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EC number: 293-049-4 | CAS number: 91051-01-3
Toxicological information
Acute Toxicity: dermal
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key 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 for cross-reference:
- 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 Unpublished safety data on the Lithium Stearate Group.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:
- 1 976
- 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:
- 2 010
- 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 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.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- 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.
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:
- other: Not stated
- Gross pathology:
- Not stated
- Other findings:
- Not stated
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for 10 % zinc stearate in eye shadow form (formulation) is > 2000 mg/kg bw for rabbits.
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."
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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