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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:
not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white rabbits
Remarks:
female
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 15 weeks old
- Weight at study initiation: not specified
- Housing: Individually in aluminium cages
- Diet: RC4 pellet, diet ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 50 ± 20
- Air changes (per hr): 8 to 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 20 Oct. 1995, To: 31 May 1996

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
other: washed control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g of the test substance
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours

Number of animals or in vitro replicates:
6 (3 washed and 3 remained unwashed after application)
Details on study design:
ANIMAL TREATMENT AND REMOVAL OF TEST SUBSTANCE
- Unwashed group: The animals in the unwashed group were held in a restrainer, and 0.1 g of the test article was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower eyelid away from the eyeball. Both lids were gently held together for about 1 second to prevent loss of the test article. The right eye served as an untreated control
- Washed group: For the washed group, 0.1 g of the test article was applied in the same way and 2 to 3 minutes after application, the eyes were washed with 200 mL of physiological saline for 1 minute. The right eye was washed with 200 mL of physiological saline and served as a washed control.

SCORING SYSTEM:
- Method of calculation: the eye damage was scored according to the Draize scale scoring system (see Table 1 in 'any other information on materials and methods incl. tables').

TOOL USED TO ASSESS SCORE:
- The eyes were examined by ophthalmoscope
- A drop of 2% fluorescein sodium solution was instilled in the eyes of all animals 24 hours after application, and after immediately rinsing with water for injection, the cornea was examined for the presence or absence of stained marks resulting from corneal damage.

OBSERVATION
Observation for other ocular reactions and clinical signs was made periodically for 6 hours after application and once daily thereafter at the time of eye examination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
On a single application of the test substance to the rabbit eye, only grade 1 conjunctival redness and conjunctival oedema were observed in the washed and unwashed groups and eye closure or more than normal discharge were observed as other changes in the eye, but all observed effects disappeared within 24 hours.
Other effects:
There were no abnormalities in the clinical signs in either of the groups.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on this study, it was concluded that the test substance did not cause irritant effects
Executive summary:

In a primary eye irritation study, 0.1 g of test substance (98.6%) was instilled into the conjunctival sac of the left eye (13 week old, white, 6 female rabbits) for 24 hours. (3 rabbits were observed for the effectiveness of eye washing.) Animals then were observed for 3 days. Irritation was classified according to the Federal Register. In the observation of irritation, grade 1 conjunctival redness and conjunctival oedema were observed in the unwashed group but positive effects were not observed. Eye closure and more than normal discharge were observed as other changes. These changes disappeared by 24 hours after application. On the other hand, in the washed group, the same changes as those in the unwashed group were observed except for eye closure. There were no abnormalities in the clinical signs in either of the groups. Based on the study’s results and under the conditions of this study, it was concluded that the test substance was tested negative for irritant effects on the rabbit eye.