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Toxicological information

Eye irritation

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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:
reference to same study

Data source

Referenceopen allclose all

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 Unpublished safety data on the Lithium Stearate Group.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 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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.