Registration Dossier
Registration Dossier
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EC number: 276-344-2 | CAS number: 72102-84-2
Eye irritation
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid
- EC Number:
- 276-344-2
- EC Name:
- 5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid
- Cas Number:
- 72102-84-2
- Molecular formula:
- C12H10N6O4
- IUPAC Name:
- 5-[(1E)-2-(6-methyl-2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)diazen-1-yl]-1,3-diazinane-2,4,6-trione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: LV 86
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Age at study initiation: adult
- Weight: 1.5-2 kg
- Housing: individually in metal cages
- Diet: ad libitum access to standard rabbit food - NAFAG, Gossau SG
- Water: ad libitum access to water
- Acclimation period: a minimum of 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: Untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- one instillation
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6: 3 male, 3 female
- Details on study design:
- Application: The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
SCORING SYSTEM: The eye irritation was appraised on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit on Cornea (Opacity, Area involved), Iris and Conjunctiva (Redness, Chemosis, Discharge).
TOOL USED TO ASSESS SCORE: slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.67
- Max. score:
- 4
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 2-7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- other: primary irritation index
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0.33
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- other: primary irritation index
- Basis:
- mean
- Time point:
- other: 1-7 days
- Score:
- 0
- Remarks on result:
- other: rinsed eyes
- Irritant / corrosive response data:
- The test substance was found to cause a minimal irritation when applied to the rabbit eye mucosa.
Any other information on results incl. tables
Time after exposure days |
Mean reaction score of 3 rabbits per inspection time |
|||||
Unrinsed eyes |
Rinsed eyes |
|||||
Cornea |
Iris |
Conjunctiva |
Cornea |
Iris |
Conjunctiva |
|
1 |
1.67 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
Subtotal |
1.67 |
0 |
0 |
0 |
0 |
0 |
Total |
1.67 |
0 |
||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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