Potassium fluoride

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

May 1995 - June 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study comply with the Principles of GLP OECD and was conducted in accordance with EPA OPP 81-4 guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Remarks:

GLP statement included

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: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Composite NaF
- Molecular formula (if other than submission substance): NaF
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: white powder
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 199-7-4
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
- Date received: April 27, 1995

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.52, 1.02 and 1.98 mg/L

No. of animals per sex per dose:

five males and five females per group

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at least daily for signs of gross toxicity and mortality; bodyweights recorded just prior to exposure (day 0) and on days 7 and 14 (i.e. termination) or after death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

Mortality at 0.52 mg/L: Total 2/10 (i.e. Males 0/5; Females 2/5)
Mortality at 1.02 mg/L: Total 5/10 (i.e. Males 1/5; Females 4/5)
Mortality at 1.98 mg/L: Total 8/10 (i.e. Males 3/5; Females 5/5)

Clinical signs:

other: All animals, irrespective of their exposure level, displayed clinical signs such as: ocular and nasal discharge facial staining ano-genital staining abnormal respiration abnormal posture pilo-erection hypoactivity. Survivors from all exposure groups reco

Body weight:

Some surviving animals lost bodyweight through day 7, however all gained weight over the entire 14 -day observation period.

Gross pathology:

- Gross necropsy of decedents:
discoloration of the lungs, gastro-intestinal tract, liver and spleen; edema of the lungs; distention of the gastro-intestinal tract; fluid in the stomach and/or rigor mortis.

- Gross necropsy of survivors from all groups was generally unremarkable. Two survivors from the group exposed to 0.52 mg/L exhibited dark red foci on the lungs.

Applicant's summary and conclusion

Conclusions:

An acute inhalation toxicity study was conducted with rats to determine the toxicity via inhalation for NaF and the defined LC50 value is 1.00 mg/L.

Executive summary:

An acute inhalation toxicity study was conducted with rats to determine the toxicity via inhalation for NaF.

After establishing the desired generation procedures during pre-test trials, 30 healthy rats were selected and equally distributed into three exposure groups of five males and five females each. Exposure values were 0.52, 1.02 and 1.98 mg/L and each test group was exposed for four hours. Chamber concentration and particle size distribution were determined periodically during each exposure.

The animals were observed for signs of gross toxicity and mortality at least daily for 14 days. Bodyweights were recorded just prior to exposure (day 0) and again on days 7 and 14 (i.e. termination) or after death. Necropsies were performed on all animals.

The mortality at each exposure level is provided below:

Exposure levelmg/L	Mortality
	Males	Females	Total
0.52	0/5	2/5	2/10
1.02	1/5	4/5	5/10
1.98	3/5	5/5	8/10

Following exposure all animals, irrespective of their exposure level, displayed clinical signs such as: ocular and nasal discharge, facial staining, ano-genital staining, abnormal respiration, abnormal posture, pilo-erection and hypoactivity. Survivors from all exposure groups recovered from these symptoms by day 12 of the study. Although some surviving animals lost bodyweight through day 7, all gained weight over the entire 14 -day observation period. Gross necropsy of the decedents revealed discoloration of the lungs, gastro-intestinal tract, liver and spleen, edema of the lungs, distention of the gastro-intestinal tract, fluid in the stomach and/or rigor mortis. Gross necropsy of the survivors from all groups was generally unremarkable. Two survivors from the group exposed to 0.52 mg/L exhibited dark red foci on the lungs.

Based on the results, the acute inhalation toxicity study defined LC50 of NaF is 1.00 mg/L.