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Description of key information

Bayhibit AM was tested as a ca. 50 % solution water in vivo and as a water-free substance (Bayhibit AM wasserfrei)  in vitro.
The water-free substance (Bayhibit AM wasserfrei) was found to be not irritating or corrosive in vitro experiments with 3D-skin.
The water-free substance (Bayhibit AM wasserfrei) was found to be irritating in the Human Corneal Epithelial Model (HCE) but slightly irritating in the Hen's Egg Chorioallantoic Membrane (HET-CAM) test.
Skin and eye irritation tests with the 50% aqueous gave negative results.

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

Bayhibit AM was tested as a ca. 50 % solution water in vivo and as a water-free substance (Bayhibit AM wasserfrei) in vitro.

The water-free substance (Bayhibit AM wasserfrei) was found to be not irritating or corrosive to skin in vitro experiments with 3D-skin.

The water-free substance (Bayhibit AM wasserfrei) was found to be irritating to eye in the Human Corneal Epithelial Model (HCE) and slightly irritating to eye in the Hen's Egg Chorioallantoic Membrane (HET-CAM) test.

Skin and eye irritation tests with the 50% aqueous gave negative results.


Effects on eye irritation: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin:

The water-free substance (Bayhibit AM wasserfrei) was found to be not irritating or corrosive in vitro experiments with 3D-skin.

Skin irritation tests with the 50% aqueous gave negative results.

Eye:

The water-free substance (Bayhibit AM wasserfrei) was found to be irritating in the Human Corneal Epithelial Model (HCE) and slightly irritating in the Hen's Egg Chorioallantoic Membrane (HET-CAM) test.

Eye irritation tests with the 50% aqueous gave negative results.

Overall, the water-free substance (Bayhibit AM wasserfrei) should be classified with R36 based on the in vitro data.

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