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EC number: 946-968-6 | 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
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 29 August 2016 - 05 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ω-hydroxy fatty acid methyl esters, C16 (saturated and unsaturated) alkyl and fatty acid methyl esters, C16 (unsaturated) alkyl
- EC Number:
- 943-164-7
- Molecular formula:
- A generic molecular formula cannot be given for this UVCB substance.
- IUPAC Name:
- ω-hydroxy fatty acid methyl esters, C16 (saturated and unsaturated) alkyl and fatty acid methyl esters, C16 (unsaturated) alkyl
- Test material form:
- solid
- Details on test material:
- Identification: (w-hydroxy) fatty acid methyl esters and (w-hydroxy) fatty acids
Appearance: Brown solid (at 2-8°C)
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
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 with Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1 (direct plate assay):
Preliminary test (without and with S9) TA100 and WP2uvrA: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000μg/plate
Main study: TA1535, TA1537 and TA98:
Without and with S9-mix: 52, 164, 512, 1600 and 5000 μg/plate
Experiment 2 (pre-incubation assay):
Without and with S9-mix: 52, 164, 512, 1600 and 5000 μg/plate
Experiment 3 (pre-incubation assay):
TA1535, TA1537 and TA100, without S9-mix: 5.4, 17, 52, 164 and 512 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: A solubility test was performed. The test item was dissolved in dimethyl sulfoxide. In the dose range finding test and the third mutation experiment the test item was heated up to a maximum of 62.0°C with a maximum of 45 minutes before use.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191, 2.5 μg/plate in DMSO for TA1537 (direct plate assay)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO; 1 μg/plate for TA98 and TA100 (direct plate assay), 2.5 μg/plate for TA1535 and TA1537, 5 μg/plate for TA100 (pre-incubation assay) and 15 μg/plate for WP2uvrA.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION: Exposure duration = 48 hours; Preincubation period = 30 minutes
NUMBER OF REPLICATIONS: Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
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.
OTHER EXAMINATIONS: The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 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 follow up experiment. - Statistics:
- Statistical analysis not performed
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- in the pre-incubation assay
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle 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:
- 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
- Remarks:
- in the pre-incubation assay without S9-mix
- Vehicle 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
- Remarks:
- in the pre-incubation assay
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Dose range finding test: Precipitation of the test item on the plates was observed at the start of the incubation period at concentrations of 512 μg/plate and upwards in both tester strains and at 5000 μg/plate at the end of the incubation period in tester strain WP2uvrA only.
First mutation experiment: Precipitation of the test item on the plates was observed at the start of the incubation period at concentrations of 512 μg/plate and upwards and at 5000 μg/plate at the end of the incubation period for all three tester strains. In addition, precipitation at the end of the incubation period was also observed at the concentration of 1600 μg/plate in tester strain TA1535 (absence of S9-mix).
Second mutation experiment: Precipitation of the test item on the plates was observed at the start of the incubation period at concentrations of 512 μg/plate and upwards and at 5000 μg/plate at the end of the incubation period.
Third mutation experiment: Precipitation of the test item on the plates was not observed at the start or at the end of the incubation period in any tester strain.
RANGE-FINDING/SCREENING STUDIES:
In the dose range finding study, the test item was initially tested up to concentrations of 5000 μg/plate in the tester strains TA100 and WP2uvrA in the direct plate assay. Precipitation of the test item on
the plates was only observed in tester strain WP2uvrA at the top dose level of 5000 μg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.
HISTORICAL CONTROL DATA
The negative and strain-specific positive control values were within the testing laboratory's historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Positive historical control data:
TA1535; TA1537; TA98
S9-mix: -; +; -; +; -; +
Range: 78 - 1381; 78 - 1058; 55 - 1565; 55 – 1112; 410 - 2057; 263 - 1907
Mean: 785; 228; 653; 387; 1155; 860
SD: 167; 105; 290; 143; 370; 323
n: 1684; 1662; 1448; 1536; 1646; 1686
TA100; WP2uvrA
S9-mix: - + - +
Range: 549 – 1848 620 - 2651 127 – 1951 85 - 1390
Mean: 892 1404 1263 342
SD: 178 327 461 165
n: 1650 1677 1370 1410
Negative (solvent/vehicle) historical control data:
TA1535; TA1537; TA98; TA100; WP2uvrA
S9-mix: -; +; -; +; -; +; -; +; -; +
Range: 4 - 36; 3 - 34; 3 - 25; 3 - 28; 9 - 50; 9 - 57; 63 - 153; 60 - 156; 12 - 68; 12 - 70
Mean: 14; 13; 7; 9; 17; 25; 100; 103; 26; 32
SD: 6; 5; 3; 4; 5; 7; 16; 18; 7; 8
n: 1662; 1677; 1548; 1547; 1662; 1703; 1659; 1691; 1421; 1424
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between 31 May 2014 - 31 May 2016.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- First mutation experiment: Cytotoxicity, as evidenced by a decrease in the number of revertants, was only observed in tester strain TA1537 in the absence and presence of S9-mix.
- Second mutation experiment: In tester strain WP2uvrA, no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed. In tester strain
TA98, a slight reduction of the bacterial background lawn was observed at the top dose of 5000 μg/plate in the absence of S9-mix only and no biologically relevant decrease in the number of revertants was observed. In the tester strains TA1535, TA1537 and TA100, reductions of the bacterial background lawn and decreases in the number of revertants were observed in the absence and presence of S9-mix.
- Third mutation experiment: Cytotoxicity, as evidenced by a reduction of bacterial background lawn and/or a decrease in the number of revertants, was observed in all three tester strains.
Applicant's summary and conclusion
- Conclusions:
- In an AMES test, performed according to OECD 471 guideline and GLP principles, (w-hydroxy) fatty acid methyl esters and (w-hydroxy) fatty acids was found not to be mutagenic with or without metabolic activation.
- Executive summary:
An AMES test was performed according to OECD 471 guideline and GLP principles. The first experiment was a direct plate asaay and the second experiment a pre-incubation assay. All bacterial strains showed negative responses up to 5000 μg/plate, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was seen. Precipitation of the test item on the plates was observed at 5000 μg/plate at the end of the incubation period. In the first experiment, cytotoxicity, as evidenced by a decrease in the number of revertants, was only observed in tester strain TA1537 in the absence and presence of S9-mix. In the second experiment, toxicity was observed in all Salmonella strains except for tester strain WP2uvrA. No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed. 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.
Based on the results of this study it is concluded that (w-hydroxy) fatty acid methyl esters and (w-hydroxy) fatty acids is not mutagenic in the Salmonella typhimurium reverse mutation assay or in the Escherichia coli reverse mutation assay with or without metabolic activation.
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