Reaction mass of calcium disilicide and calcium silicide

Genetic toxicity: in vitro

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 for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

Calcium silicate

EC Number:

233-250-6

EC Name:

Calcium silicate

Cas Number:

10101-39-0

IUPAC Name:

calcium oxosilanediolate

Details on test material:

- Name of test material (as cited in study report): Silene (calcium silicate, hydrated)

Method

Species / strain

Species / strain / cell type:

mammalian cell line, 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:

mammalian cell line, 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.