Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro cytogenicity / micronucleus study
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
in vitro mammalian cell micronucleus test

Test material

Constituent 1
Reference substance name:
Silver nitrate
EC Number:
231-853-9
EC Name:
Silver nitrate
Cas Number:
7761-88-8
Molecular formula:
Ag.HNO3
Test material form:
solid

Method

Species / strain
Species / strain / cell type:
human lymphoblastoid cells (TK6)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not applicable
Test concentrations with justification for top dose:
1.00-1.75 µg/ml
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
not specified

Results and discussion

Test results
Key result
Species / strain:
human lymphoblastoid cells (TK6)
Metabolic activation:
not specified
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Ag+ can cause genotoxicity via oxidative stress