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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:
19 April 1994 - 29 April 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2,4-dichlorophenyl)ethan-1-one
EC Number:
218-780-8
EC Name:
1-(2,4-dichlorophenyl)ethan-1-one
Cas Number:
2234-16-4
Molecular formula:
C8H6Cl2O
IUPAC Name:
1-(2,4-dichlorophenyl)ethan-1-one
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae. 88400 Biberach.
- Age at study initiation: About 3-5 months
- Weight at study initiation: 2.8-3.3 kg
- Housing: In fully air-conditiones rooms, separate cages.
- Diet (e.g. ad libitum): Ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg test item.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With isotonic saline at approx. 37 ºC.
- Time after start of exposure: 24 hours.

SCORING SYSTEM: The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after installation of one drop of 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
One hour p.a. the conjuctiva of the animals showed slight swelling as well as up to 24 hours p.a. definitely injected blood vessels to diffuse deeper crimson red colour. 48 hours p.a. the irritations were reversible. Additional a clear colourless discharge was observed.
Other effects:
- Lesions and clinical observations: No.
- Effects of rinsing or washing: No.
- Other effects: A clear colourless discharge was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Testing of test item for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
Executive summary:

An in-vivo eye irritation test was performed according to OECD Guideline 405 and EU Method B.5 (GLP study). 100 mg of test item was applied once to the conjuctival sac of the left eye of tree rabbits. 24 hours after application and at all the other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out throughly with isotonic saline at approx. 37 ºC. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesiones under UV light after installation of one drop of 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjuctivae were graded numerically. One hour p.a. the conjuctiva of the animals showed slight swelling as well as up to 24 hours p.a. definitely injected blood vessels to diffuse deeper crimson red colour. 48 hours p.a. the irritations were reversible (mean 24 -72h scores of corneal opacity, iris and chemosis of conjuctiva as 0.0 for all three animals; mean 24 -72h scores of redness of conjuctiva was 0.0 for one animal and 0.3 for the other two). Additional a clear colourless discharge was observed. Based on these results, the test item was determined to be not irritating to the eye.