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Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
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 peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Final Report of the safety assessment of lithium stearate, aluminium distearate, aluminium tristearate, Ammonium stearte, calcium stearate, magnesium stearte, potassium stearate, sodium stearate and zink stearte
Author:
American College of Toxicology
Year:
1982
Bibliographic source:
International Journal of Toxicology, pp143-177

Materials and methods

Objective of study:
absorption
Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Absorption of calcium
GLP compliance:
not specified

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
Test material form:
other: solid
Details on test material:
Name of test material (as cited in study report): Calcium Stearate
Molecular formula : C36H70CaO4
Molecular weight: 607.04 g/mol
Smiles notation :C(CCCCCCCCCCC)CCCCCC(=O)[O].C(CCCCCCCCCCC)CCCCCC(=O)[O].[Ca+2]
InChl:1S/2C18H36O2.Ca/c2*123456789101112131415161718(
19)20;/h2*217H2,1H3,(H,19,20);/q;;+2/p2
Substance Type: Organic
Physical State: Solid
Radiolabelling:
not specified

Test animals

Species:
dog
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
not specified
Vehicle:
not specified
Duration and frequency of treatment / exposure:
Not specified
Doses / concentrations
Remarks:
Not specified
No. of animals per sex per dose / concentration:
Not specified
Control animals:
not specified
Details on study design:
Not specified
Details on dosing and sampling:
Not specified
Statistics:
Not specified

Results and discussion

Main ADME results
Type:
absorption
Results:
Calcium Stearate “Seems to be slightly absorbed by the supplementation of Some bile

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Calcium Stearate “Seems to be slightly absorbed by the supplementation of Some bile.

Metabolite characterisation studies

Metabolites identified:
not specified

Applicant's summary and conclusion

Conclusions:
The influence of bile and bile acid on the absorption of insoluble calcium salts in isolated dog intestine was studied. It was reported that Calcium Stearate “Seems to be slightly absorbed by the supplementation of Some bile.
Executive summary:

The influence of bile and bile acid on the absorption of insoluble calcium salts in isolated dog intestine was studied. It was reported that Calcium Stearate “Seems to be slightly absorbed by the supplementation of Some bile.