Magnesium hexafluorosilicate

Endpoint summary

Description of key information

Reliable information on acute oral toxicity indicates that the substance shall be classified according to in force regulations.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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)

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

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

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

Preliminary study:

NA

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

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.

 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

291 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA
- Weight at study initiation: 185 +/- 15 g
- Diet: Herilan MRH
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 ºC
- Humidity (%): 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION/ TEST ATMOSPHERE
- Exposure apparatus: cascaded impinger and downstream frits bottle
- Method of holding animals in test chamber: The animals sit in tubes with their snouts in the inhalation space
- Place of sampling: in the immediate vicinity of the animal noses
- Brief description of analytical method used: Titrimetric determination of magnesium

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 4 h

Concentrations:

Concentrations (mg/l) (5 dosis-groups):
nominal: 9.92, 7.85, 7.44, 4.81, 1.18
analytical: 6.06, 5.86, 4.16, 3.15, 1.07

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Sex:

male/female

Dose descriptor:

LC50

Effect level:

ca. 3.6 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Sex:

male/female

Dose descriptor:

LC50

Effect level:

ca. 14.4 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 3.9 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 3.4 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 15.6 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 13.6 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

Dosis-group 1 (analytical concentration 6,06 mg/l) mortality (dead/exposed): 9/10 (male), 10/10 (female)
Dosis-group 2 (analytical concentration 5,86 mg/l) mortality (dead/exposed): 5/10 (male), 3/10 (female)
Dosis-group 3 (analytical concentration 4,16 mg/l) mortality (dead/exposed): 8/10 (male), 9/10 (female)
Dosis-group 4 (analytical concentration 3,15 mg/l) mortality (dead/exposed): 3/10 (male), 5/10 (female)
Dosis-group 5 (analytical concentration 1m07 mg/l) mortality (dead/exposed): 0/10 (male), 0/10 (female)

Clinical signs:

other: Dosis-group 1-4: watery or red eyes, and nasal discharge, dyspnoea, tremor (group 1), staggering gait, crouch, apathy (group 1, 3); shaggy and glued fur. Dosis-group 5: watery eye discharge, reddish nasal discharge, subsequently reddish encrusted noses

Body weight:

Group 1
Before trial: 185 g (male, number of animals: 10), 181 g (female, number of animals: 10)
After 7 days: 117 g (male, number of animals: 1), -
After 14 days: 146 g (male, number of animals: 1), -

Group 2
Before trial: 186 g (male, number of animals: 10), 188 g (female, number of animals: 10)
After 7 days: 163 g (male, number of animals: 5), 195 g (male, number of animals: 7)
After 14 days: 215 g (male, number of animals: 5), 212 g (male, number of animals: 7)

Group 3
Before trial: 174 g (male, number of animals: 10), 185 g (female, number of animals: 10)
After 7 days: 173 g (male, number of animals: 2), 189 g (male, number of animals: 1)
After 14 days: 243 g (male, number of animals: 2), 224 g (male, number of animals: 1)

Group 4
Before trial: 191 g (male, number of animals: 10), 188 g (female, number of animals: 10)
After 7 days: 209 g (male, number of animals: 7), 190 g (male, number of animals: 5)
After 14 days: 263 g (male, number of animals: 7), 208 g (male, number of animals: 5)

Group 5
Before trial: 187 g (male, number of animals: 10), 183 g (female, number of animals: 10)
After 7 days: 234 g (male, number of animals: 10), 204 g (male, number of animals: 10)
After 14 days: 292 g (male, number of animals: 10), 219 g (male, number of animals: 10)

Control Group
Before trial: 183 g (male, number of animals: 10), 182 g (female, number of animals: 10)
After 7 days: 231 g (male, number of animals: 10), 199 g (male, number of animals: 10)
After 14 days: 274 g (male, number of animals: 10), 214 g (male, number of animals: 10)

Gross pathology:

Heart: acute dilation or acute hyperaemia; lung: multiple patchy blood and wealth edemous, multiple acute flatulence center of learning degree.

Other findings:

Organ o. B.

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information harmful if inhaled Criteria used for interpretation of results: EU

Conclusions:

harmful if inhaled

Executive summary:

In an in vivo test, the acute inhalation effects in rats of Magnesium Hexafluorosilicate Hexahydrated were studied according to a dynamic head-nose inhalation method with an analytical and nominal determination of exposure concentration (aerosol exposition). The animals were Sprague-Dawley rats divided in five dose groups (10 male / 10 female for each dose), the body weight of the rats was 185±15 g.

 

The results showed a LC50 (4 hours) for male and female of 3,6 mg/L of air and a LC50 (1 hour) for male and female of 14,4 mg/L of air.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

3 900 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an in vivo test, the acute oral toxicity effects in rats of Magnesium Hexafluorosilicate hexahydrated was studied. The study performed in 1980 has shown a LD50 after 14 days of 291 mg/kg.

An in vivo test of acute inhalation toxicity in rat of magnesium hexafluorosilicate hexahydrated gave a LC50 of 3.9 mg/l.

Justification for classification or non-classification

This substance is classified according to the CLP Regulation (EC) 1272/2008 in Oral Acute Toxicity Category 3.

However, according to an in vivo study for acute inhalation toxicity, magnesium hexafluorosilicate hexahydrated should also be classified as Inhalation Acute Toxicity Category 4.