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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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.

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 Unpublished safety data on the lithium stearate group.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 irritaion
Author:
CTFA
Year:
1978
Bibliographic source:
Busch, J.T., CIR Cosmetic Ingredient Review (1982). Int J Toxicol 1 (2), 143-177.
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 Unpublished safety data on the lithium stearate group. Primary irritancy, sodium stearate. Product Type/In-House Code: DS 5011-55 Stick deodrant
Author:
CTFA
Year:
1975
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 % zinc stearate was supplied in eyeshadow form to rabbits.
GLP compliance:
not specified

Test material

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:
Fatty acids, C16-18, zinc salts
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

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Rabbits were used.
No further information on the test animals was stated.

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 % zinc stearate in eyeshadow form.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
not stated
Observation period:
not stated
Number of animals:
6 rabbits
Details on study design:
not stated

Results and discussion

In vivo

Results
Irritation parameter:
other: Primary Iirritation Index (PII)
Time point:
other: not stated
Score:
0
Remarks on result:
other: PII score of 0 translates into an overall irritation score of 0 according to OECD 404 (2002). Zinc stearate was not irritating. Due to methological deficiencies, this study cannot be used for the hazard assessment.
Irritant / corrosive response data:
Zinc stearate was not irritating.
Other effects:
not stated

Applicant's summary and conclusion

Interpretation of results:
other: Data not relavant for hazard assessment and classification and labelling purposes as formulation was tested.
Conclusions:
The formulation of zinc stearate was not irritating.