Registration Dossier
Registration Dossier
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EC number: 259-224-4 | CAS number: 54553-90-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Title:
- No information
- Author:
- Anonymous
- Year:
- 2 007
- Bibliographic source:
- IUCLID4 data set, 2007
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
- EC Number:
- 259-224-4
- EC Name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
- Cas Number:
- 54553-90-1
- Molecular formula:
- C10H6O8.C9H10N2
- IUPAC Name:
- benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
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:
- - Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.3 - 5.3 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Amount of substance instilled: 0.1 g
- Postexposure observation period: 6 days
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, and 6 days 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
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 3.75
- Max. score:
- 110
- Reversibility:
- fully reversible within: 6d
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.94
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 3.75/110
REVERSIBILITY: complete in 6 days
OTHER EFFECTS: distinct redness in nictitating membranes of all animals
at 24 hours only
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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