Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 253-256-2 | CAS number: 36888-99-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
- EC Number:
- 253-256-2
- EC Name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
- Cas Number:
- 36888-99-0
- Molecular formula:
- C16H9N5O6
- IUPAC Name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dipyrimidine-2,4,6(1H,3H,5H)-trione
- Test material form:
- solid: nanoform
- Details on test material:
- - Physical state: Solid; ground / dark yellow
- Analytical purity: 92 %
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- - Physical state: Solid; ground / dark yellow
- Analytical purity: 92 %
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: about 6 months
- Weight at study initiation: 3.60 kg - 3.95 kg
- Housing: single
- Diet (e.g. ad libitum): Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12h/12h
Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 26 mg of the comminuted test substance)
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48, 72 h and 7 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
The treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure:
About 1 hour after application of the solid test substance
SCORING SYSTEM: Draize test
TOOL USED TO ASSESS SCORE:
Daylight tubes "Lumilux" (L 58W/860 PLUS EGO 25X1, Osram, Germany)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: see table for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24/48 h
- Remarks on result:
- other: fully reversible in 1/3 animals within 24 h, in 2/3 animals within 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h (mean)
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h (mean)
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h (mean)
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h (mean)
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h (mean)
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Other effects:
- Discharge: mean 24 - 72 h: 0.22/max.score 3; reversible in 1/3 animals within 24 h; in 2/3 animals within 48 h.
Any other information on results incl. tables
Animal |
Reading |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
|
|
Opacity |
Cornea area |
|
Redness |
Chemosis |
Discharge |
|
1 |
1 h |
0 |
0 |
0 |
2 |
1 |
1 |
Scleral vessels injected, circular |
2 |
1 h |
0 |
0 |
0 |
2 |
1 |
2 |
Scleral vessels injected, circular |
3 |
1 h |
0 |
0 |
0 |
2 |
1 |
2 |
Scleral vessels injected, circumscribed area |
1 |
24 h |
0 |
0 |
0 |
2 |
0 |
0 |
Scleral vessels injected, circumscribed area |
2 |
24 h |
0 |
0 |
0 |
2 |
1 |
1 |
Scleral vessels injected, circumscribed area |
3 |
24 h |
0 |
0 |
0 |
2 |
1 |
1 |
Scleral vessels injected, circumscribed area |
1 |
48 h |
0 |
0 |
0 |
1 |
0 |
0 |
Scleral vessels injected, circumscribed area |
2 |
48 h |
0 |
0 |
0 |
1 |
0 |
0 |
Scleral vessels injected, circumscribed area |
3 |
48 h |
0 |
0 |
0 |
2 |
0 |
0 |
Scleral vessels injected, circumscribed area |
1 |
72 h |
0 |
0 |
0 |
1 |
0 |
0 |
Scleral vessels injected, circumscribed area |
2 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Study discontinued because the animal was free of findings |
3 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Study discontinued because the animal was free of findings |
1 |
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
|
| mean | animal 1 24 - 72 h |
0.00 |
0.00 |
1.33 |
0.00 |
|||
| mean | animal 2 24 - 72 h |
0.00 |
0.00 |
1.00 |
0.33 |
|||
| mean | animal 3 24 - 72 h |
0.00 |
0.00 |
1.33 |
0.33 |
|||
| mean | total 24 - 72 h |
0.00 |
0.00 |
1.22 |
0.22 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
