Glycerides, C16-22

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A 13 wks (90 d) oral combined repeated dose and reproduction / developmental screening study was conducted in Sprague Dawley rat to evaluate the reproductive parameters.
After 10 weeks of treatment with 15% crude soy oil, 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

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:

acetone

Details on exposure:

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

Details on mating procedure:

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.

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

Not applicable

Duration of treatment / exposure:

13 wks (90 d)

Frequency of treatment:

Daily

Doses / concentrations

Dose / conc.:

15 other: %

Remarks:

Basis: nominal in diet

No. of animals per sex per dose:

10 males, 20 females for the reproduction screening

Details on study design:

No data

Positive control:

No data

Examinations

Parental animals: Observations and examinations:

See section 7.5.1 for details on 13 WEEK FEEDING STUDY

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.

Postmortem examinations (offspring):

Microscopic pathology of liver and kidney of young rats from the reproduction screening at 35 days of age.

Statistics:

No data

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Organ weight findings including organ / body weight ratios:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Other effects:

not examined

Details on results (P0)

- 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 (P0)

Dose descriptor:

NOAEL

Effect level:

15 other: % in diet (equivalent to 7-17 g/kg bw/d)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no significant toxicity were observed on maternal rats or pups

Target system / organ toxicity (P0)

Critical effects observed:

no

Results: F1 generation

Effect levels (F1)

Remarks on result:

not measured/tested

Overall reproductive toxicity

Reproductive effects observed:

no

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the NOAEL can be considered to be 15% in diet, equivalent to 17 - 7 g/kg bw/day, as no significant toxicity were observed on maternal rats and pups.

Executive summary:

A combined repeated and reproductive screening 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, equivalent to 17 - 7 g/kg bw/day, as no significant toxicity were observed on maternal rats and pups.