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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
other information
Study period:
4-13 August 2009
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: ICH. Topic S2A Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals; CPMP/ICH/141/95 Step 5 Guideline (Into Operation April 1996).
Qualifier:
according to guideline
Guideline:
other: ICH. Topic S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals; CPMP/ICH/174/95 Step 5 Guideline (Into Operation March 1998).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[3-(2-methoxy-5-nitrophenoxy)propyl]-4-methylpiperazine
EC Number:
700-445-7
Cas Number:
846023-54-9
Molecular formula:
C15H23N3O4
IUPAC Name:
1-[3-(2-methoxy-5-nitrophenoxy)propyl]-4-methylpiperazine

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535
Details on mammalian cell type (if applicable):
Histidine mutation: hisG46
Mutation type:Base-pair substitutions
Species / strain / cell type:
S. typhimurium TA 1537
Details on mammalian cell type (if applicable):
Histidine mutation: hisC3076
Mutation type:Frameshift
Species / strain / cell type:
S. typhimurium TA 98
Details on mammalian cell type (if applicable):
Histidine mutation: hisD3052/R-factor*
Mutation type:Frameshift
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
Histidine mutation: hisG46/R-factor*
Mutation type:Base-pair substitutions
Species / strain / cell type:
E. coli WP2 uvr A
Details on mammalian cell type (if applicable):
Mutation type:base-pair substitutions.
Metabolic activation:
with and without
Metabolic activation system:
Rat liver microsomal enzymes were routinely prepared from adult male Wistar rats, which were obtained from Charles River, Sulzfeld, Germany.
Test concentrations with justification for top dose:
3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Milli-Q water.
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (2AA) (Sigma).

Results and discussion

Test resultsopen allclose all
Species / strain:
other: Salmonella typhimurium reverse mutation assay
Metabolic activation:
with and without
Genotoxicity:
positive
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: Escherichia coli reverse mutation assay
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative Escherichia coli reverse mutation assay
positive Salmonella typhimurium reverse mutation assay,

Based on the results of this study it is concluded that WAY-190192-A is mutagenic in the Salmonella typhimurium reverse mutation assay, but not mutagenic in the Escherichia coli reverse mutation assay.