Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-919-5 | CAS number: 12040-43-6
Toxicological information
Acute Toxicity: oral
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:
- 2 009
- 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
- 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
Constituent 1
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
