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Toxicological information

Repeated dose toxicity: oral

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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.