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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diphenyl carbonate
EC Number:
203-005-8
EC Name:
Diphenyl carbonate
Cas Number:
102-09-0
Molecular formula:
C13H10O3
IUPAC Name:
diphenyl carbonate
Details on test material:
purity: 99.95 %, Phenol 0.05 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
females

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated, and thus served as a control
Amount / concentration applied:
Concentration: 100 %
The test substance was ground to a fine powder and a dose of 0.1 grams was administered to the left eye of each animal.
Duration of treatment / exposure:
The eyes of the test animals were not washed out for 24 hours following instillation. 
Observation period (in vivo):
Eyes were examined at 1,  24, 48, and 72 hours after treatment using the Draize scale.
Number of animals or in vitro replicates:
6
Details on study design:
Fluorescein staining was used during each examination, excluding the 1 hour examination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, and 72 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible within: the first 24 hours after treatment
Remarks on result:
other: Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points, therefore the study was not continued
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating according to EU criteria
Conclusions:
Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.
Executive summary:

The eye irritation potential of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 405 under GLP conditions.

The test material was ground to a fine powder and a dose of 0.1 grams was administered into the left eye of six female New Zealand White rabbits. The eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points.

Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.