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EC number: 291-445-1 | CAS number: 90411-68-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 19 Dec 2006 - 16 Jan 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance Hexadecyl 2-ethylhexanoate. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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)
- Remarks:
- Groupe Interministéririel des Produits Chemiques (GIPC), 12 rue Villiot, Paris cedex 12, France
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexadecyl 2-ethylhexanoate
- EC Number:
- 261-619-1
- EC Name:
- Hexadecyl 2-ethylhexanoate
- Cas Number:
- 59130-69-7
- Molecular formula:
- C24H48O2
- IUPAC Name:
- hexadecyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): Ethyl 2 Hexanoate de Cetyle
- Identification No: 06-901
- Lot/batch No.: 06090084
- Physical state: thick colouless liquid
- Analytical purity: 99.9%
- Expiration date of the lot/batch: 04 Sep 2008
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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.
- Test concentrations with justification for top dose:
- Pretest: 10, 100, 500, 1000, 2500 and 5000 µg/plate with and without metabolic activation
Main test: 312.5, 625, 1250, 2500, 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (batch: V6I963106L, CARLO ERBA, Val de Reuil, France)
- Justification for choice of solvent/vehicle: as test material is not soluble in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine (2AM, 2 µg/plate for TA1535, TA1537, TA98 and TA100, 10 µg/plate for TA102)
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (NAN3, 1 µg/plate for TA1535 and TA100); 9-Aminoacridine (9AA, 50 µg/plate for TA1537); 2-Nitrofluorene (2NF, 0.5 µg/plate for TA98); Mitomycine C (MMC, 0.5 µg/plate for TA102)
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation): pretest, experiment 1, experiment 2 without S9 mix
Preincubation: experiment 2 with S9 mix
DURATION
- Preincubation period: 60 min, 37°C
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- An reproducible 2-fold increase (for the TA98, TA100 and TA102 strains) or a 3-fold increase (fort the TA1535 and TA1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered a positive results. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
- Statistics:
- The mean number of revertants with the corresponding standard deviation and ratio were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: a moderate emulsion was observed in the plates at dose levels of ≥625 µg/plate and ≥2500 µg/plate, with and without S9 mix, respectively.
RANGE-FINDING/SCREENING STUDIES:
A moderate emulsion was observed in the plates at dose levels ≥ 500 µg/plate. No noteworthy toxicity was noted towards the three strains used, either with or without S9 mix
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No cytotoxicity was observed in any strains at any dose-level tested. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Pre test:
Dose Level (µg/plate) | Liver S9 mix | TA 98 | TA100 | TA102 |
Ethanol | - | 25 | 110 | 428 |
10 | - | 24 | 105 | 405 |
100 | - | 18 | 120 | 410 |
500 | - | 23* | 131* | 481* |
1000 | - | 30* | 111* | 449* |
2500 | - | 28* | 116* | 487* |
5000 | - | 29* | 137* | 499* |
Ethanol | + | 36 | 89 | 526 |
10 | + | 42 | 89 | 489 |
100 | + | 36 | 103 | 619 |
500 | + | 40* | 99* | 601* |
1000 | + | 46* | 101* | 565* |
2500 | + | 32* | 99* | 550* |
5000 | + | 35* | 86* | 590* |
*: moderate emulsion
Main test experiment 1:
Dose Level (µg/plate) | Liver S-9 mix | TA1535 | TA1537 | TA98 | TA100 | TA102 | |||||||||||||||
Individual revertant colony counts | mean | Individual revertant colony counts | mean | Individual revertant colony counts | mean | Individual revertant colony counts | mean | Individual revertant colony counts | mean | ||||||||||||
Ethanol | - | 17 | 16 | 19 | 17 | 6 | 6 | 6 | 6 | 23 | 36 | 25 | 28 | 104 | 108 | 104 | 105 | 372 | 362 | 388 | 374 |
312.5 | - | 24 | 23 | 25 | 24 | 5 | 12 | 4 | 7 | 28 | 26 | 18 | 24 | 129 | 140 | 110 | 126 | 357 | 384 | 296 | 346 |
