4-O-β-D-galactopyranosyl-D-glucitol

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting 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 of the test substance was performed in mice and rats by administering the drug intravenously or subcutaneously.

GLP compliance:

not specified

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

Test animals

Species:

other: rat and mouse

Strain:

other: SD rat and ddY mouse

Sex:

male/female

Administration / exposure

Route of administration:

other: intravenously, subcutaneously

Vehicle:

water

Details on exposure:

intravenous via caudal vein
subcutaneous on back

Doses:

1 , 3, 10 g/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

The test material was administered as a single dose followed by a 14-day observation.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD100

Effect level:

> 10 other: g/kg

Based on:

test mat.

Remarks on result:

other: mice and rats; intravenously and subcutaneously

Mortality:

No mortality observed

Clinical signs:

Decreased spontaneous movement, diarrhoea, oligopnea or prone position.

Body weight:

No effects observed

Gross pathology:

No gross changes

Applicant's summary and conclusion

Conclusions:

Lethal dose was more than 10 g/kg intravenously and subcutaneously in mice and rats of both sexes.

Executive summary:

A single dose toxicity study of lactitol  was performed in ddY mice and SD rats of both sexes by administering the test material intravenously or subcutaneously. The test material was administered as a single dose followed by a 14-day observation. Lethal dose was more than 10 g/kg intravenously and subcutaneously in mice and rats of both sexes. The signs of toxicity in mice and rats observed following the administration of the test material included decreased spontaneous movement, diarrhoea, oligopnea, or prone position. There were no treatment-related changes in gross examination.