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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data avaialble
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented publication, methods described in detail and results presented adequately

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Effect of silver compounds on in vitro cultured mammalian cells. II.study of gentoxicity and the effect of diamminesilver tetraborate on macromolecular synthesis of V79cells
Author:
Dusinska, M., Slamenova, D.
Year:
1990
Bibliographic source:
Biologia 45, 211-218
Reference Type:
publication
Title:
Occurrence of induced 6-thioguanine-resistant colonies in synchronized V79 cells after treatment with ftorafur. Effects of the S9 fraction.
Author:
Slamenová, D.; et al.
Year:
1984
Bibliographic source:
Neoplasma 31, 339-346

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In the present study the effect of diammine silver tetraborate (DSTB) on V79 hamster cells were reported.
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
diammine silver tetraborate
IUPAC Name:
diammine silver tetraborate
Details on test material:
- Test substance: Diamminesilver tetraborate (silver salt)
- Molecular formular: [Ag(NH3)2] [B4O5(OH)4]
- Physical state: solid
- Producer: Slovakofarma, Hlohovec, Czechoslovakia
No further details are given.

Method

Target gene:
hprt locus
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
Diploid V79 hamster cells were used.
- Type and identity of media: Eagle's minimum essential medium (MEM)
Cells were incubated for 24 hours.
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
- without metabolic activation: 0.2, 0.5, 1.0 and 2.0 µg/mL;
- with metabolic activation: 0.2, 0.5, 1.0 and 2.0 µg/mL.
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: phosphate buffered saline (PBS): The concentration of the stock solution was 63 mg/mL in water. The substance was diluted in PBS.
- Justification for choice of solvent/vehicle: no data

Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
V79 cells kept for 60 minutes in PBS with or without S9-mix were used as controls.
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 3,4-benzo(a)pyrene; 10 µg/mL (dissolved in PBS, treated for 120 minutes)
Remarks:
with and without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 60 minutes in PBS
- Expression time (cells in growth medium): 8 days
- Selection time (if incubation with a selection agent):10 days; The colonies were stained and evaluated on day 10 after plating.

SELECTION AGENT (mutation assays): 6-thioguanine (6-TGr; 5 µg/mL)
STAIN (for cytogenetic assays): methylene blue

NUMBER OF REPLICATIONS: three separate experiments per concentration


NUMBER OF CELLS EVALUATED: At each concentration of DSTB and 3,4-benzo(a)pyrene 2.5 x 10^6 cells were evaluated for mutants.
EVALUATION: The number of 6-TGr mutations per 1x10^5 viable cells was scored.

DETERMINATION OF CYTOTOXICITY
- Method: colony forming ability:
Treated cells and control cells were wahed, trypsinised and plated in Petri dishes for estimation of cytotoxicity. The colonies were stained and evaluated on day 7 after plating.

OTHER: The assay for detection of 6-TGr mutations was performed as described previously by Slamenová et al. 1984.
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test resultsopen allclose all
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
The test item induced no gene mutation.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
A cytotoxic effect of about 27-91% was observed at concentrations of 0.2 to 2.0 µg/mL (for details see table in the technical dossier).
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
The test item induced no gene mutation.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
A cytotoxic effect of about 17-29% was observed at concentrations of 0.2 to 2.0 µg/mL (for details see table in the technical dossier).
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
No further details are given.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Test for mutagenicity showed that the test item, diamminesilver tetraborate, did not induce gene mutation in hamster cells.