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Toxicological information

Basic toxicokinetics

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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

Constituent 1
Chemical structure
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 triphosphate
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.