Registration Dossier
Registration Dossier
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EC number: 215-710-8 | CAS number: 1344-95-2
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:
- key study
- Study period:
- 21 Aug. - 04 Sep. 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Details on test material:
- Sident 9,
CAS-Name: Silica, precipitated, cryst.-free;
CAS-No.: 112926-00-8
Analytical data after ignition: SiO2 >98% , Na20 <1%, Al2O3 <0.2%, Fe2O3 <0.03%:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen/Germany
- Age at study initiation: 9 wks (male), 10 wks (females)
- Weight at study initiation: 183 - 191 g (male), 141 - 152 g (female)
- Fasting period before study: 16 h before start
- Housing: single in Macrolon cages
- Water: ad libitum
- Acclimation period: >= 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 22.5 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous suspension with 1 % carboxymethyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 237 mg silica/mL suspension
- Amount of vehicle (if gavage): 21.5 ml/kg bw (including 5100 mg TS)
- Justification for choice of vehicle: suspending the test material and stabilising the suspension
- Lot/batch no. (if required):
MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg bw
- Doses:
- 5110 mg/kg bw
237 mg/ml - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not relevant
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: no particular findings
- Gross pathology:
- no particular findings
Applicant's summary and conclusion
- Interpretation of results:
- other: non-toxic
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