Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute dermal irritation on an analogue of the substance has been assessed in the rabbit using OECD/EU test methods. The irritation observed was not of sufficient severity or persistence for the substance to require classification as a skin irritant. This is supported by in-vitro studies on the substance itself and a number of analogues.

Acute eye irritation of an analogue of the substance has been assessed in the rabbit using OECD/EU test methods. The severity and persistence of ocular response was sufficient for the substance to require classification as an eye irritant.

Justification for selection of skin irritation / corrosion endpoint:

Several studies available for evaluation

Justification for selection of eye irritation endpoint:

Single study available for evaluation

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin:

Based on the results of the available data the substance does not require to be classified and labelled according to Regulation 1272/2008/EC (CLP) or Directive 67/548/EEC (DSD).

Eyes:

The information available is regarded as sufficient to be able to draw conclusions regarding the need for classification. Classification as serious eye damage Category 1 - H318 according to CLP (1272/2008/EC) and risk of serious damage to eyes - R41 according to 67/548/EEC is indicated.