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Toxicological information

Eye irritation

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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:
2004
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

Constituent 1
Chemical structure
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)

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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