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EC number: 700-132-5 | CAS number: 863782-35-8
- 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:
- 19 May - 2 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(C6-16, (even numbered) and C16 unsaturated alkyl)-4-(C7-17 (odd numbered) and C17 unsaturated alkylidene)-oxetan-2-one
- EC Number:
- 700-132-5
- Cas Number:
- 863782-35-8
- Molecular formula:
- See remarks.
- IUPAC Name:
- 3-(C6-16, (even numbered) and C16 unsaturated alkyl)-4-(C7-17 (odd numbered) and C17 unsaturated alkylidene)-oxetan-2-one
- Details on test material:
- - Name of test material (as cited in study report): Aquapel® 203
- Substance type: yellow fatty liquid
- Physical state: liquid
- Analytical purity: 88.7%
- Lot/batch No.: G11AN059
- Expiration date of the lot/batch: 21 January 2010
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- histidine in Salmonella
tryptophan in Escherichia Coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Dose range finding: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate (+/- S9)
Mutation assay: 33, 100, 333, 1000, 3330 µg/plate (+/- S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: not indicated
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- pos. control for TA1535 (-S9)
Migrated to IUCLID6: diluted in saline 5 µg/plate
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- pos. control for TA1537 (-S9)
Migrated to IUCLID6: diluted in water conc. 60 µg/plate
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- pos. control for TA98 (-S9)
Migrated to IUCLID6: diluted in DMSO conc. 10 µg/plate
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- pos. control for TA100 (-S9)
Migrated to IUCLID6: diluted in DMSO conc. 650 g/plate
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- pos. control for WP2uvrA
Migrated to IUCLID6: diluted in DMSO conc. 10 µg/plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene diluted in DMSO
- Remarks:
- Conc. 1 µg/plate for strains TA98 (5 & 10% S9) and TA100 (5% S9); Conc. 2.5 µ/plate for strains TA1535 (5 & 10% S9), TA1537 (5% S9) and TA100 (10% S9); Conc. 5 µg/plate for strain TA1537 (10% S9); Conc. 10 µg/plate for strain WP2uvrA (5 & 10% S9),
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: At least five different doses (increasing with approximately half-log steps) of the test substance were tested in triplicate in each strain.
DETERMINATION OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
OTHER EXAMINATIONS:
- Other: precipitation - 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 control.
b) The negative response should be reproducible in at least one independently repeated 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 control.
b) In case a repeat 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 independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Aquapel® 203 precipitated on the plates at the top dose of 3330 μg/plate.
RANGE-FINDING/SCREENING STUDIES:
Aquapel® 203 was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix.
Precipitation of Aquapel® 203 on the plates was observed at the start and at the end of the incubation period at concentrations of 3330 and 5000 µg/plate.
No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
In the dose range finding test, no increase in the number of revertants was observed upon treatment with Aquapel® 203 under all conditions tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
- 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
Based on the results of this study it is concluded that Aquapel® 203 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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