Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Apr 26, 1982 - May 24, 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Section 1500.42- Federal Hazardous Substances Act Regulations CFR16 P. 125.
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino rabbit; strain unknown
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Techboard, Shepherd Products Company
- Weight at study initiation: no data available
- Housing: individually housed in stainless steel cages with wire mesh flooring
- Diet (e.g. ad libitum): Wayne 15 % Rbbit Ration was provided ad libitum
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70 +/- 2
- Humidity (%): 45 % +/- 5 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
0.1 mL test material was instilled into the conjunctival sac of one eye of the test animal. After instillation of the test material, the upper and lower lids were held closed for approximately 1 second to minimize loss of material. The contralateral eye was manipulated in an identical manner and served as an un-dosed control. The test material was not washed from the eyes.
Observation period (in vivo):
The eyes were examined and graded for ocular reaction at 1h, and 1, 2, 3, 4, 7days following instillation of test material into the eyes.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.
- Time after start of exposure: not applicable.

SCORING SYSTEM:
Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: average irritation score
Basis:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
other: average irritation score
Basis:
mean
Time point:
other: 1 d
Score:
0.7
Irritation parameter:
other: average irritation score
Basis:
mean
Time point:
other: 2 d
Score:
0
Irritation parameter:
other: average irritation score
Basis:
mean
Time point:
other: 3 d
Score:
0
Irritation parameter:
other: average irritation score
Basis:
mean
Time point:
other: 4 d
Score:
0
Irritation parameter:
other: average irritation score
Basis:
mean
Time point:
other: 7 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1d, 2d, 3d
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1d, 2d, 3d
Score:
0
Irritation parameter:
other: conjunctivae readness
Basis:
mean
Time point:
other: 1d, 2d, 3d
Score:
0.17
Irritation parameter:
other: conjunctivae edema
Basis:
mean
Time point:
other: 1d, 2d, 3d
Score:
0.17
Irritant / corrosive response data:
Overall Primary Ocular Irritation Index: 0.7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material did not cause irritating effects on the eyes, and was not a primary ocular irritant.
Executive summary:

In a primary eye irritation study, 0.1 mL of the test substance was placed into conjuctival sac of one eye of each of the albino rabbits. The eyes were examined and graded for ocular reaction at 1h, and 1, 2, 3, 4, 7 days following instillation of test material into the eyes. The overall primary ocular irritation index was 0.7 and the test substance was unlikely to be an ocular irritant in the test animals