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Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
other: Read across from a member of the Hydrotropes category
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

Constituent 1
Chemical structure
Reference substance name:
Sodium toluene-4-sulphonate
EC Number:
211-522-5
EC Name:
Sodium toluene-4-sulphonate
Cas Number:
657-84-1
Molecular formula:
C7H7O3S.Na
IUPAC Name:
sodium 4-methylbenzenesulfonate
Specific details on test material used for the study:
Sodium tosylate-35S (99% purity)
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Duration and frequency of treatment / exposure:
Single dose was administered.
Doses / concentrations
Dose / conc.:
34.8 mg/kg bw/day (nominal)
Remarks:
Single dose.
No. of animals per sex per dose / concentration:
Two

Results and discussion

Main ADME results
Type:
excretion
Results:
Excretion of the unchanged parent substance: urine 82% of which 80% was excreted within the first 24 hours; Feces 13% of which the first 11.7% was excreted within 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 excretion:
The primary excretory pathway is urinary with 82 to 85% of the dose being elimited via this route.
Toxicokinetic parameters
Key result
Toxicokinetic parameters:
half-life 1st: 75 minutes

Metabolite characterisation studies

Metabolites identified:
no
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 then excreted unchanged primarily in the urine.
Executive summary:

In a metabolism study the substance was administered to Sprage Dawley rats (2 animals/sex/dose) by oral gavage at a dose level of 34.8 mg/kg bw (single administration). Urine and feces were collected daily for 4 days. The substance was excreted unchanged primarily in the urine.