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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:
24.11.2003 - 22.1.2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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:
adopted in 1997
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one
EC Number:
608-748-5
Cas Number:
324763-46-4
Molecular formula:
C25 H39 N3 O5
IUPAC Name:
(3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one

Method

Target gene:
his and trp
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction of rat liver homogenate and mixture of cofactors.
Test concentrations with justification for top dose:
first experiment:
without metabolic activation: 50, 500, 1250, 2500 and 5000 µg/plate for all strains
with metabolic activation: 2, 20, 50, 100 and 200 µg/plate for Salmonella strains and 50, 500, 1250, 2500 and 5000 µg/plate for E. coli

second experiment:
without metabolic activation: 2, 20, 50, 100 and 200 µg/plate for S. typhimurium TA 100 and 50, 500, 1250, 2500 and 5000 µg/plate for all other strains
with metabolic activation: 50, 500, 1250, 2500 and 5000 µg/plate for all strains
Vehicle / solvent:
- Vehicle used: Dimethyl sulfoxide (DMSO)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: sodium azide (1.5 µg/plate), 4-nitro-o-phenylenediamine (20 µg/plate), 2-aminofluorene (10 µg/plate), 2-aminoanthracene (1 and 25 µg/plate), 9-aminoacridine hydrochloride monohydrate (100 µg/plate), N-methyl-N'-nitro-N-nitrosoguanidine (20 µg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 - 72 h

NUMBER OF REPLICATIONS: 3 replications each in 2 independent assays

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Under the experimental design described above, test substance was nonmutagenic for all bacterial strains TA 100, TA 1535, TA 98 and TA 1537 of Salmonella typhimurium in experiments without as well as with metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

According to REGULATION (EC) No 1272/2008 (CLP) the test substance does not require classification for mutagenicity.

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