Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed data, acceptable for assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Genotoxic activity and potency of 135 compounds in the Ames reversion test and in a bacterial DNA-repair test.
Author:
De Flora S. et al.
Year:
1984
Bibliographic source:
OECD SIDS-Draft; original source: Mutat. Res., 133, 161-198

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
nickel nitrate
IUPAC Name:
nickel nitrate
Details on test material:
- Name of test material (as cited in study report): nickel nitrate

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA1535, TA100, TA1538, TA98, TA1537, TA97
Metabolic activation:
with and without
Test concentrations with justification for top dose:
no data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA1535, TA100, TA1538, TA98, TA1537, TA97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Negative results were seen in the bacterial reverse mutation assay.

Applicant's summary and conclusion