Registration Dossier
Registration Dossier
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EC number: 287-007-4 | CAS number: 85408-46-4
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- EC Number:
- 287-007-4
- EC Name:
- Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- Cas Number:
- 85408-46-4
- Molecular formula:
- C17H12N4O3 . C17H12N4O3 . Cr. C12H28N to C14H32N
- IUPAC Name:
- Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single housing in V2A wire cages
- Diet: NAFAG (Gossau SG) rabbit food ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- single treatment (30 seconds)
- Observation period (in vivo):
- The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.
SCORING SYSTEM:
on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
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: days 1,2,3,4,7 after application
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: days 1,2,3,4,7 after application
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: days 1,2,3,4,7 after application
- Score:
- 0.2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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