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EC number: 210-478-4 | CAS number: 616-38-6
Eye irritation
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:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200, January 28 1985.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimethyl carbonate
- EC Number:
- 210-478-4
- EC Name:
- Dimethyl carbonate
- Cas Number:
- 616-38-6
- Molecular formula:
- C3H6O3
- IUPAC Name:
- dimethyl carbonate
- Details on test material:
- - Name of test material (as cited in study report): Dimethyl carbonate
- Substance type:
- Physical state: Colourless liquid
- Analytical purity: Not stated
- Purity test date: Not given
- Lot/batch No.: E2D2307
- Expiration date of the lot/batch: Not given
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks approx.
- Weight at study initiation: 2.60 - 3.10 kg
- Housing: The animals were indiVidually housed in suspended metal cages.
- Diet (e.g. ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol available ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21°C
- Humidity (%): 47-66%
- Air changes (per hr): 15
IN-LIFE DATES: From: 2 November 1992 To: 9 November 1992.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated (left) eye of treated animals used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Group 1: applied without washing
Group 2: 2-3 minutes after application of the test material, treated eye irrigated - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Group 1: 6
Group 2: 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 2, eye washed
- Time after start of exposure: 2-3 minutes after exposure
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix II, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were
designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + 8 + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
A modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chern., 1962 13 281-289 was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential
of the test material.
TOOL USED TO ASSESS SCORE: light source from opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- group 1
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 9.5
- Max. score:
- 29
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: one rabbit, reversible within 7 days
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 2
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- animal 16 female
- Time point:
- 24/48/72 h
- Score:
- 8.3
- Max. score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- animal 73 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- animal 57 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- animal 46 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- animal 72 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- animal 71 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- animal 16 female
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- animal 73 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- animal 57 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- animal 46 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- animal 72 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- animal 71 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- animal 16 female
- Time point:
- 24/48/72 h
- Score:
- 19.7
- Max. score:
- 27
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- animal 73 male
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- animal 57 male
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- animal 46 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- animal 72 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- animal 71 female
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- animal 16 female
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- animal 73 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- animal 57 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- animal 46 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- animal 72 male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- animal 71 female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Results given above give the maximum group mean score for each treatment group, which was achieved 1 hour after exposure to the test substance. In group 1 one rabbit had a score of 29, indicating a positive effect. The effects on this rabbit were fully reversible after 7 days. The effects in the remaining rabbits in group 1 were fully reversible within 72 hours. In group 2 no corneal or iridial effects were noted during the study. Minimal conjunctival redness was noted in two treated eyes one hour after treatment. All treated eyes were normal 24 hours after treatment.
Table 1 and 2 below give the individual total scores for ocular irritation at each time point for each rabbit in groups 1 and 2.
Table 1. Individual Total Scores For Ocular Irritation Group 1, dimethylcarbonate applied as supplied, no irrigation
Rabbit No.
|
16F |
73M |
57M |
46F |
72M |
71F |
||||||||||||||||||
Time Point (hrs) |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Overall Score |
29 |
27 |
23 |
9 |
6 |
2 |
0 |
0 |
6 |
2 |
0 |
0 |
4 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
8 |
2 |
0 |
0 |
Note: Score for rabbit 16F returned to 0 after 7 days.
Table 2. Individual Total Scores For Ocular Irritation Group 2, dimethylcarbonate applied as supplied, with irrigation
Rabbit No.
|
44M |
70M |
48M |
|||||||||
Time Point (hrs) |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Overall Score |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-irritating on a 1 to 8 scale
- Remarks:
- Criteria used for interpretation of results: other: modified Kay and Calandra scoring system
- Conclusions:
- The test material instilled without irrigation of the eye, produced positive effects in one rabbit although no reactions were found in the other rabbits.
The test material when applied as supplied and washed from the eye 2-3 minutes after treatment produced a maximum group mean score of 1.3 and was classified as non-irritating (class 1 on a 1 - 8 scale) to the rabbit eye by a modified Kay and Caleandra clssification system. No positive effects were noted.
According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (3.32.7.1 -2, Table 3.3.2), dimethyl carbonate is not classified as irritating to the eyes.
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