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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-03-26 to 2007-06-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guidelines for Toxicity Studies of Cosmetics, Attachments to the Report issued by a Working Group for Guidelines for Assessment of the Safety of Novel Cosmetics and Others.( Japanese Ministry of Health, Labour and Welfare)
Version / remarks:
April 1990
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
442-650-1
EC Name:
-
Cas Number:
56450-90-9
Molecular formula:
F4Mg5Na2O20Si8
IUPAC Name:
silanedione hydrofluoride magnesium dihydride sodium hydride
Test material form:
solid: particulate/powder
Details on test material:
One sample of Sodium Magnesium Fluoride Silicate, Lot No. 91107
EINECS# 442-650-1
CAS# 56450-90-9
Sample submission date: 16.11.2009
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Topy Industries Ltd. / 51114
- Expiration date of the lot/batch: does not expire

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 19.7 to 25.1 °C under light-rsistant, dehumified conditions in a container
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The substance was pulverized using a motar and a pestle, and suspended in the 0.5 % methylcelulose solution at a concnetration of 66.7 mg/mL.

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboartories Japan. Inc. (Hino Breeding Center)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 4 weeks when received, 5 weeks at dosing
- Weight at study initiation: males 77 - 87 g 1 day fater receipt, females 65 - 74 g 1 day after receipt
- Fasting period before study: 19 h
- Housing: In groups of up to 5 per cage in stainless steel suspended cages (240 x 380 x 200 mm) during qurantine and acclimatisation periods. After group assignment, the animals were housed individually in stainlaess steel 5-vompartment cages (755 x 210 x 170 mm).
- Diet (e.g. ad libitum): ad lbitum
- Water (e.g. ad libitum): ad lbitum, except after group assignment and 6 h after administration
- Acclimation period: 2 d (plus 5 d qurantine)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 to 24.4 °C
- Humidity (%): 33.1 to 68.0 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 7 12

IN-LIFE DATES: From: 2007-04-04 To: 2007-04-25

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 66.7 mg/mL
- Amount of vehicle (if gavage): 30 mL
- Justification for choice of vehicle: solubility of test item, non-toxic
- Lot/batch no. (if required): 502517

MAXIMUM DOSE VOLUME APPLIED: 30 mL, resulting in a dose of 2000 mg/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation period 14 d, weighing 1, 3, 7, 10 and 14 d after administration
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, general signs
Statistics:
group mean values and standard deviations were calculated for body weight. To perform significance tests, data obtained were tested by an F-test for homogeneity of variance. Then, the data were compared between control (vehicle) group and the gropu treated with the test itme by Student's t-test when the variances were homogeneous and Aspin-Welch's t-test when the variances were heterogeneous.
Probabilities < 5 % were considered statistically significant and are shown as p < 00.5 (< 5 %) or p < 0.01 (< 1 %).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: none
Gross pathology:
No abnormalities were found in the necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance magnesium sodium fluoride silicate is non-toxic up to a concentration of >/- 2000 mg/kg bw after single oral administration.
Executive summary:

The acute oral toxicity of magnesium sodium fluoride silicate was investigated in a study according to a Japanese guideline.

The substance magnesium sodium fluoride silicate is non-toxic up to a concentration of > 2000 mg/kg bw after single oral administration.