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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
other: Range-finding Acute Oral
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 25 - < 2 000 mg/kg bw
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:
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/kg dose level.
Body weight:
All surviving animals showed the expected increase in body weight during the study
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.