Reaction mass of sodium chloride and potassium chloride and trisodium hexafluoroaluminate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study in conformance with requirements of the standard repeated dose toxicity testing protocols, assessment taken from EU-RAR.

Justification for type of information:

The read-across can be performed because trisodium hexafluoroaluminate is component parts of ADS 2-5, and is the only component with possible negative effects on human health. In view of this fact, we will detail its effect, based on published studies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Principles of method if other than guideline:

Study in conformance with requirements of the standard repeated dose toxicity testing protocols.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

impurity 1

Reference substance name:

Trisodium hexafluoroaluminate

EC Number:

237-410-6

EC Name:

Trisodium hexafluoroaluminate

Cas Number:

13775-53-6

Molecular formula:

AlF6Na3

IUPAC Name:

trisodium hexafluoroalumanetriuide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: : Crl:CD(SD)BR

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Duration of treatment / exposure:

90 days

Frequency of treatment:

continuously

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
3.8, 399.2, and 4172.3 mg/kg bw/day in males; 4.5, 455.9, and 4758.1 mg/kg bw/day in females
Basis:

Doses / concentrations 2

Remarks:

Doses / Concentrations:
50, 5000, and 50000 ppm
Basis:
nominal in diet

No. of animals per sex per dose:

40

Control animals:

yes

Results and discussion

Results of examinations

Details on results:

At 50000 ppm male and female rats exhibited reduced body weights and decreases in haemoglobin and haematocrit. At necropsy the stomach of male and female rats receiving ≥5000 ppm exhibited thickened walls, dark contents, raised focal areas, glandular thickened walls, non-glandular light focal areas, glandular dark focal areas and red glandular areas. Microscopical examination revealed submucosal lymphoid foci, hyperplasia, hyperkeratosis/acanthosis, erosion/ulcerations, mucosal atrophy and chronic submucosal inflammation. Fluoride accumulated in bones and teeth at all dose levels. The LOAEL for fluoride accumulation for male and female rats was 50 ppm, representing 3.8/4.5 mg/kg bw/day. The NOAEL for this effect could not be determined in this study. The LOAEL for lesions observed in the stomach was 5000 ppm (399.2 mg/kg bw/day in males and 455.9 mg/kg bw/day in females). The NOAEL for stomach effects in rats was 50 ppm, representing 3.8 mg/kg bw/day in males and 4.5 mg/kg bw/day in females.

Effect levels

1

Dose descriptor:

LOAEL

Effect level:

4.5 mg/kg bw/day (nominal)

Based on:

other: fluoride accumulation in bones and teeth

Sex:

female

2

Dose descriptor:

LOAEL

Effect level:

3.8 mg/kg bw/day (nominal)

Sex:

male

Basis for effect level:

other: fluoride accumulation in bones and teeth