Registration Dossier
Registration Dossier
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EC number: 939-383-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[4-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonamide, reaction products with aqueous organic chromium(III) complex sodium salt, then laked with acidified C10-14-tert-alkyl(linear and branched) amines
- EC Number:
- 939-383-2
- Molecular formula:
- UVCB substance
- IUPAC Name:
- 3-[4-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonamide, reaction products with aqueous organic chromium(III) complex sodium salt, then laked with acidified C10-14-tert-alkyl(linear and branched) amines
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: no data
- Weight at study initiation: 2510 to 2810 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-12-01 To: 1993-12-11
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL (56 mg)
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h - 3 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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