Registration Dossier

Administrative data

Description of key information

In an in vivo skin irritation study performed according to OECD 404 and GLP principles, the substance was not irritating.
In an in vivo eye irritation study performed according to OECD 405 and GLP principles, the substance was not irritating.

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

Skin irritation/corrosion

In an in vitro skin corrosion test performed according to OECD 431 the test substance was found to be not corrosive.

In a subsequent test in rabbits performed according to OECD 404 FAT 40854/A TE was not irritating.

Eye irritation/corrosion

In an in vitro eye irritation test (BCOP) performed according to OECD 437 the test substance was found to be not irritating.

In a subsequent test in rabbits performed according to OECD 405 FAT 40854/A TE showed irritation of the conjunctivae, consisting of redness, chemosis and discharge, that had resolved within 48 hours. Staining of the sclera resolved within 14 days after instillation. FAT 40854/A TE was concluded to be not irritating.


Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study performed according to guideline.

Justification for selection of eye irritation endpoint:
Reliable in vivo study performed according to guideline.

Justification for classification or non-classification

Based on the results above, FAT 40854/A TE does not have to be classified for irritation/corrosion according to

the:

-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),

-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.