Registration Dossier
Registration Dossier
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EC number: 215-684-8 | CAS number: 1344-00-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- addition of test substance to diet
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Molecular formula:
- nSiO2*mAl2O3*zNa2O n = 2-4; m = 0.12-3.20; z = 0.11-4.5
- IUPAC Name:
- aluminium(3+) sodium bis(oxosilanebis(olate))
- Test material form:
- solid: nanoform, no surface treatment
- Remarks:
- crystalline-free
Constituent 1
- Specific details on test material used for the study:
- Aluminium silicate P 820
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TNO
- Age at study initiation: "young adult"
- Weight at study initiation: 116 - 328 g (males); 78 - 160 g (female)
- Fasting period before study: no
- Housing: 1/cage during dose feeding, 5/cage the remainder of the study
- Diet: defined supplemented amount at dosing, ad libitum with unsupplemented stock diet
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-1°C
- Humidity (%): no data
- Air changes (per hr): "well ventilated"
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- VEHICLE (Feed):
- Concentration in vehicle: 20 % (1:4, w/w)
- Justification for choice of vehicle: In the diet, higher dosing was possible, due to the voluminous character of the test material.
- Doses:
- approx. 10 g/kg bw over 24 hours
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: regularly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 10 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other:
- Gross pathology:
- no indication of treatment-related changes
Any other information on results incl. tables
Most animals consumed the supplemented diet quantitatively. No clinical symptoms or other pathological findings following an autopsy. No diarrhea, stool changed colour to grey, but showed normal consistency with faecal pellets considerably bigger than normal.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-toxic
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- no classification (EU + GHS)
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