Registration Dossier
Registration Dossier
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EC number: 233-433-0 | CAS number: 10163-15-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute oral toxicity of dentrifrice fluorides in rats and mice.
- Author:
- Gruninger SE, Clayton R, Chang SB and Siew C
- Year:
- 1 988
- Bibliographic source:
- J Dent Res. 67:884
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Disodium fluorophosphate was administered to rats and mice in order to determine an acute oral LD50.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium fluorophosphate
- EC Number:
- 233-433-0
- EC Name:
- Disodium fluorophosphate
- Cas Number:
- 10163-15-2
- Molecular formula:
- FH2O3P.2Na
- IUPAC Name:
- disodium fluorophosphate
- Details on test material:
- - Name of test material (as cited in study report): monofluorophosphate (Na2MFP)
Constituent 1
Test animals
- Species:
- other: rats and mice
- Strain:
- other: Rats: Sprague Dawley, Mice: Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Rats: 175-200 g, Mice: 20-25 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- Rats: up to 125 mg F/kg
Mice: up to 100 mg F/kg - No. of animals per sex per dose:
- No data - 288 mice and rats were used. Study states equal numbers of males and females were tested.
- Control animals:
- not specified
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 102 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- F
- Remarks on result:
- other: Rats
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 54 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- F
- Remarks on result:
- other: Mice
- Mortality:
- No deaths occured after 3 days post-exposure.
Any other information on results incl. tables
Female rats demonstrated greater sensitivity than males to all forms of fluoride. This phenomenon was not apparent in mice.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of the study have been used to calculate an estimated LD50 for the substance itself based on the content of F in disodium fluorophosphate being ca. 13%.
Rats: ca. 784 mg/kg bw
Mice ca. 415.38 mg/kg bw
This study is not sufficient for use as key data as only the abstract is available.
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