Soybean oil, reaction products with ethaneperoxoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 December 2005 - 2 January 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP/Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Authors reported that they followed a modification of the Draize test and U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42).

Reference:
IJ.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, (The Association of Food and Drug Officials of the United States, 1959), pp. 49 - 51.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, reaction products with ethaneperoxoic acid

Cas Number:

693217-63-9

Molecular formula:

C59 H106 O11

IUPAC Name:

Soybean oil, reaction products with ethaneperoxoic acid

Test material form:

liquid: viscous

Details on test material:

Agrol 4.0 Polyol, Lot # SY-18-106 was used. The viscosity of the test material was 19,160 cP

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Six (6) New Zealand White rabbits, weighing approximately two (2) kilograms and about three (3) months of age, were obtained through a suitably licensed dealer. The animals were checked carefully upon receipt for ocular defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general condition. Any animal exhibiting visible ocular defects or irritation or in poor condition, was not used in this test.

Arlimals were acclimated for at least 19 days prior to test initiation. They were individually housed in stainless steel cages, in a room with a 12 hour light/dark cycle. The room temperature was controlled to comply with Animal Welfare Regulations with an approximate range of 65 to 75 F. The humidity was also monitored. The animals were identified through individual markings on the outer ear of each animal, as well as a cage label. Diet consisted of Lab Diet Certified Rabbit Diet #5322, at 100 grams per day per animal, as well as water, ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml applied to one eye of each animal

Duration of treatment / exposure:

Any test material remaining in the eye was washed out after the 24-hour reading.

Observation period (in vivo):

Seven days

Number of animals or in vitro replicates:

6

Details on study design:

Immediately prior to test initiation, the animals were momentarily restrained. A dose of one-tenth of one milliliter (0.1 ml) of the test article was placed in one (1) eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The eyelids were gently held together for one (1) second. The contralateral eye, remaining untreated, served as a control. If any of the test article remained in the eye at 24 hours, both eyes were washed out with room temperature distilled water after the 24 hour reading.

Observations of ocular irritation were recorded 24, 48 and 72 hours following instillation of the test article. Additional readings were made at four (4) and seven (7) days after application, if irritation persisted.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

Redness of the Conjunctivae was observed in each animal. The value for A in the Draize rating system ranged from 1-2, resulting in a Total Score of 2-4. There was no effect noted on the Cornea or Iris or B or C as pertains to the Conjunctivae at any time during the 7 day observation period. Two of the 6 rabbits had a Conjunctivae value for A of 2 on day 7. The other 4 rabbits had been considered normal either prior to day 7 or on day 7.

Other effects:

No other effects noted.

Any other information on results incl. tables

Table 1 Average Draize Scores following installation of test material into the eye of 6 rabbits.

Average Draize Scores
	Hours			Days
Group	24	48	72	4	7
Unwashed	3.7	3.3	2.0	1.3	0.7

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42)

Conclusions:

According to U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42), and under the conditions of this test, this test article elicited positive responses in five (5) animals and is considered an ocular irritant

Executive summary:

An eye irritation test was conducted using a modified Draize method. Six (6) New Zealand White rabbits, free from visible ocular defects, each received a single intraocular application of one-tenth of one milliliter (0.1 ml) of the test article in one (1) eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment, and at four (4) and seven (7) days if irritation persisted. The test article was used as received.

Average Draize Scores
	Hours			Days
Group	24	48	72	4	7
Unwashed	3.7	3.3	2.0	1.3	0.7

According to U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42), and under the conditions of this test, this test article elicited positive responses in five (5) animals and is considered an ocular irritant