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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
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) No 1907/2006 (REACH), this study was considered reliable with restrictions.
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 Unpublished safety data on the Lithium Stearate Group.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 % zinc stearate in eyeshadow form was applied dermally to rabbits.
GLP compliance:
not specified
Test type:
other: in vivo

Test material

Reference
Name:
Unnamed
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

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

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 % zinc stearate in eyeshadow form was applied dermally to rabbits.
No further information on dermal exposure was stated.
Duration of exposure:
Not stated
Doses:
Not stated
No. of animals per sex per dose:
10 rabbits
Control animals:
not specified
Details on study design:
No information on the study design was stated.
Statistics:
Not stated.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was reported.
Clinical signs:
Not stated
Body weight:
Not stated
Gross pathology:
Not stated
Other findings:
Not stated

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for 10 % zinc stearate in eye shadow form (formulation) is > 2000 mg/kg bw for rabbits.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified.

This conclusion is in accordance with the EU RAR.
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: "Zinc distearate does not need to be classified on the basis of its acute toxicity according to the EC criteria."