Soybean oil, epoxidized, ether with ethylene glycol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

13 July 1981 to 4 September 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-comparable study

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

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

The optimisation test was used, an intracutaneous sensitisation procedure exceeding the sensitivity of the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Guideline-comparable study

Test material

Test material information

Constituent 1

Reference substance name:

TK 11'278

IUPAC Name:

TK 11'278

Constituent 2

Reference substance name:

ESBO

IUPAC Name:

ESBO

Constituent 3

Reference substance name:

Epoxidised Soybean Oil

IUPAC Name:

Epoxidised Soybean Oil

Constituent 4

Reference substance name:

Soybean oil, epoxidized

EC Number:

232-391-0

EC Name:

Soybean oil, epoxidized

IUPAC Name:

232-391-0

Constituent 5

Reference substance name:

8013-07-8

Cas Number:

8013-07-8

IUPAC Name:

8013-07-8

Constituent 6

Reference substance name:

Soybean oil, epoxidised

IUPAC Name:

Soybean oil, epoxidised

Details on test material:

- Name of test material (as cited in study report): TK 11'278
- Physical state: Liquid
- Lot/batch No.: prod. Oct. 80
- Expiration date of the lot/batch: January 1982

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White

Sex:

male/female

Details on test animals and environmental conditions:

The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright White Strain, bred on the premise,s and weighing between 400 to 540 grams.
The animals were housed individually in type 3 Macrolon cages, kept at a constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and in a 12 hour light cycle per day.
The animals were fed standard guinea pig pellets - NAFAG, No. 830, Gossau SG, SWitzerland - ad libitum and had ad libitum access to water.
Bodyweights were recorded immediately before initiation of dosing in the inductin phase and at termination of the study.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

other: propylenglycol 50 % / saline 50 %

Induction 2

Concentration / amount:

0.1 mL of 0.1 % solution of TK 11'278

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: propylenglycol 50 % / saline 50 %

Challenge 2

Concentration / amount:

0.1 mL of 0.1 % solution of TK 11'278

No. of animals per dose:

10 male and 10 female

Details on study design:

The optimisation test was used, an intracutaneous sensitisation procedure exceeding the sensitivity of the method recommended in the "Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

During the induction period the animals received injections every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 11'278 in propylenglycol 50 % / saline 50 %. One control group was treated with the vehicle alone ("negative control").

On the first day of week 1, two injections of 0.1 mL were administered into the shaven skin of the right flank and on the following days a single intracutaneous injection was given into the flank.

During the second and third week of the induction period the test material was incroporated in a mixture of saline with complete Bacto Adjuvant. (saline : adjuvant = 1:1)

During week 6 a challenge injection of 0.1 mL of a freshly prepared 0.1 % solution of TK 11'278 in propylenglycol 50 % /saline 50 % was administered into the skin of the left flank.

Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.

The two largest perpendicular diameters (in mm) and the increase in the skin-fold thickness (in mm) were measured and by multiplication of these values the "reaction volume" was obtained (in µL) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergenic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control").

During week 8 a subirritant dose (30 % TK 11'278 in vaseline) of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The skin irritation was recorded according to Draize (described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959 of the US Association of Food and Drug Officials (AFD0) 24 hours after removal of the dressings. For irritation score see table below:

Score for Skin Irritation

Erythema and eschar formation
No erythema........................................................ 0
Very slight erythema (barely perceptible) ...... 1
Well defined erythema ....................................... 2
Moderate to severe erythema .......................... 3
Severe erythema (beed redness) to slight
eschar formation (injuries in depth) ...............4
Total Possible Erythema Score .........................4

Challenge controls:

No data

Positive control substance(s):

no

Results and discussion

Positive control results:

No data

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 20.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 2.0. Total no. in groups: 20.0.

Any other information on results incl. tables

No further data to report.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No evidence of skin sensitisation was seen under the conditions of this study

Executive summary:

The skin sensitisation potential of the read-across substance ESBO (epoxidised soybean oil) was assessed in a guinea pig study. No evidence of skin sensitisation was seen under the conditions of this study; a comparable level of reactions was seen following challenge exposure in test and control animals.