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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journals

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report on the safety assessment of various stearate salts
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1982
Bibliographic source:
International Journal of Toxicology, 1982
Reference Type:
secondary source
Title:
European Union Risk Assessment Report- ZINC DISTEARATE
Author:
European Chemicals Bureau
Year:
2004
Bibliographic source:
European Union Risk Assessment Report, European Chemicals Bureau, 2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize Shelanski Patch test
Principles of method if other than guideline:
Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of the test chemical present in an eye shadow formulation
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : zinc distearate
- Molecular Formula:C36H70O4.Zn
- Molecular Weight:632.22 g/mol
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material: zinc distearate
- Molecular Formula: C36H70O4.Zn
- Molecular Weight: 632.22 g/mol
- Substance type: Organic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
other: Not applicable.
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: eyeshadow formulation
Concentration / amount:
10% in eyeshadow formulation
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: eyeshadow formulation
Concentration / amount:
10 % in eyeshadow formulation
Adequacy of challenge:
not specified
No. of animals per dose:
99 human volunteers
Details on study design:
Each subject was then examined at baseline and one, two, three, and four weeks after application.
Challenge controls:
no data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
99
Clinical observations:
The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.
Hence,the eye shadow formulation containing 10% zinc stearate can be considered to be not sensitizing to human skin.
Executive summary:

Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of ZInc stearate present in an eye shadow formulation..

The eye shadow formulation containing 10% test chemical was exposed to the skin of 99 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).

The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.

Hence,the eye shadow formulation containing 10% zinc stearate can be considered to be not sensitizing to human skin.