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EC number: 939-526-9 | CAS number: 90506-73-3
- 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:
- April - August 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: USA, EPA (TSCA) OCSPP harmonized guidelines 40 CFR 799.9510 TSCA bacterial reverse mutation test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadecyl dihydrogen phosphate
- EC Number:
- 220-983-1
- EC Name:
- Octadecyl dihydrogen phosphate
- Cas Number:
- 2958-09-0
- Molecular formula:
- C18H39O4P
- IUPAC Name:
- octadecyl dihydrogen phosphate
- Reference substance name:
- Hexadecyl dihydrogen phosphate
- EC Number:
- 222-581-1
- EC Name:
- Hexadecyl dihydrogen phosphate
- Cas Number:
- 3539-43-3
- Molecular formula:
- C16H35O4P
- IUPAC Name:
- hexadecyl dihydrogen phosphate
- Reference substance name:
- Dioctadecyl hydrogen phosphate
- EC Number:
- 221-237-8
- EC Name:
- Dioctadecyl hydrogen phosphate
- Cas Number:
- 3037-89-6
- Molecular formula:
- C36H75O4P
- IUPAC Name:
- dioctadecyl hydrogen phosphate
- Reference substance name:
- Dihexadecyl hydrogen phosphate
- EC Number:
- 218-594-7
- EC Name:
- Dihexadecyl hydrogen phosphate
- Cas Number:
- 2197-63-9
- Molecular formula:
- C32H67O4P
- IUPAC Name:
- dihexadecyl hydrogen phosphate
- Reference substance name:
- hexadecyl octadecyl hydrogen phosphate
- Cas Number:
- 93803-11-3
- Molecular formula:
- C34H71O4P
- IUPAC Name:
- hexadecyl octadecyl hydrogen phosphate
- Reference substance name:
- Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.
- Molecular formula:
- N/A
- IUPAC Name:
- Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.
- Test material form:
- solid
- Details on test material:
- CAS Number 39471-52-8
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
impurity 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9
- Test concentrations with justification for top dose:
- Experiment 1: Concentrations of 1.5, 5, 15, 50, 150, 500, 1500 & 5000 µg/plate.
Experiment 2: Concentrations of 50, 150, 500, 1500 & 5000 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:Tetrahydrofuran
Justification: The test material was insoluble in sterile distilled water, dimethyl sulphoxide, dimethyl formamide and acetonitrile at 50 mg/mL and acetone at 100 mg/mL but fully soluble in tetrahydrofuran at 200 mg/mL in solubility checks performed in-house within the testing laboratory. Tetrahydrofuran was therefore selected as the vehicle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- ENNG: 2µg/plate for WP2uvrA, 3µg/plate for TA100, 5µg/plate for TA1535; 9AA: 80µg/plate for TA1537; 4NQO: 0.2µg/plate for TA98.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrohydrofuran
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 2AA: 1µg/plate for TA100, 2µg/plate for TA1535 and TA1537, 10µg/plate for WP2uvrA; BP: 5µg/plate for TA98.
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The test material was accurately weighed and approximate half-lg dilutions prepared in tetrahydrofuran by mixing on a vortex mixer and sonication for 30 minutes at 40°C in the day of each experiment. Tetrahydrofuran is toxic to the bacterial cells at above 50µl after employing the pre-incubation modification, therefore all of the formulation for Experiment 2 were prepared at concentrations four times greater than required on Vogel-Bonner agar plates. To compensate, each formulation was dosed using 0.025 mL (25µL) aliquots. All formulations were used within four hours of preparation and were assumed to be stable for this period. Analysis for concentration, homogeneiry and stability of the test material formulation is not a requirement of the test guidelines and was, therefore not determined. This is an exeption with regards to GLP and has been reflected in the GLP compliance statement. Prior to use, the solvent was dried to remove water using molecular sieves i.e. 2mm sodium alumino-silicate pellets with a nominal pore diameter of 4E-4 microns.
TEST PROCEDURE
Experiment 1 - Plate Incorporation Method
- Dose: The maximum concentration was 5000µg/plate. Eight concentrations of the test material (1.5, 5, 15, 50, 150, 500, 1500 amd 5000 µg/plate) were assayed in triplicate against each tester strain.
- Without activation: 0.025mL of the concentration of test material or vehicle or 0.1 mL of appropriate positive control was added to 2mL of trace amino-acid supplemented media containing 0.1mL of one of the bacterial strain cultures and 0.5mL of phosphate buffer. These were then mixed and overlayed onto a Vogel-Bonner agar plate. Each concentration of test material, positive control and each bacterial strain, was assayed using triplicates plates.
- With activation: The procedure was as above, except that following the addition of the test material formulation and bacterial culture, 0.5mL of S-9 mix was added to the trace amino-acid supplemented media in place of phosphate buffer.
Experiment 2 - Pre-Incubation Method
- Dose: The dose range used for Experiment 2 was determined by the results of Experiment 1, 50, 150, 500, 1500 amd 5000 µg/plate.
- Witout activation: 0.1mL of the appropriate bacterial strain culture, 0.5mL of phosphate buffer and 0.025mL of the test material formulation or vehicle or 0.1mL of appropriate positive control were incubated at 37 ± 3°C for 20 minutes (with shaking) prior to addition of 2mL of aminio-acid supplemented media and subsequent plating onto Vogel-Bonner plates.
-With activation: The procedure was as above, except that following the addition of the test material formulation and bacterial strain culture, 0.5mL of S-9 mix was added to the tube instead of phosphate buffer. All testing for this experiment was performed in triplicate.
All plates were incubated at 37 ± 3°C for 20 minutes for approximately 48 hours.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
The test material was considered to be non-mutagenic under the conditions of the study.
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