Registration Dossier
Registration Dossier
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EC number: 276-675-2 | CAS number: 72479-28-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics (1959) of the association (AFDO).
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
- EC Number:
- 276-675-2
- EC Name:
- Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
- Cas Number:
- 72479-28-8
- Molecular formula:
- C22H14Cl3N4NaO5S
- IUPAC Name:
- sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Exp. Toxicology, CIBA-Geigy Ltd.- Housing: single housing in V2A wire cages - Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.1 g
- Duration of treatment / exposure:
- few seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (3 males + 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.SCORING SYSTEM: according to DraizeTOOL 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: 24, 48, 72 hours
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed and rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.665
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed and rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed
- Irritant / corrosive response data:
- The tested substance showed some irritating effect of conjunctivae (redness) during the first 24 hours but the irritation signs were fully reversible within 96 hours for the unrinsed eyes. No effects on iris and on cornea and for chemosis.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation during the first 24 hours, the irritation effects were fully reversible. The test material is considered to be not irritating to the eye.
- Executive summary:
Based on the test results, the test material is considered to be not irritating to the eye.
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