Registration Dossier
Registration Dossier
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EC number: 288-678-6 | CAS number: 85865-79-8
Eye irritation
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:
- 1 986
- 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
- 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
Constituent 1
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.
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