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EC number: 271-547-2 | CAS number: 68585-02-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-01-15 to 2018-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- EC Number:
- 271-547-2
- EC Name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- Cas Number:
- 68585-02-4
- Molecular formula:
- C28H63N5O4
- IUPAC Name:
- acetic acid;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;octadecanoic acid
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- Histidine locus
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:
- microsomal preparation derived from Aroclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- Concentrations of 10.0, 31.6, 100, 316, 1000 and 3160 μg test substance per plate were chosen for the main experiments based on priliminary cytotoxicity tests.
- Vehicle / solvent:
- The test substance was dispersed in highly purified water to stable suspensions for all tested concentrations. The test item was not soluble in dimethyl sulfoxide (DMSO) or ethanol.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Remarks:
- not applicable water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st experiment: plate incorporation method
2nd experiment: preincubation method
- Cell density at seeding: Overnight culture final cell density was approximately 10E8 - 10E9 cells/mL.
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): Histidine
NUMBER OF REPLICATIONS: duplicate
DETERMINATION OF CYTOTOXICITY
Cytotoxicity is defined as reduction in the number of colonies by more than 50% compared to the solvent control and/or a scarce background lawn. - Evaluation criteria:
- A test item is considered to show a positive response if
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY, compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537 and 1.5-fold of the solvent control for TA102 in both independent experiments.
- a concentration-related increase over the range tested in the number of the revertants per plate is observed. The Spearman's rank correlation coefficient may be applied.
- Biological relevance of the results should be considered first.
Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitutions or frameshifts in the genome of Salmonella typhimurium.
A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the AMES test. - Statistics:
- No statistical analysis was performed, as all fold changes were below the evaluation criteria of mutagenicity.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions, Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine did not cause a mutagenic effect in the Salmonella typhimurium strins TA97, TA100, TA102, TA1535 and TA1537 neither in the presence nor absence of mammaliean metabolic activation when tested up to a cytotoxic and precipitation concentration of 3160 µg/plate.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471, strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 of S. typhimurium were exposed to Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine, at concentrations of 10.0, 31.6, 100, 316, 1000 and 3160µg/plate without metabolic activation. The first experiment was conducted as plate incorporation assay, the second as pre-incubation test, both in the absence and presence of a mammalian metabolic activation.
Precipitation of the test item was observed at 1000 µg/plate and higher in all experiments.
Pronounced cytotoxicity, evaluated by reduction in the number of revertants by more than 50%, was noted in the plate incorporation test and in the pre-incubation tests, each carried out without and with metabolic activation at the top concentration of 3160 μg /plate in the following test strains:
Experiments without metabolic activation: TA98, TA1535 and TA1537;
Plate incorporation test with metabolic activation: all test strains;
Preincubation test with metabolic activation: TA98, TA102 and TA1537
No biological relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.
The reference mutagen induced a distinct increase of revertant colonies indicating the validity of the experiments.
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