Registration Dossier
Registration Dossier
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EC number: 243-855-7 | CAS number: 20506-24-5
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
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 U.S Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)
- EC Number:
- 243-855-7
- EC Name:
- Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)
- Cas Number:
- 20506-24-5
- Molecular formula:
- C34 H26 Cl2 Co N8 O8 S2 . C20 H31 N . H
- IUPAC Name:
- (2Z,2'Z)-7,7'-bis(3-chlorophenyl)-15,15'-dimethanesulfonyl-5,5'-dimethyl-9,9',11,11'-tetraoxa-2,2',3,3',6,6',7,7'-octaaza-10-cobalta-10,10'-spirobi[tricyclo[10.4.0.0⁴,⁸]hexadecane]-1(12),1'(12'),2,2',4(8),4'(8'),5,5',13,13',15,15'-dodecaen-10-uide; [1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,8a,9,10,10a-decahydrophenanthren-1-yl]methanaminium
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- see observation period; washing out was conducted for 3/6 animals after 30 sec.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 mL lukewarm water
- Time after start of exposure: 30 sec
SCORING SYSTEM: According to Draize et al. (1959)
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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed
- Irritant / corrosive response data:
- A conjunctival effect was only observed in one animal when rinsing the eye. No other irritating parameters were detected. The irritation index was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae.
Any other information on results incl. tables
Eyes not rinsed:
| Rabbit 4 | Rabbit 5 | Rabbit 6 | |||||||
| Days after application | Cornea | Iris | Conjunctiva | Cornea | Iris | Conjunctiva | Cornea | Iris | Conjunctiva |
| 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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