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Registration Dossier
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EC number: 241-793-5 | CAS number: 17832-28-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study already available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-(vinyloxy)butan-1-ol
- EC Number:
- 241-793-5
- EC Name:
- 4-(vinyloxy)butan-1-ol
- Cas Number:
- 17832-28-9
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 4-(ethenyloxy)butan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Vinyl-4-Hydroxybutylether
- Physical state: liquid
- Analytical purity: approximately 100%
- Expiration date of the lot/batch: April 1984
- Stability under test conditions: not reported
- Storage condition of test material: not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler, 6050 Offenbach
- Weight at study initiation: female-3.33 kg, mean weight for males was 3.58 kg
- Housing: single
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Dusseldorf (ca. 130 g/animal/day)
- Water: tap water (ca. 250 ml/animal/day)
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 (6:00-18:00 hrs/18:00-6.00hrs)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent untreated eye of same animals served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml undiluted - Duration of treatment / exposure:
- Treatment was once. The eye was left unwashed.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 (2 males and 1 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
Animal |
Reading |
Opacity |
Iritis |
Redness |
Chemosis |
Symptoms |
1 |
1 h |
0 |
0 |
2 |
3 |
|
2 |
1 h |
0 |
0 |
2 |
2 |
|
3 |
1 h |
0 |
0 |
2 |
3 |
|
1 |
24 h |
1 |
1 |
2 |
1 |
|
2 |
24 h |
1 |
1 |
2 |
1 |
scar on upper lid and retraction of upper lid |
3 |
24 h |
1 |
0 |
2 |
2 |
scar on upper lid and retraction of upper lid |
1 |
48 h |
1 |
1 |
2 |
1 |
scar on upper lid and retraction of upper lid/ constricted pupil |
2 |
48 h |
1 |
0 |
2 |
1 |
scar on upper lid and retraction of upper lid/ constricted pupil |
3 |
48 h |
1 |
0 |
2 |
1 |
scar on upper lid and retraction of upper lid/ constricted pupil |
1 |
72 h |
1 |
0 |
2 |
1 |
scar on upper lid and retraction of upper lid/ constricted pupil |
2 |
72 h |
1 |
0 |
2 |
1 |
scar on upper lid and retraction of upper lid/ constricted pupil |
3 |
72 h |
1 |
0 |
2 |
1 |
scar on upper lid and retraction of upper lid/ constricted pupil |
1 |
8 d |
1 |
0 |
1 |
0 |
scar on upper lid and retraction of upper lid/ constricted pupil/ cornea ablation |
2 |
8 d |
0 |
0 |
1 |
0 |
scar on upper lid and retraction of upper lid |
3 |
8 d |
0 |
0 |
1 |
0 |
scar on upper lid and retraction of upper lid |
1 |
14 d |
0 |
0 |
1 |
0 |
scar on upper lid and retraction of upper lid |
2 |
14 d |
0 |
0 |
1 |
0 |
scar on upper lid and retraction of upper lid |
3 |
14 d |
0 |
0 |
1 |
0 |
scar on upper lid and retraction of upper lid |
mean |
24 - 72 h |
1.00 |
0.33 |
2.00 |
1.10 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Executive summary:
This study was conducted according to guidelines with no GLP. 0.1 mL of the unchanged test substance was instilled to the eyes of three rabbits and left unwashed. The scores for cornea, iris, conjunctivae and chemosis were 1.0, 0.3, 2.0 and 1.1, respectively (mean of the 24, 48 and 72 h readings).
Conclusion: According to the test results, 4-(vinyloxy)butan-1 -ol is irritating to eye (GHS cat. 2A).
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