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EC number: 701-215-9 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-Jun-2001 to 18-Sep-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines on Industrial Chemicals
- Version / remarks:
- 1997
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Sodium salts of [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid (5-7 Na:1)
- EC Number:
- 701-216-4
- Molecular formula:
- DTPMP-5Na C9H23N3Na5O15P5 DTPMP-6Na C9H22N3Na6O15P5 DTPMP-7Na C9H21N3Na7O15P5
- IUPAC Name:
- Sodium salts of [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid (5-7 Na:1)
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: CHL/IU (originally derived from female Chinese hamster lung)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle's minimum essential medium
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
- Cells were purchased from Dainippon Pharmaceutical co.
- Cell suspension was mixed with ne tenth volume of DMSO and then frozen and stored in liquid nitrogen. The suspended cells were used after thawing and cultivation through up to 5 passages - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital- and 5,6-benzoflavone-induced male rat liver S9
- Test concentrations with justification for top dose:
- 625-5000 µg mixed sodium salts/ml (pulse treatment)
150-3000 µg mixed sodium salts/ml (24-hour continuous treatment)
50-400 µg mixed sodium salts/ml (48-hour continuous treatment) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: saline
- Justification for choice of solvent/vehicle: solubility of test substance in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without S9, 0.1 µg/ml (pulse treatment), 0.03 µg/ml (continuous treatment)
- Positive control substance:
- mitomycin C
- Remarks:
- Mitomycin was dissolved in saline
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with S9, 15 µg/ml (pulse treatment)
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Benzo(a)pyrene was dissolved Dimethyl Sulfoxide (DMSO)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: pulse treatment 6 hours; continuous treatment, 24 or 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): pulse treatment 24 hours; continuous treatment 24 or 48 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemid, 0.1 µg/ml, 2 hours
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 100 cells /culture, 2 cultures/treatment
DETERMINATION OF CYTOTOXICITY
- Method: other: cell density after crystal violet staining
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes
- Other: mitotic index - Evaluation criteria:
- Negative: both the incidence of aberrant cells (excluding gaps) and that of numerical aberrations <5%
Inconclusive: either of these incidences is 5-10%
Positive: either of these incidences >10%
A cell with at least one structural chromosomal aberration was classified as aberrant cell. The number of aberrant cells was counted in two different ways, one includes cells with no aberration other than gaps and another excludes these types of cells. - Statistics:
- When the test was positive the D20 values were calculated from the test results. The D20 value was the concentration (mg/ml) required to induce any aberration in 20% of metaphases.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- mammalian cell line, other: CHL/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- pulse treatment ( 6 and 24 hour exposure)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=2500 µg mixed sodium salts/ml (pulse treatment),
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- mammalian cell line, other: CHL/IU
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- 48 hour treatment
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=50 µg mixed sodium salts/ml (48-hour continuous treatment)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Water solubility: soluble in water
- Precipitation: no precipitation observed
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES:
- No, but cell survival was evaluated at 156-5000 µg mixed sodium salts/ml (pulse treatment, 24-hour continuous treatment and 48-hour continuous treatment) and the data used to determine the concentrations that were to be evaluated for chromosome aberrations
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cell survival:
- Pulse treatment -S9, µg mixed sodium salts/ml: 156 (109%), 313 (109%), 625 (97%), 1250 (96%), 2500 (76%), 5000 (58%)
- Pulse treatment +S9, µg mixed sodium salts/ml: 156 (98%), 313 (104%), 625 (103%), 1250 (108%), 2500 (102%), 5000 (77%)
- 24-hour continuous treatment -S9, µg mixed sodium salts/ml: 156 (115%), 313 (81%), 625 (47%), 1250 (37%), 2500 (19%), 5000 (0%)
- 48-hour continuous treatment -S9, µg mixed sodium salts/ml: 156 (50%), 313 (25%), 625 (7%), 1250 (5%), 2500 (1%), 5000 (0%)
Any other information on results incl. tables
Full details of the results from the 48 hours treatment (result reported as positive) are not presented in the study report. A graph of the results indicates that the incidence of cells with structural aberrations was 2.5% at 50 µg/ml; 5% at 100; 15% at 150; 37% at 200 and 49% at 300 µg/ml.
