Cyclohexanamine, 4,4'-methylenebis[2,6-dimethyl-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study conducted in accordance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 437

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine

EC Number:

634-657-5

Cas Number:

65962-45-0

Molecular formula:

C17H34N2

IUPAC Name:

4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine

Test animals / tissue source

Species:

other: isolated bovine corneas

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Duration of treatment / exposure:

10 min

Observation period (in vivo):

2 hrs post-incubation period

Number of animals or in vitro replicates:

Each treatment group (test substance, negative control and positive control) consisted of 3 corneas.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: In vitro Irritancy score (IVIS)

Basis:

mean

Score:

157

Remarks on result:

other: test substance

Results 2

Irritation parameter:

other: In vitro Irritancy score (IVIS)

Basis:

mean

Score:

2.6

Remarks on result:

other: negative control

Results 3

Irritation parameter:

other: In vitro Irritancy score (IVIS)

Basis:

mean

Score:

184

Remarks on result:

other: positive control

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Based on the observed results and applying the evaluation criteria cited in chapter 3.10 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.

Executive summary:

The potential of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane to cause serious damage to the eyes was assessed by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hours post-incubation period. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas. Based on the observed results and applying the evaluation criteria cited in chapter 3.10 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.