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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This GLP Study was conducted equivalent or similar to OECD 405 protocol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
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:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA, US
- Weight at study initiation: 1955 - 2198 g
- Housing: Single caged
- Diet: ad libitum)
- Water: ad libitum
- Acclimation period: five (5) days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): within OECD guidelines
- Humidity (%): within OECD guidelines
- Photoperiod (hrs dark / hrs light): within OECD guidelines

IN-LIFE DATES: From: 10 March 1986 To: 13 March 1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL/eye 100%
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
SCORING SYSTEM:
An animal exhibited a positive reaction when the test substance produced one of more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible. Grading of irritation was according to the method of Draize, 1965. The test was considered positive if four or more of the animals in the test group exhibited a positive reaction. If only one animal exhibited a positive reaction, the test would have been regarded as negative. If two or three animals exhibited a positive reaction, the study director in charge of the test may have designated the substance to be an irritant unless the sponsor, at additional cost, suggested repeating the test using a different group of animals.

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:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
All animals exhibited conjunctival redness that was fully reversible within 72 hr. 4 of 6 animals exhibited chemosis that was fully reversible within 24 hours.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the test material is not classified as an eye irritant.
Executive summary:

In an eye irritation study, New Zealand white rabbits were treated with 0.1 ml of test substance into their right eyes. Observations were recorded at 1, 24, 48, and 72 h. Positive ocular scores were recorded at the 1 and 24 hour observation periods. No other positive scores were recorded. Based on the results of this study, the test substance is not classified in accordance with the classification system of GHS. This study is classified as acceptable and satisfies the guideline requirement for eye irritation study in rabbits.