Zinc dimyristate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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 Unpublished safety data on the Lithium Stearate Group. Acute oral intubation, acute dermal toxicity, primary skin irritation and ocular irritation.

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

Principles of method if other than guideline:

10 % concentration of zinc stearate was applied in eyeshadow form to the eyes of six rabbits. Observations were made at 24, 48, and 72 hours.

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

Cas Number:

91051-01-3

Molecular formula:

Zn(C18H35O2)2 for C18 and Zn(C16H31O2)2 for C16

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.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
Rabbits were used.
No further information on the test animals was stated.

Test system

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 % concentration of zinc stearate in undiluted eyeshadow form was applied to the rabbit eyes.
No further information on the amount/concentration applied was stated.

Observation period (in vivo):

At 24, 48, and 72 hours

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

No further information on the study design was stated.

Results and discussion

In vivo

Results

Irritation parameter:

other: Ocular irritation score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: Zinc stearate as formulation (10% in undiluted eyeshadow form) was not irritating to the eye. Due to insufficient documentation the study cannot be used for hazard assessment.

Any other information on results incl. tables

The score was 0 in all animals at 24, 48, and 72 hours.

Zinc stearate as formulation (10% in undiluted eyeshadow form) was not irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:

other: Due to insufficient documentation the study cannot be used for hazard assessment.

Conclusions:

Zinc stearate as formulation (10% in undiluted eyeshadow form) was not irritating to the eye.