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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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): sodium tetrafluoroborate
- Physical state: white crystalline solid
- Lot/batch No.: 1364A
- 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 (UK) Ltd., Manston, Kent, UK
- Age at study initiation: ca. 5-8 weeks
- Weight at study initiation: 120-146 g (males), 120-147 g (females)
- Fasting period before study: overnight
- Housing: in groups of up to 5 by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet No. 1, Special diet Services Limited, witham, Essex, UK, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 42-68
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1/sex/dose in the dose-range finding study; 5/sex/dose in the main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily
- Frequency of weighting: individual body weights were recorded prior to dosing on day 0 and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
There were no deaths or clinical signs of toxicity in the dose-range finding study using a single dose level of 2000 mg/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs of systemic toxicity were noted during the study.
Body weight:
All animals gained weight during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the observations the LD50 of the test substance is greater than 2000 mg/kg body weight
Executive summary:

In a GLP-compliant OECD Guideline 401 study with rats, sodium tetrafluoroborate was administered to 5 male and 5 female rats (2000 mg/kg bw) by gavage. Animals were observed for 14 days and necropsied. There were no deaths or clinical signs of toxicity. All animals gained weight during the study. No pathological findings were revealed at necropsy. Based on the results of the study, the LD50 was above 2000 mg/kg bw.