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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 9, 1998 - Dec. 19, 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Well documented study in humans, but not done according to OECD Guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin sensitization potential of the test substance was determined in a human patch test using 33 volunteers. Volunteers were exposed to 100%, 50%, and 0% of the test substance, with corn oil used as a negative control and vehicle. For the induction phase, test subjects were exposed to patches containing the test substance 9 times over a 3 week period, with each exposure lasting 24 hrs. After 2 weeks, a challenge exposure was performed which lasted 24 hrs. Readings were taken at 24, 48, and 72 hrs after exposure.
GLP compliance:
yes
Remarks:
Study was performed in accordance with Good Clinical Practice for Trials on Medicinal Products in the European Community
Type of study:
patch test
Justification for non-LLNA method:
Human data providing rlevant information on skin sensitisation is available.

Test material

Constituent 1
Reference substance name:
Sucrose tetrastearate triacetate
IUPAC Name:
Sucrose tetrastearate triacetate

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 20 to 59 years (average 37 years)

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100% and 50%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%, 50%, and 0%
No. of animals per dose:
33 (7 males and 26 females)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hrs
- Test groups: Each subject was exposed to 100% and 50% test substance
- Control group: Each subject was also exposed to 100% vehicle
- Site: back and upper arms
- Frequency of applications: 9 times within 3 weeks
- Concentrations: 100% and 50%B.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 hrs
- Test groups: Each subject was exposed to 100% and 50% test substance
- Control group: Each subject was also exposed to 100% vehicle
- Site: naive skin on the back- Concentrations: 100% and 50%
- Evaluation (hr after challenge): 24, 48, and 72 hrs after challenge.
Challenge controls:
Corn oil

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
33
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
33
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
33
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
33
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
33
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
33
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

No test subjects showed any skin reactions during the induction phase. No skin reactions were noted during the challenge phase.

Individual Results - 100% test substance

 Subject  Induction  Challenge  Sensitization
 97297  0  0  -
 98522  0  0  -
 94265  0  0  -
 98609  0  0  -
 97336  0  0  -
 98526  0  0  -
 97116  0  0  -
 96174  0  0  -
 92179  0  0  -
 95179  0  0  -
 91598  0  0  -
 98602  0  0  -
 91799  0  0  -
 99207  0  0  -
 98002  0  0  -
 97333  0  0  -
 96084  0  0  -
 96120  0  0  -
 98529  0  0  -
 96175  0  0  -
 99171  0  0  -
 98106  0  0  -
 98006  0  0  -
 94202  0  0  -
 95270  0  0  -
 98020  0  0  -
 97338  0  0  -
 91329  0  0  -
 95014  0  0  -
 97003  0  0  -
 95012  0  0  -
 97115  0  0  -
 97161  0  0  -

Individual Results - 50% test substance

 Subject  Induction  Challenge  Sensitization
 97297  0  0  -
 98522  0  0  -
 94265  0  0  -
 98609  0  0  -
 97336  0  0  -
 98526  0  0  -
 97116  0  0  -
 96174  0  0  -
 92179  0  0  -
 95179  0  0  -
 91598  0  0  -
 98602  0  0  -
 91799  0  0  -
 99207  0  0  -
 98002  0  0  -
 97333  0  0  -
 96084  0  0  -
 96120  0  0  -
 98529  0  0  -
 96175  0  0  -
 99171  0  0  -
 98106  0  0  -
 98006  0  0  -
 94202  0  0  -
 95270  0  0  -
 98020  0  0  -
 97338  0  0  -
 91329  0  0  -
 95014  0  0  -
 97003  0  0  -
 95012  0  0  -
 97115  0  0  -
 97161  0  0  -

Individual Results - Corn oil

 Subject  Induction  Challenge  Sensitization
 97297  0  0  -
 98522  0  0  -
 94265  0  0  -
 98609  0  0  -
 97336  0  0  -
 98526  0  0  -
 97116  0  0  -
 96174  0  0  -
 92179  0  0  -
 95179  0  0  -
 91598  0  0  -
 98602  0  0  -
 91799  0  0  -
 99207  0  0  -
 98002  0  0  -
 97333  0  0  -
 96084  0  0  -
 96120  0  0  -
 98529  0  0  -
 96175  0  0  -
 99171  0  0  -
 98106  0  0  -
 98006  0  0  -
 94202  0  0  -
 95270  0  0  -
 98020  0  0  -
 97338  0  0  -
 91329  0  0  -
 95014  0  0  -
 97003  0  0  -
 95012  0  0  -
 97115  0  0  -
 97161  0  0  -

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
The test substance is not sensitizing to skin.
Executive summary:

The skin sensitization potential of the test substance was determined in a human patch test using 33 volunteers. Volunteers were exposed to 100%, 50%, and 0% of the test substance, with corn oil used as a negative control and vehicle. No volunteers showed any reaction to the test substance in either the induction or challenge phases.