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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.02. - 11.03.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
resp. EU method B1.tris
GLP compliance:
yes (incl. QA statement)
Remarks:
Groupe Interministeriel Des Produits Chimiques, 75572 Paris Cedex 12, France
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, aluminum magnesium sodium salt
EC Number:
234-919-5
EC Name:
Silicic acid, aluminum magnesium sodium salt
Cas Number:
12040-43-6
Molecular formula:
Na(0.017-1.739)Mg(0.008-0.823)Al(0.002-0.2473)SiO(2.018-3.837)
IUPAC Name:
aluminium(3+) magnesium(2+) sodium tris(oxosilanebis(olate))
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): Silicic acid Aluminium Magnesium Sodium salt
- Physical state: White powder
- Analytical purity: >99%
- Lot/batch No.: 901274002
- Expiration date of the lot/batch: 26 January 2011
- Production date: 27 January 2009
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 186 - 202 g
- Fasting period before study: Food was removed at D-1 and then redistributed 4 h after test item administration.
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; each cage contains sawdust bedding which was changed at least 2 times a week; each cage was installed in conventional airconditioned animal husbandry.
- Diet: ad libitum (M20, rat/mouse maintenance, made from the formulation EXTRALABO from PIETREMENT)
- Water: ad libitum (tap water from public distribution system, microbiological and chemical analyses carried out every six months by the Institut europeen de l'Environnement de Bordeaux)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 h continuous light (7:00 to 19:00)/12 hours darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
single dose of 2000 mg/kg bw
No. of animals per sex per dose:
6 (3 animals in Step 1, 3 animals in Step 2), 3 control animals
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations (symptoms, mortality); weighings on D0, D2, D7 and D14
- Necropsy of survivors performed: yes
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
other: deduced from LD0 value
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No clinical signs related to the administration of the test item were observed.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU