Soybean oil, reaction products with ethaneperoxoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February to March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD guideline with no deficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

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:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Agrol® 3.6 Soy-Based Polyol
- Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: 13-3.6-ASO-004
- Expiration date of the lot/batch: Given as 360 days from date of analysis: 8 February 2013
- Storage condition of test material: Ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Labs; Hdq: Indianapolis, IN
- Age at study initiation:
- Weight at study initiation: 3.104-3.991 kg / 3.311-4.113 kg
- Housing: 1 per cage
- Diet (e.g. ad libitum): PMI Feeds, Inc.™ Lab Rabbit Diet #5321, ~8 oz. daily
- Water (e.g. ad libitum): Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 22-77%
- Air changes (per hr): 10+ air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours; then 7 days.

Number of animals:

3.

Details on study design:

TEST SITE
- Area of exposure: 8 x 8 cm
- % coverage:
- Type of wrap if used: 4 ply 2.5 x 2.5 cm surgical gauze patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After four hours, patches and wrappings were removed. Test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test item as possible.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Primary Dermal Irritation Scoring Scale (Draize Technique*)
Evaluation of Skin Reactions

Erythema Formation Score
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Maximum Possible 4

Edema Formation Score
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Maximum Possible 4

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

0.8

Max. score:

8

Reversibility:

no data

Any other information on results incl. tables

Animal	Erythema					Edema					PII
Number	Hours				Days	Hours				Days
	1	24	48	72	7	1	24	48	72	7
0041 -M	1	1	1	1	0	0	0	0	0	0	1.00
0040 -F	1	1	1	1	0	0	0	0	0	0	1.00
0042 -F	1	1	0	0	0	0	0	0	0	0	0.50

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

The Primary Irritation Index of 0.8 out of a possible 8.0 was obtained from observations at 1, 24, 48 and 72 hours, and used to give Agrol® Polyol 693217-63-9 a descriptive rating of slightly irritating. Based on 72-hour observations only, the test item is assigned Toxicity Category IV (per Proposed Rule, FR Vol. 49, No. 188).

Executive summary:

A primary dermal irritation study was conducted on three albino rabbits using test item Agrol® Polyol 693217-63-9. There was one intact test site per animal. Each test site was treated with 0.5 mL of undiluted test item and covered with a semi-permeable dressing. The test item was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours, and 7 days after removal of the dressings. Irritation scores derived from respective erythema and edema scores through the 72-hour observations for each animal are presented below.

Animal           Erythema           Edema  Irritation  Number           Hours After Unwrap           Hours After Unwrap  Scores    1 24  48  72  1  24  48  72     0041 -M  1 1  1  1  0  0  0  0   1.00  0040 -F  1 1 1  1  0  0  0  0   1.00  0042 -F 1  1  0  0 0  0  0  0   0.50

Primary Irritation Index (PII) = 0.8

Based on 0.8 PII, the test item is rated slightly irritating. Irritation was no longer evident on Day 7. Based on scores at the 72-hour observation only, the test item is assigned Toxicity Category IV.