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Toxicological information

Repeated dose toxicity: oral

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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 triphosphate
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

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