Registration Dossier
Registration Dossier
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EC number: 616-079-5 | CAS number: 74336-55-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1984
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:
- 2-methyl-1H,9H-pyrazolo[3,2-b]quinazolin-9-one
- EC Number:
- 616-079-5
- Cas Number:
- 74336-55-3
- Molecular formula:
- C11 H9 N3 O
- IUPAC Name:
- 2-methyl-1H,9H-pyrazolo[3,2-b]quinazolin-9-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, GER
- Age at study initiation: not specified
- Weight at study initiation: 3.06 kg, 2.45 kg and 2.53 kg
- Housing: single housing in stainless steel cages with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: Ovator Solikanin 4 mm; Muskator-Werke D-4000 Düsseldorf-1, GER (about 130 g per animal per day)
- Water: About 250 ml per animal per day: demineralized vater (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: at least 8 days before study start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 - 20 times/h
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml bulk volume (ca. 40 mg of the triturated test substance)
- Duration of treatment / exposure:
- Single application to the conjunctival sac of the eyelid; the substance is not washed out
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize Scoring System, readings 1 h, 24 h, 48 h and 72 h after application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Mild redness of the conjunctiva was observed in all animals starting at 1h after instillation, reversible within 48 hours the latest.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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