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EC number: 202-603-6 | CAS number: 97-72-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 2 animals tested; 50µl instead of 100µl instilled; no observation point after 72 hours, Maximum observation time was 8 days
- GLP compliance:
- no
Test material
- Reference substance name:
- Isobutyric anhydride
- EC Number:
- 202-603-6
- EC Name:
- Isobutyric anhydride
- Cas Number:
- 97-72-3
- Molecular formula:
- C8H14O3
- IUPAC Name:
- isobutyric anhydride
- Details on test material:
- - Physical state: liquid
no further data provided
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 3.08 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: treatment of the control eye with physiol. saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- not washed out
- Observation period (in vivo):
- 1, 24, 48 hours and after 8 days
- Number of animals or in vitro replicates:
- 2 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize (re-evaluation according to the scoring system of Draize as recommended by the actual guideline requirements
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 and 48 hours
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 and 48 hours
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 and 48 hours
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 and 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
Table 1: Individual results:
Readings |
Animal |
Cornea |
Iris |
conjunctiva |
Symptoms |
||
opacity |
redness |
swelling |
discharge |
||||
1 h |
1 |
1 |
0 |
2 |
2 |
2 |
|
2 |
1 |
0 |
2 |
2 |
2 |
|
|
24 h |
1 |
1 |
0 |
1 |
2 |
1 |
|
2 |
2 |
0 |
2 |
2 |
1 |
|
|
48 h |
1 |
2 |
1 |
2 |
2 |
3 |
|
2 |
2 |
1 |
2 |
2 |
3 |
Na |
|
8d |
1 |
1 |
0 |
1 |
0 |
1 |
|
2 |
1 |
0 |
1 |
0 |
0 |
Na |
|
mean 24 - 48 h |
1 |
1.5 |
0.5 |
1.5 |
2.0 |
2.0 |
|
2 |
2.0 |
0.5 |
2.0 |
2.0 |
2.0 |
|
|
mean |
|
1.8 |
0.5 |
1.8 |
2.0 |
2.0 |
|
Na: Scar
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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