Pentasodium triphosphate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: No GLP, no guideline and study as presented in the literature did not contain sufficient information to justify higher reliability.

Data source

Reference

Reference Type:

publication

Title:

The hydrolysis and excretion of polymeric phosphate

Author:

Gosselin RE, Rothstein A, Miller GJ and Berke HL

Bibliographic source:

Division of Pharmacology, Department of radiation biology, University of Rochester School of medicaine and dentristry, Rochester, N.Y.

Materials and methods

Objective of study:

excretion

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

STPP was injected intravenously. The urine was monitored for excretion of STPP and orthophosphate

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium triphosphate

EC Number:

231-838-7

EC Name:

Pentasodium triphosphate

Cas Number:

7758-29-4

Molecular formula:

H5O10P3.5Na

IUPAC Name:

pentasodium bis(phosphonatooxy)phosphinate

Details on test material:

- Name of test material (as cited in study report): sodium tripolyphosphate
- Physical state: Crystalline
-

Radiolabelling:

no

Test animals

Species:

rat

Strain:

other: albino

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 270-310 g
- Fasting period before study: deprived of feed only after dosage
- Housing: all-glass metabolism cage
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): occasionally they were allowed a standard chow ration during the experiment.
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

intravenous

Vehicle:

water

Details on exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): between 15.5 and 33.5 mg P per rat

Duration and frequency of treatment / exposure:

once

Doses / concentrations

Remarks:

Doses / Concentrations:
15.5 and 33.5 mg P per rat

No. of animals per sex per dose / concentration:

6

Control animals:

yes

Details on dosing and sampling:

PHARMACOKINETIC STUDY ( excretion)
- Tissues and body fluids sampled : urine,
- Time and frequency of sampling: frequency not stated. Mean excretion during 24 hr post dose was assessed.
- Other:


METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled : urine,
- Time and frequency of sampling:Mean excretion during 24 hr post dose was assessed.
- From how many animals: 22
- Method type(s) for identification: reference to a method by Meyerhof and Oesper, 1947.
- Limits of detection and quantification: not stated
- Other:

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:

Average excretion of orthophosphate was higher than the average control value (14.9 mg ortho-P) (see table 1)

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

sodium orthophosphate

Any other information on results incl. tables

Table 1: Urinary excretion of polymer phosphorus in the rat

No. rats	Mean 24-hour excretion on % of dose
	Labile P	Excess ortho-P	Total P
6	9	66	75

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
STPP was extensively hydrolysed to orthophosphate in rats.