Registration Dossier
Registration Dossier
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EC number: 700-283-7 | 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:
- 24 Mar - 27 Apr 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- OECD 471
- Deviations:
- yes
- Remarks:
- In case of strain TA 100, frozen stock culture after expiration of minimum shelf life (two years) was used for experiments - a deviation from SOP. The bacteria were tested for their properties (fenotype confirmation, response to positive controls). All th
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- sukls28108/2009
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of acetic acid and acetylferrocene and butan-1-ol and 2-methylpropan-1-ol and propan-1-ol and propan-2-ol
- EC Number:
- 700-283-7
- Molecular formula:
- Exact molecular formula is not known as it is a reaction mass. Empiric formula: C5H5FeC5H4COCmHn
- IUPAC Name:
- Reaction products of acetic acid and acetylferrocene and butan-1-ol and 2-methylpropan-1-ol and propan-1-ol and propan-2-ol
- Details on test material:
- According to INQ-C-0000036278-61-01, INQ-C-0000036386-62-01, and INQ_RESULT_INQ-C-0000036417-65-01 from ECHA, identification of a substance has been changed to UVCB substance. Name of the substance on the study results is the old name (reaction mass of butan-1-ol and propan-2-ol, ReduxCo), however these reports should be regarded valid as all studies were performed on the substance that is being registered - ReduxCo.
Constituent 1
Method
- Target gene:
- detection mutation in amino-acid requiring strain (histidine or tryptophan, respectively) to produce a strain independent of an autside supply of amino-acid.,
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine dependant
- 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:
- For mutagenicity tests, the dose of 5000ug per plate was used as maximum. This concentration was diluted according to the rules given in guidelines.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated control, solvent control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injection
- True negative controls:
- no
- Remarks:
- not known
- Positive controls:
- yes
- Remarks:
- reference mutagens
- Positive control substance:
- sodium azide
- Remarks:
- none
Migrated to IUCLID6: also used: NDP, AAc, AF, AA and MNNG
- Evaluation criteria:
- The main criterion for evaluation of results was modifies two-fold increase rule, its using is comparable with using of statistical methods. After this rule the results is positive, when reproducible dose-effect and/or doubling of ratio Rt/Rc is reached.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- other: nonmutagenic
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: histidine dependant
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The results obtained were with no substantial increase in number of revertants against solvent control (Rt/Rc <2) and no experiment with rising trend in number of revertants with inrease dose was observed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
other: nonmutagenic
Under described experiment, the test substance ReduxCo was nonmutagenic for all the Salmonella typhimurium as well as Escherichia coli strains both in experiments without as well as with metabolic activation. - Executive summary:
The test substance was nonmutagenic for all used bacterial strains with as well as without metabolic activation.
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