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EC number: 278-388-8 | CAS number: 76199-85-4
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:
- comparable to guideline study
- Remarks:
- Draize test with an observation period of 8 days
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FED. REG. 38, NO. 187, § 1500.42, S. 27019 (27.09.1973)
- Version / remarks:
- equivalent to OECD test guideline 405
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide
- EC Number:
- 278-388-8
- EC Name:
- 2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide
- Cas Number:
- 76199-85-4
- Molecular formula:
- C16H11N5O4
- IUPAC Name:
- 2-cyano-N-methyl-2-[3-(2,4,6-trioxotetrahydropyrimidin-5(2H)-ylidene)-2,3-dihydro-1H-isoindol-1-ylidene]acetamide
- Details on test material:
- - Physical state: solid, yellow
- Analytical purity: 88 %
- Stability: At least 2 years under normal conditions
- Expiration date of the lot/batch: October 1983
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Mean Weight at study initiation: males: 2.90 kg; females: 2.87 kg
- Housing: one animal per cage, stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm,
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke, Duesseldorf, Germany (about 130 g per animal per day)
- Water (e.g. ad libitum): About 250 ml per animal per day: demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: About 8 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): Conventional (about 30 - 70)
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 75 mg of the triturated test substance)/undiluted - Duration of treatment / exposure:
- unspecified; the substance was not washed out
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h and 8 d after application
- Number of animals or in vitro replicates:
- 6 (3 males, 3 females)
- Details on study design:
- APPLICATION SITE
- Single application to the conjunctival sac of the eyelid
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance is not washed out
SCORING SYSTEM: According to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effects in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- other: animals # 1,2,4,5,6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Discharge was observed in one animal at readings 24-48h (score 2) and 72h (score 1). This was reversible within 8 days.
Any other information on results incl. tables
Table 1: Irritation results
Animal | Reading | Cornea | Iritis | Conjunctiva |
| ||
Opacity | Area | Redness | Chemosis | Symptoms | |||
1 | 24 h | 0 | 0 | 0 | 0 | 0 |
|
2 | 24 h | 0 | 0 | 0 | 0 | 0 |
|
3 | 24 h | 0 | 0 | 0 | 2 | 2 | RE |
4 | 24 h | 0 | 0 | 0 | 1 | 0 |
|
5 | 24 h | 0 | 0 | 0 | 1 | 0 |
|
6 | 24 h | 0 | 0 | 0 | 1 | 0 |
|
1 | 48 h | 0 | 0 | 0 | 0 | 0 |
|
2 | 48 h | 0 | 0 | 0 | 1 | 0 |
|
3 | 48 h | 0 | 0 | 0 | 2 | 1 | RE |
4 | 48 h | 0 | 0 | 0 | 0 | 0 |
|
5 | 48 h | 0 | 0 | 0 | 0 | 0 |
|
6 | 48 h | 0 | 0 | 0 | 0 | 0 |
|
1 | 72 h | 0 | 0 | 0 | 0 | 0 |
|
2 | 72 h | 0 | 0 | 0 | 1 | 0 |
|
3 | 72 h | 0 | 0 | 0 | 1 | 0 | RE |
4 | 72 h | 0 | 0 | 0 | 0 | 0 |
|
5 | 72 h | 0 | 0 | 0 | 0 | 0 |
|
6 | 72 h | 0 | 0 | 0 | 0 | 0 |
|
1 | 8 d | 0 | 0 | 0 | 0 | 0 |
|
2 | 8 d | 0 | 0 | 0 | 0 | 0 |
|
3 | 8 d | 0 | 0 | 0 | 0 | 0 | RE |
4 | 8 d | 0 | 0 | 0 | 0 | 0 |
|
5 | 8 d | 0 | 0 | 0 | 0 | 0 |
|
6 | 8 d | 0 | 0 | 0 | 0 | 0 |
|
Mean animal 1 | 24 - 72 h | 0 | 0 | 0 | 0 | 0 |
|
Mean animal 2 | 24 - 72 h | 0 | 0 | 0 | 0.67 | 0 |
|
Mean animal 3 | 24 - 72 h | 0 | 0 | 0 | 1.67 | 1 |
|
Mean animal 4 | 24 - 72 h | 0 | 0 | 0 | 0.3 | 0 |
|
Mean animal 5 | 24 - 72 h | 0 | 0 | 0 | 0.3 | 0 |
|
Mean animal 6 | 24 - 72 h | 0 | 0 | 0 | 0.3 | 0 |
|
Mean animal 1 - 6 | 24 - 72 h | 0 | 0 | 0 | 0.7 | 0.2 |
|
RE =small retractions in the eyelids
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, the test item is not irritating to the rabbit eye.
- Executive summary:
In a primary eye irritation test the acute eye irritation or corrosion potential of the test substance was assessed by a single ocular application of 0.1 mL bulk volume (about 75 mg) of the unchanged test substance to each one eye of three Vienna White rabbits according to Fed. Reg. 38, No. 187, which is equivalent to OECD test guideline 405. The test item was not washed out. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours as well as 8 days after application.
Slight or moderate conjunctival redness was observed in some animals during the course of the study, while slight to moderate conjunctival chemosis and slight to moderate discharge only were observed in one animal.
The ocular reactions were reversible in all animals within 8 days after application at the latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 0.55 for conjunctival redness and 0.16 for chemosis. Discharge was observed in one animal at readings 24 - 48h (score 2) and 72h (score 1). This was reversible within 8 days
Considering the described ocular reactions as well as the average score for irritation, the test item is not irritating to the rabbit eye.
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