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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: oral

Currently viewing:

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1956
Report date:
1956
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

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 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

Applicant's summary and conclusion