Ammonium hexafluorosilicate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011/11/02 - 2011/11/23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001/12/17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Ammonium hexafluorosilicate

EC Number:

240-968-3

EC Name:

Ammonium hexafluorosilicate

Cas Number:

16919-19-0

Molecular formula:

F6Si.2H4N

IUPAC Name:

diammonium hexafluorosilicate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Form: powder
Colour: white
Storage: room temperature, dry
Expiry date: 2018
Purity: > 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Animals
Nine Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatization period of at least five days. At the beginning of the study, the animals of the treated group weighed between 190 g and 215 g and were 8 weeks old.
They were identified prior to inclusion in the test by means of numbered rings on the edges of their ears.
Group treated (300 mg/kg): 3 female rats (Step 1)
Group treated (50 mg/kg): 3 female rats (Step 2)
3 female rats (Step 3)

Housing
Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25 °C and 30 to 70%, respectively.
The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink
Drinking water (tap-water from public distribution system) and foodstuff (M20, SDS) were supplied freely. Food was removed at D-l and then redistributed 4 hours after the test item administration. Microbiological and chemical analyses of the water were carried out once every six months by IPL, Santé, Environnement Durables - Atlantique (Bordeaux).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

50, 300 mg/kg/bw

No. of animals per sex per dose:

3 (300 mg group)
6 (50 mg group)

Control animals:

no

Details on study design:

The animals of the treated group received an effective dose of 300 or 50 mg/kg body weight of the test item Ammonium hexafluorosilicate.
In the first step of the study, 300 mg of the test was weighed and distilled water was added to a 20 mL volumetric flask. The preparation was magnetically stirred to obtain a colourless solution just before the administration.
In the second and third step of the study, 50 mg of the test item was weighed and distilled water was added to a 20 mL volumetric flask. The preparation was magnetically stirred to obtain a colourless solution just before the administration.
The preparation was administered under a volume of 20 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 50 - < 300 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

ca. 200 mg/kg bw

Mortality:

No mortality occurred in animals treated at 50 mg/kg bw.
It was noted the death of the three rats treated at 300 mg/kg b.w. (3/3) at 3 hours (1/3), 23 hours (1/3) and 47 hours 40 minutes post-dose (1/3).

Clinical signs:

50 mg/kg bw: No clinical signs related to the administration of the test item were observed.
300 mg/kg bw: The mortalities were preceded by decrease in spontaneous activity (3/3), in muscle tone (3/3), bradypnea (2/3), lachrymation (2/3), soft faeces (1/3) and piloerection (2/3).

Body weight:

50 mg/kg bw:The body weight evolution of the animals remained normal throughout the study.
300 mg/kh bw: A decrease in body weight was also noted in animals found dead on day 1 and day 2: -9% and -14% on the day of the death compared to day 0, respectively.

Gross pathology:

50 mg/kg bw: The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
300 mg/kg bw: The macroscopical examinations of the dead animals revealed a red coloration of the corpus (3/3) associated with a thinning of the corpus (3/3) and a smooth aspect (2/3), and a thinning of the forestomach (3/3) associated with a red coloration (1/3) and a white granular aspect (1/3).

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

In conclusion, the LD50 of the test item Ammonium hexafluorosilicate is higher than 50 mg/kg and lower than 300 mg/kg body weight by oral route in the rat.
In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 200 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item Ammonium hexafluorosilicate has to be classified R25 “Toxic if swallowed”. The item has to be characterised by the symbol “T” and the warning label “Toxic”.
In accordance with the Regulation EC No. 1272/2008, the test item has to be classified in category 3. The signal word “Warning” and hazard statement H301 “Toxic if swallowed” are required.

Executive summary:

The test item Ammonium hexafluorosilicate was administered to a group of 3 female Sprague Dawley rats at the single dose of 300 mg/kg body weight and then, to a group of6female Sprague Dawley rats at the single dose of 50 mg/kg body weight. The experimental protocol was established according to the official method as defined in the OECD guideline No. 423 dated December 2001 and the test method B. ltris of the Council regulation No. 440/2008.