Registration Dossier
Registration Dossier
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EC number: 209-151-9 | CAS number: 557-05-1
Acute Toxicity: dermal
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final Report of the Safety Assessment
- Author:
- COSMETIC INGREDIENT REVIEW
- Year:
- 1 982
- Bibliographic source:
- International Journal of Toxicology
- Reference Type:
- publication
- Title:
- Acute Toxicity of compounds
- Author:
- Wiley Online
- Year:
- 2 014
- Bibliographic source:
- The MAK-Collection
- Reference Type:
- other: authoritative database
- Title:
- Acute toxicity - test chemical
- Author:
- IFA GESTIS
- Year:
- 2 018
- Bibliographic source:
- GESTIS database
- Reference Type:
- other: authoritative database
- Title:
- Acute Toxicity studies conducted on rodents
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- HSDB
- Reference Type:
- review article or handbook
- Title:
- Toxicity Effects
- Author:
- U.S. Department of Health and Human Services
- Year:
- 2 017
- Bibliographic source:
- National Toxicology Program
- Reference Type:
- secondary source
- Title:
- IUCLID Dataset
- Author:
- EUROPEAN COMMISSION – European Chemicals Bureau
- Year:
- 2 000
- Bibliographic source:
- IUCLID DATABSE- EUROPEAN COMMISSION – European Chemicals Bureau- EUROPEAN COMMISSION – 18–FEB–2000
- Reference Type:
- secondary source
- Title:
- Risk Assessment Report - Part II - Human Health
- Author:
- European Chemicals Bureau (ECB)
- Year:
- 2 004
- Bibliographic source:
- European Chemicals Bureau (ECB)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity of test chemical in rabbit.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Zinc distearate
- EC Number:
- 209-151-9
- EC Name:
- Zinc distearate
- Cas Number:
- 557-05-1
- Molecular formula:
- C18H36O2.1/2Zn
- IUPAC Name:
- zinc distearate
- Details on test material:
- - IUPAC Name: Zinc distearate
- InChI: 1S/2C18H36O2.Zn/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2
- Smiles: CCCCCCCCCCCCCCCCCC(=O)[O-].CCCCCCCCCCCCCCCCCC(=O)[O-].[Zn+2]
- Molecular formula :C36H70O4Zn
- Molecular weight :632.335 g/mol
- Substance type:Organic
- Physical state:Solid, powder white nearly odorless
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Type of coverage:
- other: Dermal
- Vehicle:
- other: in eye shadow form
- Details on dermal exposure:
- not specified
- Duration of exposure:
- not specified
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Total = 10
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed at 2000 mg/kg bw
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal toxicity dose (LD50) value was considered to be >2000 mg/kg bw, when 10 rabbits were treated with test chemical by dermal application in eye shadow form.
- Executive summary:
Acute dermal toxicity study of test chemical was conducted in 10 rabbits at the dose concentration of 2000 mg/kg bw by dermal application in eye shadow form. No mortality was observed at 2000 mg/kg bw. Hence, LD50 value was considered to be >2000 mg/kg bw, when 10 rabbits were treated with test chemical by dermal application in eye shadow form.
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