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Toxicological information

Genetic toxicity: in vitro

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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
Study period:
2007
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

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

Test material

Constituent 1
Reference substance name:
A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
EC Number:
427-090-8
EC Name:
A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
Cas Number:
116044-44-1
IUPAC Name:
reaction mass of ethyl (2R,3R)-3-(1-methylethyl)bicyclo [2.2.1]hept-5-ene-2-carboxylate and ethyl (2S,3S)-3-(1-methylethyl)bicyclo[2.2.1]hept-5-ene-2-carboxylate

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
5 to 5000ug/plate
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
Vehicle control
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
For TA 100, TA 1535 and E. coli
Untreated negative controls:
yes
Remarks:
Vehicle control
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
for TA1537
Untreated negative controls:
yes
Remarks:
Vehicle control
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
for TA98

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
weak response in TA100 at 1000ug/plate but not above historical controls and not reproducible
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
some seen at 5000ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

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