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EC number: 211-479-2 | CAS number: 650-51-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 01.03.2004 to 15.03.2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD guideline 405, but no data on GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- TCA
- EC Number:
- 211-479-2
- EC Name:
- TCA
- Cas Number:
- 650-51-1
- Molecular formula:
- C2HCl3O2.Na
- IUPAC Name:
- trichloroacetic acid
- Details on test material:
- - Name of test material (as cited in study report): Tricloroacetato de sodio
- Analytical purity: 99 % (w/w)
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: Young adult animals
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ºC
- Humidity (%): 60 %
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 01.03.2004 to 15.03.2004
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The non-treated eye of each animal was used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Three male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water for 30 sec
- Time after start of exposure: 1 hour
SCORING SYSTEM: The irritation degree was daily registered for three days to be later scored in order to make a whole effect assessment.
A. Cornea (opacity)
0 No ulceration or opacity
1 Areas opaciclad diffuse. Iris details clearly visible.
2 Areas translúsidas clearly discernible, details of iris slightly obscured.
3 Area of necrosis, details of iris visible, size of the pupil hardly discernible.
4 Opaque cornea, iris not discernible
B. Cornea (area involved)
1 Less than one quarter but not zero
2 Greater than one quarter but less than medium
3 Greater than average but less than three rooms
4 Greater than three quarters
Iris value
0 Normal
1 Rating rugocidad, congestion, moderate inflammation, hyperemia circumcorneal, or injection. Some of these signs or combination of them. Iris slow reaction to light.
2 Iris nonreactive to light. Hemorrhagic, gross destruction.
A. Erythema
0 Normal blood vessels
1 Some blood vessels definitely hiperhemicos
2 Diffuse crimson. Individual vessels not easily discernment
3 Red diffused
B. Edema
0 No edema
1 Slight edema close to nonnal
2 Edema evident with partial eversion of the lid margin
3 Parcialmenle closed eyelids edema
4 Edema with closed eyelids that parcially
C. Secretions
0 Without secretions
1 Quantity different to normal
2 Secretions with moistening of lids and hairs underlying them
3 Secretions with moistening of lids and hairs in a considerable area around eye
Scoring conjunctivae (erythema + edema + secretions) X 2
Scoring cornea (opacity involved Area X) X 5
Scoring iris (Iris) X 5
Total Score for each time = conjunctivae Scoring + cornea Scoring + iris Scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: conjunctivae oedema
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: conjunctivae oedema
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: conjunctivae oedema
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: conjunctivae erythema
- Basis:
- animal #1
- Time point:
- other: 24 -72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: conjunctivae erythema
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: conjunctivae erythema
- Basis:
- animal #3
- Time point:
- other: 24 -72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Based on the results registered, sodium trichloroacetate has shown extremelly irritant for the rabbits eyes.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results registered, sodium trichloroacetate has shown extremelly irritant for the rabbits eyes.
- Executive summary:
This study has been carried out with the aim of evaluating the possible irritant / corrosive effects of sodium trichloroacetate on the eyes, using white rabbits (Oryctolagus cuniculus). The method has been developed according to OECD Protocol No. 405, 1992.
A single dose of 0,1 grams was applied to the conjunctival sac of one eye in one rabbit (males). The non-treated eye of each animal was used as control. The irritation degree was daily registered for three days to be later scored in order to make a whole effect assessment. During the assay period, environmental conditions remained constant (Temperature: 22°C, Humidity: 60 % and Photoperiod: twelve hours light and twelve hours darkness). Based on the results registered, sodium trichloroacetate has shown extremelly irritant for the rabbits eyes.
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