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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:
1981-02-02 to 1981-02-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no data on test material purity, eye irritation was not examined 1 hour after exposure, the solid test substance was removed from the rabbits' eye already after 30 seconds instead of 1 hour)
Qualifier:
according to
Guideline:
other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred and raised on the premises
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: Standard rabbit food, NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: For a minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 14/10

Only rabbits with normal ophtalmic findings were used for these tests.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 10 ml of physiological saline (only 3 animals)
- Time after start of exposure: Approximately 30 seconds

SCORING SYSTEM: According to Draize

TOOL USED TO ASSESS SCORE: Slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: animals' eyes were rinsed after treatment
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: animals' eyes were not rinsed after treatment
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: animals' eyes were rinsed after treatment
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: animals' eyes were not rinsed after treatment
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: animals' eyes were rinsed after treatment
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: animals' eyes were not rinsed after treatment
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: animals' eyes were rinsed after treatment
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: animals' eyes were not rinsed after treatment

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance revealed no eye irritating properties under the test conditions.
Executive summary:

In an acute eye irritation study similar to OECD guideline 405, 0.1 g of the test substance was administered to 3 male and 3 female New Zeeland White rabbits. The test substance was placed into the conjunctival sac of the left eye of each animal; the right eye remained untreated and served as control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was evaluated according to Draize on day 1, 2, 3, 4, and 7. The cornea and iris scores were grade 0 in the mean over 24, 48 and 72 hours in all 6 animals (both with and without washing). The conjunctiva score was 0.4 for the animals whose eyes were washed and 0.3 for the animals whose eyes were not washed, respectively. The redness was reversible within 72 hours. The chemosis score was grade 0.1 in the mean over 24, 48 and 72 hours in all 6 animals (both with and without washing) and the eye irritating effect was fully reversible within 48 hours. Concluding, the test substance revealed no eye irritating properties under the test conditions.