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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June-July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
21st July 1997Mode opératoire MB08/45
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
604-144-0
EC Number:
604-144-0
Cas Number:
139525-77-2
Molecular formula:
C13H15NO.HCl
IUPAC Name:
604-144-0
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
Batch : 832021/001

Method

Target gene:
S. Typhimurium TA 98 : his DS. Typhimurium TA 1537 : his CS. Typhimurium TA 100 ; TA 1535 : his GE. Coli (uvrA) (pKM101) : tryp E
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Details on mammalian cell type (if applicable):
Obtained from the CNRS (UA 144) of Institut Pasteur
Additional strain / cell type characteristics:
other: ampicillin resistance, uvrB mutation, rfa mutation
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
Obtained from the CNRS (UA 144) of Institut Pasteur
Additional strain / cell type characteristics:
other: ampicillin resistance, rfa mutation, uvrB mutation
Species / strain / cell type:
S. typhimurium TA 1537
Details on mammalian cell type (if applicable):
Obtained from the CNRS (UA 144) of institut Pasteur
Additional strain / cell type characteristics:
other: rfa mutation, uvrB mutation
Species / strain / cell type:
S. typhimurium TA 1535
Details on mammalian cell type (if applicable):
Obtained from the CNRS (UA 144) of Institut Pasteur
Additional strain / cell type characteristics:
other: rfa mutation, uvrB mutation
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
Details on mammalian cell type (if applicable):
Obtained from the CNRS (UA 144) of institut Pasteur
Additional strain / cell type characteristics:
other: Ampicillin resistance, uvrA mutation
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
The test concentrations were determined in a preliminary experiment. The concentrations are : 3000 µg / 900 µg / 300 µg / 90 µg / 30 µg by plate.
Vehicle / solvent:
NaCl 0,9% p/v (Lot 0353 cooper)
Controls
Untreated negative controls:
yes
Remarks:
untreated controls
Negative solvent / vehicle controls:
yes
Remarks:
vehicule alone
True negative controls:
no
Positive controls:
yes
Remarks:
Different substances were used for tests with and without metabolic activation or for different tester strains
Positive control substance:
other:
Statistics:
Average and standard deviation by plate were used for the final analysis

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The results of Gene mutation (Genetici Toxicity in vitro / Ames test) are : S. typhimurium TA 98, TA 1537, TA 100, TA 1535: negative with and without metabolic activation; Escherichia Coli (WP2 (uvr A) (pKM101) : negative without metabolic activation (according to OECD TG 471)
Executive summary:

For the Mephtamin HCL (n°CAS 139525 -77 -2), the Ames test is negative for the species/ strain : S. typhimurium TA 98, TA 1537, TA 100, TA 1535 and Escherichia Coli (WP2 (uvr A) (pKM101) with and without S9.