Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
EC Number:
406-370-3
EC Name:
3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
Cas Number:
58890-25-8
Molecular formula:
C27H36N4O2
IUPAC Name:
3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Nature of substance: Powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
46 mg
Duration of treatment / exposure:
Not reported
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Remarks on result:
other: Mean
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Remarks on result:
other: Mean
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Max. score:
2
Remarks on result:
other: Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Remarks on result:
other: Mean
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Remarks on result:
other: Mean
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Remarks on result:
other: Mean
Irritation parameter:
chemosis score
Basis:
mean
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean
Irritation parameter:
cornea opacity score
Basis:
mean
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean
Irritation parameter:
iris score
Basis:
mean
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
All response observed were fully reversible within 7 days. Maximun duration of conjunctival redness was 7 days.
Other effects:
No signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was observed to have conjunctivae redness scores of 0.7, 1.3 and 1.7, and chemosis scores of 0.3, 0.7 and 1 1 for the 3 test animals at 24, 48 and 72 hours. A maximum score of 2 was observed for both conjunctivae and chemosis. The cornea and iris scores for all animals were 0. Any changes observed were fully reversible within 7 days and no signs of clinical toxicity were observed. Therefore, the test item is not classified for eye irritation
Executive summary:

The eye irritancy potential of the test item was investigated at a concentration of 46 mg with New Zealand White rabbits according to a standard guideline. The test item was observed to have conjunctivae redness scores of 0.7, 1.3 and 1.7, and chemosis scores of 0.3, 0.7 and 1 1 for the 3 test animals at 24, 48 and 72 hours. A maximum score of 2 was observed for both conjunctivae and chemosis. The cornea and iris scores for all animals were 0. Any changes observed were fully reversible within 7 days and no signs of clinical toxicity were observed. Therefore, the test item is not classified for eye irritation

The study is a GLP compliant, guideline study and is acceptable with restrictions for evaluation of this endpoint.