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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate and Zinc Stearate.
Author:
American college of toxicology
Year:
1982
Bibliographic source:
Journal of the American College of Toxicology 1 (2): 143-77 (1982).

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
.To evaluate the skin sensitizing potential of zinc dioctadecanoate in Human.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Reference substance name:
Zinc distearate
EC Number:
209-151-9
EC Name:
Zinc distearate
Cas Number:
557-05-1
IUPAC Name:
zinc dioctadecanoate
Details on test material:
- Name of test material : zinc distearate- Substance type: Organic- Physical state: Solid
Specific details on test material used for the study:
Name of test material: zinc distearateMolecular Formula: C36H70O4.ZnMolecular Weight: 632.22 g/mol- Substance type: Organic- Physical state: Solid

In vivo test system

Test animals

Species:
human
Strain:
other:
Remarks:
Not applicable.
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
other: no data
Vehicle:
unchanged (no vehicle)
Concentration / amount:
10 %
Challenge
Route:
other: no data
Vehicle:
unchanged (no vehicle)
Concentration / amount:
10 %
Day(s)/duration:
28 days
No. of animals per dose:
52 female penalist
Details on study design:
Two eyeshadow formulations, each containing 10% zinc stearate, were tested by means of the Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test.One of the formulations was applied twice a day for 28 days to 52 female panelists. Each subject was then examined at baseline and one, two, three, and four weeks after application.
Challenge controls:
No data available

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
672
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
52
Clinical observations:
not sensitizing
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Not sensitizing

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
The Substance zinc dioctadecanoate was considered to be not sensitizing when two eyeshadow formulation containing 10 % zinc dioctadecanoate (557-05-1)was applied twice a day for 28 days to 52 female panelists.
Executive summary:

Skin sensitization study for zinc dioctadecanoate  (557-05-1) was conducted on human.Two eyeshadow formulations, each containing 10% zinc dioctadecanoate , were tested by means of the Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test. The former test resulted in “virtually 0 reactions in 202 subjects,” whereas the latter one brought about “virtually 0 reactions in 99 subjects. In main test ,one of the formulations was applied twice a day for 28 days to 52 female panelists. Each subject was then examined at baseline and one, two, three, and four weeks after application. “No sensitization potential was exhibited by the panelists using this product under conditions. Therefore zinc dioctadecanoate  (557-05-1) was considered to be non sensitizing in human.

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