Glycerides, C8-18 and C18-unsatd.

Repeated dose toxicity: oral

Administrative data

Endpoint:

chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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, 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:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A lifespan study was conducted in mice to investigate the effect of feeding hydrogenated coconut oil on longevity, hepatic lipid peroxidation and hepatic fatty acid composition.

GLP compliance:

not specified

Limit test:

no

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

Molecular formula:

Triglycerides containing a glycerol backbone esterified to fatty acids with a carbon chain length of C8-18 as well as unsaturated C18 fatty acids

IUPAC Name:

Tri(C8-18 and C18-unsatd. fatty acyl)glycerol

Details on test material:

- Name of test material (as cited in study report): Hydrogenated coconut oil (CAS N° 84836-98-6, EC N° 284-283-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18 and C18-unsad.’

Test animals

Species:

mouse

Strain:

other: LAFJ and C3H1HeJ

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Jackson Laboratory, Bar Harbor, Maine
- Age at study initiation: 4 wks
- Diet (ad libitum): Purina Laboratory Chow

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): The sucrose and hydrogenated coconut oil were blended with the powdered diet (Purina Chow) in an electric mixer.
- Storage temperature of food: Under refrigeration

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

Not applicable

Duration of treatment / exposure:

Entire lifespan

Frequency of treatment:

Daily ad libitum in diet

Doses / concentrations

Remarks:

Doses / Concentrations:
15% hydrogenated coconut oil
Basis:
nominal in diet

No. of animals per sex per dose:

60

Control animals:

other: 15% sucrose in diet

Details on study design:

None

Positive control:

Not applicable

Examinations

Observations and examinations performed and frequency:

BODY WEIGHT: Yes
- Time schedule for examinations: At monthly intervals

LONGEVITY: Yes

Sacrifice and pathology:

When pre-terminal (12-24 h before anticipated death), the animals were killed and portion of liver extracted to determine hepatic peroxide values and
hepatic fatty acid compositions

Other examinations:

None

Statistics:

The probabilities that differences in the data were due to chance were calculated by the t test.

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

No difference in longevity, body weights, hepatic peroxide values and hepatic fatty acid compositions between the groups in both the strains

Effect levels

Dose descriptor:

NOAEL

Effect level:

15 other: % in diet

Based on:

test mat.

Sex:

male

Basis for effect level:

other: No effect on longevity, body weight, hepatic peroxide values and hepatic fatty acid compositions

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, supplementation of 15% hydrogenated coconut oil in diet did not alter lifespan, body weight and hepatic peroxide/fatty acid values of mice. The NOAEL of the study was therefore equivalent to 15% in diet.

Executive summary:

A lifespan study was conducted in LAFJ and C3H1HeJ mice to investigate the effect of feeding hydrogenated coconut oil on longevity, hepatic lipid peroxidation and hepatic fatty acid composition.

15% hydrogenated coconut oil or sucrose was fed to 60 animals/strain/group for lifetime. Body weights were recorded at monthly intervals. When pre-terminal (12-24 h before anticipated death), the animals were killed and portion of liver extracted to determine hepatic peroxide values and

hepatic fatty acid compositions.

No differences were observed in longevity, body weights, hepatic peroxide values and hepatic fatty acid compositions between the groups in both the strains. No information was provided about the general toxicological effects.

Under the test conditions, the NOEAL was determined to be equivalent to 15% hydrogenated coconut oil in the diet.