Registration Dossier
Registration Dossier
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EC number: 240-896-2 | CAS number: 16871-90-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 24 hours
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test parameters evaluated in this study do not totally comply with a specific test guideline, but are well documented and scientifically acceptable. The study was not in GLP compliance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 24-Hour LD50 values were obtained on the basis of a statistical method developed by W eil
which takes into consideration, among other factors, the mortality rate occurring within each
dose level of sodium fluoride administered and a geometric progression factor associated with
the increases in dose levels. Solutions of sodium fluoride were made by dissolving sodium
fluoride in distilled, deionized water. Animals were fasted 24 hours prior to and after
administration of sodium fluoride dose levels, but were allowed drinking water ad libitium.
Control animals were intubated with distilled water. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- IUPAC Name:
- sodium fluoride
- Details on test material:
- - Name of test material (as cited in study report): sodium fluoride
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: white Rochester
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- W eight at study initiation: 100-140 g
- Fasting period before study: 24 hours
- W ater (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 24 hours
- Statistics:
- LD50 values were obtained on the basis of a statistical method developed by W eil which takes
into consideration, among other factors, the mortality rate occurring within each dose level of
sodium fluoride administered and a geometric progression factor associated with the increases
in dose levels.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 114 mg/kg bw
- Remarks on result:
- other: as sodium fluoride
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 51.6 mg/kg bw
- Remarks on result:
- other: as fluorine
Applicant's summary and conclusion
- Conclusions:
- The 24-hour sodium fluoride LD50 for male white Rochester strain rats = 114 mg/kg body
weight (equivalent to 51.6 mg/kg body weight, as fluorine ion).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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