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EC number: 222-960-1 | CAS number: 3681-71-8
- Life Cycle description
- Uses advised against
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 30 April 2012 and 11 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (Z)-hex-3-enyl acetate
- EC Number:
- 222-960-1
- EC Name:
- (Z)-hex-3-enyl acetate
- Cas Number:
- 3681-71-8
- Molecular formula:
- C8H14O2
- IUPAC Name:
- (Z)-hex-3-enyl acetate
- Details on test material:
- - Name of test material (as cited in study report): (z)-hex-3-enyl acetate (LEAC)
- Physical state: clear colourless liquid
- Analytical purity: 98.45 %
- Lot/batch No.: 1Z00151
- Expiration date of the lot/batch: 13 June 2015
- Stability under test conditions: room temperature in the dark under nitrogen
- Storage condition of test material:
- Other:
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.45 or 2.94 kg
- Housing: the animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a lvel that might have affected the purpose or integrity of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- Immediately and 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- PROCEDURE
Initially, a single rabbit was treated. A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about 1 sec immediately after treatment, to prevent loss of the test item, and then released. Immediately after administration of the test item, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, a second animal was treated.
Any other ocular effects were also noted. Any clinical signs of toxicity, if present, were also recorded. Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
SCORING SYSTEM: Draize scale (see Appendix 2 attached). If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean score for all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: mean score for all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: mean score for animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: mean score for animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.67
- Irritation parameter:
- chemosis score
- Basis:
- other: mean score for animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.67
- Irritation parameter:
- chemosis score
- Basis:
- other: mean score for animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Irritant / corrosive response data:
- No corneal effects were noted during the study.
Iridial inflammation was noted in 1 treated eye 1 h after treatment.
Moderate conjunctival irritation was noted in both treated eyes 1 h after treatment. Moderate conjunctival irritation persisted in 1 treated eye with minimal conjunctival irritation noted in the other treated eye at the 24-Hour observation. Minimal conjunctival irritation was noted in both treated eyes at the 48-Hour observation.
Both treated eyes appeared normal at the 72-Hour observation. - Other effects:
- Bodyweight: both animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Individual scores and individual total scores for ocular irritation
Rabbit number and sex |
71969 Male |
71992 Male |
||||||
IPR= 2 |
IPR= 2 |
|||||||
Time after treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
CORNEA |
||||||||
E= Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F= Area of cornea involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
||||||||
D |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
||||||||
A= Redness |
2 |
2 |
1 |
0 |
2 |
1 |
1 |
0 |
B= Chemosis |
2 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
C= Discharge |
2 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
12 |
8 |
4 |
0 |
8 |
4 |
2 |
0 |
Total score |
17 |
8 |
4 |
0 |
8 |
4 |
2 |
0 |
IPR= initial pain reaction
Individual total scores and group mean scores for ocular irritation
Rabbit number and sex |
Individual total scores at: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
71969 Male |
17 |
8 |
4 |
0 |
71992 Male |
8 |
4 |
2 |
0 |
Group total |
25 |
12 |
6 |
0 |
Group mean score |
12.5 |
6.0 |
3.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was assessed for acute eye irritation according to OECD guideline 405. The test item is classified as not irritating although it was found to be a mild irritant under the conditions of this study according to a modified Kay and Calandra classification system.
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