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EC number: 206-851-6 | CAS number: 383-63-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed similarly to OECD guideline but no GLP compliance.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 6 animals instead of 3.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethyl trifluoroacetate
- EC Number:
- 206-851-6
- EC Name:
- Ethyl trifluoroacetate
- Cas Number:
- 383-63-1
- Molecular formula:
- C4H5F3O2
- IUPAC Name:
- ethyl 2,2,2-trifluoroacetate
- Details on test material:
- - Name of test material (as cited in study report): Trfluoroacétate d'éthyle
- Physical state: incolor liquid
- Stability under test conditions: no data. Assume to be stable (sponsor responsibility)
- Storage condition of test material: no data
- Other: pH measurement was impossible (instable measure)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino New-Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Roucher (86700, Couhé); EGAV (61350 Passais la conception); Elevage scientifique des Dombes (01400 Chatillon sur Chalaronne); Gwen Meur (22200 Trégonneau)
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (+/- 200 g)
- Housing: individual polystyrene cages (540 x 360 x 315 mm) with a perforated polystyrene floor.
- Diet (e.g. ad libitum): 150 g of complete maintenance food (granulés lapin Entretien "112" UAR, 91360 Villemoisson/Orge) is provided per rabbit and per day.
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: yes for 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 times per hour
- Photoperiod (hrs dark / hrs light): 12hrs / 12 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the test item was applied as supplied by the sponsor
- Controls:
- other: the left eye, untreated, served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable.
VEHICLE
not applicable - Duration of treatment / exposure:
- no rinsing was performed.
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 96h and on day 7 after the instillation of the test item. If the seven days observation is insufficient for fully evaluating the reversibility or the irreversibility of the lesions observed, it might be extended (maximum 21 days).
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Not applicable as no rinsing was performed.
SCORING SYSTEM: according to the Draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp and an ophtalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- score of 6 animals
- Time point:
- other: overall 24, 48, 72h
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- score of 6 animals
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0.61
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- score of 6 animals
- Time point:
- other: overall 24, 48, 72h
- Score:
- 1.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- score of 6 animals
- Time point:
- other: overall 24, 48, 72h
- Score:
- 1.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- other: Acute occular irritation index
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 26.17
- Irritation parameter:
- other: Mean occular irritation index
- Basis:
- mean
- Time point:
- other: 96h
- Score:
- 7.67
- Irritant / corrosive response data:
- see details in table 7.3.2/1
- Other effects:
- no data.
Any other information on results incl. tables
Table 7.3.2/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
2/2/3/2/2/2 |
1/1/1/1/1/1 |
1/1/2/1/1/2 |
2/2/2/1/2/2 |
24 h |
2/2/2/2/2/2 |
1/1/0/1/1/1 |
1/2/1/1/2/2 |
2/2/1/1/2/2 |
48 h |
2/1/2/2/2/2 |
1/1/0/0/1/0 |
1/2/0/0/2/1 |
1/1/0/0/2/1 |
72 h |
2/0/2/1/2/2 |
1/1/0/0/1/0 |
1/1/0/0/2/1 |
1/1/0/0/1/1 |
Average 24h, 48h, 72h Mean individual scores |
1.78 2.0/1.0/2.0/1.7/2.0/2.0 |
1.83 1.0/1.0/0.0/0.3/1.0/0.3 |
1.1 1.0/1.7/0.3/0.3/2.0/1.3 |
1.06 1.3/1.3/0.3/0.3/1.7/1.3 |
Reversibility*) |
c/c/c/c/c/c |
c/c/c/c/c/c |
c/c/c/c/c/c |
c/c/c/c/c/c |
Average time (day) for reversion |
7/3/47/7/7 |
4/4/1/2/7/2 |
4/4/2/2/7/4 |
4/4/2/2/7/7 |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Ethyl trifluoroacetate is classified as Eye Irr. 2 (Causes serious eye irritation, H319) according to the Annex I of the Regulation (EC) 1272/2008 (CLP) and as irritating to eyes (Xi, R36) according to the Annex VI of the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study performed similarly to the OECD No. 405, 0.1 mL of undiluted Ethyl Trifluoroacetate (purity of 97.3%) was instilled into the conjunctival sac of the right eye of 6 male New Zealand albino Rabbits. After the instillation the substance was not remained. Animals were then observed for 7 days for eye edema and erythema of the conjunctive, corneal opacity and iris lesion.
Eye irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72, 96 and 168 hrs after the instillation of the substance. The arithmetic mean score of all animals were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean scores of all animals were 1.06 for chemosis, 1.1 for conjunctival erythema, 1.78 for corneal opacity and 1.83 for the lesions of the iris to conclude according to the criteria of the Directive 67/548/EEC. Considering another calculation, the mean individual scores were 1.3/1.3/0.3/0.3/1.7/1.3 for chemosis, 1.0/1.7/0.3/0.3/2.0/1.3 for conjunctival erythema, 2.0/1.0/2.0/1.7/2.0/2.0 for corneal opacity and 1.0/1.0/0.0/0.3/1.0/0.3 for the lesions of the iris. In any case, all of these ocular effects were fully reversible within 7 days.
Under the test conditions, as all animals (6/6) presented mean corneal opacity scores higher than 1.0 at 24, 48 and 72h after the end of exposure, Ethyl trifluoroacetate is classified as Eye Irr. 2 (Causes serious eye irritation, H319) according to the Annex I of the Regulation (EC) 1272/2008 (CLP). In another way, as the mean score for iridal lesion of all animals over 24, 48,72h is higher than 1, Ethyl trifluoroacetate is classified as irritating to eyes (Xi, R36) according to criteria of the Annex VI of the Directive 67/548/EEC.
Under the test conditions, ethyl trifluoroacetate is classified as Eye Irr. 2 (Causes serious eye irritation, H319) according to the Annex I of the Regulation (EC) 1272/2008 (CLP) and as irritating to eyes (Xi, R36) according to the Annex VI of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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