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EC number: 214-881-6 | CAS number: 1205-17-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 March 2006 to 23 March 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- The eye irritation potential of three batches of the test material was assessed in the rabbit.
- GLP compliance:
- no
Test material
- Reference substance name:
- α-methyl-1,3-benzodioxole-5-propionaldehyde
- EC Number:
- 214-881-6
- EC Name:
- α-methyl-1,3-benzodioxole-5-propionaldehyde
- Cas Number:
- 1205-17-0
- Molecular formula:
- C11H12O3
- IUPAC Name:
- 3-(1,3-benzodioxol-5-yl)-2-methylpropanal
- Details on test material:
- - Appearance: Light yellow liquid, Clear Liquid
- Stability: There was no apparent change in the physical state of the test material during administration
- Storage conditions of test material: Room temperature, protected from exposure to light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: JW
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL/eye - Duration of treatment / exposure:
- Eyes were closed for about 1 second after instillation.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male animals were exposed to each batch of test material (9 animals in total)
- Details on study design:
- SCORING SYSTEM
The Draize scoring system was used. Reactions were assessed 1, 24, 48 and 72 hours after test material application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- score for all 9 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean score for all 9 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- score for all 9 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- score for all 9 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- score for all 9 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.
Any other information on results incl. tables
Table 1: Summary of Scores for the First Batch of Test Material
Animal number |
Observation |
Time (hours) |
|||
1 |
24 |
48 |
72 |
||
601 (right eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
602 (left eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
603 (right eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
Table 2: Summary of Scores for the Second Batch of Test Material
Animal number |
Observation |
Time (hours) |
|||
1 |
24 |
48 |
72 |
||
611 (right eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
612 (left eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
613 (right eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
Table 3: Summary of Scores for the Third Batch of Test Material
Animal number |
Observation |
Time (hours) |
|||
1 |
24 |
48 |
72 |
||
621 (right eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
622 (left eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
623 (right eye) |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria.
- Executive summary:
A study was conducted to assess the potential of the test material to cause irritation to the eyes of rabbits using methodology similar to that outlined in the standardised guideline OECD 405.
The eye irritation potential of three batches of the test material was assessed in male JW rabbits (three per batch). The dose level administered was 0.1 mL/eye. The eyes of the rabbits were closed for about one second after instillation. Observations were made at 1 hour after instillation and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of eye reaction.
At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.
Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria.
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