Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Skin irritation:

Two key studies are available with the test item.

In one in-vitro skin irritation study (Human Skin Model Test, similar to OECD TG 439), the undiluted test item was considered as potentially non irritant.

In one in-vitro skin corrosion study (Human Skin Model Test, similar to OECD 431, except an exposure period of 42 hours instead of 15 min- 4 hours), the test item at a concentration of 2% in water is considered as potentially well tolerated, even if the observed results are close to the not well tolerated/well tolerated limit.

Considering these results, it is conclude that the undiluted substance is not considered as irritant to the skin according to CLP criteria.

 

Eye irritation:

One key study is available with the test item. In this study performed according to OECD testing guideline No. 405, no eye irritation was noted in the rabbits exposed to the test item at a concentration of 10% in sterile water. However as the tested concentration is lower than the one required in a standard test (i.e. 100% concentration), the result is considered as insufficient for the purpose of classification and labelling.

By precaution and in absence of additional information concerning eye irritation, we consider that the test item should be classified as irritating to eyes (category 2) according to CLP criteria.