Registration Dossier
Registration Dossier
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EC number: 231-838-7 | CAS number: 7758-29-4
Acute Toxicity: oral
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:
- 1 997
- 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
- 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
- Physical state: White powder
- Lot/batch No.: E10287-113
Constituent 1
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:
- other: The only clinical signs noted were abdominogenital staining, decreased locomotion, and diarrhea; all signs had resolved within 24 hour post dosing.
- 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
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