Fatty acids C16-18 (even numbered), mono, di and tri esters with sucrose

Basic toxicokinetics

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

Test material information

Constituent 1

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 or test system 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 / concentration:

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 parameters

Toxicokinetic parameters 1

Key result

Toxicokinetic parameters:

half-life 1st: 0.41 hrs

Toxicokinetic parameters 2

Key result

Toxicokinetic parameters:

half-life 2nd: 6.9 hrs

Toxicokinetic parameters 3

Key result

Toxicokinetic parameters:

AUC: 2.39 µg*hr/mL

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) 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.