Registration Dossier
Registration Dossier
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EC number: 231-545-4 | CAS number: 7631-86-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 12-26, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- GLP compliance:
- yes (incl. QA statement)
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
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- CAS 112945-52-5, Pyrogenic, Surface area / BET [m2/g] 175-225
Constituent 1
- Specific details on test material used for the study:
- fumed silica, M5 - OL, batch no.: 5E05 99A
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 98-116 g at the start of experiment, 6-7 weeks old, 7 days acclimatisation; from: Fredrick Institute, Padappai, India
12h light/dark, 5 animals of same sex per cage, standart pellet feed ad libitum, Aquaguard filtered water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg/bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- single administration, 14 days of post administration observation
- Statistics:
- comparison of experimenta with control group using Student's t-test.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortaility
- Clinical signs:
- no clinical signs observed
- Body weight:
- on par with controls
- Gross pathology:
- no test substance related lesions
Applicant's summary and conclusion
- Conclusions:
- The LD50 of Cab-O-Sil fumed silica for wistar rats was considered to be greater than 5,000 mg/kg/bw.
- Executive summary:
The experiment examined the oral LD50 of Cab-O-Sil fumed silica (M5).
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