Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
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 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:
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 Inhalation toxicity of test chemical in rat.
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:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remark on MMAD/GSD:
not specified
Details on inhalation exposure:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Remarks on duration:
not specified
Concentrations:
200 mg/L (200000 mg/m3)
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:
LC50
Effect level:
> 200 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
1/10 rats died within the 14 day-observation period.
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 inhalation toxicity dose (LC50) value was considered to be >200 mg/L (>200000 mg/m3), when 10 rats were treated with test chemical by inhalation route for 1 hour exposure.
Executive summary:

Acute inhalation toxicity study of test chemical was conducted in 10 rats at the dose concentration of 200 mg/L (200000 mg/m3) for 1 hour exposure. 1 out of 10 rats died within the 14 day-observation period. Therefore, LC50 value was considered to be>200 mg/L (>200000 mg/m3), when 10 rats were treated with test chemical by inhalation route for 1 hour exposure.