Registration Dossier
Registration Dossier
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EC number: 275-639-3 | CAS number: 71566-54-6
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: Limited data given. Deficiencies: - limited details on animals and husbandry - after application eyes were held open, not closed - eyes of female animals were rinsed 30 seconds after treatment - no data on chemosis
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (- limited details on animals and husbandry - after application eyes were held open, not closed - eyes of female animals were rinsed 30 seconds after treatment - no data on chemosis)
- GLP compliance:
- no
Test material
- Reference substance name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- EC Number:
- 275-639-3
- EC Name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Cas Number:
- 71566-54-6
- Molecular formula:
- C50 H42 Cl2 N6 O8
- IUPAC Name:
- diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Test material form:
- solid
- Details on test material:
- The test material is identified by its trade name.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: singly
- Diet (ad libitum): NAFAG rabbit food
- Water (ad libitum): drinking water
No further details.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single treatment of male and female animals; exposure of 30 seconds for female animals
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male and 3 female animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of female rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
SCORING SYSTEM: according to Draize J.H., Woodard G., Calvery H.O. (1944). "Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes". J. Pharmacol. And Exp. Therapeutics 82: 377–390.
TOOL USED TO ASSESS SCORE: slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1-24-48-72 hours post treatment
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: applies for females (eyes rinsed after treatment) and males (eyes not rinsed after treatment)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-24-48-72 hours post treatment
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: applies for females (eyes rinsed after treatment) and males (eyes not rinsed after treatment)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1-24-48-72 hours post treament
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: applies for females (eyes rinsed after treatment) and males (eyes not rinsed after treatment)
- Irritant / corrosive response data:
- No data concerning chemosis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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