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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed according to OECD and GLP guidelines
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Zeanyne salt
EC Number:
618-777-5
Cas Number:
91662-51-0
Molecular formula:
C33H36ClOP
IUPAC Name:
Zeanyne salt

Method

Target gene:
TA97: hisD6610, TA 98: hisD3052; TA 100 hisG46 TA102 hisG428 and TA 1535 hisG46
Species / strain
Species / strain / cell type:
other: TA97, TA 98, TA 100, TA102 and TA 1535
Additional strain / cell type characteristics:
other: rfa, delta-uvrB, pKM101, pAQ1
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
0, 1, 3, 10, 33, 100, 333, 1000, 3333, 5000 ug/plate in the preliminary test,
2 to 200 ug/plate in the main experiment
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
mitomycin C
other: ICR 191, 2-Aminoanthracene

Results and discussion

Test results
Species / strain:
other: TA97, TA 98, TA 100, TA102 and TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

-

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Neither Zeanyne salt per se, nor any of the formed metabolites was mutagenic in the Ames test under the described experimental
conditions.
Executive summary:

Zeanyne salt was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a

preincubation modification assay in absence and in presence of an exogenous

metabolic activation system (S9) were performed. Five Salmonella typhimurium tester strains (TA1535, TA97, TA98, TA100, and TA102) were employed. The activity of the S9-mix and the responsiveness of the tester strains were verified by including

appropriate controls into each experiment.

The substance was dissolved in dimethylsulfoxide (DMSO). Toxic effects were observed in a preliminary toxicity experiment starting at 333 ug/plate (on VB plates).

Therefore the concentration range 2 to 200 pg/plate was evaluated in the main experiments. Upon addition to the aqueous medium no precipitation of the compound was observable. Strain dependent toxic effects were observed (reduction in the number

of revertants and/or reduction in the background growth). Using the preincubation

modification assay, known to be more sensitive for several class of compounds, the

toxic effects were more pronounced. No increase of the number of mutant colonies was apparent in any of the five investigated

tester strains. Thus it can be concluded, that neither Zeanyne salt per se, nor any of the formed

metabolites was mutagenic in the Ames test under the described experimental conditions.

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