Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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

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:
no adverse effect observed (not irritating)

Additional information

Skin irritation

One reliable in vivo study described by Hansen (2013)(OECD 404; GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be irritating to the skin.

Based on the experience with other metal substances (model substances) in in vitro human skin model test systems for skin corrosion and skin irritation testing, it was decided to deviate from the sequential testing strategy as foreseen in the REACH regulation, Annex VII and VIII in conjunction with Article 12(1). The testing strategy for skin corrosion/irritation testing is presented in the report in Attachment I of the CSR and in endpoint summary of IUCLID Section 7.3.

Eye irritation

One reliable in vivo study described by Pooles (2013) (OECD 405; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating 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

Justification for classification or non-classification

Skin irritation

Reference Hansen (2013) 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

Reference Pooles (2013) is considered as the key study for in vivo eye irritation and will be used for classification. During the study the test item was applied to one eye of two animals each and the eye irritation was scored according to the Draize scale. The following mean scores (24, 48 and 72 hours) were obtained for the two animals:

cornea: 0 for both animals

iris:0 for both animals

conjunctival redness: 1.67 for both animals

chemosis: 1.33 and 0.67

The ocular effects were fully reversible within 14 days.Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes. Furthermore, the substance has not to be classified as eye irritant according to Directive 67/548 EC.