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EC number: 263-793-4 | CAS number: 63022-06-0
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:
- 25 Mar 1996 - 17 Apr 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate
- EC Number:
- 263-793-4
- EC Name:
- Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate
- Cas Number:
- 63022-06-0
- Molecular formula:
- Not applicable as the substance is UVCB
- IUPAC Name:
- reaction products of ethyl 2-[3-(ethylamino)-6-ethylimino-2,7-dimethylxanthen-9-yl]benzoate with silicomolybdic acid
- Test material form:
- solid: nanoform
- Details on test material:
- Shape
Shape Category: spheroidal
Shape: spherical
Pure Shape: Yes
Typical Composition: ≤100%
range: >0; ≤100%
Particle size distribution & range
Shape Category: spheroidal
Percentile D10, typical value: 35nm
Percentile D10, range: ≥10; ≤50nm
Percentile D50, typical value: 50nm
Percentile D50, range: ≥35; ≤100nm
Percentile D90, typical value: 85nm
Percentile D90, range: ≥50; ≤150nm
Fraction in size range 1-100nm: ≥50; ≤100%
Crystallinity
structure: Amorphous
Pure structure: Yes
Specific Surface Area
Typical specific surface area: ca. 45m2/g
Range: ≥10; ≤200m2/g
Skeletal density: ca. 1,8 g/cm3
Surface Functionalisation/treatment
surface treatment applied: no
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: LUMIERE PINK 8135C
- Storage: room temperature
- Description: dark maroon powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 – 16 weeks old
- Weight at study initiation: 2.54 – 2.73 kg
- Housing: suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 45 - 69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (=49 mg) - Duration of post- treatment incubation (in vitro):
- 1, 24, 48 and 72 hours, additional observatios were made on Days 7, 14 and 21
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): N/A
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no opacity noted
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
Any other information on results incl. tables
| animal #1 | animal #2 | animal #3 | |||||||||||
| 24 h | 48 h | 72 h | mean animal #1 | 24 h | 48 h | 72 h | mean animal #2 | 24 h | 48 h | 72 h | mean animal #3 | mean |
|
Conjunctival Redness |
2 |
1 |
1 |
1.3 |
1 |
1 |
0 |
0.7 |
2 |
2 |
2 |
2 |
1.3 |
Conjunctival Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0.7 |
2 |
2 |
2 |
2 |
0.9 |
| Iritis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0.3 |
Corneal opacity |
1 |
0 |
0 |
0.3 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0.6 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item was found to irritating to rabbit eye.
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