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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-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
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Biological evaluation of hydrogenated rapeseed oil
Author:
Nolen GA
Year:
1981
Bibliographic source:
J. Am. Oil Chem. Soc. 58(1):31-37

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
yes
Remarks:
; study at single dose; not all parameters measured
Principles of method if other than guideline:
The effect of dietary soybean oil was investigated (as control) in a subchronic toxicity study.

GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
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
IUPAC Name:
67701-30-8
Details on test material:
- Name of test material (as cited in study report): Soybean 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.’

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Housing: The animals were housed in individual stainless steel wire-mesh cages
- Diet: Ad libitum
- Water: Ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1
- Humidity (%): 50±5%
- Photoperiod (h dark / h light): 12/12

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Normal diet without any other fat source
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
Not applicable

Duration of treatment / exposure:
91 d
Frequency of treatment:
Daily ad libitum in food
Doses / concentrations
Remarks:
Doses / Concentrations:
19%
Basis:
nominal in diet
No. of animals per sex per dose:
20 animals/sex/group


Control animals:
other: Soybean oil group was itself used as control to study effect of 7.5% fully hydrogenated soybean oil
Details on study design:
- Rationale for animal assignment: Random


Positive control:
Not applicable

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly


FOOD CONSUMPTION (if feeding study): Yes
- Time schedule for examinations: Weekly


HAEMATOLOGY: Yes
- Time schedule for collection of blood: At time of sacrifice (end of study)
- Anaesthetic used for blood collection: Yes
- Animals fasted: No data
- How many animals: 10 animals/sex/group
- Parameter examined: Standard hemograms done


CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At time of sacrifice (end of study)
- Animals fasted: No data
- How many animals: 10 animals/sex/group
- Parameter examined: Serum cholesterol and phospholipids


URINALYSIS: Yes
- Time schedule for collection of urine: 24 h collection in 11th wk of study
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameter examined: Volume, nitrogen, ketones, glucose, bilirubin, albumin and pH

OTHER: During the 3rd and 11th wks, feces were collected from 10 animals/sex/group for analysis of unabsorbed fat.
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
(The heart, liver, kidneys and gonads were removed and weighed. Sections of these organs and of lung, pancreas, stomach, jejunum, adrenals, spleen, mesenteric lymph nodes and gastrocnemius muscle were examined)
Other examinations:
None

Statistics:
All of the data were analyzed by the Analysis of Variance and partitioned by the Tukey minimum significant difference method.

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):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not specified
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:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
No adverse effects were observed on any of the parameters in soybean oil group (control) as mentioned above.

Effect levels

Dose descriptor:
NOAEL
Effect level:
19 other: % in diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects on any of the parameters recorded.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

 Fat Absorbability: High absorption was observed for soybean oil (95±1% - males; 98±1% - females).

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the NOAEL of soybean oil in rat was found to be equivalent to 19% in diet.

Executive summary:

The effect of dietary soybean oil was investigated (as control) in a subchronic toxicity study.

Diet containing 7.5% fully hydrogenated soybean oil (plus 11.5% soybean oil as normal fat source) was fed to 20 Sprague-Dawley rats/sex for 91 d. the control group was fed with 19% soybean oil for same duration.

There was no indication of any systemic toxicity (including body weight gain, food consumption, organ weights, urinalysis, clinical chemistry, haematology, gross and histopathology) in the soybean oil group.

Hence, under the conditions of this study, the NOAEL of soybean oil in rat was found to be 19% in diet.