Tin difluoride

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:

comparable to guideline study

Justification for type of information:

After dissolution and disociation in environmental (aqueous)/physiolological media the constituents of tin difluoride become bioavailable and the overall toxicity of the dissociated substance can be described by the toxicity of the individual constituents/ions. Since synergistic effects are not to be expected, the human health and environmental hazard assessment of the assessment entity tin difluoride consists of an individual assessment of the assessment entities tin cation and the fluoride anion. The tin cation and the fluoride anion are considered to represent the overall toxicity of tin difluoride in a manner proportionate to the fluoride and the metal (represented by one of its readily soluble salts). Based on the above information, unrestricted read-across is considered feasible and justified.

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

Test material information

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

Test material form:

solid

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

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- 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:

Category 3 based on GHS criteria

Conclusions:

LD50 (female rats): 148.5 mg/kg bw (95% confidence limits of 116.3 - 185.5 mg/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is acutely toxic via the oral route (Category 3).