4-O-β-D-galactopyranosyl-D-glucitol

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Reference 2

Reference Type:

other: Published secondary source

Title:

Lactitol

Author:

WHO/FAO

Year:

1983

Bibliographic source:

WHO/FAO: Expert Committee on Food Additives Summary of Toxicological Data of Certain Food Additives Series 18 (http://www.inchem.org/documents/jecfa/jecmono/v18je10.htm)

Materials and methods

Objective of study:

toxicokinetics

Principles of method if other than guideline:

Distribution of the test substance in rats after oral exposure was reported.

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

Radiolabelling:

yes

Test animals

Species:

rat

Sex:

male

Details on test animals or test system and environmental conditions:

Three male rats; 150-200 g; six to eight weeks of age

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on exposure:

Three male rats (one not pretreated and two habituated to a diet containing 7% lactitol) were orally intubated with about 2 mg D-(sorbitol-1-14C) lactitol.

Doses / concentrations

Dose / conc.:

2 other: mg D-(sorbitol-1-14C) lactitol

Remarks:

one rat not pre-treated; 2 rats habituated to diet containing 7% lactitol)

No. of animals per sex per dose / concentration:

3 males

Control animals:

yes, concurrent no treatment

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:

The gastrointestinal tract contained 33% of the radioactivity after five hours and 5% after 24 hours; the remainder of the body contained 20% after five hours and 9% after 24 hours.

Details on excretion:

In the studies with the rats habituated to lactitol, 9-15% of the radioactivity was recovered from the air exhaled in the period 0-5 hours and 48% from the air exhaled in the period 0-24 hours. The urine and the faeces contained a minor proportion of the administered radioactivity (urine, 2.3% after five hours and 6.8% after 24 hours faeces, 11.7% after 24 hours).

Applicant's summary and conclusion

Conclusions:

Lactitol extensively degraded in the rat after oral administration presumably mainly by the intestinal microflora and that habituation of the rats to unlabelled lactitol did not essentially affect the rate and extent of degradation.

Executive summary:

Three male rats (150-200 g; six to eight weeks of age; one not pre-treated and two habituated to a diet containing 7% lactitol) were orally intubated with about 2 mg D-(sorbitol-1-¹⁴C) lactitol. In the studies with the rats habituated to lactitol, 9-15% of the radioactivity was recovered from the air exhaled in the period 0-5 hours and 48% from the air exhaled in the period 0-24 hours. The urine and the faeces contained a minor proportion of the administered radioactivity (urine, 2.3% after five hours and 6.8% after 24 hours faeces, 11.7% after 24 hours). The gastrointestinal tract contained 33% of the radioactivity after five hours and 5% after 24 hours; the remainder of the body contained 20% after five hours and 9% after 24 hours. It was concluded that lactitol is extensively degraded in the rat after oral administration presumably mainly by the intestinal microflora and that habituation of the rats to un-labelled lactitol did not essentially affect the rate and extent of degradation.