Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication, similar to guideline, a subchronic study was taken to determine the acute LD50 value based on the resulting NOAEL value

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD guideline 453

Deviations:

no

GLP compliance:

no

Test type:

other: subchronic study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

α-d-Glucopyranoside, β-d-fructofuranosyl, octadecanoate

EC Number:

253-459-6

EC Name:

α-d-Glucopyranoside, β-d-fructofuranosyl, octadecanoate

Cas Number:

37318-31-3

Molecular formula:

C18 H36 O2 . x C12 H22 O11

Test animals

Species:

rat

Strain:

Fischer 344/DuCrj

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan Inc.
- Age at study initiation: 5 weeks old at the start of treatment
- Housing: Polycarbonate cages with hardwood chip bedding were used, and in each housed two animals
- Diet: radiation-sterilized powder feed, CRF-1, Oriental Yeast Co., Ltd. ad libitum, replaced weekly, feed mix was prepared twice during the study (1 week before the start of administration and 5 weeks later).
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20-25 °C
- Humidity: 40-70 %
- Air changes: 12 changes/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: CRF-1

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 % in feed equivalent to 3240 mg/kg bw/day males and 3430 mg/kg bw/day females.

Doses:

636, 1900 and 3240 mg/kg bw/day (males)
666, 1950 and 3430 mg/kg bw/day (females)

No. of animals per sex per dose:

groups of 20 per sex

Control animals:

yes

Details on study design:

- Duration of observation period: 13 weeks
- Frequency of observations: Daily, weekly, before the end of treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Ophtalmology, Urinalysis

Statistics:

Bartlett´s equal variance test
Analysis of variance (ANOVA)
Dunnett´s method
Scheffé´s method
Kruskal-Wallis H test
Amitage´s x^2 test

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 240 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Results based on subchronic study

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 3 430 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Results based on subchronic study

Mortality:

No mortality was observed

Clinical signs:

other: No clinical signs were observed

Gross pathology:

No effects were observed

Other findings:

- Organ weights: Male animals showed a significant decrease in absolute kidney weight in the medium- and high-dose groups and a decrease in relative kidney weights in all treated groups. A significant decrease of relative liver weight was also observed in the male high-dose group.
- Food consumption: An increase in food consumption was noted in the male animals of the high-dose group near the end of the adminsitration period.
- Histopathology: NON-NEOPLASTIC: Extramedullary hematopoesis of the spleen was observed.
- Other observations: URINANALYSIS: Ketone bodies in the urine were decreased in male animals of the high-dose group.

The effects described above were judged to be not based on compound related effects. The study demonstrated that the test substance was not toxic in Fischer rats.