Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
review article or handbook
Title:
Dose doc. no.: P177
Author:
RSC Publishing
Year:
2011
Bibliographic source:
Dictionary of Substances and their effects (DOSE);Martindale: The Extra Pharmacopoeia 31st ed., 1996, The Royal Pharmaceutical Society, London, UK

Materials and methods

Objective of study:
absorption
Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Data is from DOSE
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amorphous
Details on test material:
- Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- Substance type: Organic
- Physical state: Solid
Radiolabelling:
not specified

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified

Results and discussion

Preliminary studies:
Poorly absorbed (in humans) after oral administration. =95% remaining in the intestine and 5% being slowly
hydrolysed to sulfathiazole, which is absorbed
Main ADME results
Type:
absorption
Results:
5% being slowly hydrolysed to sulfathiazole, which is absorbed

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Poorly absorbed (in humans) after oral administration

Metabolite characterisation studies

Metabolites identified:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
The substance phthalylsulfathiazole was found to be poorly absorbed (in humans) after oral administration. =95% remaining in the intestine and 5% being slowly hydrolysed to sulfathiazole, which is absorbed.
Executive summary:

The substance phthalylsulfathiazole was found to be poorly absorbed (in humans) after oral administration. =95% remaining in the intestine and 5% being slowly hydrolysed to sulfathiazole, which is absorbed.