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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:
January 24, 1989 - January 27, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
EC Number:
406-940-1
EC Name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
Cas Number:
126019-82-7
Molecular formula:
C30-54H47-87O3PS
IUPAC Name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
Details on test material:
- Physical state: viscous liquid, insoluble in water; pH 7
- Storage condition of test material: room temperature
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 wks
- Weight at study initiation: 2560-2700 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet (Nafag No. 814), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
- OTHER: All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of the animal served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The test item was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The eyes were not washed after instillation.
Observation period (in vivo):
3 d
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to the OECD draize system
TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect

Any other information on results incl. tables

Bodyweights (g):

animal #1: (day 1) 2660; (day 3) 2610

animal #2: (day 1) 2560; (day 3) 2550

animal #3: (day 1) 2700; (day 3) 2730

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the exerimental conditions employed the test item induced mild irritation of the conjunctiva when instilled into the conjunctival sac of albino rabbits. Because the mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, the test item is regarded as non-irritant.
Executive summary:

In an acute eye irritation/corrosion study according to OECD guideline 405 and in compliance with GLP, single samples of 0.1 mL of the undiluted test article was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. Instillation of the test substance resulted in mild redness of the conjunctivae, reversible within 2 days the latest. Based on these results and according to the GHS (EU) criteria for classification the test substance does not need to be classified.