Soybean oil, reaction products with ethaneperoxoic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 February to 27 March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed to a recognised OECD protocol with no significant deviations.

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 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

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

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley; Indianapolis, IN
- Age at study initiation: 8 weeks
- Weight at study initiation: 21.3 - 24.3 g
- Housing: Polycarbonate boxes with bedding; 1-5 per cage
- Diet (e.g. ad libitum): PMI Feeds Inc.™ Formulab #5008; available ad libitum
- Water (e.g. ad libitum): Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system
- Acclimation period: Not given.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 28-79%
- Air changes (per hr): 10+ air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

IN-LIFE DATES: From: 20 March 2013 To: 25 March 2013

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

100%; 50% and 25% in 4:1 acetone:olive oil

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS: N/A
- Compound solubility:
- Irritation:
- Lymph node proliferation response:

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Liquid scintillation counting/disintegrations per minute
- Criteria used to consider a positive response: Positive control test item produced a stimulation index > 3, and is therefore considered a sensitizer.

TREATMENT PREPARATION AND ADMINISTRATION:
Healthy mice were released from quarantine prior to testing. Five females were selected for each of three Test groups (Groups I - III). On Days 1, 2 and 3, each Test animal in its group received an open application of 25 μL of appropriate dilution (25 or 50%) of test item, or 100% test item undiluted, to the dorsum of both ears. The Vehicle Control group (5 females) was treated the same way as test animals, but with vehicle alone instead of test item. The Positive Control group (5 females) was treated with 100% alpha-hexylcinnamaldehyde. All Test and Control animals were given a two-day rest period on Days 4 and 5.
On Day 6 of the study, all Test and Control animals were injected in the tail vein with 250 μL of 0.01 M phosphate-buffered saline (PBS; Sigma, Lot 081M8207, Exp Nov 2021), pH 7.4 at 25oC per manufacturer, containing 20 μCi of [methyl-3H] Thymidine (PerkinElmer, Lot 201303, Exp Mar 2014). Five hours after injection, animals were sacrificed with an overdose of CO2, the draining auricular lymph nodes excised and pairs from each individual animal processed.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

No statitical analyses were performed on the data.

Results and discussion

Positive control results:

Animal number DPM Count
1 8290.0
2 7585.7
3 3320.8
4 5718.7
5 8876.5

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: See table below.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See table below.

Any other information on results incl. tables

 

Animal Group	Test Item Concentration	Average Count per Mouse	Number of Mice in Group	Stimulation Index
Vehicle control	N/A	622	5	N/A
Test Group I	25%	655	5	1.1
Test Group II	50%	414	5	0.7
Test Group III	100%	749	5	1.2
Positive control	N/A	6758	5	10.9

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Agrol® Polyol (CAS 693217-63-9) produced a stimulation index < 3 in all groups of Test animals, and is not therefore considered a sensitizer (defined as producing a positive response).

Executive summary:

A skin sensitization study was conducted on 3 groups of 5 female mice to determine if test item Agrol® Polyol (CAS 693217-63-9) possesses a significant potential to cause skin sensitization. Five females were assigned to each of three groups, designated Groups I - III. Test groups were treated with an appropriate dilution (25 or 50%) in 4:1 acetone:olive oil, or 100% test item. Each animal received 25 μL to the dorsum of each ear. Animals were treated once daily for three days. After a two-day rest period, all animals were injected with tritiated methyl-thymidine in the tail vein. Five hours later, animals were sacrificed, and the draining auricular lymph nodes removed and prepared for cell suspension and scintillation counting. A Vehicle Control group of five females was run concurrently, treated in the same manner with vehicle only instead of test item or dilution. A Positive Control group of five females was also run concurrently, treated with 100% alpha-hexylcinnamaldehyde. The test item produced a stimulation index