Registration Dossier

Diss Factsheets

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

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)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 1:1 propylene glycol:saline
Concentration / amount:
1st: Induction .1 % intracutaneous
2nd: Challenge .1 % intracutaneous
3rd: Challenge 30 % occlusive epicutaneous
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: 1:1 propylene glycol:saline
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.

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