Glycerides, C16-18 and C18-unsatd., deodorizer distillates

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

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, acceptable for assessment

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:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Principles of method if other than guideline:

Groups of 30 (15 male and 15 female) weanling rats were fed diets containing 10% of either crude palm oil, groundnut oil or refined palm olein oil and adequate amounts of all other nutrients for 90 days. Food intake and bodyweight were monitored weekly. At the end of the experiment, cholesterol and triglycerides of serumm, liver and heart of all animals were analysed and compared statistically.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

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.

Cas Number:

67701-30-8

Molecular formula:

No generic molecular formula is available

IUPAC Name:

Glycerides, C16-18 and C18-unsatd.

Details on test material:

- Name of test material (as cited in study report): Crude palm oil (obtained from the Regional Research Laboratories, CSIR, at Trivandrum) (CAS N° 8002-75-3, EC N° 232-316-1); under the SDA nomenclature the name of this substance is 'Glycerides, C16-18 and C18 unsatd.'
- Other: Refined groundnut oil (control) (purchased from a local market (imported from Malaysia).
Refined palm olein oil (control) (purchased from a local market (imported from Malaysia)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The National Research Council's guide for the care and use of laboratory animals was followed.
Diet and water were given ad libitum.

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

90 days exposure and the rats were divided as followed:
Group 1: Protein free group
Group 2: 20% casein protein with 10% groundnut oil
Group 3: 20% casein protein with 10% crude palm oil
Group 4: 20% casein protein with 10% refined palm olein oil

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

No

Duration of treatment / exposure:

90 days

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
10%
Basis:
nominal in diet

No. of animals per sex per dose:

15

Control animals:

yes

Details on study design:

No

Positive control:

No

Examinations

Observations and examinations performed and frequency:

Body weights and food intake were recorded weekly

Sacrifice and pathology:

Cholesterol and triglycerides of serum, liver and heart of the animals were analyzed and statistically compared amongst groups.

Other examinations:

None

Statistics:

No data

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

no effects observed

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

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Gross pathological findings:

effects observed, treatment-related

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not examined

Details on results:

The crude palm oil and refined palm oil-fed animals showed higher concentrations of cholesterol than did the groundnut oil-fed animals, though these difference were not found to be statistically significant. The triglyceride concentrations of the crude palm oil and refined groups remained higher, whereas all other parameters had comparable values among different groups.

Effect levels

Dose descriptor:

NOAEL

Effect level:

10 other: % in diet

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no effect on growth rate, feed efficiency ratio, net protein utilization, digetstibility, fat absorption, nitrogen balance, phosphosour and calcium retention, lipid profiles, serum enzymes and hematology)

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Groundnut oil, gain in body weight in 28 days (n=10): 215.6 ± 14.8

Crude palm oil, gain in body weight in 28 days (n=10): 196.5 ± 14.8

Palm-olein oil, gain in body weight in 28 days (n=10): 196.2 ± 13.8

Groundnut oil, feed efficiency ratio: 19.8

Crude palm oil, feed efficiency ratio: 18.5

Refined palm-olein oil, feed efficiency ratio: 18.9

Serum, Cholesterol (mmol/L)

Groundnut oil: 2.39 ± 0.18

Crude palm oil: 2.38 ± 0.46

Refined palm oil: 2.15 ± 0.53

Serum, Triglycerides (mmol/L)

Groundnut oil: 1.08 ± 0.18

Crude palm oil: 1.43 ± 0.23

Refined palm oil: 1.39 ± 0.24

Liver, Cholesterol (mmol/L of total lipid)

Groundnut oil: 114.8 ± 2.84*

Crude palm oil: 132.4 ± 5.17*

Refined palm oil: 173.8 ± 2.84

Liver, Triglycerides (mmol/L of total lipid)

Groundnut oil: 19.8 ± 2.03

Crude palm oil: 20.8 ± 2.60

Refined palm oil: 20.8 ± 2.82

Heart, Cholesterol (mmol/L of total lipid)

Groundnut oil: 60.3 ± 0.78*

Crude palm oil: 68.0 ± 0.52*

Refined palm oil: 44.9 ± 0.26

Heart, Triglycerides (mmol/L of total lipid)

Groundnut oil: 25.4 ± 1.02

Crude palm oil: 29.0 ± 0.90

Refined palm oil: 25.5 ± 0.79

* Significantly different from refined palm oil value, P < 0.05.

Applicant's summary and conclusion

Conclusions:

The study suggests that the test substance has adequate nutritional value compared to groundnut and palm olein oil. A NOAEL of 10 palm oil in diet was established.

Executive summary:

A study was conducted to evaluate the nutritional effects and safety of crude ‘glycerides, C16-18 and C18-unsatd.’ (as palm oil) in rat.

The test substance was administered through the diet to groups of fifteen male and female rats for up to 90 consecutive days at dose levels of 10%.

No adverse effects compared to controls were observed as judged by growth rate, feed efficiency ratio, protein efficiency ratio, net protein utilization, digestibility, fat absorption, nitrogen balance, phosphorous and calciul retention, serum enzymes and hematology. There was also no difference in lipid concentrations compared to controls.

The study suggests that the test substance has adequate nutritional value compared to groundnut and palm olein oil.