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EC number: 203-940-1 | CAS number: 112-15-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 May - 11 Sep 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- (simultaneous testing of 6 animals, no data on intactness of the eyes before application)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethyldiglykolacetat
- Physical state: liquid
- Analytical purity: 99.8%
- Density: 1.01 g/cm³
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian (Chbb-SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: individually in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, Germany; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye of each animal served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48, and 72 h and 6, 8, 10, 13, 17, and 21 days after application - Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the treated eyes were instilled with Na-fluorescein solution to assess corneal damage followed by washing with water.
- Time after start of exposure: 72 hours
SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects at any reading time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: still circumcorneal injections after 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: circumcorneal injections at day 6-8
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: circumcorneal injections at day 6
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 17
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 17
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 17
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritant / corrosive response data:
- All effects decribed below were already present at the 1-h scoring. Slight corneal opacity (score 1 - 2) was present in all animals which was reversible within 8 days in 5/6 animals. Slight effects on iris (score = 0 - 1) were observed in 5/6 animals, that were fully reversible within 2-10 days in 4 animals. Conjunctival redness (scores = 3) and swelling (scores = 1 - 2) was seen in all animals and lasted until day 17 and day 10 in 3/6 animals, respectively. Exudate formation at 24 - 72 h after application was observed in 2/6 animals. Thus, at day 21 effects were still seen in only 1/6 animal.
Any other information on results incl. tables
Table 1 . Results of study.
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
1 |
0 |
2 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
0 |
1 |
|
average |
3.0 |
1.0 |
0.0 |
1.3 |
|
2 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
1 |
2 |
|
48 |
3 |
2 |
1 |
2 |
|
72 |
3 |
2 |
0 |
2 |
|
average |
3 |
2 |
0.7 |
2 |
|
3 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
0 |
2 |
|
48 |
3 |
2 |
1 |
2 |
|
72 |
3 |
2 |
0 |
2 |
|
average |
3 |
2 |
0.3 |
2 |
|
4 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
1 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
0 |
2 |
|
average |
3 |
1.3 |
0.3 |
1.3 |
|
5 |
1 |
3 |
1 |
0 |
1 |
24 |
3 |
1 |
0 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
0 |
1 |
|
average |
3 |
1 |
0 |
1 |
|
6 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
0 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
2 |
0 |
1 |
|
average |
3 |
1.7 |
0 |
1 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
3.00 |
1.83 |
0.00 |
1.00 |
24 |
3.00 |
1.67 |
0.33 |
1.50 |
|
48 |
3.00 |
1.33 |
0.33 |
1.33 |
|
72 |
3.00 |
1.50 |
0.00 |
1.50 |
|
24+48+72 |
3.00 |
1.50 |
0.22 |
1.44 |
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye irrit 2, H319
DSD: Xi, R36 - Executive summary:
Acute eye irritation has been investigated in the rabbit. Irritation was observed of sufficient severity and duration to require classification.
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