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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Biological evaluation of hydrogenated rapeseed oil
Author:
Nolen GA
Year:
1981
Bibliographic source:
J. Am. Oil Chem. Soc. 58(1):31-7

Materials and methods

Objective of study:
absorption
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The absorption of soybean oil was measured in a 15-d feeding study by analysis of unabsorbed fecal fat. The net fat absorption was calculated from dietary intakes and fecal excretion.




GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Glycerides, C16-18 and C18-unsatd.
IUPAC Name:
Glycerides, C16-18 and C18-unsatd.
Constituent 2
Reference substance name:
Glycerides, C16-18 and C18-unsatd.
EC Number:
266-948-4
EC Name:
Glycerides, C16-18 and C18-unsatd.
IUPAC Name:
266-948-4
Constituent 3
Reference substance name:
67701-30-8
Cas Number:
67701-30-8
IUPAC Name:
67701-30-8
Details on test material:
- Name of test material (as cited in study report): Soybean oil (CAS N° 8001-22-7, EC N° 232-274-4); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18 and C18-unsatd.’

Radiolabelling:
no

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Housing: The animals were housed in individual stainless steel wire-mesh cages
- Diet: Ad libitum
- Water: Ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1
- Humidity (%): 50±5%
- Photoperiod (h dark / h light): 12/12

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on exposure:
DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Normal diet without any other fat source

Duration and frequency of treatment / exposure:
15 d; daily ad libitum in food
Doses / concentrations
Remarks:
Doses / Concentrations:
15%



No. of animals per sex per dose / concentration:
10 animals/group

Control animals:
no
Details on study design:
- Rationale for animal assignment: Random


Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption)
- Tissues and body fluids sampled: Feces
- Time and frequency of sampling: For the final 10 d, the feces were collected for analysing the unabsorbed fat. The net fat absorption was calculated from dietary intakes and fecal excretion.

Results and discussion

Main ADME results
Type:
absorption
Results:
94±2%

Toxicokinetic / pharmacokinetic studies

Details on absorption:
High absorption (94±2%) was observed for soybean oil.

Metabolite characterisation studies

Metabolites identified:
not measured

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the constituent was highly absorbed (94%) after dietary administration in rats.

Executive summary:

The oral absorption of the constituent 'glycerides, C16 -18 and C18 -unsatd.' (as soybean oil) was measured in a 15 d feeding study by analysis of fecal unabsorbed fat. Diet containing 15% of the constituent was fed to 10 male Sprague-Dawley rats for 15 d. For the final 10 d, the feces were collected for unabsorbed fat analysis. The net fat absorption was calculated from dietary intakes and fecal excretion. High (94%) absorption was observed. Under the test conditions, the constituent was highly absorbed after dietary administration in rats (Nolen, 1981 (1)).

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