Fatty acids, palm-oil, hydrogenated

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is well documented, meets generally accepted scientific principles and is acceptable for assessment.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1968

Materials and methods

Objective of study:

absorption

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The absorption of coconut oil was determined in a 47 wk repeated dose study in rats. At intervals during the study, feces were collected daily, pooled in weekly samples, and analyzed for fat content. The net fat absorption was calculated from dietary intakes and fecal excretion.

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C8-18 and C18-unsatd.

EC Number:

266-946-3

EC Name:

Glycerides, C8-18 and C18-unsatd.

Cas Number:

67701-28-4

IUPAC Name:

Glycerides, C8-18 and C18-unsatd.

Details on test material:

- Name of test material (as cited in study report): Coconut oil (CAS N° 8001-31-8, EC N° 232-282-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18 and C18-unsatd.’

Radiolabelling:

no

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: Individual screen-bottom cages
- Diet: Normal diet; ad libitum
- Water: Ad libitum


ENVIRONMENTAL CONDITIONS
Air-conditioned animal rooms

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

DIET PREPARATION
- Mixing appropriate amounts with (type of food): 18.5% coconut oil was mixed with diet containing additional 2.5% safflower oil as fat source to insure adequacy of the essential fatty acids. No other fat source was used in diet.

Duration and frequency of treatment / exposure:

47 wks; ad libitum in diet

Doses / concentrations

Remarks:

Doses / Concentrations:
18.5%

No. of animals per sex per dose / concentration:

15 animals/sex/group

Control animals:

no

Positive control reference chemical:

None

Details on study design:

No data

Details on dosing and sampling:

PHARMACOKINETIC STUDY (Absorption)
- Tissues and body fluids sampled: Feces
- Details: At intervals during the study, feces were collected daily, pooled in weekly samples, and analyzed for fat content. The net fat absorption was calculated from dietary intakes and fecal excretion.

Statistics:

None

Results and discussion

Preliminary studies:

None

Toxicokinetic / pharmacokinetic studies

Details on absorption:

The net fat absorption, calculated from dietary intakes and fecal excretion, was 96%. The absorption of coconut oil can be considered to be similar to this value as 2.5% safflower oil was the only other fat source in diet.

Details on distribution in tissues:

Not performed

Details on excretion:

Not performed

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

Not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: High absorption
Under the conditions of the test, the test substance was highly absorbed after dietary administration in rats.

Executive summary:

The absorption of 'glycerides, C8-18 and C18-unsatd.' (as coconut oil) was determined in a 47 week repeated dose study in rats.

The test substance was included at 18.5% level in diets of 15 wistar rats/sex/group for 47 weeks. Additional 2.5% safflower oil was included to insure adequacy of the essential fatty acids. At intervals during the study, feces were collected daily, pooled in weekly samples, and analyzed for fat content. The net fat absorption was calculated from dietary intakes and fecal excretion.

The net fat absorption was 96%. The absorption of the test substance can be considered to be similar to this value as 2.5% safflower oil was the only other fat source in diet.

Hence, under the conditions of the test, the test substance was highly absorbed after dietary administration in rats.