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EC number: 308-114-5 | CAS number: 97862-65-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- EC Number:
- 308-114-5
- EC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Cas Number:
- 97862-65-2
- Molecular formula:
- C40H28CrN8O10S2.C28H31N2O3.C20H32N
- IUPAC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): drinking water, ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +-3 °C
- Humidity: 55 +/- 15 %
- Air changes: 15 per h
- Photoperiod: 12/12 h dark/light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 - Duration of treatment / exposure:
- Following administration, the lids were gently closed for 15 seconds.
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of steile pysiological saline. - Observation period (in vivo):
- The eyes were examined 24, 48, 72 hours and 4 and 7 days after treatment.
- Number of animals or in vitro replicates:
- 6 in total. 3 males (unrinsed) and 3 females (rinsed).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: For three females of the six test animals, the treated eyes were flushed with saline 30 seconds after treatment.
SCORING SYSTEM: : The eye irritation scores were evaluated according to the scoring system by OECD and Draize (1977)
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- female
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- female
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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