Registration Dossier
Registration Dossier
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EC number: 276-701-2 | CAS number: 72496-88-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 3, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)
- EC Number:
- 276-701-2
- EC Name:
- Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)
- Cas Number:
- 72496-88-9
- Molecular formula:
- C32H28CoN8NaO10S2
- IUPAC Name:
- monosodium bis[2-((E)-((Z)-3-oxido-1-oxo-1-(phenylamino)but-2-en-2-yl)diazenyl)-4-sulfamoylphenolate (2-)] cobaltate (1-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: IVANOVAS
- Weight at study initiation: 2-3 kg
- Housing:individually in metal cages
- Diet: rabbit food - NAFAG, No. 814, Gossau SG ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g
After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline - Duration of treatment / exposure:
- After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline
- Observation period (in vivo):
- The rabbits were examined 1, 24, 48, 72 hours and 7 days
- Number of animals or in vitro replicates:
- The test was performed on 3 male and 3 female adult rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes
TOOL USED TO ASSESS SCORE:
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was found to cause no irritation when applied to the rabbit eye mucosa.
- Executive summary:
The substance has been tested for eye irritation according to (EPA) § 163.81-4 "Primary eye irritation study". According to the Regulation EC n. 1272/2008 the test material was found to cause no irritation when applied to the rabbit eye mucosa.
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