Registration Dossier
Registration Dossier
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EC number: 448-020-2 | 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:
- 7.2. 2000 - 30.3.2000
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: B.14 Mutagenicity, test of reversal mutagenicity, Salmonella typhimurium OECD NO. 471
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Test batch: No.. 7/99
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium : (TA1537, TA98, TA100 , TA1535)
- Metabolic activation:
- with and without
- Metabolic activation system:
- The simulation of the absorption metabolism was carried out by S9 fraction of the liver homogenate and the co-factors mixture.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): .01 ... .5 µg/plate
Concentration range in the main test (without metabolic activation): .01 ... .5 µg/plate - Vehicle / solvent:
- Solvent: dimethylsulphoxid
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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
According to the mentioned results Dusantox L is not
mutagenic, by test with metabolic as without metabolic
activation. - 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 with metabolic activation
negative without metabolic activation
The test results : whithout the bacterial backround changes - all concentration are not toxic.
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