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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Investigations of the toxicological and biological properties of xylitol.
Author:
Salminen SJ
Year:
1982
Bibliographic source:
A thesis submitted in accordance to the requirements of the University of Surrey for the Degree of Doctor of Philosophy, Robens Inst. of Indust. Environ. Hlth Safety and Dept. of Biochem. U. of Surrey, UK.

Materials and methods

Objective of study:
toxicokinetics
Principles of method if other than guideline:
Study conducted as PhD thesis. Rats were fed radio-labelled test substance then levels in blood were examined.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration and frequency of treatment / exposure:
Sixty Wistar albino rats were gradually adapted to 20% dietary xylitol. Fully adapted and control rats were fasted overnight and dosed by oral intubation with 5 μCi of U-14C xylitol. The isotope dose was mixed with corresponding ("cold") material to obtain a final dose of 0.625 g/kg bw.
Doses / concentrations
Remarks:
Doses / Concentrations:
0.625 g/kg bw.
No. of animals per sex per dose:
60
Control animals:
yes

Results and discussion

Main ADME results
Type:
distribution
Results:
There was a significant increase in peak xylitol blood levels as determined by radioactivity in xylitol adapted rats as compared to controls.

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:
There was a significant increase in peak xylitol blood levels as determined by radioactivity in xylitol adapted rats as compared to controls.

Metabolite characterisation studies

Metabolites identified:
not measured

Any other information on results incl. tables

Xylitol adapted rats did not exhibit diarrhoea following the dose administration.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Xylitol adapted rats did not exhibit diarrhoea following the dose administration. There was a significant increase in peak xylitol blood levels as determined by radioactivity in xylitol adapted rats as compared to controls.
Executive summary:

Sixty Wistar albino rats were gradually adapted to 20% dietary xylitol. Fully adapted and control rats were fasted overnight and dosed by oral intubation with 5 μCi of U-14C xylitol. The isotope dose was mixed with corresponding ("cold") material to obtain a final dose of 0.625 g/kg bw.

Xylitol adapted rats did not exhibit diarrhoea following the dose administration. There was a significant increase in peak xylitol blood levels as determined by radioactivity in xylitol adapted rats as compared to controls.