Registration Dossier
Registration Dossier
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EC number: 215-199-1 | CAS number: 1312-76-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Oct 2004 - 16 Dec 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Silicic acid, potassium salt
- EC Number:
- 215-199-1
- EC Name:
- Silicic acid, potassium salt
- Cas Number:
- 1312-76-1
- Molecular formula:
- K2O x (SiO2)n with Molar Ratio (MR) (SiO2/K2O): 0.5 – 5 (with exception of MR = 1)
- IUPAC Name:
- potassium hydroxysilanoylolate
- Details on test material:
- - Name of test material (as cited in study report): AgSil TM 25 Potassium silicate solution
- Physical state: claer to hazy white, thick liquid
- Composition of test material, percentage of components: 70% water, 30% silicic acid, potassium salt, potassium silicate
- Lot/batch No.: C052804K1
- Stability under test conditions: stable for the duration of testing
- Storage condition of test material: at room temperature
- Other: ratio: 2.47; specific gravity: 1.231 g/mL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown
- Age at study initiation: 10 weeks
- Weight at study initiation: 179 - 190 g
- Fasting period before study: overnight
- Housing: singly in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 15 - 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Oct To: 4 Nov 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently during the first several hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: No effects on body weight. All animals were active and healthy throughout the experiment. At necropsy, no gross abnormalities were found.
Applicant's summary and conclusion
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