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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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

Constituent 1
Chemical structure
Reference substance name:
Calcium trisodium pentetate
EC Number:
235-169-1
EC Name:
Calcium trisodium pentetate
Cas Number:
12111-24-9
Molecular formula:
C14H18CaN3O10.3Na
IUPAC Name:
trisodium 5,8-bis(carboxylatomethyl)-3,13,16-trioxo-2$I3,14$I3,15$I3-trioxa-5,8$I2,11-triaza-1-calcapentacyclo[9.3.3.01.5.01.8.0.1.11]heptadecane-1,1-bis(ylium)-2,14,15-triide
Constituent 2
Reference substance name:
Ca-DTPA
IUPAC Name:
Ca-DTPA
Constituent 3
Chemical structure
Reference substance name:
Trisodium [N,N-bis[2-[bis(carboxylatomethyl)amino]ethyl]glycinato(5-)]zincate(3-)
EC Number:
234-305-7
EC Name:
Trisodium [N,N-bis[2-[bis(carboxylatomethyl)amino]ethyl]glycinato(5-)]zincate(3-)
Cas Number:
11082-38-5
Molecular formula:
C14H18N3O10Zn.3Na
Constituent 4
Reference substance name:
Zn-DTPA
IUPAC Name:
Zn-DTPA
Details on test material:
Na3(Ca-DTPA) and Na3(Zn-DTPA)

Method

Subjects:
One 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 consistently caused an increased excetion of Zinc in the urine. No other metals appeared to be significantly affected. Administration of Zn-DTPA did not produce the same results (after controlling for the zinc administered with the DTPA). Both the zinc salt of DTPA as well the calcium salt of DTPA were dosed with no evidence of systemic toxicity at therapeutic doses