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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
Study period:
Manuscript received 24th February 1971
Reliability:
2 (reliable with restrictions)
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:
Metabolism of Sodium Tosylate-35S by Rats and Dogs
Author:
Dreyfuss, J., Shekosky, J.M., Ross, J.J. Jr.
Year:
1971
Bibliographic source:
Toxicology and Applied Pharmacology, vol. 20, p. 548-551

Materials and methods

Objective of study:
excretion
metabolism
toxicokinetics
Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Sodium tosylate-35S (99% purity)
Radiolabelling:
yes

Test animals

Species:
dog
Strain:
Beagle
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Duration and frequency of treatment / exposure:
Single administration
Doses / concentrations
Dose / conc.:
17.4 mg/kg bw/day (nominal)
No. of animals per sex per dose:
1/sex/dose
Control animals:
not specified

Results and discussion

Main ADME results
Type:
excretion
Results:
Excretion of the unchanged parent substance measured: urine 84.5% of which 80.4% was excreted in the first 24 hours; feces 17.5% of which 12.2% was excreted in the first 24 hours.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The substance is rapidly absorbed given that almost 85% of the substance was excreted in the urine within 24 hours of dosing.
Details on distribution in tissues:
Not specified.
Details on excretion:
The substance was excreted primarily in the urine, with 84.5% being excreted over 4 days.
Toxicokinetic parameters
Key result
Toxicokinetic parameters:
half-life 1st: 75 minutes

Metabolite characterisation studies

Metabolites identified:
not specified
Details on metabolites:
Chromatographic analysis of excreta indicated that only the unaltered tosylate-35S moeity had been excreted. In none of the three solvent systems employed was the presence of any metabolite detected.

Applicant's summary and conclusion

Conclusions:
The substance is rapidly absorbed following oral gavage adminstration and the substance is excreted unchanged primarily in the urine.
Executive summary:

In a metabolism study the substance was administered to beagle dogs (1 animals/sex/dose) by oral gavage at a dose level of 17.4 mg/kg bw (single administration). Urine and feces were collected daily for 4 days. The substance was excreted unchanged primarily in the urine.