Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Aug 2005 - 28 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12-Nousan-No.8147, Eye Irritation Study
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: KITAYAMA LABES Co., Ltd. (Ina, Japan)
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.82 - 2.98 kg
- Housing: The animals were caged individually in suspended aluminium cages with stainless steel wire-meshed front and floor (W45 x D55 x H35 cm, Yamato Scientific Co., Ltd., Japan). The cages were placed on racks. Cages were changed once per two weeks with washed and sterilized ones.
- Diet: Approximately 120 g/day of LRC4 (Lot No. 050518, Oriental Yeast Co., Ltd., Japan)
- Water: Filtered tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2 (actual temperature measured: 21.7 - 22.2 °C)
- Humidity (%): 30 - 70 (actual humidity measured: 51.7 - 71.9%)
- Air changes (per hr): More than 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, equivalent to 0.043 g.


Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed eye was washed 24 hrs after exposure started
- Time after start of exposure: 24 hrs

SCORING SYSTEM:
Grading of irritation reactions was performed according to the Draize system. The irritation potential of the substance was classified according to the method of Kay and Calandra (Maximum Mean Total Score, MMTS).

TOOL USED TO ASSESS SCORE:
A hand-slit lamp was used to score corneal opacity, and then fluorescein as an additional aid during the scoring at 24, 48 and 72 hrs.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The test substance caused a mild discharge from the eye of one animal, observed 1 hr after the administration. The reaction was fully reversible within 24 hours. The other two animals did not show any reaction to the exposure to the test substance.
Other effects:
No clinical signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information