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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test method and test sytem are described in details. Acceptable, well-documented publication which meets basic scientific principles .

Data source

Reference
Reference Type:
publication
Title:
Reduction of the mutagenicity of lead chromate-based pigments by encapsulation with silica
Author:
Thomas H. Connor and Stanley M. Pier
Year:
1990
Bibliographic source:
Mutation Research 245, 129-133

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
13 lead chromate-based pigments were assayed for mutagenicity and toxicity using salmonella typhimurium TA100.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Lead carbonate
EC Number:
209-943-4
EC Name:
Lead carbonate
Cas Number:
598-63-0
Molecular formula:
CH2O3.Pb
IUPAC Name:
λ²-lead(2+) carbonate

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
500, 100 & 50µg per plate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide & cyclophosphamide

Results and discussion

Test results
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In the conditions of the study, lead carbonate was found non toxic nor mutagenic.