Registration Dossier
Registration Dossier
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EC number: 213-180-2 | CAS number: 928-70-1
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:
- October 23, 2012 - November 20, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was regarded reliable without restriction since the study was conducted according to the OECD guideline 471 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium isopentyl dithiocarbonate
- IUPAC Name:
- Potassium isopentyl dithiocarbonate
- Reference substance name:
- Potassium isopentyl dithiocarbonate
- EC Number:
- 213-180-2
- EC Name:
- Potassium isopentyl dithiocarbonate
- Cas Number:
- 928-70-1
- Molecular formula:
- C6H11KOS2
- IUPAC Name:
- potassium {[(3-methylbutyl)sulfanyl]carbonyl}sulfanide
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Potassium Iso-amyl Xanthate
- Physical state: solid pellets
- Analytical purity: 90.2 %
- Purity test date: July 2, 2012
- Lot/batch No.: 2012-06
- Expiration date of the lot/batch: January, 2013
- Storage condition of test material: Ambient temperature (15-25 deg. C)
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- A preliminary range-finding assay
- without metabolic activation (nine concentrations)
5, 2.5, 1, 0.75, 0.5, 0.1, 0.01, 0.001, 0.0001
- with metabolic activation (seven concentrations)
0.5, 0.1, 0.01, 0.001, 0.0001, 0.00001, 0.000001
Main assay
-without metabolic activation (six concentrations)
0.5, 0.1, 0.05, 0.01 0.001, 0.0001
Confirmation assay with preincubation
-without metabolic activation 8seven concentrations)
0.1, 0.01, 0.001, 0.0005, 0.0001, 0.00001, 0.000001
-with metabolic activation
0.1, 0.01, 0.001, 0.0005, 0.0001, 0.00001, 0.000001 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Untreated negative controls:
- yes
- Remarks:
- sterile water
- Statistics:
- Student's t-test was used for evaluation of statistical significance of mutation frequency increase against solvent control value.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed test item concentrations 0.5 or higher.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed test item concentrations 0.75 or higher.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed test item concentrations 0.5 or higher.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed test item concentrations 0.5 or higher.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed test item concentrations 2.5 or higher.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Potassium isoamyl xanthate was tested for mutagenic potential using in vitro bacterial reverse mutation test. The test substance did not exert mutagenic activity both in presence and absence of metabolic activation. - Executive summary:
Potassium isoamyl xanthate was tested for the mutagenic potential using in vitro bacterial reverse mutation test (Ames tes)(corresponding to the OECD No. 471). A preliminary range-finding asay was performed using five strains of Salmonella typhimurium (TA97, TA98, TA100, TA102 and TA1535) up to a maximum dose of 5.0 mg/plate to determine the optimal non-toxic test dose.
Potassium isoamyl xanthate was tested for mutagenic potential in main assay using five strains of Salmonella typhimurium in concentration range of 0.0001 -0.5 mg/plate. The test was conducted by preincubation of the test substance in the absence and presence of external matabolic activation with S9 fraction prepared from Sparague-Dawley rats.
Potassium isoamyl xanthate did not produce any significant increase of mutation frequency in these strains up to the maximum dose 5.0 mg/plate both in the absence or presence of metabolic activation. Based on the study results the test substance is considered to be non-mutagenic.
The test result is used as a key value in the hazard assessment.
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