4-O-α-D-glucopyranosyl-D-glucitol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

-reliability scoring based on 2001 guideline

Deviations:

yes

Remarks:

-source/origin of test article, age of the animals, acclimatization period, individual observations of clinical signs, and specific time-points for observation period were not provided; dose volume administered was higher than recommended amount by OECD

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Syrups, corn, hydrogenated

EC Number:

270-337-8

EC Name:

Syrups, corn, hydrogenated

Cas Number:

68425-17-2

Molecular formula:

UVCB substance: not applicable

IUPAC Name:

Syrups, hydrolyzed starch, hydrogenated

Details on test material:

- Name of test material (as cited in study report): Lycasin® 80/55
- Physical state: Liquid (clear, colorless)
- Analytical purity: 75% dry weight
- Lot/batch No.: 1773
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:

mouse

Strain:

other: OF1 (Swiss)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO (FRANCE)
- Age at study initiation: Not reported
- Weight at study initiation: Mean body weight range: 25.4 to 27.2 g (males); 22.2 to 23.6 g (females)
- Fasting period before study: No food was available on the night before the experiment. Water was given as needed.
- Housing: Makrolon cages (5 animals/cage)
- Diet (e.g. ad libitum): U.A.R. Réf. A03 15 mm pellets (daily ration, according to age and weight: 16 to 22 g); ad libitum
- Water (e.g. ad libitum): Water was acidified with hydrochloric acid (pH 2 -3) and autoclaved for 15 minutes at 115°C; ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21
- Humidity (%): 55 to 60
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.25 mL/10 g body weight
Controls received the same amount of distilled water.

Doses:

14.62 g/kg body weight for both males and females [based on Lycasin® 80/55 dry weight]
19.50 g/kg body weight for both males and females [based on Lycasin® 80/55 dry weight]
24.37 g/kg body weight for both males and females [based on Lycasin® 80/55 dry weight]

No. of animals per sex per dose:

5/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently on the day of the experiment. During the following 13 days, mortality and the general aspect of the survivors were recorded. Each animal was weighed the day of the experiment and on Days 3, 7, 10, and 14.
- Necropsy of survivors performed: no

The authors noted that in the case of a death, the experiment would be redone on 20 (10/sex) other animals; however, no deaths were reported during the study period.

Statistics:

Statistical analysis was conducted on body weight gain data.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

other: LD50 could not be determined.

Remarks on result:

other: No mortalities were reported during the study period.

Mortality:

No mortalities were reported during the study period.

Clinical signs:

There were no significant clinical signs observed during the 14 days of the study.

Body weight:

The mean body weight of mice administered Lycasin® 80/55 at a dose level of 14.62, 19.50, or 24.37 g/kg body weight was reported to be 25.4, 26.6, and 27.2 g for males, and 22.2, 23.6 and 22.8 for females, respectively. The weight gain in the animals treated by oral route is comparable between the treated groups and the control group with one exception; females receiving the dose of 19.5 g/kg body weight had weights significantly greater than those females of the control group. The authors reported that since these observations are not found in groups which received the greater doses, it is unlikely that the variations in weight gain are directly related to the test substance.

Gross pathology:

Not examined.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: CLP EC 1272/2008