Registration Dossier

Administrative data

Description of key information

4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test. Furthermore, the test item causes serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

skin irritation

The objective was to assess the potential for corrosive activity and skin irritation of the test material upon first contact with skin. The assessment of the skin corrosion/irritation potential is included in international regulatory requirements for the testing of chemicals. Due to animal welfare reasons corrosivity and skin irritation were determined using the reconstructed human epidermal model EpiDerm. The present test is based on the experience that corrosive and irritant chemicals produce cytotoxicity in human reconstructed epidermis after a short term topical exposure. The test is designed to predict a skin corrosion or irritation potential of a chemical by using the three dimensional human epidermis model EpiDermTM. After application of the test material to the stratum corneum surface of the EpiDermTM tissue the induced cytotoxicity (= loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol-extraction of the formazan from the tissues, the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of test-substance treated tissues is compared to negative control values from tissues and expressed as relative tissue viability.

Based on the observed results and applying the evaluation criteria it was concluded, that 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen. [BASF SE, 2011]

eye damaging

The objective was to assess the potential of the test substance to cause serious damage to isolated bovine corneas for product safety and regulatory purposes. The assessment of serious eye damage is included in international regulatory requirements for the testing of chemicals. Due to animal welfare reasons serious eye damage was determined using the isolated corneas from the eyes of freshly slaughtered cattle. After application of the test material to the epithelial surface of the corneas, corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro Irritancy Score (IVIS) of the test substance, which is used for prediction of serious eye damage.

Based on the observed results and applying the evaluation criteria it was concluded, that 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane causes serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. [BASF SE, 2011]


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the results 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane is skin irritating (EU: R38; GHS: skin irritation cat. 2, H315) and eye damaging (EU: R41; GHS: eye damaging cat. 1, H318) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.