Registration Dossier

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:
2009-04-07 to 2009-09-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Orient Bio, Ltd, 143-1 Sangdaewon-Dong, Jungwon-Gu, Seongnam-Si, Gyeonggi-Do, Korea
- Age at study initiation: 2 months
- Weight at study initiation: 1900 to 2079 g; the 3 rabbits selected for the study ranged from 2193 to 2445.
- Housing: During acclimation, quarantine and the test period, rabbits were hosued individually in 3 lines x 4 ros of stainless acges (590 mm w x 460 mm l x 360 mm h).
- Diet (e.g. ad libitum): Pelleted food was obtained from Purina Korea and was available ad libitum
- Water (e.g. ad libitum): Municipal tap water was available ad libitum following uv irradiatio and filtration.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 20 times/h
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle with a light intensity of 150 - 300 lux.

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each animal remained untreated as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hrs (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs after application)
Number of animals or in vitro replicates:
3 male

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no positive reponse in any animal at any time point.
Observations performed at 1, 24, 48 and 72 h after the application elucidated no irritative response on cornea, iris or conjunctiva. The acute eye irritation index of the test item was calculated to be 0.
Other effects:
Clinical signs and mortality
There were no deaths or detecable clinical signs in any test animals which coud be attributed to the test item.

Body weight
No treatment-related body weight changes were observed.

Any other information on results incl. tables

Results of eye reaction

Animal No.

 

1

2

3

Cornea opacity

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Iris

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Conjunctiva redness

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Chemosis

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The test substance was assessed for eye irritation in three healthy New Zealand white rabbits. No clinical sings, body weight changes, body weight changes, dead animals or abnormal eye reaction considered to be due to test item were observed. The test item was considered to be non-irritating to eyes.