Fatty acids, tallow, zinc salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004". In accordance with Section 1 (0.5), Annex I of Regulation (EC) 1907/2006 (REACH), this study was considered reliable with restrictions.

Data source

Reference

Reference 1

Reference Type:

other: CIR Cosmetic Ingredient Revie, peer-reviewed in EU RAR

Title:

Submission of data by CTFA. Unpublished safety data on the Lithium Stearate Group. Schwartz-Peck Prophetic Patch Test and Draize-Shelanski Repeated Insult Patch Test. Zinc Stearate (10 percent) in eye shadow 923 - 100.

Author:

CTFA

Year:

1976

Bibliographic source:

Busch, J.T., CIR Cosmetic Ingredient Review (1982). Int J Toxicol 1 (2), 143-177.

Reference 2

Reference Type:

other: communication

Title:

Zinc stearate (10 %) in eye shadow 923-100

Author:

CIR Safety.org, Cosmetic Ingredient Review 1101 17th St. N. W. Suite 412 Washington D. C. 20036-4702, USA

Year:

2010

Bibliographic source:

Communication to bibliographic source Busch, J.T, CIR Cosmetic Ingredient Review (1982), Int J Toxicol 1 (2), 143-177.

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

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.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

91051-01-3

Cas Number:

91051-01-3

IUPAC Name:

91051-01-3

Constituent 2

Reference substance name:

Fatty acids, C16-18, zinc salts

EC Number:

293-049-4

EC Name:

Fatty acids, C16-18, zinc salts

IUPAC Name:

293-049-4

Details on test material:

- Name of test material (as cited in study report): Zinc stearate
Substances named zinc stearate or zinc distearate are considered equal to substance fatty acid, C16-18, zinc salts. Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In practice, the description “Fatty acids, C16-18, zinc salts” registered under CAS no 91051- 01-3 is a more exact fit with commercial zinc stearate (c.f. EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN, page 7).
No further information on the test material was stated.

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 202 subjects participated in the Schwartz-Peck Prophetic Patch Test and 99 subjects participated in the Draize-Shelanski Repeated Insult Patch Test.
No further information on subjects was stated.

Clinical history:

Not stated

Controls:

Not stated

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test)
No further information on the study design was stated.

Results and discussion

Results of examinations:

Results from the Schwartz-Peck Prophetic Patch Test: Virtually 0 reactions in 202 subjects
Results from Draize-Shelanski Repeated Insult Patch Test: Virtually 0 reactions in 99 subjects

Applicant's summary and conclusion

Conclusions:

The results showed that two eyeshadow formulations, each containing 10 % zinc stearate, which were tested by means of the Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test, resulted in virtually 0 reactions in the subjects.

Conclusions of EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004: Based on the accepted derogation and the fact that zinc oxide is not a skin sensitiser, it is consequently concluded that zinc distearate is not likely to be skin sensitising, and therefore does not need to be classified/labelled. This is supported by the fact that the use of zinc distearate in pharmaceutical and cosmetic products is without reported skin sensitisation effects.