Registration Dossier
Registration Dossier
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EC number: 252-669-5 | CAS number: 35674-68-1
Acute Toxicity: dermal
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 (http://echa.europa.eu/documents/10162/08799aec-42c5-44e0-9969-baa022c66db1). 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 Unpublished safety data on the Lithium Stearate Group.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
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
- Based on:
- other: product
- Remarks on result:
- other: 10 % zinc stearate
- 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:
- 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. (http://echa.europa.eu/documents/10162/08799aec-42c5-44e0-9969-baa022c66db1): "Zinc distearate does not need to be classified on the basis of its acute toxicity according to the EC criteria."
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