4-O-β-D-galactopyranosyl-D-glucitol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

publication

Title:

Single Dose Toxicity Studies of Lactitol (NS-4) in Mice and Rats

Author:

Okazaki S, Suwa K, Hamasu Y, and Sumi N

Year:

1994

Bibliographic source:

J Toxicol. Sci., 19(Suppl. 3):295-299

Materials and methods

Principles of method if other than guideline:

The single dose toxicity study of lactitol were performed in SD rats of both sexes by administering the substance via gavage followed by a 14-day observation period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-O-β-D-galactopyranosyl-D-glucitol

EC Number:

209-566-5

EC Name:

4-O-β-D-galactopyranosyl-D-glucitol

Cas Number:

585-86-4

Molecular formula:

C12H24O11

IUPAC Name:

4-O-beta-D-galactopyranosyl-D-glucitol

Specific details on test material used for the study:

Test material:
- Lot No. 6 used in study

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan SLAC
- Age at study initiation: 6 weeks
- Weight at study initiation: 150~174 g for males; 127~150 g for females
- Fasting period before study: yes (overnight for a total of ~16 hours)
- Housing: Plastic enclosure containing floor coverings
- Diet (e.g. ad libitum):fixed-shaped food ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: ~1-2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Air changes (per hr): 11-13
- Photoperiod (hrs dark / hrs light): 12 hr light/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test substance was prepared by dissolving it in distilled water for injection at time of use.

Doses:

11, 14, 18, 23, 30 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of administration, the general condition and mortality status of the animals were checked at 5, 15, and 30 minutes and 1, 2, 4, and 6 hours after administration, and then once per day thereafter. Body weights were recorded immediately prior to administration and on days 1, 2, 3, 7, 10, and 14 after administration.
- Necropsy of survivors performed: yes

Statistics:

Not reported

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 30 other: g/kg

Based on:

test mat.

Mortality:

1 of 5 males and 2 of 5 females died at 30 g/kg. Death was observed in 1 male and 1 female at 4 and 6 hours, respectively after administration and in 1 female on the 3rd day after administration.

Clinical signs:

other: Decreased spontaneous locomotor activity and diarrhoea were observed after 30 minutes in animals that died at 30 g/kg. Prone position was observed prior to death. In surviving animals, diarrhoea was observed in a few males and females beginning at 15 minu

Gross pathology:

No gross changes were observed in either animals that died or survived to scheduled termination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rats): >30 g/kg

Executive summary:

The single dose toxicity study of lactitol was performed in SD rats of both sexes by administering the test material orally. The test material was administered as a single dose followed by a 14-day observation. Oral LD50 value of the test material was >30 g/kg in male and female rats. The signs of toxicity observed in rats following the administration of the test material included decreased spontaneous movement, diarrhoea, oligopnea, or prone position, and transient decreased body weight. There were no treatment-related changes in gross examination.