Soybean oil, epoxidised, reaction products with methanol and water

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

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Principles of method if other than guideline:

Ten intracutaneous injections of 0.1 ml were given on alternate days in the induction phase. Animals were first challenged three weeks later by an injection of the same 0.1% solution, and again two weeks later with a 24-hour covered patch test using a 30% solution.

GLP compliance:

no

Type of study:

Maurer optimisation test

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, epoxidized

EC Number:

232-391-0

EC Name:

Soybean oil, epoxidized

Cas Number:

8013-07-8

IUPAC Name:

8013-07-8

In vivo test system

Test animals

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 400-540 g
- Housing: individually in Macrolon cages
- Diet ad libitum NAFAG, No. 830, Gossau SG, Switzerland
- Water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: 1:1 propylene glycol:saline

Induction 2

Concentration / amount:

1st: Induction .1 % intracutaneous
2nd: Challenge .1 % intracutaneous
3rd: Challenge 30 % occlusive epicutaneous

Challenge

Challenge 1

Route:

intradermal

Vehicle:

other: 1:1 propylene glycol:saline

Challenge 2

Concentration / amount:

1st: Induction .1 % intracutaneous
2nd: Challenge .1 % intracutaneous
3rd: Challenge 30 % occlusive epicutaneous

No. of animals per dose:

20

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 20 days
- Test groups: 20 animals
- Control group: 20 animals (vehicle alone)
- Frequency of applications: every second day
-Site: 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.
- Concentrations: 0,1 % in propylenglycol 50 % & saline 50 %.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: once during week 6
- Exposure period: once
- Test groups: 20 animals
- Control group: 20 animals (vehicle alone)
- Site: injection Into the skin of the left flank
- Concentrations: 0,1%
- Evaluation (hr after challenge): 24

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0,1%

No. with + reactions:

2

Total no. in group:

20

Clinical observations:

no data

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Test material was negative in the guinea pig sensitization test.