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EC number: - | CAS number: -
- 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
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- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- For the read-across justification see section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- The test substance provided by NOF Corporation was used. The test substance was stored at room temperature until use. After the test was completed, the residual test substance was analyzed by the test substance provider, and as a result, there was no problem with stability.
- Target gene:
- his operon (S. typhimurium strains), trp operon (E. coli strain)
- 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:
- S9 mix was prepared from the liver of male Sprague-Dawley rats treated with phenobarbital and 5,6-benzoflavone as inducers.
- Test concentrations with justification for top dose:
- 156, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 2-(2 Furyl)-3-(5-nitro-2-furyl)acrylamide (0.01 µg/plate);Sodium azide(0.5 µg/plate);Aminoacridine hydrochloride(80 µg/plate);+S9: 2-Aminoanthracene(1.0 µg/plate;TA100),(2 µg/plate;TA1535;TA1537),(10 µg/plate;WP2 uvrA),(0.5 µg/plate;TA98)
- Remarks:
- These positive control substances were dissolved using DMSO, dispensed in small portions, and then cryopreserved (-20 ° C).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes at 37 °C
- Exposure duration: 48 hours; after that, the growth state of the test strain on the plate was observed using a stereomicroscope (× 60) in order to confirm the growth inhibitory effect of the test substance on the test strain
NUMBER OF REPLICATIONS: 2 times (3 plates/concentration/test)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- An increase twice the number of revertant colonies in test concentration plates compared to the solvent control plates and an observable dose-dependency is considered as a positive result.
- Key result
- Species / strain:
- other: 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
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- 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
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results:
negative - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- For the read-across justification see section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster lung (CHL) cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle-MEM liquid medium (LIFE TECHNOLOGIES)
- Properly maintained: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- -S9 mix (short-term exposure): 0, 875, 1750, 3500 µg/mL
+S9 mix (short-term exposure): 0, 875, 1750, 3500 µg/mL
-S9 mix (24 h continuous exposure): 0, 350, 700, 1400, 2800 µg/mL
-S9 mix (48-hour continuous exposure): 0, 288, 575, 1150, 2300 µg/mL - Vehicle / solvent:
- 1% aqueous solution of sodium carboxymethyl cellulose (Wako Pure Chemical Industries, Ltd.)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: continuous exposure: mitomycin C (0.05 µg/mL for 24 hours and 0.025 µg/mL for 48 hours); short-term exposure: cyclophosphamide (12.5 µg/mL)
- Details on test system and experimental conditions:
- DURATION
- Preincubation period: 3 days
- Exposure duration: 6 (short-term exposure), 24, 48 h
STAIN (for cytogenetic assays): Giemsa (1.2% for 12 min)
NUMBER OF CELLS EVALUATED: 200
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The frequency of polyploid cells or cells with abnormal structure of each test group were determined according to the criteria of Ishidate. The frequency of occurrence of cells with chromosomal abnormalities was negative (-) for less than 5%, false positive (±) for 5% or more and less than 10%, and positive (+) for 10% or more. Ultimately, it was judged positive when reproducibility or dose dependence was observed.
- Key result
- Species / strain:
- mammalian cell line, other: Chinese hamster lung (CHL) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: insoluble in water, soluble in alcohol, ether, chloroform and acetone
- Precipitation: observed on the slide of continuous exposure high dose group
COMPARISON WITH HISTORICAL CONTROL DATA: this test was valid, since the frequency of chromosomal aberration in positive control was within background data. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results: negative.
