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Registration Dossier
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EC number: 277-823-9 | CAS number: 74336-59-7
Toxicological information
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:
- other: Comparable to OECD Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38, No. 187, § 1500.42, p. 27019 of Sep. 27, 1973
- Deviations:
- no
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one
- EC Number:
- 277-823-9
- EC Name:
- 3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one
- Cas Number:
- 74336-59-7
- Molecular formula:
- C17H11ClN6O3
- IUPAC Name:
- 3-[(4-chloro-2-nitrophenyl)diazenyl]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one
- Details on test material:
- - Name of test material (as cited in study report): Pigmentorange Kan 78/1775
- Test substance number: 80/404
- Physical state: solid, orange
- Analytical purity: > 98 %
- Lot/batch No.: Batch 8
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Mean weight at study initiation: males 2.87 kg (2.99, 3.03, 2.82, 2.62 kg), females 2.87 kg (2.54, 3.19 kg)
- Housing: 1 animal per cage; Cage made of stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, Duesseldorf 1, Germany (about 130 g per animal daily)
- Water: About 250 ml water per animal daily: fully demineralized water (Mondays - Fridays), tap water (Saturday/Sunday)
- Acclimation period: about 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (corresponding to about 15 mg of pulverized test substance)
- Concentration (if solution): undiluted
- Application site: Conjunctival sac of the right eyelid - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 (4 males and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not rinsed
SCORING SYSTEM: According to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health
READINGS: 1, 24, 48 and 72 h after the beginning of application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of animal 1, 3, 4, 5, 6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of animal 1, 2, 5, 6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Primary irritation index = 1
- Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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