Registration Dossier
Registration Dossier
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EC number: 945-327-8 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reliability 2 according to OECD SIDS (2004).
Data source
Reference
- Reference Type:
- other: Collection of data from published literature and company data.
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 413
- GLP compliance:
- 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:
- Silicon dioxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Aerosil 200: >99.8 % (SiO2): CAS-Name: Silica, amorphous,fumed
(precipitated), cryst.-free; CAS-No.: 112945-52-5
Surface area (BET): 150 - 200 m2/g - Radiolabelling:
- not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 10 males and 10 females were used. Exposure was performed in inhalation chambers.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- not specified
- Details on exposure:
- Exposure performed in inhalation chambers. Single housing during exposure.
- Duration and frequency of treatment / exposure:
- Exposure time: 90 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1.3 mg/m³ air (analytical)
- Dose / conc.:
- 5.9 mg/m³ air (analytical)
- Dose / conc.:
- 31 mg/m³ air (analytical)
- No. of animals per sex per dose / concentration:
- Not specified
- Control animals:
- not specified
- Details on dosing and sampling:
- 1.3, 5.9 and 31 mg/m3 (mean analytical values), 6 h/day, 5 days/week. 10 males and 10 females per group were sacrificed after 90 days. 50 males and 50 females were kept for a recovery period of up to 52 weeks (13, 26, 39 and 52 weeks).
Results and discussion
Main ADME results
- Type:
- distribution
- Results:
- Relatively small amounts of silica were detected in lungs at the end of the 90 day exposure period. No silica could be recovered from any animal following the post-exposure observation period.
Applicant's summary and conclusion
- Conclusions:
- Relatively small amounts of silica could be detected in lungs of rats following 90 days of exposure. No silica could be recovered from any animal following the post-exposure observation period.
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