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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
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
-reliability scoring based on 2002 guideline
Deviations:
yes
Remarks:
-purity and physico-chemical properties of test substance not reported; housing condition, rationale for in vivo testing, and age, body weight, and strain of animals not reported
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloropyridine
EC Number:
203-646-3
EC Name:
2-chloropyridine
Cas Number:
109-09-1
Molecular formula:
C5H4ClN
IUPAC Name:
2-chloropyridine
Details on test material:
- Name of test material (as cited in study report): Olin 757 (2-Chloropyridine; PD-646)
- Physical state: Liquid (clear light yellow)
- Analytical purity: Not reported. The author reported that the test compound was considered to be free of impurities.
- Lot/batch No.: Not reported.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Not reported.
- Weight at study initiation: Not reported.
- Housing: Individually housed in metal cages suspended above the droppings.
- Diet (e.g. ad libitum): Food was provided ad libitum.
- Water (e.g. ad libitum): Water was provided ad libitum.
- Acclimation period: Not reported.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as the control eye for each animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Not applicable.

Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 to 28 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable.

SCORING SYSTEM: Method of Draize as described in the Manual "Appraisal of the Study of Chemicals in Foods, Drugs and Cosmetics", published by the Association of Food and Drug Officials of the United States, Business Office, Bureau of Food and Drugs, Texas State Department of Health, Austin 1, Texas, 1959, pp. 49-51. Scale provided below.

Scale for Scoring Ocular Lesions:

Cornea:
(A) Opacity-degree of density (area most dense taken for reading)
No opacity - 0
Scattered or diffuse area, details of iris clearly visible - 1
Easily discernible translucent areas, details of iris slightly obscured - 2
Opalescent areas, no details of iris visible, size of pupil barely discernible - 3
Opaque, iris invisible - 4
(B) Area of cornea involved
One quarter (or less) but not zero - 1
Greater than one quarter but less than half - 2
Greater than half, but less than three quarters - 3
Greater than three quarters, up to whole area - 4
Score equals A x B x 5 Total maximum = 80

Iris:
(A) Values
Normal - 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any or all of these) - 2
Score equals A x 5 Total maximum = 10

Conjunctivae:
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal - 0
Vessels definitely injected above normal - 1
More diffuse, deeper crimson red, individual vessels not easily discernible - 2
Diffuse beefy red - 3
(B) Chemosis
No swelling - 0
Any swelling above normal (includes nictitating membrane) - 1
Obvious swelling with partial eversion of lids - 2
Swelling with lids about half closed - 3
Swelling with lids about half closed to completely closed - 4
(C) Discharge
No discharge - 0
Any amount different from normal (does not include amounts observed in inner canthus of normal animals) - 1
Discharge with moistening of the lids and hairs just adjacent to lids - 2
Discharge with moistening of the lids and hairs, and considerable area around the eye - 3
Score equals (A + B + C) x 2 Total maximum = 20

The total score for the eye is the sum of all scores obtained from the cornea, iris, and conjunctivae. Total maximum score possible = 110.

TOOL USED TO ASSESS SCORE: 2% sodium fluorescein and a small-window, ultraviolet, quartz, mercury pencil lamp

Observations were recorded at 30 and 90 minutes, 2, 4, 8, 24, 48, and 72 hours, and daily thereafter up to 8 days. Animals that continued to display effects past the 8-day observation period were observed up to 28 days or until the effects were no longer present.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hr
Score:
4.6
Max. score:
80
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hr
Score:
13.3
Max. score:
80
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hr
Score:
31.7
Max. score:
80
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hr
Score:
3.3
Max. score:
10
Reversibility:
fully reversible within: 9 days
Irritation parameter:
conjunctivae score
Remarks:
(includes observations of chemosis, redness, and discharge)
Basis:
mean
Time point:
other: 24 hr
Score:
12.7
Max. score:
20
Reversibility:
fully reversible within: 19 days
Irritation parameter:
conjunctivae score
Remarks:
(includes observations of chemosis, redness, and discharge)
Basis:
mean
Time point:
other: 48 hr
Score:
12.3
Max. score:
20
Reversibility:
fully reversible within: 19 days
Irritation parameter:
conjunctivae score
Remarks:
(includes observations of chemosis, redness, and discharge)
Basis:
mean
Time point:
other: 72 hr
Score:
12.7
Max. score:
20
Reversibility:
fully reversible within: 19 days
Irritant / corrosive response data:
During the observation period 4 out of 6 rabbits exhibited corneal opacity. All 6 rabbits showed circumcorneal injection of the iris as well as varying degrees of irritation to the conjunctivae. Purulent discharge appeared in 4 out of 6 animals following application of the test article. Severe ocular irritation in the form of pannus was observed in 2 out of 6 animals. Phlyctenar reactions and dendritic vascularization was noted in 1 out of 6 rabbits tested.
All animals tested were negative to sodium fluorescein examination prior to instillation of the test article. Seven days following application of test article, examination was conducted again with sodium fluorescein and 3 of the 6 rabbits showed varying degrees of corneal opacity. Observations were continued beyond the normal 7-day period for a total of 28 days. One of the 6 animals continued to show corneal opacity at 28 days, as well as dendritic vascularization.

See attached file for individual results of each animal and average scores for all animals at all time-points recorded.

Applicant's summary and conclusion