Registration Dossier
Registration Dossier
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EC number: 231-545-4 | CAS number: 7631-86-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
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:
- Silica gel; CAS-No. 7631-86-9; EINECS-No. 231-545-4; BET: 340 - 390 m2/g
Constituent 1
- Specific details on test material used for the study:
- synthetic amorphous silicon dioxide Syloid 244
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - vehicle: 0.85 % saline
- Volume of the vehicle: no data
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: no data - Details on exposure:
- 3 time points: sampling at 6, 24, and 48 h in the single-dose study
1 time point: sampling at 6 h after the last dose in the repeated-dose study
Colcemide (4 mg/kg bw i.p) was given 2 h prior to kill. - Duration of treatment / exposure:
- single administration (acute) and repeated administration (5 times, subacute)
- Frequency of treatment:
- 1x, and 5x(1x/d)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1.4 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 14 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 140 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5; but 3 as vehicle control
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Route of administration: i.p.
- Doses / concentrations: 0.3 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone-marrow cells
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- synthetic amorphous silicon dioxide Syloid 244 was negativein in in vivo chromosome aberration test.
- Executive summary:
An in vivo chromosome aberration test similar to OECD 475 was conducted with synthetic amorphous silicon dioxide Syloid 244
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