Registration Dossier
Registration Dossier
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EC number: 275-640-9 | CAS number: 71566-55-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- 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 guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drogs and Cosmetics" published by the Editorial Committee of the Association of Food and Drug Officials of the United States of America.
- Version / remarks:
- 1965
- GLP compliance:
- no
Test material
- Reference substance name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-N-3-(isopropoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)
- EC Number:
- 275-640-9
- EC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-N-3-(isopropoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)
- Cas Number:
- 71566-55-7
- Molecular formula:
- C44H50CoN10O10S2.C28H31N2O3
- IUPAC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-N-3-(isopropoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3-5 months
- mean weight at study initiation: males 2.90 kg, females 2.73 kg
- Housing: Rabbits were caged singly in a room.
- Diet: commercial irradiated diet (Styles-Oxoid) was fed ad libitum and sterile filtered water was available at all times.
- Acclimation period: six rabbits were maintained under pretest conditions for one week prior to the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): Animals were exposed to fifteen hours of artificial light from 8.00 hours to 23.00 hours daily.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and shaved
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance was mixed with 0.5 mL 66 OP Industrial Spirit - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application side: back
- % coverage: at least 10% of the total body surface
- Type of wrap if used: aluminium foil secured with "sleek" adhesive tape, which was in turn covered by Coban 6 wide self-adhering elastic bandages
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h, 72h
- Score:
- 0.09
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 72 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h, 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- Due to the staining of the stratum corneum by the test compound, it was impossible to assess the degree of erythema.
Any other information on results incl. tables
Histopathological report on Biopsy Specimens:
One animal No. 15 revealed a minimal acanthosis of the epidermis. This lesion is of little significance and is such as might be caused by clipping and cleaning the area of skin involved.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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