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EC number: 939-340-8 | CAS number: 28182-81-2
Genetic toxicity: in vitro
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:
- 12 Dec 2006 - 19 Jan 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only one positive control used for tests with metabolic activation
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 28182-81-2
- Molecular formula:
- Unspecified (UVCB substance)
- Reference substance name:
- HDI oligomers, biuret
- EC Number:
- 939-340-8
- Cas Number:
- 28182-81-2
- Molecular formula:
- (C8H12N2O2)n
- IUPAC Name:
- HDI oligomers, biuret
Constituent 1
Constituent 2
Method
- Target gene:
- histidine locus of S. typhimurium
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: uvrB-deletion, rfa-mutation
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: uvrB-deletion
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix from the liver of phenobarbitone/ beta-naphthoflavone induced rats
- Test concentrations with justification for top dose:
- Initial test: 0, 50, 158, 500, 1581 and 5000 µg/plate
Final test: 0, 1, 2, 4, 8, 16, 32, 64, 128 µg/plate - Vehicle / solvent:
- Ethylene glycol dimethylether (EGDE)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (-S9, TA 1535); Nitrofurantein (-S9, TA 100); 4-Nitro-1 ,2-phenylene diamine (-S9, TA 1537 and TA 98); Mitomycin C (-S9, TA 102); Cumene hydroperoxide (-S9, TA 102); 2-Aminoanthracene (+/-S9, all strains).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates per strain and dose
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 100, TA 1537, TA 98, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations > 8 µg/plate (strain-specific)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- None of the five strains used showed a dose-related and/or biologically relevant increase in mutant counts over those of the negative controls in the plate incorporation test. This applied both to the tests with and without S9 mix and was confirmed by the results of the preincubation trials.
The positive controls increased mutant counts to well over those of the negative controls.
CYTOTOXICITY:
There was no indication of a bacteriotoxic effect of the test substance at doses of up to and including 8 µg/plate. Higher doses had a strong, strain-specific bacteriotoxic effect. Therefore they could only partly be used for assessment purposes up to and including 128 µg/plate. - 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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