Registration Dossier
Registration Dossier
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EC number: 233-043-0 | CAS number: 10025-82-8
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Measurement of the rate of stomach emptying using Indium-113m and a 10-crystal rectilinear scanner
- Author:
- Coates G, Gilday DL, Cradduck TD, Wood DE
- Year:
- 1 973
- Bibliographic source:
- Canadian Medical Association journal 108:180-183.
Materials and methods
- Type of study / information:
- Healthy volunteers and patients with GI disease
- Endpoint addressed:
- basic toxicokinetics
- Principles of method if other than guideline:
- The radionuclide detection technique was used to determine gastric emptying rates in adult human subjects after ingestion of a meal containing a gamma-emitting radioactive isotope 113mIn(InCl3)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Indium trichloride
- EC Number:
- 233-043-0
- EC Name:
- Indium trichloride
- Cas Number:
- 10025-82-8
- Molecular formula:
- Cl3In
- IUPAC Name:
- indium trichloride
- Details on test material:
- - Name of test material (as cited in study report): indium-113m chloride
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- - Number of subjects exposed: 17
- Sex: males and females
- Age: 42-60 years
- Race: No data
- Known diseases: 7 patients with gastrointestinal disease - Exposure assessment:
- measured
- Details on exposure:
- Route of exposure: oral
After an overnight fast the subjects each ate a "standard egg sandwich", containing 500 ,Ci of Indium-113m chloride foliowed by two ounces of
water.
Results and discussion
- Results:
- no detectable absorption of a 500-µCi dose of 113In administered as InCl3 to human adults..
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, no detectable absorption of a 500-µCi dose of 113In administered as InCl3 to human adults was observed
- Executive summary:
The radionuclide detection technique was used to determine gastric emptying rates in adult human subjects after ingestion of a meal containing a gamma-emitting radioactive isotope 113mIn(InCl3). Under the test conditions, no detectable absorption of a 500-µCi dose of 113In administered as InCl3 to human adults..
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