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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:
From November 17, 1981 through November 24, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP-study performed according to a method similar to OECD Guideline 405 without deviations.

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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4236-43-5, Order# J-86
- Substance type: yellow liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in physiological 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: Perfection Breeders, Inc., Douglassville, Pennsylvania
- Weight at study initiation: males 2.021-2.096 kg; females 2.103-2.124 kg
- Housing: Separate isolation by test system; rabbits were housed individually in cages sized in accordance with the "Guide for the Care of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce boiling, bridging, and scattering.
- Water (e.g. ad libitum): Availability - 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., Waterford, Wisconsin
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 51-58%
- 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 control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours and 7 days after treatment.
Number of animals or in vitro replicates:
six animals
Details on study design:
SCORING SYSTEM: 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), and 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: according to the method of Draize

Classification of the test substance:
Non-irritant: 0 or 1 rabbit with positive scores
Indeterminate: 2 or 3 rabbtis with positive scores
Irritant: 4 to 6 rabbits with positive scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Five rabbits exhibited a positive response at the one hour observation period. Two rabbits exhibited a positive response at the 24 hour reading. One positive response was observed at the 48 hour reading. No positive responses were observed at 72 hour or on day 7. Eight positive responses were recorded during the course of the study.
Other effects:
No effects on body weight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the substance was determined to be a mild eye irritant. Based on the CLP classification criteria, the substance does not need to be classified for eye irritation.