Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 291-905-1 | CAS number: 90506-43-7
- 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:
- 2017-07-07 to 2017-07-28
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1997)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phosphoric acid, C12-18-alkyl esters, potassium salts
- EC Number:
- 291-905-1
- EC Name:
- Phosphoric acid, C12-18-alkyl esters, potassium salts
- Cas Number:
- 90506-43-7
- Molecular formula:
- Not applicable for UVCB substance
- IUPAC Name:
- Phosphoric acid, C12-18-alkyl esters, potassium salts
- Test material form:
- solid - liquid: suspension
Constituent 1
Method
- Target gene:
- Histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
TA 98: 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
TA 100: 0.3; 1; 3; 10; 33; 100; 333; and 1000 µg/plate
all remaining strains: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Precipitation was observed from 333 to 5000 µg/plate in Experiment I and from 1000 to 5000 µg/plate in Experiment II. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 4-NOPD -TA 1537 and TA 98; 2-aminoanthracene, 2-AA With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) experiment I and the pre-incubation test (experiment II)
- Cell density at seeding (if applicable): (10E8-10E9 cells/mL).
DURATION
- Preincubation period: 60 min at 37 °C
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: three plates/strain/concentration
- Evaluation criteria:
- The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce an increase above the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control
- a minimum of five analysable dose levels should be present with at least three dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5.
A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Precipitation: yes
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 µg/plate in Experiment I and from 1000 to 5000 µg/plate in Experiment II.
HISTORICAL CONTROL DATA
- Positive historical control data:
- Negative (solvent/vehicle) historical control data:
Strain without S9 mix with S9 mix
Mean SD Min Max Mean SD Min Max
Solvent control 12 2.5 6 25 12 2.5 7 26
TA 1535 Untreated control 12 3.1 6 28 12 2.9 7 26
Positive control 1130 143.1 334 1816 388 58.2 176 668
Solvent control 10 2.2 6 19 13 3.5 7 30
TA1537 Untreated control 11 2.7 5 21 14 4.0 7 31
Positive control 82 12.7 43 157 191 60.8 83 434
Solvent control 25 4.4 13 43 34 6.2 15 58
TA 98 Untreated control 27 4.9 12 43 37 6.5 11 57
Positive control 378 73.7 211 627 3949 771.8 360 6586
Solvent control 156 26.0 78 209 148 32.3 73 208
TA 100 Untreated control 176 23.6 79 217 172 25.4 85 218
Positive control 1966 293.2 498 2767 3798 830.4 536 6076
Solvent control 41 5.6 27 63 50 6.8 28 72
WP2 uvrA Untreated control 42 5.8 30 63 52 6.8 36 88
Positive control 798 362.7 319 4732 378 112.6 167 1265
Mean = mean value of revertants/plate
SD = standard deviation
Min = minimal value/Max = maximal value
Any other information on results incl. tables
In Experiment II in strain TA 1537 with S9 mix the positive control did not reach the lower limit of the historical control data. Since the deviation is rather small (82±8 colonies vs. 83) and the threshold of thrice the number the corresponding solvent control was exceeded by far (induction factor of 8.2) the test was considered to be valid.
Applicant's summary and conclusion
- Conclusions:
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Phosphoric acid, C12-18 alkyl esters, potassium salts at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix).
Phosphoric acid, C12-18 alkyl esters, potassium salts is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 21 July 1997), Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA were exposed to Phosphoric acid, C12-18 alkyl esters, potassium salts in water at the following concentrations in the absence and presence of mammalian metabolic activation (rat liver S9 mix):
Experiment I 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
TA 98: 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
TA 100: 0.3; 1; 3; 10; 33; 100; 333; and 1000 µg/plate
all remaining strains: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plateExperiment I was conducted using the plate incorporation method, experiment II using the pre-incubation method.
The test substance was tested up to cytotoxic concentrations. Toxic effects were observed in all strains with and without metabolic activation, based on reduced number of spontaneous revertants.
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 µg/plate in Experiment I and from 1000 to 5000 µg/plate in Experiment II.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Phosphoric acid, C12-18 alkyl esters, potassium salts at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Phosphoric acid, C12-18 alkyl esters, potassium salts is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
