Registration Dossier
Registration Dossier
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EC number: 217-218-9 | CAS number: 1779-49-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Quaternary (triphenyl-) phosphonium compounds: Environmental behavior and toxicity
- Author:
- Simon Brand, Michael P. Schlüsener, Dinah Albrecht, Uwe Kunkel, Claudia Strobel, Tamara Grummt, Thomas A. Ternes
- Year:
- 2 018
- Bibliographic source:
- Water Research 136 (2018) 207-219
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only tester strains S. typhimurium TA98 and TA100 were used
- Qualifier:
- according to guideline
- Guideline:
- other: DIN 38415-4
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyltriphenylphosphonium bromide
- EC Number:
- 217-218-9
- EC Name:
- Methyltriphenylphosphonium bromide
- Cas Number:
- 1779-49-3
- Molecular formula:
- C19H18P.Br
- IUPAC Name:
- methyl(triphenyl)phosphonium bromide
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Aroclor 1254-induced male Sprague Dawley rat liver
- method of preparation of S9 mix: S9 in KCl, Moltox®, Molecular Toxicology, Inc., USA
- concentration or volume of S9 mix and S9 in the final culture medium: 18.5% S9 mix (0.5 mL in 2.7 mL)
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): not reported - Test concentrations with justification for top dose:
- up to 0.03 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: no data
- Justification for choice of solvent/vehicle: not reported
- Justification for percentage of solvent in the final culture medium: not reported
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: not reported
- Number of independent experiments: not reported
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1E08 cellsin 2.7 mL
- Test substance added in medium; in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: not reported - Evaluation criteria:
- A substance was considered to be mutagenic if the amount of revertants was increased to the defined induction difference or higher in at least one strain and if a dose-response relationship was found. The induction factor was calculated as the quotient of the number of induced revertants and the number of spontaneous revertants. An induction factor (IF) of 1.2 or higher indicted genotoxicity.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce reverse mutations in the tester strains S. typhimurium TA98 and TA100 when tested up to 0.03 mg/plate with and without metabolic activation.
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