Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Published data, methods and results sufficiently reported to make a judgement.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Removal of zinc from humans by DTPA chelation therapy

Author:

Slobodien, M. J.

Year:

1973

Bibliographic source:

327-30. [Health physics]

Materials and methods

Study type:

clinical case study

Endpoint addressed:

not applicable

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Calcium salt of DTPA

IUPAC Name:

Calcium salt of DTPA

Details on test material:

- Name of test material (as cited in study report): Na3CaDTPA

Method

Type of population:

other: patient treated by low dose (14 mg/kg/week)-long term DTPA administration

Subjects:

- Number of subjects exposed: one
- Sex: Male
- Age: 35
- Race: no data
- Other: height was 5 ft 11 inch. and weight 70 kg, accidental exposure to an 241Am body burden as high as 1.8 µC(14) or 36 times the occupational exposure limit

Ethical approval:

not specified

Route of exposure:

other: no data

Reason of exposure:

accidental

Exposure assessment:

measured

Details on exposure:

The patient accidentally acquired an 241Am body burden as high as 1.8 µC (14) or 36 times the occupational exposure limit

Examinations:

- Urine analysis: yes. Daily total urine samples have been collected by the patient in polyethylene containers for subsequent bioassay of 241Am, samples were stored after analyses.
- Haematology: no data
- Lung function parameters: no data
- Other: Fecal samples were collected briefly at the outset of treatment, but was discontinued later

Medical treatment:

The treatment consists of an I.V. infusion of 1 g Na3CaDTPA in 250 ml saline administered once a week. Daily total urine samples have been collected by the patient in polyethylene containers for subsequent bioassay of 241Am. After 241Am analyses, the remaining samples were stored at -15°C. Fecal samples were collected briefly at the outset of treatment, but this practice had been discontinued. No modification or analyses of the patient’s diet and its zinc content were made.

Zinc analyses were performed on urine samples collected during the last three months
(September-November 1970) of a 5 month rest period, and during a period of treatment with DTPA (December 1970-April 1971). Prior July 1970, the patient had been treated weekly with DTPA for 15 and 19 month periods, separated by a one month rest period.

Results and discussion

Clinical signs:

None

Results of examinations:

- Urine analysis: The mean daily urine zinc excretion during the baseline period was 0.65 ± 0.13 mg/day (range 0.2-0.9 mg/day) and this was considered normal. The mean daily urinary zinc excretion for the treatment period was 3.15 ± 0.70 mg/day. Zinc excretion levels were highest for the first 24 hours post infusion and then decreased in two stages to a level at or slightly above the baseline value
- Haematology: no data
- Lung function parameters: no data

Effectivity of medical treatment:

no data

Outcome of incidence:

Zinc excretion levels rerurned to a level or slightly above the baseline value

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Urinary zinc excretion during 24 hr after i.v. infusion of Na3CaDTPA was 20-30 times greater than the mean daily zinc excretion during a period with no treatment. During the treatment period, the average weekly zinc excretion was increased 5 fold.