Trisodium hexafluoroaluminate

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:

other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Label: CRIOLITE SINTETICA
Description: white powder
Batch No.: 11

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Starin: Cr1:CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males 225-250 g, females 200 - 225 g
- Housing: 5 animals/sex/cage in air-conditioned rooms
- Diet (e.g. ad libitum): GLP 4RF21 pelleted diet ad libitum
- Water (e.g. ad libitum): from the municipal water main system ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

deionized water, administrationvolume 20 ml/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, clinical signs and mortality
(since no changes were found at necropsy, histological examination was not performed)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed on animals treated at 5000 mg/kg bw (limit dose) during the post-treatment observation period.

Clinical signs:

other: Some of the animals showed piloerection starting 6 hours after administration. This sign lasted up to day 5. One male rat showed diarrhea, with short duration, at the 6 hour observation. All animals achieved recovery within day 6.

Gross pathology:

No appreciable macroscopic findings were observed.