Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 January 1992 - 04 February 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard acute oral toxicity method. The test substance was administered to rats by oral gavage at a single dose of 5000 mg/kg bw, and animals were monitored for 14 days.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

EC Number:

949-694-5

Molecular formula:

Mg2.7K0.7Si4O10F2

IUPAC Name:

Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

Test material form:

solid: crystalline

Specific details on test material used for the study:

Nonswellable mica MK (Micromica), supplied by Co-op Chemical Co., Ltd.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sankyo Lab Service
- Age at study initiation: 4 weeks
- Weight at study initiation: 91.6 g (males)/81.2 g (females)
- Fasting period before study: 16 hours
- Housing: 5/sex in polycarbonate cages bedded with wood chips
- Diet (e.g. ad libitum): commercial diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 °C (± 2 °C)
- Humidity (%): 50% ± 10%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hours (artificial light provided 0600 - 1800)

IN-LIFE DATES: Not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: standard vehicle

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Remarks:

Vehicle only

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily (in the morning)
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of "organs" [not further specified]

Statistics:

Not specified

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed in any treated animals

Clinical signs:

other: No changes were noted in the general condition of any treated animals

Gross pathology:

No macroscopic abnormalities were found in any organs of the rats examined

Other findings:

Food intake in females appeared to be reduced on the day after dosing, then returned to normal; food intake in males was unaffected by treatment. Locomotion activity was normal in all treated rats.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity limit test, the LD50 of magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was determined to be > 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was investigated in a non-guideline limit test. Male and female rats received single gavage doses of 5000 mg/kg bw. There were no deaths, no changes to body weight gain during the 14-day observation period, and no macroscopic abnormalities in the organs observed at necropsy. The LD50 was concluded to be > 5000 mg/kg bw.