Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating (OECD 404, GLP)
Eye irritation: corrosive (OECD 405; GLP)

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

Skin irritation

One reliable in vivo study described by Hansen (2014)(OECD 404; GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be irritating to the skin.

Eye irritation

One reliable in vivo study described by Hansen (2014)(OECD 405; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be corrosive to the eye.

Furthermore, a reliable in vitro study described by Heppenheimer (2012) (OECD 437; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be neither corrosive nor severely irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation

Reference Hansen (2014) is considered as the key study for in vivo skin irritation and will be used for classification. The skin irritation was scored according to the Draize scale. The mean score (24, 48, 72 h) for erythema and oedema for all three animals were as follows:

Erythema: 0 for all animals

Oedema: 0 for all animals

Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the skin. Furthermore, the substance has not to be classified as skin irritant according to Directive 67/548 EC.

Eye irritation

Hansen (2014) is considered as the key study for in vivo eye irritation and will be used for classification. The eye irritation was scored according to the Draize scale. The following mean score (24, 48, 72 h) for three animals were as follows:

cornea: 1, 2, and 1.33

iris: 0 for all animals

conjunctival redness: 1.67 for all animals

chemosis: 0.67, 3 and 2.67

The effects were not fully reversible. All animals were euthanised by day 6 (one animal by day 6 and the other animals by day 5), since the animals showed continuing severe pain or distress. Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will be classified as Category 1. Furthermore, the substance has to be classified as risk of serious damage to eyes according to Directive 67/548 EC.