Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation including read-across information form structural related source substances, Phosphoric acid, C12-18-alkyl esters, potassium salts does not need to be classified for germ cell mutagenicity according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Link to relevant study records
- 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
- 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
- Target gene:
- Histidine locus
- 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. - 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.
- 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 - 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.
- 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
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Available data from Phosphoric acid, dodecyl ester, potassium salt were used to evaluate the clastogenic potential of Phosphoric acid, C12-18-alkyl esters, potassium salts. Phosphoric acid, dodecyl ester, potassium salt is considered to be non-clastogenic in a chromosome aberration test according to OECD guideline 473.
Based on a read-across approach there is no evidence of a clastogenic potential for Phosphoric acid, C12-18-alkyl esters, potassium salts based on information from Phosphoric acid, dodecyl ester, potassium salt. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Available data from an OECD 476 guideline study with Phosphoric acid, dodecyl ester, potassium salt were used to evaluate the mutagenicity in mammalian cells of Phosphoric acid, C12-18-alkyl esters, potassium salts. Phosphoric acid, dodecyl ester, potassium salt is considered to be non-mutagenic in HPRT locus using V79 cells of the Chinese Hamster.
Based on a read-across data there is no evidence of a mutagenic potential in mammalian cells for Phosphoric acid, C12-18-alkyl esters, potassium salts based on information from Phosphoric acid, dodecyl ester, potassium salt.
Referenceopen allclose all
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In-vitro studies
Gene mutation in bacteria
Phosphoric acid, C12-18 alkyl esters, potassium salts
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/plate
Experiment 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).
Phosphoric acid, C12-18 alkyl esters, potassium salts is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Phosphoric acid, dodecyl ester, potassium salt
In a reverse gene mutation assay in bacteria according to OECD guideline 471 the potential of Phosphoric acid, dodecyl ester, potassium salt to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA was evaluated.
The assay was performed in two independent experiments both with and without liver microsomal activation at concentrations up to 5000 µg/plate. Toxic effects occurred in all strains at higher concentrations.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with at any dose level, neither in the presence nor absence of metabolic activation. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
Mammalian cell gene mutation assay
Phosphoric acid, dodecyl ester, potassium salt
In an in vitro gene mutation study in mammalian cells according to OECD guideline 476 Phosphoric acid, dodecyl ester, potassium salt was assessed for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese Hamster. Experiment I with and without metabolic activation and experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as 20 h long time exposure assay.
The test item was investigated at the following concentrations:
Experiment I
without metabolic activation: 50, 100,250,500,750, 1000, 1250, 1500 and 2000 µg/ml,
with metabolic activation: 50, 100,250,500, 750, 1000, 1250 and 1500 µg/ml.
Experiment II
without metabolic activation: 7.5,10,25,50,75,100,125,150 and 175 µg/ml,
with metabolic activation: 150,200,300,600,800, 1000, 1200 and 1400 μg/mL
Biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation. In both experiments no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). No dose-response relationship was observed.
DMBA and EMS were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
In conclusion, under the experimental conditions reported, Phosphoric acid, dodecyl ester, potassium salt is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
Chromosome Aberration:
Phosphoric acid, dodecyl ester, potassium salt
In an in vitro chromosome aberration assay, Phosphoric acid, dodecyl ester, potassium salt was investigated for the potential to induce structural chromosomal aberrations in Chinese hamster V79 cells in the absence and presence of metabolic activation with S9 homogenate.
The chromosomes were prepared 20 h after start of treatment with the test item. The treatment intervals were 4 h with and without metabolic activation (experiment I) and 4 h with and 20 h without metabolic activation (experiment II). Two parallel cultures were set up. At least 200 metaphases per concentration were scored for structural chromosomal aberrations.
The following concentrations were selected for microscopic analysis:
Experiment I:
without metabolic activation: 15 .6, 250, 500 and 1000 µg/mL
with metabolic activation: 15.6, 500, 1000 and 1500 µg/mL
Experiment II:
without metabolic activation: 15.6, 31.3, 62.5 and 125.0 µg/mL
with metabolic activation: 900, 1600 and 1800 µg/mL
Precipitation of the test item was observed with and without metabolic activation in both experiments.
Toxic effects of the test item were observed in experiment I without metabolic activation at concentrations of 500 µg/mL and higher, with metabolic activation at concentrations of 1000 µg/mL and higher. In experiment II (long time exposure) without metabolic activation toxic effects of the test item were observed at concentrations of 62.5 µg/mL and higher, with metabolic activation at concentrations of 1600 µg/mL and higher.
In both experiments, no biologically relevant increase of the aberration rates was noted after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control.
No biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item in neither of the experiments.
Positive controls induced distinct and biologically relevant increases in cells with structural chromosomal aberrations.
Phosphoric acid, dodecyl ester, potassium salt is considered to be non-clastogenic in this chromosome aberration test.
Justification for read-across
Evaluation of structure-activity relationship is based on data from structural similar substances with the same basic structure, salts of phosphoric acid alkyl ester, varying mainly in the chain length of fatty acid moiety. A detailed justification document for the read-across is attached in the respective target records of IUCID.
Conclusion
Negative data from gene mutation studies in bacteria were available for the target substance Phosphoric acid, C12-18 alkyl esters, potassium salts and the source substancePhosphoric acid, dodecyl ester, potassium salt.
Information from in-vitro mammalian cell gene mutation assays fromPhosphoric acid, dodecyl ester, potassium salt, indicates no mutagenic potential.
Further data from in-vitro chromosome aberration assay are available for Phosphoric acid, dodecyl ester, potassium salt, no statistically significant increase in aberration frequency was noted.
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation, including those form the structurally closely related read-across substances Phosphoric acid, dodecyl ester, potassium salt,Phosphoric acid, C12-18 alkyl esters, potassium saltsis considered to be non-mutagenic in mammalian cells.
Justification for classification or non-classification
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation including read-across information form a structural related source substance, Phosphoric acid, C12-18-alkyl esters, potassium salts does not need to be classified for germ cell mutagenicity according to CLP, EU GHS (Regulation (EC) No 1272/2008).
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.