Registration Dossier
Registration Dossier
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EC number: 201-627-4 | CAS number: 85-73-4
Basic toxicokinetics
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:
- 2 011
- 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
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from DOSE
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phthalylsulfathiazole
- EC Number:
- 201-627-4
- EC Name:
- Phthalylsulfathiazole
- Cas Number:
- 85-73-4
- Molecular formula:
- C17H13N3O5S2
- IUPAC Name:
- 2-({4-[(1,3-thiazol-2-yl)sulfamoyl]phenyl}carbamoyl)benzoic acid
- Test material form:
- other: amorphous
- Details on test material:
- - Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- Substance type: Organic
- Physical state: Solid
Constituent 1
- 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.
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