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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

Constituent 1
Chemical structure
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:
No changes were noted in the general condition of any treated animals
Body weight:
Body weight increases of all treated animals were normal throughout the observation period
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.