Registration Dossier
Registration Dossier
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EC number: 259-226-5 | CAS number: 54553-91-2
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:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- GLP was not implemented at the time of study conduct.
Test material
- Reference substance name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
- EC Number:
- 259-226-5
- EC Name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
- Cas Number:
- 54553-91-2
- Molecular formula:
- C10H6O8.2C9H10N2
- IUPAC Name:
- benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g of 100% substance
- Duration of treatment / exposure:
- 72h not rinsed
- Observation period (in vivo):
- 6d
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.0 - 5.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Postexposure observation period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data
sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual
inspections
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.33
- Conjunctivae (Chemosis): 0
- Overall irritation score: 1.67/110
REVERSIBILITY: complete within 72 hours
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test Item is considered not irritating based to the availabel data according to OECD405 in rabbits.
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