Registration Dossier

Administrative data

Description of key information

To date, two different studies on skin irritation/corrosion of the test material are available:
Mallaun (2010): In an in vivo skin irritation study in rabbits according to OECD Guideline 404 and EU Method B.4, FAT40850/A TE is not irritating to skin.
Heppenheimer (2010): In an in vitro skin corrosion study using a human skin model test according to OECD Guideline 431 and EU Method B.40, FAT40850/A TE was found to be not corrosive to skin.
In an in vitro BCOP test according to OECD Guideline 437, FAT40850/A TE was found to be not corrosive to the eyes. Applying the criteria of INVITTOX protocol no. 98, FAT40850/A TE can be judged to be moderately irritating to the eyes.
In an in vivo eye irritation study in rabbits according to OECD Guideline 405 , FAT40850/B TE was found to be moderately irritating to the eyes.

No study on respiratory irritation is available to date.

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)

Additional information

According to the recommendations, the test material has first been tested on skin corrosive properties using a validated in vitro human skin model test. The outcome of this test showed that the test material is not corrosive to skin. Subsequently, an in vivo skin irritation test on rabbits has been performed; showing that the test material is also not a skin irritant.

 

To elucidate irritant/corrosive effects on the eye, an in vitro BCOP test has been performed with the test material. The outcome of this test was that, according to the criteria laid down in OECD Guideline No. 437, the test material is considered not be corrosive or a severe eye irritant. Applying the classification criteria of the INVITTOX protocols No. 98 and 124, which served as basis for the OECD Guideline 437, the test material can be classified as moderate eye irritant due to the observed in vitro irritancy score. According to the OECD Guideline, the classification as eye irritant was confirmed by an in vivo eye irritation test according to OECD 405. The study showed that the substance is a moderate eye irritant.


Effects on eye irritation: moderately irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the aforementioned results, the test material needs not to be classified as skin irritant according to the criteria laid down in Regulation (EC) 1272/2008 and Directive 67/548/EEC.

 

Based on the results of the BCOP test and applying the criteria of the above mentioned INVITTOX protocols No. 98 and 124 and based on the results of the in vivo study performed according to OECD Guideline 405, the test material should be classified as Eye irritation Category 2 according to Regulation (EC) 1272/2008 and as R36 (Irritating to eyes).