Registration Dossier
Registration Dossier
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EC number: 231-180-0 | CAS number: 7440-74-6
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:
- An evaluation of 113m indium DTPA chelate in the measurement of gastric emptying by scintiscanning
- Author:
- Heading RC, Tothill P, Laidlaw AJ and Shearman DJ
- Year:
- 1 971
- Bibliographic source:
- Gut 12:611-615
Materials and methods
- Type of study / information:
- study with volunteers
- Endpoint addressed:
- basic toxicokinetics
- Principles of method if other than guideline:
- The sequential scintiscanning technique was used to determine gastric emptying rates in adult human subjects after ingestion of a meal of cornflakes and milk to which a gamma-emitting radioactive isotope (113m In DTPA chelate) had been added.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc chloride
- EC Number:
- 231-592-0
- EC Name:
- Zinc chloride
- Cas Number:
- 7646-85-7
- Molecular formula:
- ZnCl2
- IUPAC Name:
- Zinc dichloride
- Details on test material:
- - Name of test material (as cited in study report): 113mIn DTPA chelate
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- - Number of subjects exposed: 8
- Sex: males and females
- Age: No data
- Race: No data
- Known diseases: All were ambulatory and without taking anticholinergic drugs or had undergone previous upper gastrointestinal surgery. - Exposure assessment:
- measured
- Details on exposure:
- Route of exposure: oral
All subjects were given a standard meal of 20 gcornflakes with 15 g sugar to which 150 ml of milk containing 200 microcuries of the appropriate radioactive isotope was added immediately beforehand.
Results and discussion
- Results:
- Adult volunteers absorbed less than 2% of a 200µCi dose of 113In as DPTA complex
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the adult volunteers absorbed less than 2% of a 200µCi dose of 113In as DPTA complex
- Executive summary:
The sequential scintiscanning technique was used to determine gastric emptying rates in adult human subjects after ingestion of a meal of cornflakes and milk to which a gamma-emitting radioactive isotope (113m In DTPA chelate) had been added.
Under the test conditions, the adult volunteers absorbed less than 2% of a 200µCi dose of 113In as DPTA complex
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