Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data, methods and results sufficiently reported to make a judgement.

Data source

Reference
Reference Type:
publication
Title:
1976 Hanford Americanum exposure incident: urinary excretion of trace metals during DTPA treatment
Author:
Kalkwarf DR, Thomas VW Jr, Nielson KK, Mauch ML
Year:
1983
Bibliographic source:
Health Phys 45(4): 937-947

Materials and methods

Study type:
clinical case study
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Na3(Ca-DTPA)

Method

Subjects:
1 subject exposed to 241 Americanum treated intravenously for three years with DTPA salts (calcium or zinc) to promote the excretion of the 241 Americanum.
Route of exposure:
other: intravenous
Reason of exposure:
intentional
Exposure assessment:
measured

Results and discussion

Any other information on results incl. tables

Administration of Ca-DTPA consistently caused an increased excetion of Zinc in the urine. No other metals appeared to be significantly affected. Administration of ZnDTPA did not produce the same results (after controlling for the Zinc administered with the DTPA).

1g of Ca-DTPA appeared to be associated with an increased zinc excretion of approximately 18 mg.

Applicant's summary and conclusion

Conclusions:
Administration of Ca-DTPA caused the increased excretion of zinc in a patient exposed to 241Am. Supplementation with zinc or replacement with Zn_DTPA