Registration Dossier
Registration Dossier
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EC number: 406-040-9 | CAS number: 125643-61-0
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:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 406-040-9
- EC Name:
- -
- Cas Number:
- 125643-61-0
- Molecular formula:
- C24 H40 O3 C25 H42 O3 C26 H44 O3
- IUPAC Name:
- C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 313 to 5000 µg/plate
Concentration range in the main test (without metabolic activation): 313 to 5000 µg/plate - Vehicle / solvent:
- - Vehicle; acetone
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period:
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS:
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: Concentration of test substance resulting in precipitation: 5000µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 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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