Registration Dossier
Registration Dossier
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EC number: 243-855-7 | CAS number: 20506-24-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 US 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
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- other: polyethylene glycol
- Controls:
- other: Untreated skin served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- see observation period; no washing was done
- Observation period:
- 72 hours
- Number of animals:
- 6 (3x shaved; 3x abraded)
- Details on study design:
- TEST SITE
- Area of exposure: whole back and flanks
- coverage: 2.5x2.5 cm gauze patch soaked with the test substance
- Type of wrap if used: plastic film fixed with adhesive tape
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite
raising 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scarified skin
- Irritant / corrosive response data:
- No irritating effects were seen in any of the six animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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