625 | - | 19 | 12 | 24 | 18 | 4 | ap | 8 | 6 | 14 | 18 | 19 | 17 | 111 | 89 | 93 | 98 | 332 | 398 | 406 | 379 |
1250 | - | 16 | 20 | 16 | 17 | 5 | 5 | 11 | 7 | 24 | 25 | 12 | 20 | 101 | 93 | 104 | 99 | 394 | 390 | 408 | 397 |
2500 | - | 23* | 13* | 13* | 16 | 8* | 10* | 12* | 10 | 10* | 20* | 18* | 16 | 117* | 96* | 104* | 106 | 286* | 347* | 338* | 324 |
5000 | - | 25* | 19* | 18* | 21 | 5* | 6* | 6* | 6 | 34* | 24* | 17* | 25 | 113* | 122* | 1216* | 117 | 358* | 316* | 359* | 344 |
NAN3 (1 µg/plate) | - | 468* | 60* | 582* | 552 | 672 | 647 | 600 | 640 | ||||||||||||
9AA (50 µg/plate) | - | 105 | 143 | 117 | 122 | ||||||||||||||||
2NF (0.5 µg/plate) | - | 160 | 153 | 134 | 149 | ||||||||||||||||
MMC (0.5 µg/plate | - | 2442 | 2024 | 2302 | 2256 | ||||||||||||||||
Ethanol | + | 16 | 14 | 16 | 25 | 12 | 10 | 14 | 12 | 26 | 19 | 40 | 28 | 98 | 93 | 101 | 97 | 382 | 248 | 230 | 287 |
312.5 | + | 13 | 14 | 22 | 16 | 10 | 4 | 11 | 8 | 26 | 26 | 16 | 23 | 104 | 90 | 77 | 90 | 283 | 216 | 216 | 238 |
625 | + | 14* | 14* | 22* | 17 | 2* | 13* | 4* | 6 | 19* | 25* | 18* | 21 | 84* | 97* | 99* | 93 | 425* | 505* | 287* | 406 |
1250 | + | 8* | 14* | 14* | 12 | 4* | 6 | 5* | 5 | 29* | 44* | 25* | 33 | 109* | 84* | 90* | 94 | 359* | 356* | 353* | 356 |
2500 | + | 14* | 12* | 14* | 13 | 2* | 10* | 6* | 6 | 29* | 23* | 20* | 24 | 91* | 80* | 99* | 90 | 443* | 190* | 396* | 343 |
5000 | + | 16* | 35* | 13* | 21 | 11* | 11* | 12* | 11 | 19* | 18* | 41* | 26 | 93* | 78* | 114* | 95 | 295* | 490* | 446* | 410 |
2AM (2 µg/plate) | + | 116 | 126 | 122 | 121 | 85 | 69 | 104 | 86 | 959 | 1054 | 1035 | 1016 | 679 | 703 | 701 | 700 | ||||
2AM (10 µg/plate) | + | 2177 | 3035 | 3289 | 2834 |
*:moderate emulsion
ap: aberrant plate
Main test experiment 2:
Dose Level (µg/plate) | Liver S-9 mix | TA1535 | TA1537 | TA98 | TA100 | TA102 | |||||||||||||||
Individual revertant colony counts | mean | Individual revertant colony counts | mean | Individual revertant colony counts | mean | Individual revertant colony counts | mean | Individual revertant colony counts | mean | ||||||||||||
Ethanol | - | 26 | 26 | 25 | 26 | 4 | 4 | 6 | 5 | 11 | 20 | 29 | 20 | 95 | 92 | 96 | 94 | 279 | 315 | 281 | 292 |
312.5 | - | 31 | 18 | 26 | 25 | 7 | 2 | 1 | 3 | 17 | 17 | 19 | 18 | 113 | 102 | 95 | 103 | 333 | 320 | 320 | 324 |
625 | - | 34 | 23 | 32 | 30 | 7 | 7 | 1 | 5 | 19 | 12 | 20 | 17 | 107 | 99 | 120 | 109 | 296 | 378 | 254 | 309 |
1250 | - | 26 | 14 | 26 | 22 | 6 | 5 | 6 | 6 | 11 | 22 | 19 | 17 | 92 | 80 | 113 | 95 | 365 | 338 | 347 | 350 |
2500 | - | 22* | 23* | 25* | 23 | 1* | 6* | 4* | 4 | 19* | 31* | 23* | 24 | 99* | 116* | 111* | 109 | 332* | 337* | 296* | 322 |
5000 | - | 29* | 17* | 23* | 23 | 1* | 10* | 5* | 5 | 22* | 42* | 19* | 28 | 96* | 102* | 140* | 113 | 392* | 308* | 265* | 322 |
NAN3 (1 µg/plate) | - | 484 | 576 | 493 | 518 | 593 | 565 | 543 | 567 | ||||||||||||
9AA (50 µg/plate) | - | 171 | 87 | ap | 129 | ||||||||||||||||
2NF (0.5 µg/plate) | - | 95 | 104 | 137 | 112 | ||||||||||||||||
MMC (0.5 µg/plate | - | 1871 | 1811 | 2003 | 1895 | ||||||||||||||||
Ethanol | + | 19 | 18 | 18 | 18 | 4 | 7 | 2 | 4 | 22 | 31 | 28 | 27 | 72 | 91 | 77 | 80 | 429 | 441 | 353 | 408 |
312.5 | + | 26 | 17 | 16 | 20 | 8 | 12 | 5 | 8 | 42 | 28 | 28 | 33 | 97 | 114 | 107 | 106 | 446 | 455 | 341 | 414 |
625 | + | 15* | 14* | 18* | 16 | 10* | 12* | 10* | 11 | 32* | 34* | 32* | 33 | 97* | 78* | 96* | 90 | 531* | 441* | 428* | 467 |
1250 | + | 17* | 19* | 20* | 19 | 5* | 5* | 16* | 9 | 22* | 25* | 32* | 26 | 121* | 109* | 90* | 107 | 493* | 410* | 382* | 428 |
2500 | + | 20* | 22* | 20* | 21 | 14* | 10* | 7* | 10 | 71* | 32* | 52* | 52 | 79* | 96* | 119* | 98 | 462* | 426* | 432* | 440 |
5000 | + | 24* | 11* | 20* | 18 | 11* | 12* | 8* | 10 | 44* | 31* | 35* | 37 | 104* | 125* | 99* | 109 | 510* | 366* | 416* | 464 |
2AM (2 µg/plate) | + | 113 | 96 | 105 | 105 | 105 | 101 | 104 | 103 | 1212 | 1315 | 1238 | 1255 | 770 | 696 | 685 | 717 | ||||
2AM (10 µg/plate) | + | 1812 | 2061 | 1759 | 1877 |
*:moderate emulsion
ap: aberrant plate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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