Registration Dossier
Registration Dossier
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EC number: 256-917-3 | CAS number: 51022-74-3
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Biotransformation of Ioglycamic Acid, Iodoxamic Acid and Iotroxic Acid in Man
- Author:
- Mützel W. et al.
- Year:
- 1 976
- Bibliographic source:
- Invest Radiol 11(6), 598-601
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Iotroxic acid
- EC Number:
- 256-917-3
- EC Name:
- Iotroxic acid
- Cas Number:
- 51022-74-3
- Molecular formula:
- C22H18I6N2O9
- IUPAC Name:
- 3-{2-[2-(2-{[(3-carboxy-2,4,6-triiodophenyl)carbamoyl]methoxy}ethoxy)ethoxy]acetamido}-2,4,6-triiodobenzoic acid
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 131I-labelling
Test animals
- Species:
- other: human
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: injection
- Vehicle:
- not specified
- Positive control reference chemical:
- N.A.
- Details on study design:
- The biotransformation of the 131I-labeled cholegraphic media iotroxic acid in man is investigated. Plasma, urine and fistular bile were analyzed for unchanged and metabolized constituents of the administered substances using thin layer chromatography.
- Details on dosing and sampling:
- N.A.
- Statistics:
- N.A.
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- No metabolites were found in plasma, but up to two were found in urine in addition to unchanged contrast media (a total of 50% of the total elimination in 24 h urine). A metabolite was only found in the fistular bile after the injection of iotroxic acid.
Applicant's summary and conclusion
- Conclusions:
- The biotransformation of the 131I-labeled cholegraphic media ioglycamic acid, iodoxamic acid and iotroxic acid in man is investigated. Plasma, urine and fistular bile were analyzed for unchanged and metabolized constituents of the administered substances using thin layer chromatography. No metabolites were found in plasma, but up to two were found in urine in addition to unchanged contrast media (a total of 50% of the total elimination in 24 hr. urine). A metabolite was only found in the fistular bile after the injection of iotroxic acid.
- Executive summary:
The biotransformation of the 131I-labeled cholegraphic media ioglycamic acid, iodoxamic acid and iotroxic acid in man is investigated. Plasma, urine and fistular bile were analyzed for unchanged and metabolized constituents of the administered substances using thin layer chromatography. No metabolites were found in plasma, but up to two were found in urine in addition to unchanged contrast media (a total of 50% of the total elimination in 24 hr. urine). A metabolite was only found in the fistular bile after the injection of iotroxic acid.
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