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EC number: 208-212-7 | CAS number: 515-84-4
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:
- 1 983
- Report date:
- 1983
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:
- Ethyl trichloroacetate
- EC Number:
- 208-212-7
- EC Name:
- Ethyl trichloroacetate
- Cas Number:
- 515-84-4
- Molecular formula:
- C4H5Cl3O2
- IUPAC Name:
- ethyl 2,2,2-trichloroacetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Ethyl trichloroacetate; Trichloressigsäureethylester; Trichlorethansäureethylester
- Substance type: Organic monoconstituent substance
- Physical state: Colourless, clear liquid
- Analytical purity: 98.9%
- Purity test date: COA: no. 07960 dd 2003-08-16
- Lot/batch No.: Op. 165 ( manufactured: 2003-08-14 by Hoechst AG (now: CABB GmbH))
- Storage condition of test material: At 4°C in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: raised by Hoechst AG, site Hattersheim-Kastengrund near Frankfurt am Main, Germany
- Age at study initiation: Not provided
- Weight at study initiation: 3.3-3.9 kg
- Housing: Individual battery cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät- Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum
- Water (e.g. ad libitum): deionized, chlorinated water from automatic watering, ad libitum
- Acclimation period: Not provided
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%):55 ± 10 %
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12
selection: intact cornea
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
left eye treated (conjunctival sac), right eye: control - Duration of treatment / exposure:
- 24 h
- 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): The treated eyes were thoroughly washed with 37 ° C warm physiological saline.
- Time after start of exposure: 24 hours.
SCORING SYSTEM:
Numerical scores according to Draize
CORNEA
Opacity: Degree of density (area most dense taken for reading)
0 No ulceration or opacity
1* Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2* Easily discernible translucent area, details of iris slightly obscured
3* Nacrous area, no details of iris visible, size of pupil barely discernible
4* Opaque cornea, iris not discernible through the opacity
IRIS
0 Normal
1* Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2* No reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAE
Redness:
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic (injected)
2* Diffuse, crimson solour, individual vessels not easily discernible
3* Diffuse, beefy red
Chemosis:
0 No swelling
1 Any swelling above normal (including nictitating membranes
2* Definite swelling with partial eversion of lids
3* Swelling with lids about half closed
4* Swelling with lids more than half closed
* means positive effect
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- 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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were minor irritative symptoms. 1 Hour after application in one of 3 animals slight turbidity in the cornea was seen. The conjunctivae showed redness and swelling at this time. There was small, clear discharge. 24 Hours post application in only one animal, a slight conjunctival redness was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1) "In accordance with the classification criteria of the EC Directive and taking into account all relevant toxicological findings, the substance Ethyl trichloroacetate is described as non-irritating to the eye." Dr. Rupprich, Department of Toxicology - Toxicology commercial Hoechst Aktiengesellschaft, 1983
2) "In accordance with the classification criteria of EU Directive 83/467/EEC and in consideration of all relevant toxicological findings the substance Ethyl trichloroacetate does not require labeling." Dr. Kreiling, Dr. Jung, Pharma Research Toxicology - Toxicology commercial Hoechst AG, 1996 - Executive summary:
Eye irritation was tested in 3 New Zealand White rabbits according to OECD guideline 405.
24 hours before the start of the test the eyes of the animals to be treated, were examined under UV light after instillation of a drop of sodium fluorescein solution (0.01%) for damage of the cornea. Only animals without findings, were taken in the experiment.
In 3 rabbits single application of 0.1 mL of the test substance Ethyl trichloroacetate was performed into the conjunctival sac of the left eye. The untreated eye served as a control. 24 Hours after administration of the test substance, the treated eyes were thoroughly washed with 37 ° C warm physiological saline.
The assessment of the eyes was performed 1, 24, 48 and 72 hours after instillation. Damage to the cornea, iris and conjunctivae were rated numerically according to Draize. All other toxicologically significant findings were recorded. In addition, following administration of a drop of fluorescein sodium solution (0.01% by weight), the eyes were examined 24 and 72 hours after instillation of the test substance under UV light for damage of the cornea.
There were minor irritative symptoms. 1 Hour after application in one of 3 animals slight turbidity in the cornea was seen. The conjunctivae showed redness and swelling at this time. There was small, clear discharge. Mean 24 -72h scores were 0/4 for cornea, 0/2 for iris, 0.1/3 for conjuctival redness and 0/4 for chemosis. 24 Hours post application in only one animal, a slight conjunctival redness was observed.
In accordance with the classification criteria of the EC Directive and taking into account all relevant toxicological findings, the substance Ethyl trichloroacetate is described as non-irritating to the eye.
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