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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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: The study was conducted according generally valid procedures and all parameters described were closely related or comparable to guideline methods.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1984
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
- a control group was not included.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
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): D0028.02
- Physical state: solid
- Stability under test conditions: Stability testing was done
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Portage, MI, USA
- Weight at study initiation: 190 - 300 g (fasted weight)
- Fasting period before study: No data

ENVIRONMENTAL CONDITIONS
- Followed approved Standard Operating Procedures of the test facility


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: deionized water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4.0% w/v in deionized water
- Amount of test substance and vehicle dosed (if gavage): 2.86, 3.4, 4.0 or 5.6 mL/kg body weight
- Justification for choice of vehicle: test substance was readily soluble up to 4% in water


Doses:
Dose levels evaluated were: 114, 136, 160 and 224 mg NaF/kg body weight.
No. of animals per sex per dose:
10 female rats per dose
Control animals:
no
Details on study design:
After a single oral gavage dose, all animals were observed for mortality at frequent intervals during the first 4 hours after dosing (at least once during the first 30 minutes) and daily thereafter for the next 14 days.
Statistics:
The LD50 value and 95% confidence limits were calculated by the Probit Method [ J. Finney, Probit Analysis, 3rd Ed., Cambridge Univ. Press, 1971, pp. 50-90] by use of the computer program BLISS17 [Fortran version of BLISS17 program, written by D.J. Finney].

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 148.5 mg/kg bw
95% CL:
116.3 - 185.5
Mortality:
Dose Level Number of Deaths
114 mg/kg 2/10
136 mg/kg 4/10
160 mg/kg 7/10
224 mg/kg 8/10
336 mg/kg 8/8
500 mg/kg 8/8

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for sodium fluoride in female Sprague-Dawley rats was 148.5 mg/kg body weight with 95% confidence limits of 116.3 - 185.5 mg/kg body weight.