Table 1 Chromosome aberration test - treatment time 6 hours
Concentration µg/ml | +/- S9 mix | No. of cells analysed | Chromatid breaks | Chromatid exchanges | No. of cells with aberration (%) | No. of cells with gaps | Cell growth index (%) | Polyploid cells |
Control | - | 200 | 0 | 0 | 0 | 1 | 100 | 0 |
625 | - | 200 | 1 | 0 | 1 | 0 | 98 | 0 |
1250 | - | 200 | 3 | 1 | 4 | 0 | 91 | 0 |
2500 | - | 200 | 6 | 1 | 7 | 4 | 71 | 2 |
5000 | - | 200 | 9 | 1 | 9 | 3 | 41 | 0 |
Positive control | - | 200 | 54 | 121 | 139 | 1 | - | 0 |
Control | + | 200 | 0 | 0 | 1 | 0 | 100 | 0 |
625 | + | 200 | 0 | 2 | 2 | 1 | 91 | 0 |
1250 | + | 200 | 0 | 1 | 1 | 0 | 95 | 0 |
2500 | + | 200 | 3 | 3 | 4 | 0 | 99 | 0 |
5000 | + | 200 | 1 | 0 | 1 | 0 | 67 | 0 |
Positive control | + | 200 | 7 | 42 | 46 | 1 | - | 0 |
Chromosome aberration test - treatment time 24 hours
Concentration µg/ml | +/- S9 mix | No. of cells analysed | Chromatid breaks | Chromatid exchanges | No. of cells with aberration (%) | No. of cells with gaps | Cell growth index (%) | Polyploid cells |
Control | - | 200 | 2 | 0 | 2 | 1 | 100 | 0 |
4.7 | - | 200 | 1 | 1 | 2 | 1 | 101 | 0 |
9.4 | - | 200 | 2 | 0 | 2 | 0 | 102 | 0 |
18.8 | - | 200 | 4 | 0 | 4 | 1 | 104 | 0 |
37.5 | - | 200 | 3 | 2 | 5 | 0 | 107 | 0 |
75 | - | 200 | 2 | 1 | 3 | 3 | 103 | 0 |
150 | - | 200 | 8 | 0 | 8 | 2 | 113 | 0 |
300 | - | - | TOXIC | |||||
Positive control | - | 200 | 30 | 30 | 58 | 0 | - | 0 |
Control | + | 200 | 2 | 0 | 2 | 0 | 100 | 0 |
50 | + | 200 | 4 | 1 | 5 | 0 | 99 | 0 |
100 | + | 200 | 7 | 4 | 11 | 2 | 68 | 0 |
150 | + | 200 | 31 | 9 | 34 | 0 | 57 | 0 |
200 | + | 200 | 67 | 9 | 74 | 1 | 43 | 0 |
300 | + | 200 | 87 | 10 | 97 | 2 | 20 | 0 |
400 | + | - | TOXIC | |||||
Positive control | + | 200 | 47 | 56 | 86 | 0 | - | 0 |
Applicant's summary and conclusion
- Conclusions:
- DTPMP (5-7Na) has been tested for clastogenicity in a valid in vitro mammalian chromosome aberration study in mammalian cell line CHL/IU with and without metabolic activation, conducted according to OECD Test Guideline 473 and in compliance with GLP. A dose-related increase in the number of cells with aberrations was observed after 48 hours treatment, without metabolic activation. No dose-depended increase in the number of cells with aberrations was observed after 6 or 24 hours treatment, with and without metabolic activation. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that DTPMP (5-7Na) is positive for clastogenicity in vitro under the conditions of this test.
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