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Administrative data

Description of key information

Skin irritation: not irritating (OECD 439; GLP compliant)
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 vitro study described by Heppenheimer (2012) (OECD 439; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the skin.

Eye irritation

One reliable in vivo study described by Leuschner (2012) (OECD 405; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
One reliable in vitro study described by Heppenheimer (2012) (OECD 439; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the skin.

Justification for selection of eye irritation endpoint:
One reliable in vivo study described by Leuschner (2012) (OECD 405; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the eyes.

Justification for classification or non-classification

Skin irritation

Reference Heppenheimer (2012) will be used for classification. The mean relative absorbance (% of the negative control, correlating with mean tissue viability) after 15 minutes incubation in the in vitro human skin model test (EpiSkin, according to OECD 439) was as follows:

Heppenheimer (2012): relative viability = 92.0%

The classification criteria according to regulation (EC) 1272/2008 as skin irritant were not met, since the mean tissue viability was above the threshold for skin irritants of 50.0%.

Eye irritation

Reference Leuschner (2012) 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 three animals each and the eye irritation was scored according to the Draize scale.The corneae and irises were not affected by instillation of the test item. For one animal a mean score of 0.33 (24, 48 and 72 hours) was recorded for conjunctival redness (fully reversible within 48 hours). The remaining animals did not show any effect on the conjunctivae.Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes.

Respiratory irritation

The classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.

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