Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: authoritative database
Justification for type of information:
RTECS DATA

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Stearic acid, calcium salt; RTECS Number WI3000000
Author:
RTECS - United States trademark owned and licensed under authority of the U.S. Government
Year:
2015
Bibliographic source:
RTECS, Registry of Toxic Effects of Chemical Substances last updated: December, 2015.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: not available
Principles of method if other than guideline:
Acute inhalation toxicity study of Calcium stearate in rats
GLP compliance:
not specified
Test type:
other: no data
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium distearate
EC Number:
216-472-8
EC Name:
Calcium distearate
Cas Number:
1592-23-0
Molecular formula:
C18H35O2.1/2Ca
IUPAC Name:
calcium bis(12-hydroxyoctadecanoate)
Constituent 2
Reference substance name:
Calcium stearate
IUPAC Name:
Calcium stearate
Details on test material:
- Name of test material (as cited in study report): Calcium Stearate
- Molecular formula (if other than submission substance): C36H70O4.Ca
- Molecular weight (if other than submission substance): 607.14 g/mole
- Substance type: Organic

Test animals

Species:
other: Mammal - species unspecified
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
No data available
Duration of exposure:
4 h
Concentrations:
1241 mg/m3
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 1 241 mg/m³ air
Based on:
not specified
Exp. duration:
4 h
Remarks on result:
other: No mortality observed
Mortality:
No data available
Clinical signs:
other: No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LC50 was considered to be >1241mg/m3 when Mammals were exposed with Calcium stearate by inhalation for 4 hour.
Executive summary:

In a acute inhalation toxicity study, Mammal by using Calcium stearate in the concentration of 1241mg/m3 inhaled. No effect on survival of treated Mammal was observed at 1241mg/m3. Therefore, LC50 was considered to be >1241mg/m3 when Mammals were exposed with Calcium stearate by inhalation for 4 hour.