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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A skin irritation test (OECD 404 and GLP compliant) and an eye irritation test (OECD 405 and GLP complaint) were performed in rabbits. These irritation studies indicate no skin or eye irritation.  

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A skin irritation test was performed according to OECD 404 and in compliance with GLP. In this study, three Kleinrusse, Chbb:HM rabbits were exposed to 0.5g test substance for 4 hours under semi-occlusive conditions. The effects were scored after 1, 24, 48 and 72 hours and the rabbits were observed for 7 days. The mean score of 24, 48 and 72 hours for erythema was 2.33, 0.66 and 0 for animal 1, 2 and 3, respectively. The mean score of 24, 48 and 72 hours for edema was 0.66, 0 and 0 for animal 1, 2 and 3, respectively. The reactions disappeared totally within 7 days. Under the conditions of this study the substance was considered to be not irritating to the skin.

 

An eye irritation test was performed according to OECD 405 and in compliance with GLP. In this study, three Kleinrusse, Chbb:HM rabbits were exposed to 0.1g test substance for 24 hours and after exposure the eyes were rinsed with warm water. The effects were scored after 1, 24, 48 and 72 hours and the rabbits were observed for 72 hours. Effects on the cornea and iris were not observed and no chemosis was observed. A slight reddening of the conjunctivae in two animals until the 24 -hour assessment was observed. The mean score of 24, 48 and 72 hours was 0.33 for both animals. After 48 hours all animals were without symptoms. Under the conditions of this study the substance was considered not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
GLP compliant, guideline study, available as unpublished report, fully adequate for assessment

Justification for selection of eye irritation endpoint:
GLP compliant, guideline study, available as unpublished report, fully adequate for assessment

Justification for classification or non-classification

Based on the results of skin irritation and eye irritation test, the substance does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.