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EC number: 242-901-3 | CAS number: 19234-20-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 24 April 2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (Aug 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147 (adopted 2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, London, UK
Test material
- Reference substance name:
- 2-(1-methylethoxy)ethyl acetate
- EC Number:
- 242-901-3
- EC Name:
- 2-(1-methylethoxy)ethyl acetate
- Cas Number:
- 19234-20-9
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 2-(propan-2-yloxy)ethyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 57033
- Expiration date of the lot/batch: 25 November 2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Details on strain: Hsdlf:NZW
- Source: Harlan Laboratories UK Ltd. Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.33-2.66 kg
- Housing: individually in suspended cages
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye of the same animal served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 1 single application
- Observation period (in vivo):
- 7 days (reading time points: directly after application, 1, 24, 48, and 72 hours and 7 days thereafter)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize Scoring System
Additionally, a modified version of the system (Kay and Calandra (1962), J. Soc. Chem. 13: 281-289) was used to classify the ocular irritancy potential of the test item. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The scores for cornea, iris and conjunctivae were calculated as follows:
Conjunctivae total score = (redness score + chemosis score + discharge score) x 2
Iris score = iris score x 5
Cornea score = (degree of opacity x area of cornea involved) x 5
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
OTHER
Body weights were recorded on day 0 and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: revrsibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of animal #1 and #2
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2 in both animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of animal #1 and #2
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2 in both animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2
- Irritant / corrosive response data:
- No effects on cornea and iris were observed during the study. All animals showed conjunctival redness and swelling (score = 2) at the 1 h reading. The effects were attenuated within 24 to 72 h and were fully reversible within 72 h in animal #1 and within 7 days in animal #2 and #3.
- Other effects:
- All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Eye irritation – Details on result
Animal # |
Time after treatment |
Cornea |
Iris |
Conjunctival redness |
Chemosis |
Individual total score |
#1 |
1 h |
0 |
0 |
2 |
2 |
17 |
24 h |
0 |
0 |
2 |
2 |
10 |
|
48 h |
0 |
0 |
1 |
1 |
4 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
|
7 days |
- |
- |
- |
- |
- |
|
Mean (24-72 h) |
0.00 |
0.00 |
1.00 |
1.00 |
- |
|
#2 |
1 h |
0 |
0 |
2 |
2 |
17 |
24 h |
0 |
0 |
1 |
1 |
4 |
|
48 h |
0 |
0 |
1 |
1 |
4 |
|
72 h |
0 |
0 |
1 |
1 |
4 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
|
Mean (24-72 h) |
0.00 |
0.00 |
1.00 |
1.00 |
- |
|
#3 |
1 h |
0 |
0 |
2 |
2 |
10 |
24 h |
0 |
0 |
2 |
2 |
8 |
|
48 h |
0 |
0 |
2 |
1 |
6 |
|
72 h |
0 |
0 |
1 |
1 |
4 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
|
Mean (24-72 h) |
0.00 |
0.00 |
1.67 |
1.33 |
- |
|
Group mean score(24-72 h) |
0.00 |
0.00 |
1.22 |
1.11 |
|
|
|
||||||
|
Group mean total score |
1 h |
14.7 |
|||
24 h |
7.3 |
|||||
48 h |
4.7 |
|||||
72 h |
2.7 |
|||||
7 d |
0.0 |
|||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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