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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:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1986
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium
EC Number:
288-678-6
EC Name:
Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium
Cas Number:
85865-79-8
Molecular formula:
C34H23CrLiN8NaO9S
IUPAC Name:
Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium
Test material form:
solid: particulate/powder
Details on test material:
Acid Yellow 232

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK ltd.
- Housing: individual, Cage type III-high
- Weight at study initiation: 3.0 - 3.4kg
- Diet (e.g. ad libitum): "ssniff K4" ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 14days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 45 - 65%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µl (approx. 40 mg) of the powder
Duration of treatment / exposure:
24h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24h

SCORING SYSTEM: Draize-grade

TOOL USED TO ASSESS SCORE: hand slit-lamp, fluorescein (1%), UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 & #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1 & #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #2 & #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At 24 and 48 h, one animal showed a positive fluorescense test

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acid Yellow 232 showed weak eye irritating effects within 48 hours after test item application, which did not trigger classification according to GHS.