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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:
2004-08-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP study, without quality assurance, but conducted in GLP facilities. Very brief summary report, minimal experimental details reported. Only two strains of S. typhimurium (TA98 and TA100) reported, although title also refers to E.coli. Positive results make more detailed testing unnecessary.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only two strains of S. typhimurium (TA98 and TA100) and no E. coli were tested. The number of test substance concentrations is not reported. Positive and negative controls are not stated. No details on the experimental procedures and results are given.
GLP compliance:
no
Remarks:
The study was conducted according to the current version of the UK and the OECD Principles of GLP, though not subject to Quality Assurance audit.
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4,5-oxadiazepane
EC Number:
616-123-3
Cas Number:
746595-79-9
Molecular formula:
C4H10N2O
IUPAC Name:
1,4,5-oxadiazepane
Details on test material:
- Colour: Slightly yellow
- Expiration date of the lot/batch: 2005-06 (reanalysis date)
- Storage condition of test material: <30°C (under argon, protect from light)

Method

Target gene:
his G46 (TA100)
his D3052 (TA98)

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Rat liver-derived metabolic activation system (S9-mix)
Test concentrations with justification for top dose:
5000 - 100 microgram / plate
Maximum concentration = limit concentration
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO (dimethylsulphoxide, dried)
- Justification for choice of solvent/vehicle: not reported
Controls
Negative solvent / vehicle controls:
not specified
Positive controls:
not specified
Remarks:
Work was conducted using the same facilities and study procedures which are subject to routine inspection under the QA programme; therefore an appropriate set of controls is expected.
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 3 days

NUMBER OF REPLICATIONS: not reported

NUMBER OF CELLS EVALUATED: not reported

DETERMINATION OF CYTOTOXICITY
- Method: not reported
Evaluation criteria:
Not reported
Statistics:
Not reported

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: strain/cell type: TA98

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
positive both in the presence and absence of S9 mix
Executive summary:

The test material gave positive (mutagenic) responses in two strains of S. typhimurium (TA98 and TA100), both in the presence and in the absence of metabolic activation, under the conditions of the reported assay.