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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Objective of study:
absorption
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: The absorption of sucrose monostearate was determined by administering a single dose intravenously to male rats.
- Short description of test conditions: A dose of 1 mg/kg bw was administered.
- Parameters analysed / observed: Samples were taken over the 24 hrs after dosing to determine the blood plasma concentration.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Kagaku Foods Corporation

FORM AS APPLIED IN THE TEST (if different from that of starting material): dissolved in water
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Fischer 344/DuCrj
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Japan Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: 161-206 g males, 113-133 g females
- Diet: fasting 15 hrs before dosing until 6 hrs after dosing
- Water: ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:
intravenous
Vehicle:
other: 0.9% saline solution
Duration and frequency of treatment / exposure:
Single intravenous dose
Doses / concentrations
Dose / conc.:
1 mg/kg bw/day (nominal)
No. of animals per sex per dose:
4
Control animals:
no
Details on dosing and sampling:
TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: plasma
- Time and frequency of sampling: 0.0833, 0.25, 0.5, 1, 2, 4, 8, 12, and 24 hrs after dosing
- Method type(s) for identification: GC-MS

Results and discussion

Main ADME results
Type:
metabolism
Results:
Plasma levels of sucrose monostearate were below the limit of detection within 24 hrs after dosage.

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Key result
Toxicokinetic parameters:
half-life 1st: 0.41 hrs
Key result
Toxicokinetic parameters:
half-life 2nd: 6.9 hrs
Key result
Toxicokinetic parameters:
AUC: 2.39 µg*hr/mL

Bioaccessibility

Bioaccessibility testing results:
The bioavailability was 0.3%.

Applicant's summary and conclusion

Conclusions:
Sucrose monostearate was rapidly eliminated from the blood plasma in a biphasic manner with a half-life of only 0.41 hrs. Within 24 hrs, the amount in the blood plasma was below the limit of detection.
Executive summary:

The absorption of sucrose monostearate was determined by administering a single dose intravenously to male rats. A dose of 1 mg/kg was administered, and the blood plasma levels were determined over the next 24 hrs. Sucrose monostearate was rapidly eliminated from the blood plasma in a biphasic manner with a half-life of only 0.41 hrs.  Within 24 hrs, the amount in the blood plasma was below the limit of detection.