Registration Dossier

Administrative data

Description of key information

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate compared to the negative control tissues was 6%. Since the mean relative tissue viability for Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate was below 50% after 15 minutes treatment Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate is considered to be irritant.
The positive and negative controls were within the historical control data.
Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

[Skin]

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate compared to the negative control tissues was 6%. Since the mean relative tissue viability for Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate was below 50% after 15 minutes treatment Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate is considered to be irritant.

[Eye]

Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 2.6 after 10 minutes of treatment.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

[Skin irritation Cat.2]

Since the mean relative tissue viability for Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate was below 50% after 15 minutes treatment Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate is considered to be irritant.

[Eye: not severe irritant or corrosive (can not classified under UNGHS because this study is conducted in vitro)]