The chromosomal aberration induction of docosanoic acid in cultured Chinese hamster cells was judged to be negative under the conditions of this test. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test using the Hprt and xprt genes)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Target gene:
- TK locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 complete medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital (80 mg/kg bw) and beta-naphtoflavone (100 mg/kg bw)
- Test concentrations with justification for top dose:
- Pre-Test:
Experiment 1:
- with and without metabolic activation: 0.5, 2, 4, 6, 8, 10 mM
Experiment 2:
- without metabolic activation. 0.005, 0.05, 0.2, 0.7, 1.3, 2.0 mM
Main Test:
Experiment 1:
- with metabolic activation: 0.70, 0.82, 0.94, 1.06, 1.18, 1.30, 1.42, 1.54 mM
- without metabolic activation. 0.22, 0.46, 0.58, 0.70, 0.82, 0.94, 1.06, 1.18 mM
Experiment 2:
- with metabolic activation: 1.0, 1.12, 1.24, 1.36, 1.48, 1.60, 1.72, 1.84 mM
- without metabolic activation. 0.0005, 0.001, 0.002, 0.005, 0.01, 0.06, 0.18, 0.3 mM - Vehicle / solvent:
- RPMI cell culture medium
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- since medium was used as solvent, no further solvent control was necessary
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- ethylmethanesulphonate
- methylmethanesulfonate
- Remarks:
- S9: methylmethanesulfonate (10 µg/mL, dissolved in 0.9% NaCl); ethylemethanesulphanate (200 and 500 µg/mL, dissolved in medium);
+S9: benzo(a)pyrene (3.5 µg/mL, dissolved in DMSO (1% final concentration in medium)) - Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Experiment 1: 4 h (short-term exposure) with and without metabolic activation
Experiment 2: 4 h (short-term exposure) with metabolic activation and 24 h (long-term exposure) without metabolic activation
- Expression time (cells in growth medium): 3 days (short-term exposure) or 2 days (long-term exposure)
- Selection time (if incubation with a selection agent): 11 - 14 days
- Fixation time (start of exposure up to fixation or harvest of cells): 13 - 18 days
SELECTION AGENT (mutation assays): 5 µg/mL trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; cloning efficiency; mitotic index
OTHER:
Small and large colonies were differentiated, as small colonies are capable to indicate chromosomal mutations - Evaluation criteria:
There are several criteria for a positive result:
- clear and dose-related increase in the mutant frequency
- biologically relevant response (at least a 2-fold increase of mutant frequencies related to the respective negative control values and higher than the historical range of negative controls) for at least one of the dose groups
- combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (slow growth colonies) indicated by a low large/Small colonies ratio (1.5 times the ratio of clastogenic control MMS and/or B[a]P) is an indication for potential clastogenic effects and/or chromosomal aberrations.
The test substance is considered to be negative if there is no biologically relevant increase in the induction of mutant cells above concurrent control levels, at any dose level.- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1.54 mM with metabolic activation and at 1.18 mM without metabolic activation in experiment 1, respectively; at 1.84 mM with metabolic activation and at 0.30 mM without metabolic activataion in experiment 2, respectively.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: within the physiological range
- Effects of osmolality: within the physiological range
- Precipitation: in the pre-test with metabolic activation from concentrations of 4 mM and higher
RANGE-FINDING/SCREENING STUDIES:
All mutant values were found to be within the range of the historical control data of the test facility BSL Bioservice (about 51 to 170 mutants per 10^6 cells)
COMPARISON WITH HISTORICAL CONTROL DATA:
All mutant values were found to be within the range of the historical control data of the test facility BSL Bioservice (about 51 to 170 mutants per 10^6 cells) - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item decanoic acid is considered to be non-mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
Referenceopen allclose all
Colony sizing was performed for the highest concentrations of the test item and for the negative and positive controls. A mutation frequency above 2 in combination with an increased occurrence of small colonies (defined by slow growth and/or morphological alteration of the cell clone), indicated by a low large/small colony ratio (ratio of the clastogenic controls MMS and/or B[a]P with a coefficient of 1.5), is an indication for potential clastogenic effects and/or chromosomal aberrations.
Although in experiment 1 with metabolic activation an increased number of small colonies was noted at doses of 1.30 mM and 1.42 mM (26 and 31 small colonies, respectively, compared to 11 and 9 at control) all dose groups were considered as not clastogenic since no mutagenicity was found at these doses.
All other dose groups in the other experiments were also found not to be clastogenic, respectively.
