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:

Reading Hours after challenge Group Dose level No. with + reactions Total no. in group Clinical observations
1st reading 24 negative control 0% 0 5
2nd reading 48 negative control 0% 0 5
1st reading 24 test group 50% 0 10
2nd reading 48 test group 50% 0 10
1st reading 24 positive control 10% 9 10
2nd reading 48 positive control 10% 10 10

As no skin sensitisation was induced in a GLP-study acc. to OECD guideline 406, test item is considered as not skin sensitising. This conclusion is furter supported by the fact that there are no indications of a sensitising potential derived from both acute as well as repeated dose toxicity studies. No skin inflammation or other signs of skin reaction were observed.

Migrated from Short description of key information:
Guinea pig maximisation test (GLP, OECD 406): not sensitising
As a consequence, no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.

Justification for classification or non-classification

Since neither any classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for sensitisation.