Pentasodium triphosphate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not performed to GLP or guideline.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Reference 2

Reference Type:

publication

Title:

Summaries of toxicological data

Author:

Hodge HC

Year:

1964

Bibliographic source:

Fd Cosmet, Toxicol (2)147-154

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

28 day rat feed study to determine effects on the kidneys of large amounts of phosphates

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
- Code No EE22
- Lot No L1019

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Administration / exposure

Route of administration:

oral: feed

Duration of treatment / exposure:

28 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0.2, 2 and 10%
Basis:
nominal in diet

No. of animals per sex per dose:

5 rats per dose

Control animals:

yes

Examinations

Observations and examinations performed and frequency:

DETAILED CLINICAL OBSERVATIONS: No


BODY WEIGHT: Yes
- Time schedule for examinations: Twice weekly


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No


FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No



OPHTHALMOSCOPIC EXAMINATION: No


HAEMATOLOGY: No


CLINICAL CHEMISTRY: No


URINALYSIS: No


NEUROBEHAVIOURAL EXAMINATION: No


ORGAN WEIGHTS: Yes (kidneys)

Sacrifice and pathology:

Rats were sacrificed serially on the 3rd, 7th, 15th and 28th days.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Gross pathological findings:

effects observed, treatment-related

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY
No mortalities occurred.


BODY WEIGHT AND WEIGHT GAIN
The 10% dose group exhibited retardations in growth. The groups fed 2% and 0.2% sodium tripolyphosphate grew normally.


ORGAN WEIGHTS
Kidney weights were increased in the 10% dose group.


GROSS PATHOLOGY
Tubular necrosis was observed in kidneys of all rats in the 10% dose group. The rats fed 2% sodium tripolyphosphate exhibited inflammatory changes that were not characteristic tubular necrosis but were probably attributable to the presence of the test material. The kidneys of the rats in the 0.2% dose group were normal.

Effect levels

Dose descriptor:

NOAEL

Effect level:

> 2 other: %

Sex:

male

Basis for effect level:

other: tubular necrosis and increase in kidney weight in animals fed 10% dietary STPP

Target system / organ toxicity

Critical effects observed:

not specified