Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 Unpublished safety data on the lithium stearate group.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 Unpublished safety data on the lithium stearate group.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.