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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, documentation is not guideline compliant, e.g. data for positive control substance are missing thus raising concerns on the validity of the study
Justification for type of information:
Read-across from supporting substance (structural analogue or surrogate), same metal ion than the substance of interest.

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of heavy metals
Author:
Wong, P.K.
Year:
1988
Bibliographic source:
Bulletin of Environmental Contamination & Toxicology 1988, 40, (4), 597-603

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no positive control substances, number of replicates is not reported, no data for TA 100 , raw data not reported (no revertant numbers), evaluation criteria not reported
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
sterilized solution of lead chloride in 0.1 M citric acid
IUPAC Name:
sterilized solution of lead chloride in 0.1 M citric acid
Test material form:
liquid

Method

Target gene:
HIS operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 1537
Species / strain / cell type:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
20 ppm
Vehicle / solvent:
0.1 M citric acid
Details on test system and experimental conditions:
plate-incorporation method
Evaluation criteria:
no details
Statistics:
no details

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field "Test system"

Applicant's summary and conclusion

Conclusions:
positive without metabolic activation in TA102
Executive summary:

It is concluded that the test substance is mutagenic in TA102 without metabolic activation in this test system. 
It is reasonable to assume that the mutagenic property of lead salts is triggered by the lead cation and not the corresponding anion.