Registration Dossier
Registration Dossier
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EC number: 231-601-8 | CAS number: 7647-18-9
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: human data
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Human study
Data source
Reference
- Reference Type:
- publication
- Title:
- Tracer studies with antimony-124 in man
- Author:
- Abdallah A. & Saif, M.
- Year:
- 1 962
- Bibliographic source:
- In: Wolstenholme, G.E.W.; O'Connor, M. (Eds.): Bilharziasis, Churchill, London: 287-309.
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 25 male volunteers were given a single dose of [124]Sb- sodium antimony dimercaptosuccinate by intramuscular (75 - 125 mg/kg bw) and intravenous (75-100 mg/kg bw) route and the excretion pattern was monitored over time.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- [124]Sb- sodium antimony dimercaptosuccinate
- IUPAC Name:
- [124]Sb- sodium antimony dimercaptosuccinate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: sodium antimony dimercaptosuccinate labelled with antimony-124
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 25
- Sex: males - Ethical approval:
- not specified
- Route of exposure:
- other: intramuscular & intravenous
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- The powdered compound in each vial (2 g) was made, just before use, into a solution containing exactly 0.1 g/mL (0.025 g antimony).
Five groups of patients were given different single doses of the test item as follows:
Group 1: 75 mg antimony intramuscularly (average 1.4 mg antimony/kg bw)
Group 2: 100 mg antimony intramuscularly (average 1.7 mg antimony/kg bw)
Group 3: 125 mg antimony intramuscularly (average 2.1 mg antimony/kg bw)
Group 4: 75 mg antimony intravenously (average 1.4 mg antimony/kg bw)
Group 5: 100 mg antimony intravenously (average 1.7 mg antimony/kg bw) - Examinations:
- Whole blood samples were taken from patients at various intervals and the corresponding radioactivity measured by the Ekco annular-type scintillation counter, model N 550, and corresponding autoscaler, the antimony level being calculated in terms of µg antimony/100 mL of whole blood. Urine radioactivity was measured by the shielded Phillips scintillation counter, type 4111, and scaler system, and the urinary antimony content was calculated in terms of mg antimony/24 hours.
Surface body scanning was carried out with a Philips PW 4111 scintillation probe provided with a 25 x 20 mm sodium iodide thallium activated crystal and fitted with the PW 4113 wide-angle collimator. Accessory lead shielding was applied when a particular organ was investigated.
The procedure carried out could accurately detect values as low as 10 µg antimony/100 mL of blood and 0.01 mg antimony total in urine.
Results and discussion
- Results of examinations:
- In the study involving 25 male volunteers being given 124Sb-DMSA by i.m. or i.v. injection, the following excretion pattern was reported:
- following i.m. administration, cumulative excretion accounted for about 25% of 124Sb after 1 d,
50% after 15 d, and 68% after 32 d.
- following i.v. injection, cumulative excretion accounted for about 35% of 124Sb after 1 day, and 63% after 4 days.
Extracorporal radioactivity counting indicated relatively high accumulation of activity in the thyroid and liver, peaking about 2 days after injection.
Elimination occurred in two phases:
- approximately 80-85% of the peak content was removed with a half-time of a few days, and the remaining 15-20% had a much longer retention time that could not be quantified over the relatively short observation period
Applicant's summary and conclusion
- Conclusions:
- Elimination occurred in two phases:
- approximately 80-85% of the peak content was removed with a half-time of a few days, and the remaining 15-20% had a much longer retention time that could not be quantified over the relatively short observation period
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