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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-doucmented study report which meets basic scientific principles.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human embryonic lung culture cells (WI-38) were exposed to calcium silicate for 24-48 hours. Anaphase preparations were then and analysed microscopically for chromosomal aberrations
GLP compliance:
not specified
Type of assay:
other: cytogenetic assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silene (calcium silicate, hydrated)

Method

Species / strain
Species / strain / cell type:
other: WI-38
Details on mammalian cell type (if applicable):
- Type and identity of media: minimal essential medium, with 1% glutamine, 200 U/ml penicillin, 200 µg/ml streptopmycin, 15% foetal calf serum
- Properly maintained: yes
Test concentrations with justification for top dose:
1, 10, 100 µg calcium silicate / ml
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: saline
Controls
Untreated negative controls:
yes
Remarks:
saline
Positive controls:
yes
Positive control substance:
triethylenemelamine
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: 24 h
- Exposure duration: 24-48 h
- Expression time (cells in growth medium): 48-72 h
- Fixation time (start of exposure up to fixation or harvest of cells): 24-48 h


NUMBER OF REPLICATIONS: no data

NUMBER OF CELLS EVALUATED: 100

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index

Evaluation criteria:
Calculation of % cells with chromosomal aberrations. Comparison with negative and positive controls.
% cells with acentrig fragments, % cells with bridges, % multipolar cells and % cells with other aberrations were also calculated.
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: WI-38
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No aberrations were observed due to calcium silicate exposure.
The mitotic index was not affected.

Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: 1530

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Calcium silicate did not induce chromosomal aberrations in human embryonic lung cultures (WI-38).
Executive summary:

The potential of calcium silicate (1 -100 µg/ml) to induce chromosomal aberrations was tested in vitro with human embryonic lung cultures (WI-38) (Litton 1974). No inductions of aberrations were seen, indicating that calcium silicate is not genotoxic in vitro.