Registration Dossier
Registration Dossier
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EC number: 275-640-9 | CAS number: 71566-55-7
Eye irritation
Administrative data
- Endpoint:
- eye 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation under the Federal Hazardous Substance Labelling Act (February 1965) Part 191.12(b)(2)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3-5 months
- mean body weight at study initiation: males 2.90 kg and females 2.73 kg
- Housing: 6 rabbits were maintained under pretest conditions for one week prior to to the test.
- Diet: a commercial irradiated diet /Styles-Oxoid) was fed ad libitum
- Water: water was available at all times.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 - 70%
- Photoperiod (hrs dark / hrs light): animals were exposed to fifteen hours of artificial light from 08.00 hours to 23.00 hours daily.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg (= 0.1 mL bulk volume) - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- - the test substance was applied into the conjunctival sac of the left eye. The eyelids were then closed for one second.
- the non-treated left eye served as control
- the test substance was not washed out
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 3
Any other information on results incl. tables
Clinical Symptoms:
1 hour: Very mild ptosis present in one animal (male)
2. hours. Very mild ptosis present in one male and one female
4 hours: All animals normal and remained normal until autopsy
The nature of the material precluded any further detailed assessment at the times other than the examination of the lids and evidence of chemosis.
Autopsy:
No lesions attributed to the compound were found
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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