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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study which investigated the retention of fluoride from diets containing materials produced during aluminium smelting
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male

Administration / exposure

Route of administration:
oral: feed
Duration and frequency of treatment / exposure:
7 days
Doses / concentrations
Remarks:
Doses / Concentrations:
mean intake of fluoride over the 7-day period: 8.7 mg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
Six male albino rats received cryolite with the diet for 7 consecutive days (mean intake of fluoride over the 7-day period: 8.7 mg). Urine and faeces were collected over the 7 day period and the fluoride content in urine and faeces was determined. At the end of the experiment, kidneys and left femurs were dissected for determination of the fluoride content.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
30% of the amount of fluoride that had been taken up with the diet was excreted with the urine, 15% was excreted with faeces and approximately 55% were retained.
It can be concluded that approximately 85% of the amount of fluoride that has been orally taken up in the form of cryolite, will be systemically bioavailable.

Any other information on results incl. tables

Fluoride retention and fluorine excretion from the basal diet (total cumulative fluorine intake from the basal diet over 7 days was 0.11 mg) has not been regarded in this publication.

Applicant's summary and conclusion