Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Zanthoxylum, ext.
EC Number:
310-094-8
EC Name:
Zanthoxylum, ext.
Cas Number:
102242-62-6
Molecular formula:
NA
IUPAC Name:
Zanthoxylum ext
Test material form:
liquid: viscous

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
20%

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
A mutagenesis assay of Salmonella typhimurium (reverse mutation) was performed on the test material Zanthoxylum extract. The assay was performed on five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98 and TA100).
The mutagenic activity of the test material was determined from the comparison of the number of reverting colonies with that of the reverting organisms in the control cultures. The activity was tested with the direct incorporation method in a plate both in the presence of, without, an enzymatic system for metabolic activation. The test material was tested at the following concentrations: 1.000.000 µg/mL, 100.000 µg/mL, 10.000 µg/mL, 1.000 µg/mL and 100µg/mL. The test material proved to be non-mutagenic either in the presence or absence of metabolic activation.