Registration Dossier

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:
other: OECD 437
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

Resultsopen allclose all
Irritation parameter:
other: In vitro Irritancy score (IVIS)
Basis:
mean
Score:
157
Remarks on result:
other: test substance
Irritation parameter:
other: In vitro Irritancy score (IVIS)
Basis:
mean
Score:
2.6
Remarks on result:
other: negative control
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.