Table 1: Experiment I - 4 h exposure - With Metabolic Activation
Concentration | Cloning efficiency [%] | Relative Total Growth [%] | Mutants per 1E+06 surviving cells | Mutation factor | Colony Sizing Quotient Large/Small |
0 | 100 | 100 | 86.77 | 1 | 3.66 |
0.7 | 96.63 | 95.51 | 95.86 | 1.10 | -- |
0.82 | 104.12 | 92.71 | 88.56 | 1.02 | -- |
0.94 | 109.36 | 95.60 | 76.43 | 0.88 | -- |
1.06 | 110.11 | 78.73 | 78.58 | 0.91 | -- |
1.18 | 109.36 | 60.06 | 86.55 | 1.00 | -- |
1.30 | 116.10 | 40.14 | 100.88 | 1.16 | 1.77 |
1.42 | 112.36 | 31.61 | 121.24 | 1.40 | 1.55 |
1.54 | 96.63 | 9.84 | 139.92 | 1.61 | 2.78 |
B[a]P, 3.5 µg/mL | 99.63 | 69.03 | 623.89 | 7.19 | 1.24 |
B[a]P: Benzo[a]pyrene
Table 2: Experiment I - 4 h exposure - Without Metabolic Activation
Concentration | Cloning efficiency [%] | Relative Total Growth [%] | Mutants per 1E+06 surviving cells | Mutation factor | Colony Sizing Quotient Large/Small |
0 | 100 | 100 | 79.39 | 1 | 2.75 |
0.22 | 100.33 | 90.09 | 78.53 | 0.99 | -- |
0.46 | 86.38 | 79.76 | 124.63 | 1.57 | -- |
0.58 | 91.03 | 79.70 | 77.88 | 0.98 | -- |
0.70 | 98.34 | 89.53 | 70.89 | 0.89 | -- |
0.82 | 98.34 | 71.30 | 69.28 | 0.87 | -- |
0.94 | 95.02 | 64.50 | 62.74 | 0.79 | 1.60 |
1.06 | 99.00 | 47.66 | 74.59 | 0.94 | 3.17 |
1.18 | 91.69 | 11.04 | 97.49 | 1.23 | 1.12 |
EMS, 500 µg/mL | 86.38 | 62.27 | 1337.77 | 16.85 | -- |
MMS, 10 µg/mL | 85.71 | 66.62 | 841.03 | 10.59 | 0.69 |
EMS: Ethyl methane sulphonate
MMS: Methyl methane sulphonate
Table 3: Experiment II - 4 h Exposure - With Metabolic Activation
Concentration | Cloning efficiency [%] | Relative Total Growth [%] | Mutants per 1E+06 surviving cells | Mutation factor | Colony Sizing Quotient Large/Small |
0 | 100 | 100 | 82.64 | 1.00 | 2.07 |
1 | 96.97 | 85.91 | 82.23 | 1.00 | -- |
1.12 | 101.68 | 89.08 | 61.54 | 0.74 | -- |
1.24 | 98.99 | 86.20 | 86.92 | 1.05 | -- |
1.36 | 99.66 | 83.65 | 75.75 | 0.92 | -- |
1.48 | 90.91 | 64.04 | 118.05 | 1.43 | -- |
1.60 | 96.07 | 35.51 | 70.23 | 0.85 | 2.38 |
1.72 | 91.58 | 38.25 | 84.77 | 1.03 | 2.13 |
1.84 | 98.99 | 19.98 | 98.81 | 1.20 | 4.73 |
B[a]P, 3.5 µg/mL | 86.20 | 60.39 | 829.02 | 10.03 | 0.89 |
B[a]P: Benzo[a]pyrene
Table 4: Experiment II - 24 h exposure - Without Metabolic Activation
Concentration | Cloning efficiency [%] | Relative Total Growth [%] | Mutants per 1E+06 surviving cells | Mutation factor | Colony Sizing Quotient Large/Small |
0 | 100 | 100 | 104.66 | 1 | 2.61 |
0.0005 | 95.24 | 94.64 | 76.34 | 0.73 | -- |
0.001 | 101.36 | 103.58 | 68.22 | 0.65 | -- |
0.002 | 94.56 | 95.29 | 66.56 | 0.64 | -- |
0.005 | 101.36 | 105.73 | 52.63 | 0.50 | -- |
0.01 | 102.04 | 98.98 | 64.06 | 0.61 | -- |
0.06 | 102.72 | 96.75 | 61.54 | 0.59 | 3.30 |
0.18 | 96.60 | 55.56 | 91.91 | 0.88 | 2.24 |
0.30 | 91.16 | 19.77 | 99.26 | 0.95 | 1.94 |
EMS, 200 µg/mL | 70.75 | 34.84 | 2516.55 | 24.05 | -- |
MMS, 10 µg/mL | 59.18 | 27.33 | 2625.00 | 25.08 | 0.81 |
EMS: Ethyl methane sulphonate
MMS: Methyl methane sulphonate
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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