beta-D-fructofuranosyl alpha-D-glucopyranoside octa(acetate and palmitate and stearate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 19, 2005 - Feb. 24, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sucrose tetrastearate triacetate

IUPAC Name:

Sucrose tetrastearate triacetate

Test animals

Species:

mouse

Strain:

ICR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan SLC, Inc.
- Fasting period before study: 4 hrs
- Housing: plastic cages, 5 animals per cage
- Diet: CRF-1 ad libitum
- Water: tap water ad libitum
- Acclimation period: 2 weeks;

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: hydroxypropyl methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5% weight/volume

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

DOSAGE PREPARATION (if unusual): A 100 mg/mL test suspension in 0.5% w/v hydroxypropyl methylcellulose was made using a homogenizer and a sonicator.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Remarks:

5 mice in control group

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, and 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Statistics:

Mean body weights were analyzed using the t-test (alpha = 0.05)

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

No abnormalities were observed in either the control or test groups.

Body weight:

No significant differences in body weight were observed.

Gross pathology:

No remarkable changes were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

The acute oral LD50 for female mice was >2000 mg/kg bw

Executive summary:

The acute oral LD50 for the test substance was determined in an OECD Guideline 420 test. Five female mice were dosed with 2000 mg/kg of test substance in 0.5% w/v hydroxypropyl methyl cellulose. Five animals were used as a control group. No mortality was seen in the experimental or control groups. The acute oral LD50 of the test substance in female mice is >2000 mg/kg.