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EC number: 203-751-4 | CAS number: 110-27-0
- 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:
- 04 -29 Sep 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isopropyl myristate
- EC Number:
- 203-751-4
- EC Name:
- Isopropyl myristate
- Cas Number:
- 110-27-0
- Molecular formula:
- C17H34O2
- IUPAC Name:
- isopropyl myristate
- Details on test material:
- - Name of test material (as cited in study report): Isopropyl myristate
- Physical state: colourless liquid
- Analytical purity: 98%
- Lot/batch No.: OE30926X01
- Expiration date of the lot/batch: 26 September 2015
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- his operon for S. typhimurium strains and trp operon for E.coli strain
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254 (500 mg/kg bw)
- Test concentrations with justification for top dose:
- Dose range finding assay = 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA 100 and WP2 uvrA.
First mutation assay = 52, 164, 512, 1600 and 5000 µg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA 1535, TA 1537 and TA 98.
Second mutation assay = 52, 164, 512, 1600 and 5000 µg/plate in the absence and presence of 10% (v/v) S9-mix in tester strains TA 1535, TA 1537, TA 98, TA100 and WP2 uvrA.
Third mutation assay = 52, 164, 512, 1600 and 5000 µg/plate in the absence of S9-mix in tester strains TA 98, only. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-aminoanthracene (2.5 µg/plate for TA1535 + TA1537; 5 µg/plate for TA1537; 1 µg/plate for TA98 + TA100; 2 µg/plate for TA100 and 15 µg/plate for WP2uvrA)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (5 µg/plate) for TA1535; ICR-191 (2.5 µg/plate) for TA1537; 4-nitroquinoline N-oxide (10 µg/plate) for WP2uvrA; methylmethanesulfonate (650 µg/plate) for TA100 and 2-nitrofluorene (10 µg/plate) for TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications in 3 independent experiments.
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or
WP2uvrA is not greater than three (3) times the concurrent vehicle control.
b) The negative response should be reproducible in at least one a follow-up experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent vehicle control.
b) In case a follow up experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment. - Statistics:
- Mean values and standard deviation were calculated
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- 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:
- not applicable
- Positive controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- was observed in tester strain TA 100 in the presence of S9-mix at ≥ 512 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation, droplets of isopropyl myristate on the plates was observed at the start of the incubation period at concentrations of 512 μg/plate and upwards and at 1600 and 5000 μg/plate at the end of the incubation period in all experiments.
RANGE-FINDING/SCREENING STUDIES: Isopropyl myristate was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. Isopropyl myristate precipitated (observed as droplets) on the plates at dose levels of 1600 and 5000 μg/plate. In tester strain TA100, toxicity was only observed at dose levels of 512 and 1600 μg/plate in the presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested. Based on the results of the dose range finding test, the following dose range was selected for the mutation assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 52, 164, 512, 1600 and 5000 μg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity was only observed in tester strain TA100 in the presence of S9-mix, where a moderate to extreme reduction of the revertant colonies was observed at test substance concentrations of 512 µg/plate and above. There was no reduction in the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in the other tester strains in the absence and presence of S9-mix.
ADDITIONAL INFORMATION ON MUTAGENICITY: In tester strain TA98 a 3.3-fold increases in the number of revertant colonies compared to the solvent control in the absence of S9-mix was observed. Since this increase was observed at a precipitating dose level and was not reproducible in two other experiments, this increase was not considered to be relevant. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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