Registration Dossier
Registration Dossier
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EC number: 275-735-5 | CAS number: 71630-92-7 Substance obtained by burning the husk removed from the rice paddy. Contains silica as well as the elements aluminum, calcium, carbon, chromium, copper, indium, iron, lead, magnesium, manganese, molybdenum, phosphorus, silver, sodium, tin, and zinc.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Characterization and toxicological behavior of synthetic amorphous hydrophobic silica
- Author:
- Lewinson, J. et al.
- Year:
- 1 994
- Bibliographic source:
- Regul Toxicol Pharmacol. 20(1 Pt 1):37-57
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 68 611-44-9
- IUPAC Name:
- 68 611-44-9
- Reference substance name:
- Silane, dichlorodimethyl-, reaction products with silica
- EC Number:
- 271-893-4
- EC Name:
- Silane, dichlorodimethyl-, reaction products with silica
- Cas Number:
- 68611-44-9
- IUPAC Name:
- 271-893-4
- Details on test material:
- - Name of test material (as cited in study report): Aerosil R 972 (Fumed Hydrophobic Silica, FHS)
- Analytical purity: >99.8%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S. Ivanovas GmbH & Co., Kisslegg, Germany
- Age at study initiation: 38 (females) and 42 (males) days
- Weight at study initiation: 100-105 g
- Fasting period before study: 16 h
- Housing: single (Makrolon cages Type II)
- Diet (e.g. ad libitum): Altromin 1323 (Altromin GmbH, Lage, Germany) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 0.5
- Humidity (%): 60 +/- 3
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 50 mL/kg bw - Doses:
- 2500, 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 28 days
- Necropsy of survivors performed: yes
- Other examinations performed: food intake, body weight gain, behavior.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No deaths occurred during the 4-week observation period.
- Clinical signs:
- other: No signs of toxicity were seen during the 4-week observation period.
- Gross pathology:
- No visible macroscopic lesions were observed at necropsy.
- Other findings:
- - Other observations: Food intake was not influenced as a result of the treatment.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of the acute oral toxicity study indicate that fumed hydrophobic amorphous silica is virtually acutely nontoxic by the oral route.
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