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Diss Factsheets
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EC number: 947-528-6 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- June - September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- Bis(neodecanoyloxy)dioctylstannane
- EC Number:
- 269-595-4
- EC Name:
- Bis(neodecanoyloxy)dioctylstannane
- Cas Number:
- 68299-15-0
- Molecular formula:
- C36H72O4Sn
- IUPAC Name:
- Neodecanoic acid, 1,1'-(dioctylstannylene) ester
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
16JSVA015
- Expiration date of the lot/batch:
14. September 2018
- Purity test date:
not state
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room Temperature: (20 ± 5°C), keep container tightly closed, store under inert gas
- Stability under test conditions:
assumed stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- The stock solution was used to prepare the geometric series of the concentrations to be
tested. The following nominal concentrations were prepared for the first experiment:
5 μL/plate, 1.5 μL/plate, 0.5 μL/plate, 0.15 μL/plate and 0.05 μL/plate.
The following nominal concentrations were prepared for the second experiment:
5 μL/plate, 2.5 μL plate, 1.25 μL/plate, 0.63 μL/plate, 0.31 μL/plate, 0.16 μL/plate and
0.08 μL/plate. - Vehicle / solvent:
- In a non-GLP pre-test, the solubility of the test item was determined in a concentration of
50 mL/L in demineralized water, dimethyl sulfoxide (DMSO) and ethanol.
The test item was soluble in a concentration of 50 mL/L in ethanol.
Based on these results, ethanol was used as solvent in the experiments.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,3-phenylene Diamine, 2-Amino-Anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
- Cell density at seeding (if applicable): not applicable
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: 3
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: not applicable
NUMBER OF CELLS EVALUATED: not applicable
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): not applicable
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: Number of colonies
OTHER EXAMINATIONS:
none
- OTHER: - Rationale for test conditions:
- according to Guideline
- Evaluation criteria:
- A substance is considered to have mutagenic potential, if a reproducible increase of revertant
colonies per plate exceeding an increase factor of 2 in at least one strain can be
observed. A concentration-related increase over the range tested is also taken as a sign of
mutagenic activity - Statistics:
- none
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that
Bis(neodecanoyloxy)dioctylstannane is not mutagenic in the Salmonella typhimurium
strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence
of metabolic activation under the experimental conditions in this study. - Executive summary:
Two valid experiments were performed.
The study procedures described in this report were based on the most recent OECD and
EC guidelines.
The test item Bis(neodecanoyloxy)dioctylstannane was tested in the Salmonella typhimurium
reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98,
TA100, TA102 and TA1535).
The test was performed in two experiments in the presence and absence of metabolic
activation, with +S9 standing for presence of metabolic activation, and –S9 standing for
absence of metabolic activation.
In the first experiment, the test item (dissolved in ethanol) was tested up to concentrations
of 5 μL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100,
TA102 and TA1535 using the plate incorporation method.
The test item showed no precipitates on the plates at any of the concentrations.
The bacterial background lawn was not reduced at any of the concentrations and no relevant
decrease in the number of revertants was observed in all bacteria strains. The test item
showed no signs of toxicity towards the bacteria strains in both the absence and presence
of metabolic activation.
The results of this experiment showed that none of the tested concentrations showed a
significant increase in the number of revertants in all tested strains, in the presence and the
absence of metabolic activation.
Based on the first experiment, the test item was tested up to concentrations of 5 μL/plate in
the absence and presence of S9-mix in all bacteria strains using the pre-incubation method
(= second experiment).
The test item showed no precipitates on the plates at any of the concentrations.
No bacterial background lawn and no bacteria growth could be observed at the highest concentration
(5 μL/plate) in two bacteria strains (TA97a and TA102). The lower concentrations
were not affected.
The results of this experiments showed that the test item caused no increase in the number
of revertants in all bacteria strains compared to the solvent control, in both the absence and
presence of metabolic activation. The test item did not induce a dose-related increase in the
number of revertants colonies in all strains, in the presence and absence of metabolic activation.
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