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EC number: 206-525-3 | CAS number: 352-87-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985-05-13 to 1985-05-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,2-trifluoroethyl methacrylate
- EC Number:
- 206-525-3
- EC Name:
- 2,2,2-trifluoroethyl methacrylate
- Cas Number:
- 352-87-4
- Molecular formula:
- C6H7F3O2
- IUPAC Name:
- 2,2,2-trifluoroethyl methacrylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MATRIFE
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.48 – 2.69 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5±1.5°C
- Humidity (%):50-55%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- eyes were not rinsed after application
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Conjunctival redness (grade 1, some blood vessels hyperaemic (injected)) was observed in 3/3 animals after 1 h and in 2/3 animals after 24 h. Grade 1 chemosis was observed in 1/3 animals after 1 h, which had recovered at the 24 h time point. No irritation was noted at the 48 and 72 h observations.
Any other information on results incl. tables
Rabbit number |
reaction |
Scores 1/24/48/72 h |
1 |
Cornea, opacity |
0/0/0/0 |
Iris |
0/0/0/0 |
|
Conjunctivae, redness |
1/1/0/0 |
|
Conjunctivae, chemosis |
0/0/0/0 |
|
Conjunctivae, discharge |
0/0/0/0 |
|
2 |
Cornea, opacity |
0/0/0/0 |
Iris |
0/0/0/0 |
|
Conjunctivae, redness |
1/1/0/0 |
|
Conjunctivae, chemosis |
1/0/0/0 |
|
Conjunctivae, discharge |
0/0/0/0 |
|
3 |
Cornea, opacity |
0/0/0/0 |
Iris |
0/0/0/0 |
|
Conjunctivae, redness |
1/0/0/0 |
|
Conjunctivae, chemosis |
0/0/0/0 |
|
Conjunctivae, discharge |
0/0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study TFMEA was not irritating to the eye.
- Executive summary:
In a primary eye irritation study according to OECD guideline 405, 0.1 mL of undiluted TFMEA (not given in the study report, but according to sponsor >90%) was instilled into the conjunctival sac of the right eye of 3 young adult New Zealand white rabbits. The eyes were not rinsed after application. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
Only minimal irritation was observed:Conjunctival redness (grade 1, some blood vessels hyperaemic (injected)) was observed in 3/3 animals after 1 h and in 2/3 animals after 24 h. Grade 1 chemosis was observed in 1/3 animals after 1 h, which had recovered at the 24 h time point. No irritation was noted at the 48 and 72 h observations.
In this study, TFMEA is not an eye irritant.
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