Registration Dossier
Registration Dossier
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EC number: 480-460-0 | CAS number: -
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:
- 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC/2000/32 OECD 471
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102.
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 31.6 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: aqua dest.
- Details on test system and experimental conditions:
- Metabolic activation system: Phenobarbital/beta-naphthoflavone induced male wistar rats.
A stock of the supernatant containing the microsomes was
frozen in ampoules of 2 and 4.5 ml and stored at < - 75°C.
The protein concentration in the S9 preparation was 35
mg/ml. The S9 mix preparation was performed according to
Ames et al.
100 mN sodium-ortho phosphat-buffer, pH 7,4 were ice-cold
added to the following reagents to give final
concentrations in the S9 mix of:
8mM MgCl2, 33mM KCl, 5 mM glucose-6-phosphate and 4 mM NADP.
This solution was immediately filter-sterilised and mixed
with the liver 9000 x g supernatant flid in the following
proportion:
co-factor solution 9.5 parts
liver preparation 0.5 parts
During the experiment the S9 mix was stored on ice.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 2500 µg/plate)
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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