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Registration Dossier
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EC number: 947-640-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 to 23 July 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- guideline study not conducted under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on purity; no certificate of analysis of the test substance; non-ocular local and systemic adverse effects were not followed
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-vinyl-1,3-dioxolane
- EC Number:
- 223-626-8
- EC Name:
- 2-vinyl-1,3-dioxolane
- Cas Number:
- 3984-22-3
- Molecular formula:
- C5H8O2
- IUPAC Name:
- 2-vinyl-1,3-dioxolane
- Reference substance name:
- Toluene
- EC Number:
- 203-625-9
- EC Name:
- Toluene
- Cas Number:
- 108-88-3
- Molecular formula:
- C7H8
- IUPAC Name:
- toluene
- Test material form:
- liquid
- Details on test material:
- Batch No.: LF-238-042-F3
Name of test material (as cited in study report): 2-VINYL-1,3-DIOXOLANE
Physical state: colourless liquid
Storage conditions: ambient temperature, protected from light
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbits of the stock New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Source: VIVALIS (49450 Roussay, France)
Weight:> 1.8 kg
Housing: Housed individually in PPO cages with perforated floor
Diet: Pelleted complete rabbit diet "Ergilap Anco" (COFNA, 37018 Tours, France)), ad libitum
Water: Domestic quality drinking water
Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
Temperature: 20 ± 3 °C
Humidity: 50 ± 20 %
Air changes: 10/h
Photoperiod: 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.1 mL
Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period (in vivo):
- 72 hours after the treatment
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Washing: after the first 24 h reading fluorescein was instilled. After rinsing with 5 mL 0.9 % sodium chloride solution, the eyes were examined again.
SCORING SYSTEM: According to OECD Guideline 405
TOOL USED TO ASSESS SCORE: Eyes of the animals were examined with a hand held inspection lamp fitted with white light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritant / corrosive response data:
- At day 5, all scores were at 0.
- Other effects:
- no data
Any other information on results incl. tables
Table 7.3.2/1: Scores for ocular lesions
Rabbit No. |
Region of eye
|
Scores |
|||||
1 h |
24 h |
48 h |
72 h |
Mean# |
|||
9668 |
Cornea |
0 |
2 |
1 |
0 |
1.0 |
|
Iris |
1 |
1 |
0 |
0 |
0.3 |
||
Conjunctiva: redness |
2 |
2 |
1 |
1 |
1.3 |
||
Conjunctiva: chemosis |
2 |
1 |
1 |
0 |
0.7 |
||
9669 |
Cornea |
0 |
1 |
1 |
0 |
0.7 |
|
Iris |
1 |
1 |
1 |
0 |
0.7 |
||
Conjunctiva: redness |
3 |
3 |
2 |
1 |
2.0 |
||
Conjunctiva: chemosis |
1 |
1 |
1 |
1 |
1.0 |
||
9670 |
Cornea |
0 |
1 |
1 |
0 |
0.7 |
|
Iris |
1 |
1 |
0 |
0 |
0.3 |
||
Conjunctiva: redness |
3 |
3 |
2 |
2 |
2.3 |
||
Conjunctiva: chemosis |
1 |
1 |
0 |
0 |
0.3 |
||
#: Mean scores of 24, 48 and 72 h
At Day 5, all scores were at 0.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- The mean scores obtained with 2-vinyl-1,3-dioxolane at 24, 48 and 72 h were 0.8 for cornea, 0.4 for iris, 1.9 for conjunctivae and 0.7 for chemosis, therefore it is not classified as irritating to the eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
- Executive summary:
In an eye irritation study conducted according to OECD Guideline No 405, 3 male albino rabbits of the stock New Zealand White were exposed to 0.1 mL of undiluted 2 -vinyl-1,3 -dioxolane in one eye, while other eye remained untreated and served as control. The eyelids were then gently held together for one hour before releasing. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the method of OECD Guideline No 405.
The calculated mean scores for each individual lesions for all animals within three scoring times (24, 48 and 72 h) were as follows: 0.8 for cornea score; 0.4 for iris score; 1.9 for conjunctivae score and 0.7 for chemosis score. All effects were reversible on Day 5.
Therefore, 2 -vinyl-1,3 -dioxolane is not classified as irritating to the eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
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