Dipotassium tin hexahydroxide

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1973

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1974

Materials and methods

Objective of study:

absorption

distribution

excretion

Test guideline

Qualifier:

no guideline followed

Version / remarks:

see free text field principles of methode

Principles of method if other than guideline:

Solutions for dosing. Unless otherwise specified, 113SnS04 (about 0.1 μCi/mg tin),
prepared as previously described (Hiles, 1973), was used in preparing the dosing solutions
containing 2 mg of tin/ml: (1) 113SnF2 in 0.002 N H2S04 at pH 3.7; (2) 1 13SnF4
in 0.02 N H2S04 at pH 2. 7; (3) 113Sn(II) citrate with 2 mol of citric acid/mo! of tin at
pH 5. 7; ( 4) 113Sn(IV) citrate with 4 mo! of citric acid/mo! of tin at pH 5. 7; and
(5) 1 13Sn2P201 in 0.002 N H2S04 at pH 5.6.
113Sn(II) solutions were prepared by mixing 113
SnS04 into a solution containing
NaF, citric acid or Na4P207 and then adjusting the pH (Hiles, 1973). By titration with
standard Kl04 solution to the potentiometric end point, it was shown that the tin in
these solutions was>98 % as Sn(II) and remained as such for at least 1 hr when prepared
using air-free reagents and held under an atmosphere of N2• Syringes used for dosing
Sn(II) solutions were filled and held under an atmosphere of N2 until immediately
prior to dosing. 113Sn(IV) solutions were prepared by titrating the proper 113Sn(II)
solution with H202 to the potentiometric end point before adjusting to final pH.

113Sn determinations. At necropsy, the entire organ or tissue sample was placed in a
scintillation vial. Blood samples were separated into clot and serum and the clot was
washed twice with water before counting. The bone sample was cleaned of connective
tissues before counting and after counting, dried at l l 0°C and then weighed. The carcass
was frozen in dry ice, ground to a powder, blended and samples taken for counting.Feces
were placed in scintillation vials as collected, while gastrointestinal washes were homogenized
and then aliquoted. Samples of the dosing solution were taken for counting in
each experiment. The amount of 113Sn was determined 48 hr after taking the samples
using a Packard Tandem Autogamma Counter Model 5024 and counting the activity
of the daughter element of 113Sn(113ln) at 392 Ke V. Statistical comparison of the results
was made by the method of least significant difference using Student's t test.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Stannous citrate

Cas Number:

6493-69-2

Molecular formula:

C12H14O14Sn

IUPAC Name:

Stannous citrate

Test material form:

solid: crystalline

Radiolabelling:

yes

Test animals

Species:

rat

Strain:

other: Charles River

Sex:

female

Administration / exposure

Route of administration:

other: po, iv

Vehicle:

not specified

Details on exposure:

seee attached report

Duration and frequency of treatment / exposure:

1d - 28d

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

20 other: ng Sn / kg

Remarks:

iv 1 time

Doses / concentrations 2

Dose / conc.:

2 other: mg Sn / kg

Remarks:

iv

Doses / concentrations 3

Dose / conc.:

20 other: mg /Sb / kg

Remarks:

for 28d study

Control animals:

no

Results and discussion

Main ADME results

Main ADME results 1

Type:

excretion

Results:

Feces and GI wash - 98.00 ± 2.1 %

Main ADME results 2

Type:

excretion

Results:

Urine 0.90 ± 0.23 %

Main ADME results 3

Type:

distribution

Results:

Liver 0.07 ± 0.02 %

Main ADME results 4

Type:

distribution

Results:

Kidneys 0.05 ± 0.02 %

Main ADME results 5

Type:

distribution

Results:

Pancreas <0.004 &

Main ADME results 6

Type:

other: Recovery

Results:

Recovery 99.02 ± 2.3

Main ADME results 7

Type:

distribution

Results:

Bone (femur) 0.09 ± 0.04

Main ADME results 8

Type:

distribution

Results:

Lymph nodes <0.004

Main ADME results 9

Type:

distribution

Results:

Blood clot 0.01 ± 0.00 %

Main ADME results 10

Type:

distribution

Results:

Leg muscle <0.004 %

Toxicokinetic / pharmacokinetic studies

Details on absorption:

see attached report

Details on distribution in tissues:

see adme results

Transfer into organs

Transfer into organs 1

Key result

Test no.:

#1

Transfer type:

secretion via gastric mucosa

Observation:

distinct transfer

Transfer into organs 2

Key result

Test no.:

#2

Transfer type:

other: urine

Observation:

slight transfer

Toxicokinetic parameters

Key result

Test no.:

#1

Toxicokinetic parameters:

half-life 1st:

Remarks:

23 d

Metabolite characterisation studies

Metabolites identified:

not specified

Applicant's summary and conclusion

Conclusions:

The majority of the stannic citrate given to rats is execreted via fectes. The half life time of absorped Sn(IV) was determined to be 23 d