Registration Dossier
Registration Dossier
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EC number: 616-083-7 | CAS number: 74351-78-3
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:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-[(2E)-2-[1-({4-[(2E)-2-[2-(5-carboxy-2-chlorophenyl)hydrazin-1-ylidene]-3-oxobutanamido]-2,5-dimethylphenyl}carbamoyl)-2-oxopropylidene]hydrazin-1-yl]-4-chlorobenzoic acid
- EC Number:
- 616-083-7
- Cas Number:
- 74351-78-3
- Molecular formula:
- C30 H26 Cl2 N6 O8
- IUPAC Name:
- 3-[(2E)-2-[1-({4-[(2E)-2-[2-(5-carboxy-2-chlorophenyl)hydrazin-1-ylidene]-3-oxobutanamido]-2,5-dimethylphenyl}carbamoyl)-2-oxopropylidene]hydrazin-1-yl]-4-chlorobenzoic acid
- Details on test material:
- - Batch No.: OP 31
- Purity: commercial grade
- Physical properties: solid; insoluble in water
- Storage conditions: room temperature
- Safety precautions: gloves and face masks
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2270 to 2660 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water (e.g. ad libitum): ad libitum fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours/ 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (62 mg) - Duration of treatment / exposure:
- The test substance was placed into the conjunctival sac of the left eye of each animal. The lids were then held together for about one second in order to prevent loss of the test article.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Rinsing was not reported.
SCORING SYSTEM: OECD scoring system
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 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Slight red ness was observed from one to 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: Slight redness was observed after one hour.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Sight redness was obserev from one to 72 hours.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: Slight chemosis was observed in all animals after one hour .
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD EU
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