Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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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.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of particle exposure and particle-elicited inflammatory cells on mutation in rat alveolar epithelial cells
- Author:
- Driscoll, K.E. et al.
- Year:
- 1 997
- Bibliographic source:
- Carcinogenesis 18(2):423–430
Materials and methods
- Principles of method if other than guideline:
- hprt mutation assay with a rat lung epithelial cell line (RLE-6TN)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Quartz (SiO2)
- EC Number:
- 238-878-4
- EC Name:
- Quartz (SiO2)
- Cas Number:
- 14808-60-7
- IUPAC Name:
- 14808-60-7
- Details on test material:
- - Name of test material (as cited in study report): alpha-quartz (minusil)
- Analytical purity: no data
Constituent 1
Method
- Target gene:
- hprt locus
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: RLE-6TN
- Details on mammalian cell type (if applicable):
- - Type and identity of media:Ham's F-12 Medium and RLuE media (Biological Research Facility and Faculty, Ijamsville, MD), which is a Hams F12 based media supplemented with insulin, transferrin and fetal calf serum.
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- not applicable
- Test concentrations with justification for top dose:
- 20, 40, 60, 80, 100 µg/cm2
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: physiol. saline
Controls
- Negative solvent / vehicle controls:
- yes
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 24 h
- Expression time (cells in growth medium): 10 days
- Selection time (if incubation with a selection agent): 21-28 days
SELECTION AGENT (mutation assays): 6 thioguanine (6TG)
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- 6TG-resistant cytokeratin staining colonies of >50 cells counted. Mutation frequencies were calculated as: (no. colonies/treatment)/(plating efficiency)/(10E6 cells) 5 mutants/10E6 cells.
- Statistics:
- The results were analyzed by analysis of variance with group comparisons made using the Student–Newman–Keuls test. Statistical significance was considered at P < 0.05.
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: RLE-6TN
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Any other information on results incl. tables
In vitro exposure of RLE-6TN cells to 20–100 mg/cm2 of alpha-quartz had no significant effect on hprt mutation frequency.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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