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EC number: 947-318-4 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 February 2017 - 30 March 2017
- 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 (incl. QA statement)
- Remarks:
- d.d. 3 November 2015
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium hydrogen 2-octadecenylsuccinate
- EC Number:
- 296-086-4
- EC Name:
- Potassium hydrogen 2-octadecenylsuccinate
- Cas Number:
- 92218-39-8
- Molecular formula:
- C22H40O4.K
- IUPAC Name:
- hydrogen potassium 2-octadec-1-en-1-ylsuccinate
- Test material form:
- solid
- Details on test material:
- Name as cited in report: X-19924
Appearance: thick amber paste
Storage: at room temperature
Constituent 1
- Specific details on test material used for the study:
- Purity correction factor: 1.138
Stability at higher temperatures: stable at a maximum temperature of 60°C for a maximum duration of 30 minutes
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
Preliminary test (without and with 5% S9-mix) TA100 and WP2uvrA: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate
Main study:
TA1535, TA1537 and TA98: without and with 5% S9-mix: 0.54, 1.7, 5.4, 17, 52, 164 and 512 µg/plate
Experiment 2:
TA1535, TA1537, TA98 and TA100: without and with 10% S9-mix: 12.5, 25, 50, 100, 200 and 400 µg/plate
WP2uvrA: without and with 10% S9-mix: 400, 878, 1568, 2800 and 5000 µg/plate
Additional:
TA1537: without S9-mix: 1.56, 3.13, 6.25, 12.5, 25 and 50 µg/plate
WP2uvrA: with 10% S9-mix: 400, 878, 1568 and 2800 µg/plate - Vehicle / solvent:
- - Vehicle used: dimethyl sulfoxide (DMSO)
- Justification for choice of vehicle: DMSO has been accepted and approved by authorities and international guidelines. A solubility test was performed based on visual assessment. the test item was dissolved in dimethyl sulfoxide. The stock solution was treated with ultrasonic waves until the test item had completely dissolved.
Analysis of test item in vehicle for concentration, stability, homogeneity was not performed, however, to limit the impact, the test item preparation was performed with approved procedures and documented in detail. Formulations were visually inspected for homogeneity prior to use and all formulations were used within 1.5 hours after adding vehicle to the test item.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9; 5 µg/plate in saline for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Remarks:
- without S9; 2.5 µg/plate in DMSO for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene
- Remarks:
- without S9; 10 µg/plate in DMSO for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9; 650 µg/plate in DMSO for TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9; 10 µg/plate in DMSO for WP2uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- in DMSO; 2.5 μg/plate for TA1535 (5% + 10% S9-mix) and TA1537 (5% S9-mix); 5 μg/plate for TA1537 (10% S9-mix); 1 μg/plate for TA98 (5% + 10% S9-mix) and TA100 (5% S9-mix); 2 μg/plate for TA100 (10% S9-mix); 15 μg/plate for WP2uvrA (5% + 10% S9-mix).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 ± 4 hour
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.
Since in the second mutation assay in tester strain TA98 in the presence of S9-mix, no toxicity and no precipitate on the plates was observed at the highest dose levels tested, an additional mutation experiment was performed. In addition, not enough non-toxic dose levels were present in the tester strain TA1537 in the absence of S9-mix, therefore this tester strain was also tested in the additional experiment. - Rationale for test conditions:
- A dose-range finding test was performed and the highest concentration of the test item used in the subsequent mutation assay was 5000 μg/plate or the level at which the test item inhibited bacterial growth.
- Evaluation criteria:
- ACCEPTABILITY CRITERIA
A Salmonella typhimurium reverse mutation assay and/or Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
a) The vehicle control and positive control plates from each tester strain (with or without S9-mix) must exhibit a characteristic number of revertant colonies when compared against relevant historical control data generated at Charles River Den Bosch.
b) The selected dose-range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
c) No more than 5% of the plates are lost through contamination or some other unforeseen event. If the results are considered invalid due to contamination, the experiment will be repeated.
INTERPRETATION
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in the tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent vehicle control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent vehicle control.
b) The negative response should be reproducible in at least one follow-up experiment.
A test substance is considered positive if:
a) The total number of revertants in the tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent vehicle control, or the total number of revertants in tester strains TA1535, TA1537, TA98 is greater than three (3) times the concurrent vehicle control.
b) In case a follow up 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:
- No formal hypothesis testing was done.
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:
- 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
- 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
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test item on the plates was not observed at the start of the incubation period in any tester strain. At the end of the incubation period the test item precipitated at 5000 μg/plate in the dose range finding study only.
RANGE-FINDING/SCREENING STUDIES:
- In tester strain TA100, toxicity was observed at dose levels of 164 μg/plate and above in the absence and presence of S9-mix. In tester strain WP2uvrA no toxicity was observed up to and including 5000 μg/plate in the absence and presence of S9-mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- 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.
HISTORICAL CONTROL DATA
- Positive historical control data:
TA1535 TA1537 TA98
S9-mix - + - + - +
Range 125 - 1381 78 - 1058 55 – 1311 55 – 1051 410 – 1995 250 - 1907
Mean 828 218 686 376 1270 883
SD 151 109 320 142 338 340
n 1875 1829 1560 1716 1766 1851
TA100 WP2uvrA
S9-mix - + - +
Range 554 – 1848 408 - 2651 112 – 1951 85 - 1359
Mean 892 1352 1165 388
SD 174 342 488 152
n 1820 1857 1506 1557
- Negative (solvent/vehicle) historical control data:
TA1535 TA1537 TA98
S9-mix - + - + - +
Range 5 - 36 3 - 32 3 – 23 3 – 23 8 - 41 9 - 52
Mean 12 12 6 8 16 23
SD 5 4 3 4 5 7
n 1865 1862 1740 1715 1852 1912
TA100 WP2uvrA
S9-mix - + - +
Range 66 - 156 65 - 154 10 – 56 9 - 69
Mean 100 100 25 31
SD 15 16 6 7
n 1853 1877 1571 1583
ADDITIONAL INFORMATION ON CYTOTOXICITY:
TA1535: without S9: 52 µg/plate and above; with 5% S9: 164 µg/plate and above; with 10% S9: 400 µg/plate and above
TA1537: without S9: 50 µg/plate and above; with 5%S9: 164 µg/plate and above; with 10% S9: 400 µg/plate and above
TA98: without S9: 164 µg/plate and above; with 5% S9: 512 µg/plate and above; with 10% S9: 878 µg/plate and above
TA100: without S9: 100 µg/plate and above; with 5% S9: 164 µg/plate and above; with 10% S9: 400 µg/plate and above
WP2uvrA: toxicity was observed up to and including 5000 µg/plate
Applicant's summary and conclusion
- Conclusions:
- In an AMES test, performed according to OECD 471 guideline and in accordance with GLP principles, X-19924 was found not to be mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose. - Executive summary:
In an AMES test, performed according to OECD 471 guideline and in accordance with GLP principles, X-19924 was found not to be mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
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