Glycerides, C16-22

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Remarks:

combined repeated dose and reproduction / developmental screening

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977

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:

publication

Title:

Unnamed

Year:

1977

Materials and methods

Principles of method if other than guideline:

Groups of 10 male and 30 female rats were fed during 13 weeks with diets containing 15% crude soy oil. Other groups received diets with heated soyu oil, crude/heated palm oil, crude/heated peanut oil, or crude/heated sunflower oil at the same concentration. Clinical signs and bodyweight were recorded throughout the study. After 13 weeks, hematology, clinical chemistry and urinalysis parameters were assessed.Ten males and ten females were sacrificed for gross and microscopic pathology.

After 10 weeks of treatment, 10 males and 20 females (15 - 16 weeks of age) were mated for 18 days. The females were then allowed to produce young. Maternal bodyweight and reproductive parameters (e.g. % implantation, %surviving young, % embryo loss, ...) were recorded. At 5 weeks of age, the young were sacrificed. One male and 2 females of each litter was autopsied. Liver and kidneys were weighed. For 5 males and 5 females selected randomly, these organs were examined microscopically.

GLP compliance:

no

Limit test:

no

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:

67701-30-8

Cas Number:

67701-30-8

IUPAC Name:

67701-30-8

Constituent 3

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

Details on test material:

- Name of test material (as cited in study report): Crude soy 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.’
- Substance type: Triglycerides of vegetable origin

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breeding
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 150 g
- Housing: 5 per sex per cage
- Diet (e.g. ad libitum): 40% wheat, 20% maize, 12% fish meal, 7% blood powder, 15% oil and 6%vitamin/minerals complement
- Water (e.g. ad libitum): yes

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:


DIET PREPARATION
- Rate of preparation of diet (frequency): every 4 - 5 days
- Storage temperature of food: 4°C

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

Not applicable

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

Doses / Concentrations:
15%
Basis:
nominal in diet

No. of animals per sex per dose:

10 males, 30 females for the 13 week feeding study
10 males, 20 females for the reproduction screening

Details on study design:

No data

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

13 WEEK FEEDING STUDY

Clinical signs and bodyweight were recorded throughout the study. After 13 weeks, hematology, clinical chemistry and urinalysis parameters were assessed.Ten males and ten females were sacrificed for gross and microscopic pathology.

REPRODUCTION SCREENING

Maternal bodyweight and reproductive parameters (e.g. % implantation, %surviving young, % embryo loss, ...) were recorded. At 5 weeks of age, the young were sacrificed. One male and 2 females of each litter was autopsied. Liver and kidneys were weighed. For 5 males and 5 females selected randomly, these organs were examined microscopically.

Sacrifice and pathology:

Gross and microscopic pathology at the end of the 13 week screening.
Microscopic pathology of liver and kidney of young rats from the reproduction screening at 35 days of age.

Other examinations:

No data

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):

not examined

Food efficiency:

not examined

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

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

OTHER FINDINGS
- No digestive intolerance noted during the 13 week feeding study
- During the reproductive screening study, no effects on maternal bodyweight evolution, reproductive parameters, pup liver and kidney weights, and pup liver and kidney histopathology

Effect levels

Dose descriptor:

NOAEL

Effect level:

15 other: % in diet

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: i.e. from 17,000 to 7,000 mg/kg bw/day, as the bodyweight of animals increased regularly over the course of the study.

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 conditions of this study, crude soy oil did not show any adverse effects on male and female rats compared to other crude or heated vegetable oils when administered for 13 weeks at 15% in diet, i.e. from 17,000 to 7,000 mg/kg bw/day, as the bodyweight of animals increased regularly over the course of the study.

Executive summary:

A study was conducted to determine the effect of crude soy oil on rats when administered for 13 weeks at 15% in diet. Results were compared to those obtained with heated palm oil, crude/heated soy oil, crude/heated peanut oil, or crude/heated sunflower oil at the same concentration. Clinical signs and bodyweight were recorded throughout the study. After 13 weeks, hematology, clinical chemistry and urinalysis parameters were assessed, as well as gross and microscopic pathology.

After 10 weeks of treatment, 10 males and 20 females were mated for 18 days. Maternal bodyweight and reproductive parameters were recorded. At 5 weeks of age, the young were sacrificed. Liver and kidneys weights were recorded and these organs were examined microscopically.

Crude soy oil did not show any adverse effects on male and female rats compared to other crude or heated vegetable oils when administered for 13 weeks at 15% in diet. Furthermore, no signs of toxicity were observed on maternal rats or pups in the follow-up reproductive screening trial.

The NOAEL can be considered to be 15% in diet, i.e. from 17,000 to 7,000 mg/kg bw/day, as the bodyweight of animals increased regularly over the course of the study.