Registration Dossier
Registration Dossier
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EC number: 231-784-4 | CAS number: 7727-43-7
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Restricted relevance of the experimental data.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Further experience with barium sulfate as a bronchographic contrast medium
- Author:
- Nelson, S.; et al.
- Year:
- 1 964
- Bibliographic source:
- Am. J. Roentgenology, Radium Therapy Nuclear Med. 92, 595-614
Materials and methods
- Study type:
- medical monitoring
- Endpoint addressed:
- respiratory irritation
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Presentation of clinical studies in men using barium sulfate suspension as a bronchographic medium.
- GLP compliance:
- no
Test material
- Reference substance name:
- Barium sulfate
- EC Number:
- 231-784-4
- EC Name:
- Barium sulfate
- Cas Number:
- 7727-43-7
- Molecular formula:
- BaO4S
- IUPAC Name:
- barium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Barium sulfate suspension (35-50% (w/v) in saline)
- Physical state: solution
No further details are given.
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Details on study design:
- The majority of the bronchographies were performed on patients hospitalised in the Ohio Tuberculosis Hospital where long-term follow-up study could be carried out in about one-half of the patients.
Pulmonary function studies were performed before and after bronchography in a small series of patients.
Results and discussion
- Results:
- There were small intra-alveolar granulomas consisting of conglomerations of macrophages which contained the barium sulfate particles, and a few particles noted within the alveolar septa. There was no evidence of fibrosis or septal thickening which could be attributed to the barium sulfate.
Pulmonary function studiesshowed that there was no apparently significant degree of permanent bronchial obstruction.
Applicant's summary and conclusion
- Conclusions:
- There were small intra-alveolar granulomas consisting of conglomerations of macrophages which contained the barium sulfate particles, and a few particles noted within the alveolar septa. There was no evidence of fibrosis or septal thickening which could be attributed to the barium sulfate.
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