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EC number: 256-370-0 | CAS number: 49556-16-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 14-11-2017 to 24-01-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tin(2+) neodecanoate
- EC Number:
- 256-370-0
- EC Name:
- Tin(2+) neodecanoate
- Cas Number:
- 49556-16-3
- Molecular formula:
- C20H38O4Sn
- IUPAC Name:
- λ²-tin(2+) bis(2,2-dimethyloctanoate)
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat; Arochlor 1254 induced)
- Test concentrations with justification for top dose:
- 10.0, 31.6, 100, 316, 1000 and 3160 µg / plate
- Vehicle / solvent:
- acetone
As the test substance dissociates in water an organic solvent was used. For the experiment the solvent acetone was chosen.
Controlsopen allclose all
- Untreated negative controls:
- other: acetone
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation: TA 1535; TA 100; 10 µg/plate
- Untreated negative controls:
- other: acetone
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation: TA 1537; 100 µg/plate
- Untreated negative controls:
- other: acetone
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation: TA 98, 10 µg/plate
- Untreated negative controls:
- other: acetone
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation: TA 102, 10 µg/plate
- Untreated negative controls:
- other: acetone
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation: TA100, TA1535, 2 µg/plate
- Untreated negative controls:
- other: acetone
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation: TA 98, TA 102, TA 1537, 10 µg/plate
- Details on test system and experimental conditions:
- The first experiment was carried out as the standard plate incorporation method whereas the second was carried out as the preincubation method.
- Evaluation criteria:
- A test substance producing no biologically relevant positive response in any one of the bacterial strains tested is considered to be non-mutagenic in this system.
A biologically relevant response is described as follows:
If the number of revertants is at least twice the spontaneous reversion rate for TA 1535, TA 98, TA 100 or TA 1537 (and 1,5-fold for TA 102) and/or if there is a concentration related increasing number of revertants over the range tested. - Statistics:
- yes, p <= 0.05, U-test according to MANN and WHITNEY
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test substance dissociates in water, therefore an organic solvent was used.
- Precipitation: test item precipitation was noted at concentrations of 3160 and 5000 µg / plate in both experiments.
COMPARISON WITH HISTORICAL CONTROL DATA: The results of the negative and positive control cultures were within the range of the historical data generated by LPT
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Complete cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at a concentration of 3160 µg PU-2017-763/plate in both experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
The reported data show that the test item neodecanoic acid tin (2+)salt (2:1) did not induce gene mutations in the S. typhimurium tester strains with and without mammalian metabolic activation. In conclusion the results of this bacterial reverse mutation assay were considered negative. - Executive summary:
The potential of Neodecanoic acid, tin(2+) salt (2:1) to induce gene mutations was examined in 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
Six concentrations ranging from 10.0 to 3160 μg Neodecanoic acid, tin(2+) salt (2:1)/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation at the top concentration of 3160 μg Neodecanoic acid, tin(2+) salt (2:1)/plate in all test strains. In addtion, test item precipitation was noted at the top concentration of 3160 μg Neodecanoic acid, tin(2+) salt (2:1)/plate in both experiments in all test strains.
No increase in revertant colony numbers as compared with control counts was observed for Neodecanoic acid, tin(2+) salt (2:1), tested up to a concentration that led to cytotoxicity and test item precipitation, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, under the present test conditions, Neodecanoic acid, tin(2+) salt (2:1) tested up to a concentration that led to cytotoxicity and test item precipitation caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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