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EC number: 271-363-2 | CAS number: 68551-11-1 A complex combination of products produced by the distillation of products from the hydrogenation of butanal from the hydroformylation of propene. It consists predominantly of organic compounds such as aldehydes, alcohols, esters, ethers and carboxylic acids having carbon numbers in the range of C4-C32 and boiling in the range of approximately 143°C to 282°C (289°F to 540°F).
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD guideline 471).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): EP202
- Physical state: Liquid, colorless, clear
- Analytical purity: The test substance is a mixture containing different components.
- Test substance No.: 06/0723-1
- Batch identification: F701501mH
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period is guaranteed.
- Storage condition of test material: Room temperature
Method
- Target gene:
- his- (S. typhimurium)/trp- (E. 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:
- Aroclor-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- - standard plate test: 20.0 μg - 5000 μg/plate (all strains);
- preincubation test: 37.5 μg - 5000 μg/plate (TA 1535 with and without S9 mix); 18.8 μg - 5000 μg/plate (TA 100, without S9 mix); 37.5 μg - 5000 μg/plate (TA 100 with S9 mix); 6.3 μg - 2000 μg/plate (TA 1537 without S9 mix); 15.6 μg - 2000 μg/plate (TA 1537 with S9 mix); 62.5 μg - 5000 μg/plate (TA 98 without S9 mix); 31.3 μg - 5000 μg/plate (TA 98 with S9 mix); 312.5 μg - 5000 μg/plate (E. coli with and without S9 mix); - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- (historical control data)
- Positive controls:
- yes
- Positive control substance:
- other: see Details on test system and conditions
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 h
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), reduction in the titer
OTHER:
- positive controls: - with S9 mix: 2-aminoanthracene (2-AA), 2.5 μg/plate, dissolved in DMSO (TA 1535, TA 100, TA 1537, TA 98), 60 μg/plate, dissolved in DMSO (E. coli WP2 uvrA); - without S9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 5 μg/plate, dissolved in DMSO (TA 1535, TA 100); 4-nitro-o-phenylendiamine (NOPD), 10 μg/plate, dissolved in DMSO (TA 98); 9-aminoacridine (AAC), 100 μg/plate, dissolved in DMSO (TA 1537); 4-nitroquinoline-N-oxide (4-NQO), 5 μg/plate, dissolved in DMSO (E. coli WP2 uvrA) - Evaluation criteria:
- Generally, the experiment is considered valid if the following criteria are met: - The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain; - The sterility controls revealed no indication of bacterial contamination; - The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above; - The titer of viable bacteria was > 10^8/mL;
The test chemical is considered positive in this assay if the following criteria are met: - A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system;
A test substance is generally considered non-mutagenic in this test if: - The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other;
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:
- other: A bacteriotoxic effect was observed in the standard plate test from about 2 500 μg/plate onward, in the preincubation assay from about 100 μg/plate onward (depending on the strain and test conditions).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A bacteriotoxic effect was observed in the standard plate test from about 2 500 μg/plate onward, in the preincubation assay from about 100 μg/plate onward (depending on the strain and test conditions).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Standard plate test (20 - 5000 µg/plate) | |||||||
Strain | Metabolic activation system | mean his+/trp+revertant colonies (negative control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) | |
TA 98 | no | 30 | 1.0 (20/100) | no | negative | 27 (NQPD) | |
yes | 36 | 1.1 (100/500) | no | negative | 16.5 (2-AA) | ||
TA 100 | no | 104 | 1.0 (100/500) | no | negative | 7.3 (MNNG) | |
yes | 110 | 1.0 (20/100) | no | negative | 7.3 (2-AA) | ||
TA 1537 | no | 11 | 0.9 (20/100) | no | negative | 34.3 (AAC) | |
yes | 10 | 100 (500) | no | negative | 13 (2-AA) | ||
TA1535 | no | 15 | 1.2 (17) | no | negative | 55.5 (MNNG) | |
yes | 16 | 1.0 (2500) | no | negative | 7.6 (2-AA) | ||
E. coli WP2 uvrA | no | 44 | 1.2 (100) | no | negative | 27.8 (4-NQO) | |
yes | 54 | 1.1 (100) | no | negative | 3.2 (2-AA) | ||
reduced background growth/precipitation at 5000 µg/plate in all strains tested | |||||||
Preincubation test, experiment 1 | |||||||
Strain | Metabolic activation system | mean his+/trp+revertant colonies (control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) | dose interval (µg/plate) |
TA 98* | no | 28 | 1.0 (312.5) | no | negative | 30.3 (NQPD) | 312.5 - 5000 |
yes | 46 | 0.7 (312.5) | no | negative | 12.1 (2-AA) | ||
TA 100* | no | 124 | 0.5 (312.5) | no | negative | 7.7 (MNNG) | 312.5 - 5000 |
yes | 136 | 0.7 (312.5) | no | negative | 5.5 (2-AA) | ||
TA 1537** | no | 13 | 0.1 (125) | no | negative | 37.7 (AAC) | 125 - 2000 |
yes | 10 | 1.1 (125) | no | negative | 11.3 (2-AA) | ||
TA 1535* | no | 19 | 0.8 (312.5) | no | negative | 62.3 (MNNG) | 312.5 - 5000 |
yes | 19 | 0.7 (312.5) | no | negative | 7 (2-AA) | ||
E. coli WP2 uvrA*** | no | 41 | 1.0 (312.5) | no | negative | 13.4 (4-NQO) | 312.5 - 5000 |
yes | 46 | 1.0 (625) | no | negative | 4.7 (2-AA) | ||
* > 312.5 µg/plate: reduced background growth; 5000 µg/plate:reduced background growth/precipitation | |||||||
**>/= 125 µg/plate: reduced background growth | |||||||
*** 5000 µg/plate:reduced background growth/precipitation | |||||||
Preincubation test, experiment 2 | |||||||
Strain | Metabolic activation system | mean his+revertant colonies (control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) | dose interval (µg/plate) |
TA 98**** | no | 32 | 1.1 (125) | no | negative | 17.3 (NQPD) | 62.5 - 1000 |
yes | 31 | 1.2 (31.3/62.5) | no | negative | 17.3 (2-AA) | 31.3 - 500 | |
TA 100** | no | 100 | 1.1 (75) | no | negative | 9.5 (MNNG) | 18.8 - 300 |
yes | 107 | 1.0 (37.5/75/150) | no | negative | 7.3 (2-AA) | 37.5 - 600 | |
TA 1537*** | no | 10 | 1.0 (12.5) | no | negative | 34.7 (AAC) | 6.3 - 100 |
yes | 9 | 1.3 (31.3) | no | negative | 15.5 (2-AA) | 15.6 - 250 | |
TA 1535* | no | 17 | 1.0 (16) | no | negative | 55.4 (MNNG) | 37.5 - 600 |
yes | 17 | 0.9 (37.5/150) | no | negative | 6.8 (2-AA) | ||
* 600 µg/plate: reduced background growth | |||||||
** 300 µg/plate (without S9) / 600 µg/plate (with S9): reduced background growth | |||||||
*** 100 µg/plate (without S9) / 250 µg/plate (with S9): reduced background growth | |||||||
**** 1000 µg/plate (without S9) / 500 µg/plate (with S9): reduced background growth |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
According to the results of the present study, the test substance EP202 is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here. - Executive summary:
The mutagenic potential of EP202 was determined in the Salmonella typhimurium/Escherichia coli reverse mutation assay. Under the chosen conditions, the test substance EP202 was not mutagenic.
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