Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: clear viscous liquid
Details on test material:
- Name of test material (as cited in study report): Zonarez A-25
- Physical state: Clear viscous honey-like liquid
- Analytical purity: Not reported
- Lot/batch No.: AIA804


Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Inc.
- Weight at study initiation: 2-3 kg
- Fasting period before study:
- Housing: Separate isolation by test system
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed.
- Food Analysis: Acute dose minimize the effect of contaminants. There were no contaminants.
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc.
- Water Analyses: Conducted by Pennsylvania Gas and Water Company
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C+/-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light-12 hrs dark

Test system

Amount / concentration applied:
TEST MATERIAL
- Dose administration: 0.1 ml, undiluted

VEHICLE
- Information not reported
Duration of treatment / exposure:
Once
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9 rabbits, 6 treated-no rinsed, 3 treated-rinsed
Details on study design:
Methods of the study performance
Twenty-four hrs prior to the application of the test material, the eyes of the rabbit were examined using 2% sodium fluorescein stain. Animals with preexisting corneal injury were removed from the study. The test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of material.
The treated eyes of six rabbits remained unwashed. The treated eyed of three rabbits were rinsed for one minute with lukewarm water immediately following administration of the test material. The contralateral eye remained untreated as served as a control.

The eye were examined at 24, 48, 72 hrs and 4 and 7 days after treatment.
Grading of irritation is according to the method of Draize, J.H, et al., Pharm, Exp. Ther.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Day 4, Day 7
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Day 4, Day 7
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Day 4, Day 7
Score:
0
Max. score:
0
Irritant / corrosive response data:
One positive ocular reading was observed at 24 hrs post administration. No other positive responses were observed. One positive response were recorded during the course of the study.


Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was not an eye irritant.
Executive summary:

The study investigated the capability of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers to induce eye irritation in 9 New Zealand rabbits. The test material was instilled in the right eye of the rabbits. The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were rinsed for one minute with lukewarm water immediately following administration of the test article. One positive ocular reading was recorded at 24 hrs post administration. Only one positive response was observed during the course of the study. Based upon the observation made in the Primary Eye Irritation test, the test material is not considered an eye irritant.