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Toxicological information

Acute Toxicity: dermal

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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:
1982
Bibliographic source:
International Journal of Toxicology
Reference Type:
publication
Title:
Acute Toxicity of compounds
Author:
Wiley Online
Year:
2014
Bibliographic source:
The MAK-Collection
Reference Type:
other: authoritative database
Title:
Acute toxicity - test chemical
Author:
IFA GESTIS
Year:
2018
Bibliographic source:
GESTIS database
Reference Type:
other: authoritative database
Title:
Acute Toxicity studies conducted on rodents
Author:
U.S. National Library of Medicine
Year:
2018
Bibliographic source:
HSDB
Reference Type:
review article or handbook
Title:
Toxicity Effects
Author:
U.S. Department of Health and Human Services
Year:
2017
Bibliographic source:
National Toxicology Program
Reference Type:
secondary source
Title:
IUCLID Dataset
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
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:
2004
Bibliographic source:
European Chemicals Bureau (ECB)

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals 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:
not specified
Body weight:
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.