Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The SI values calculated for the substance concentrations 1, 2.5 and 5% were 11.4, 18.5 and 24.7 respectively. These results show that the test substance elicits an SI ≥ 3. The EC3 value (the estimated test substance concentration that will give a SI =3) was established to be between 0 and 1%. Based on these results: - according to the recommendations made in the test guidelines, Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate would be regarded as skin sensitizer. - according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate should be classified as strong skin sensitizer (Category 1, Sub-category 1A). - according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate should be classified as skin sensitizer (Category 1) and labeled as H317: May cause an allergic skin reaction.


Migrated from Short description of key information:
In an OECD TG 429 study, this substance would be regarded as skin sensitizer.

Justification for classification or non-classification

Please see above "Discussion".