Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method

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: White powder
- Lot/batch No.: E10287-113

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: Young adult
- Weight at study initiation: 218 - 255 g
- Diet (e.g. ad libitum): Purina laboratory rodent chow 5001 (pellets) available ad libitum
- Water (e.g. ad libitum): Fresh tap water provided ad libitum
- Acclimation period: 5 days prior to study start


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 63 - 73
- Humidity (%): 48 - 65
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Statistics:
The oral LD50 value and 95% confidence limits were calculated using a modified logit-linear regression program

Results and discussion

Preliminary study:
The first range finding study was conducted with dose levels of 50, 100, 250 mg/kg (at a 10% w:v concentration) and 500 and 1000 mg/kg (at a 25% w:v concentration) resulted in no mortality. The second range-finding was conducted at dose levels of 2500 and 5000 mg/kg at a 50% w:v concentration; one female died at each of these levels. These range-finding results were used to select the dosage levels for the definitive phase of the study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities
Clinical signs:
The only clinical signs noted were abdominogenital staining, decreased locomotion, and diarrhea; all signs had resolved within 24 hour post dosing.
Body weight:
All rats gained weight by day 14 of the study
Gross pathology:
There were no gross internal lesions observed in any animal

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU