Aluminium tristearate

Skin sensitisation

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

Test material information

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.