Disodium hexafluorosilicate

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:

14 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was conducted in accordance with OECD Guidlines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The study was also conducted in accordance with Good Laboratory Practice of The Department of Health of the Government of the United Kingdom.

Data source

Reference

Reference Type:

other: company data

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

other: Range-finding Acute Oral

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium fluoride

EC Number:

235-185-9

EC Name:

Ammonium fluoride

Cas Number:

12125-01-8

IUPAC Name:

ammonium fluoride

Details on test material:

- Name of test material (as cited in study report): ammonium fluoride
- Physical state: white crystalline solid
- Lot/batch No.: 1333A
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd., Margate, Kent, U.K.
- Age at study initiation: 5-8 weeks
- W eight at study initiation: males weighed 145 - 180 g and females weighed 140 - 168 g
- Fasting period before study: overnight fast immediately before dosing and for approximately
two hours after dosing
- Housing: Housed in groups of up to 3 by sex in solid polypropylene cages furnished with
woodflakes.
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diets Services Ltd.,
W itham, Essex, U.K. ad libitum except during fast before dosing and two hours after dosing.
- W ater (e.g. ad libitum): Ad libitum except during fast before dosing and two hours after dosing.
- Acclimation period: Minimum of at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 50-57
- Air changes (per hr): 15changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2.5, 20 or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: readily soluble in distilled water

Doses:

25, 200 or 2000 mg/kg body weight

No. of animals per sex per dose:

2 rats per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 1, 2 and 4 hours after dosing and then
daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and mortality

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 25 - < 2 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 25 - < 2 000 mg/kg bw

Mortality:

At 2000 mg/kg, 2/2 males and 2/2 females died within 30 minutes of dosing. At both 200 and 25
mg/kg, no animals died.

Clinical signs:

other: Common signs of systemic toxcity noted during the study were hunched posture, lethargy and decreased respiratory rate with an isolated incident of pilo-erection in one male at the 200 mg/kg dose level. No signs of systemic toxicity were noted at the 25 mg

Gross pathology:

Abnormalities noted in animals dosed at 2000 mg/kg were red lungs, dark liver and kidneys,
and severe hemorrhaging of the gastric mucosa of the stomach, small and large intestines. No
abnormalities were noted in any animal groups surviving the study (dosed at 200 or 25 mg/kg).

Applicant's summary and conclusion

Conclusions:

The acute oral median lethal dose (LD50) of ammonium fluoride in Sprague-Dawley strain rats
was found to be greater than 25 mg/kg body weight, but less than 2000 mg/kg body weight.