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Diss Factsheets

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: Guideline study (OECD 471) and in compliance with GLP.

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)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S)-3-{4-[(2-chloro-5-iodophenyl)methyl]phenoxy}oxolane
EC Number:
619-599-0
Cas Number:
915095-94-2
Molecular formula:
C17 H16 Cl I O2
IUPAC Name:
(3S)-3-{4-[(2-chloro-5-iodophenyl)methyl]phenoxy}oxolane
Constituent 2
Chemical structure
Reference substance name:
(S)-3-[4-(2-Chloro-5-iodobenzyl) phenoxy] tetrahydrofuran
Cas Number:
915095-94-2
Molecular formula:
C17 H16 Cl I O2
IUPAC Name:
(S)-3-[4-(2-Chloro-5-iodobenzyl) phenoxy] tetrahydrofuran

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:
Aroclor-induced rat liver S9
Test concentrations with justification for top dose:
initial test : maximum 5000 µL/plate
dose levels 1.5 to 5000 µL/plate

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
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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:
under the conditions of the study test article IN00078283 was concluded to be negative in the IN00078283- Bacterial Reverse Mutation Assay.