Magnesium hexafluorosilicate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium hexafluorosilicate hexahydrate

Cas Number:

18972-56-0

Molecular formula:

MgSiF6·6H2O

IUPAC Name:

Magnesium hexafluorosilicate hexahydrate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean 177g (male) 157g (female)
- Fasting period before study: 15h-20h
- Diet (e.g. ad libitum): Herilan MRH-Haltung

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%, 10%, 6.81%, 4.64%, 3.16%, 2.15%
- Amount of vehicle (if gavage) (ml/kg): 10

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

Doses:

6 dose groups:
Dosis: 5000 mg/kg, 1000 mg/kg, 681 mg/kg, 464 mg/kg, 316 mg/kg, 215 mg/kg

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: 2-4 D, 7 D and 13 D
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (dyspnoe, rattle, apathy, anomalous situation, stagger, atony, pain reflex, cornea reflex, anesthesia, tremble, twitch, clonic convulsions, shaggy fur, diarrhea, cyanosis, exsiccosis, chromodacryorrhea, general worse), body weight

Statistics:

Model of the dose-effect relationship: F(P) = A + B·LN(D)
Explanation: D=Dosis; P=Relative frequency of the dead animals after exposure to D; F=Inverse function of the cumulative normal distribution stander; LN=Natural logarithm; A,B= model parameters
Result: A=-26.26 scattering A=7.89; B=4.63 scattering B=1.39

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 291 mg/kg bw

Based on:

dissolved

95% CL:

> 246 - < 342

Mortality:

Dosis mg/kg Mortality after 14D %
215 10
316 60
464 100
6 81 100
1000 100
5000 100

Clinical signs:

other: symptoms (dosis with symptoms mg/kg) dyspnoe (5000, 1000, 681, 464, 316) rattle (1000) apathy (5000, 1000, 681, 464, 316) anomalous situation (5000, 1000, 681, 464) stagger (1000, 681, 464, 316) atony (5000, 681) pain reflex (681) cornea reflex (681) anes

Gross pathology:

Animals that died: heart: right acute dilatation, acute hyperaemia; stomach: glandular stomach diffusely reddened, partly large-scale bloody ulcers, intestinal: atonic, reddened mucous membrane inflammation

Other findings:

NA

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Acute Tox. 3 Criteria used for interpretation of results: EU

Conclusions:

The results showed a LD50 after 14 days of 291 mg/kg.

Executive summary:

In an in vivo test, the acute oral toxicity effects in rats of Magnesium Hexafluorosilicate Hexahydrated

were studied.The product was administered by gavage once to the animals. The investigations included the mortality in 14 days, poisoning symptoms and section of acute died and died after the test period with carbon dioxide. The animals were 30 male and 30 female Sprague Dawley Wiga Rats. The substance was administrated as a solution with distillated water via oral with a fasting period of 15-20 hours for application. The rats were divided in six test groups (5 male/ 5 female) with different dosis (5000 mg/kg, 1000 mg/kg, 681 mg/kg, 464 mg/kg, 316 mg/kg, 215 mg/kg). The results showed a LD50 after 14 days of 291 mg/kg with a slope factor of 1,24.