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 skin sensitisation potential of the test material was determined in a GLP-compliant guinea pig maximisation testing performed in accordance with standardised guidelines OECD 406 and EU Method B.6. The test material was applied as:

0.5% w/v in physiological saline for the intradermal induction (step 1)

5% w/v in physiological saline for the intradermal induction (step 2)

50% w/v in deionised water for the epicutaneous induction (each step) and

50% w/v in deionised water for the challenge exposure (each step).

No adverse clinical or behavioural signs were observed. No statistically significant differences were seen in mean body weights. Observations showed no adverse skin reactions in the control or animals exposed to the test material. Therefore, under the conditions of the study the test material was determined not to be a skin sensitiser.


Migrated from Short description of key information:
Key study:- Not sensitising, OECD 406, EU Method B.6, Sattler (2006).

Justification for selection of skin sensitisation endpoint:
Only one study is avaialble.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Directive 67/548/EEC and Annex I, Regulation 1272/2008, the substance does not meet the criteria for classification as a skin sensitiser.