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EC number: 612-381-6 | CAS number: 61789-91-1
- 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 cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: in vitro mammalian chromosome aberration test (migrated information)
Test material
- Reference substance name:
- no defined IUPAC name
- EC Number:
- 612-381-6
- Cas Number:
- 61789-91-1
- Molecular formula:
- no molecular structure defined
- IUPAC Name:
- no defined IUPAC name
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Components Floraesters 30
Wax Ester ---
36:2 <2
38:0 <1
38:1 2 - 4
38:2 2 - 4
40:0 2 - 4
40:1 14 - 18
40:2 17 - 21
42:0 2 - 4
42:1 14 - 18
42:2 17 - 21
44:0 <2
44:1 4 - 7
44:2 4 - 7
46:2 <3
Iodine Value** 57 - 61
Mono-ester content*** 40 - 47
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight increase in reactivity
Applicant's summary and conclusion
- Conclusions:
- The test article extracts showed no significant increase of aberrations when compared to the negative
controls. The test article is not considered to be genotoxic when exposed to CHO cells. - Executive summary:
The test was performed to screen the manufacturer's devices and materials to determine if they cause structural chromosome aberrations in industry standard Chinese Hamster Ovary (CHO) cells.
The test was performed in the presence and absence of S9 metabolic activation. The devices were extracted at 50 ± 2°C for 72 ± 2 hours in a polar and alternate solvent. The polar solvent used was
Physiological Saline (Saline). The alternate solvent used was Dimethyl sulfoxide (DMSO). The extracts were placed on cells with and without metabolic activation. Positive and negative controls were run
concurrently with devices. After the expression period, the cells were arrested in metaphase with colcemid. The cells were then harvested and dropped onto microscope slides. The chromosomes were
stained with Giemsa stain and the chromosomes were examined for presence of aberrations. The positive control and the test articles were compared to the negative controls.
The results were evaluated with the chi-square calculation using a validated spreadsheet. The positive control and test article results were compared to the negative control using the chi-square test. The
critical value for the chi-square test is 3.841 at a confidence level of 95%. Any result higher than this value was considered statistically significant. At this point, the biological relevance data was examined to
assess the potential genotoxicity of the test article or positive control.
The non-activated DMSO cytotoxicity data showed a slight increase in reactivity to the test article solutions when placed on CHO cells in comparison to the non-activated DMSO negative control. The
saline and activated DMSO cytotoxicity data showed no increase in reactivity to the test article solutions in comparison to the relative negative controls. The polyploid, endoreduplication rate, and the mitotic
index of the test article solutions showed no significant difference from the controls.
The test article extracts showed no significant increase of aberrations when compared to the negative controls. The test article is not considered to be genotoxic when exposed to CHO cells.
All test method acceptance criteria were met.
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