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Toxicological information

Eye irritation

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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:
1980
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

Constituent 1
Chemical structure
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

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.