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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to an internationally accepted guideline. Exact purity of the test substance not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: Suttocide A (powder)- Appearance: white powder- Lot/batch No.: 01/13/97 - Purity: not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA on 1/07/97 - Weight at study initiation: 2.0 - 2.3 kilograms (young adults)- System of Identification: Cage number and ear tag.- Housing: individually in cages sized in accordance with bedding.- Diet: Fresh Purina Rabbit Chow (Diet #5321), ad libitum.- Water: fresh tap water, ad libitum. ENVIRONMENTAL CONDITIONS- Light cycle - 12 hours light, 12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
50%-solution
Controls:
not required
Amount / concentration applied:
0.1 ml equivalent (90 mg)/treated eye
Duration of treatment / exposure:
The test substance was placed in one eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of material. The contralateral eye remained untreated and served as a control. The eyes of six rabbits remained unwashed. The eyes of the other three were washed with 20 ml of distilled water 30 seconds postdose.
Observation period (in vivo):
at 1, 24, 48 and 72 hours and on Days 7 and 14 after treatment
Number of animals or in vitro replicates:
9
Details on study design:
Scoring and grading of irritation was according to the method of Draize J.H. (1965), Appraisal of the Safety of chemicals in Food, Drugs and Cosmetics - Dermal Toxicity, page 49-52. Association of Food and Drug Officials of the U.S., Topeka, Kansas.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #1
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 41
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #2
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 39
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #3
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 49
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Cornea and conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #4
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 24
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #5
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 39
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #6
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 27
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 2 (Cornea and conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
Washed out
Basis:
animal #1
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 6
Max. score:
110
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Max individual irritation score: 2 ((Conjunctivae: discharge)
Irritation parameter:
overall irritation score
Remarks:
Washed out
Basis:
animal #2
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 27
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae: redness)
Irritation parameter:
overall irritation score
Remarks:
Washed out
Basis:
animal #3
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 29
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae: chemosis)

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
When administered as a 50% aqueous solution: the degree of ocular irritation was minimal to slight and involved only the conjunctivae. The irritation was also reversible by day 10 after instillation.