Factsheets

Administrative data

Description of key information

not skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008), in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.

A substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub-categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).

If, in order to evaluate skin sensitisation potential, a Guinea pig maximisation test is performed, a substance is classified as skin sensitiser when the response of at least 30 % responding at ≤ 0,1 % intradermal induction dose or at least 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose.

Under the test conditions the substance resulted in a sensitisation rate of 0 % after intra-cutaneous and epi-cutaneous application to the guinea pig. Therefore, according to the CLP Regulation (EC 1272/2008), the substance is not classified as skin sensitiser.

 

Categories Display