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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:
September 30, 1983 - October 13, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Well documented GLP study performed according to a method similar to OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-23-1
- Substance type: clear liquid
- Physical state: liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration

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, Pennsylvania and Perfection Breeders, Douglassville, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
The upper and lower lids were gently held together for one second to prevent loss of material.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours and 7, 10, and 13 days after treatment. The grades of ocular reaction were recorded at each examination.
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
Grading of irritation is according to the method of Draize, J.H., et al., J. Pharm, Exp. Ther. 82: 377 - 390 (1944).

An animal exhibited a positive reaction when the test substance produced one or 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
95.3
Max. score:
100
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Scoring after 1 hour: 2; No scoring possible after 24 hours due to high degree of opacity
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: No scoring possible after 1 hour due to high degree of opacity
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Scoring after 1 and 24 hours: 2. No scoring possible after 48 hours due to high degree of opacity
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: No scoring possible after 1 hour due to high degree of opacity
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Scoring after 1 and 24 hours: 2. No scoring possible after 48 hours due to high degree of opacity
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: Scoring after 1 hour: 2. No scoring possible after 24 hours due to high degree of opacity
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 13 days
Irritant / corrosive response data:
Positive ocular responses were observed at 1, 24, 48 and 72 hours and on days 7, 10 and 13. Rupture of the globe, conjunctival necrosis and red discharge were observed during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Positive ocular responses were recorded at 1, 24, 48 and 72 hours and on days 7, 10 and 13. Rupture of the globe, conjunctival necrosis and red discharge were observed during the course of the study. Based on the results and the criteria of the CLP Regulation, the substance is classified as category 1 eye corrosive.