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EC number: 700-903-6 | CAS number: 255830-15-0
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-02-22 to 1994-05-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- experiment was not repeated to confirm negative result, exposure period without metabolic activation 20 hours
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate
- EC Number:
- 700-903-6
- Cas Number:
- 255830-15-0
- Molecular formula:
- C3H7K5NO10P3
- IUPAC Name:
- pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate
- Details on test material:
- - Name of test material (as cited in study report): Briquest 3010-25K; Potassium salt of N-oxide nitrilotris(methylene phosphonic acid)
- Substance type: solution of monoconstituent substance
- Physical state: pale straw-coloured liquid
- Analytical purity: 40%
- Storage condition of test material: room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: peripheral human
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 - induced rat liver S9
- Test concentrations with justification for top dose:
- 393.75-1575 µg/ml (without metabolic activation), 787.5-3150 µg/ml (with metabolic activation). This is equivalent to an active acid content of approximately 250-1000 500-2000 µg/ml and 500-2000 µg/ml.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water. Hepes buffer was added to maintain pH balance.
- Justification for choice of solvent/vehicle: none given in report.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation: 500 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- without metabolic activation: 25 µg/ml
- Details on test system and experimental conditions:
- ACTIVATION: Aroclor induced rat liver S9 mix included NADP, G6P, KCl and MgCl₂ in Phosphate buffer, final concentration S9 mix in cultures was 1%
METHOD OF APPLICATION: in medium;
DURATION
- Preincubation period:
- Exposure duration: 4 hours (with metabolic activation),
- Expression time (cells in growth medium): 16 hours (with metabolic activation),
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours
SPINDLE INHIBITOR (cytogenetic assays): demecolcine (2 h before harvest)
STAIN (for cytogenetic assays): Giesma
NUMBER OF REPLICATIONS: duplicate cultures for each dose level
NUMBER OF CELLS EVALUATED: 100 well-spread metaphases from each culture were scored for gaps, breaks or rearrangements. 2000 lymphocyte cell nuclei were counted and the number of cells in metaphase recorded and expressed as mitotic index and percentage of vehicle control values.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; other: percentage of vehicle control values
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: no - Evaluation criteria:
- A positive response was recorded if the percentage of cells with aberrations markedly exceeded the concurrent vehicle control. For modest increases a dose-response relationship is generally required.
- Statistics:
- Fisher's exact test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: peripheral human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1575 µg/ml (without metabolic activation)
- 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: pH was controlled with buffer
- Effects of osmolality: not recorded
COMPARISON WITH HISTORICAL CONTROL DATA: The vehicle control cultures gave values of aberrations within the range of historical controls.
Any other information on results incl. tables
Results of Chromosome Aberration Assay
Test material: BRIQUEST 3010-25K
Harvest time: 20 hours
Treatment Group |
Replicate Identification |
No. of Cells Scored |
Total Gaps |
Chromatid |
Chromosome |
Others |
Total Aberrations |
Aberrant Cells |
Mean Mitotic Index |
||||
Breaks |
Exchanges |
Breaks |
Exchanges |
X |
(+Gaps) |
(-Gaps) |
(+Gaps) |
(-Gaps) |
|||||
Without Metabolic Activation |
|||||||||||||
Solvent Control |
Total |
200 |
3 |
1 |
0 |
0 |
0 |
0 |
4 |
7 |
4 |
1 |
8.05 |
393.75 (µg/ml) |
Total |
192 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
6.15 |
787.5 (µg/ml) |
Total |
200 |
3 |
0 |
0 |
0 |
1 |
0 |
4 |
1 |
4 |
1 |
4.73 |
1575 (µg/ml) |
Total |
200 |
1 |
0 |
0 |
1 |
0 |
0 |
2 |
1 |
2 |
1 |
3.25 |
Positive Control EMS 500 (µg/ml) |
Total |
200 |
30 |
41 |
0 |
14 |
0 |
0 |
85 |
55 |
57*** |
38*** |
4.58 |
With Metabolic Activation |
|||||||||||||
Solvent Control |
Total |
200 |
3 |
2 |
0 |
0 |
0 |
0 |
5 |
2 |
5 |
2 |
5.05 |
787.5 (µg/ml) |
Total |
200 |
4 |
0 |
0 |
1 |
0 |
0 |
5 |
1 |
5 |
1 |
4.15 |
1575 (µg/ml) |
Total |
200 |
4 |
2 |
0 |
0 |
0 |
0 |
6 |
2 |
6 |
2 |
4.15 |
3150 (µg/ml) |
Total |
200 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
4.03 |
Positive Control CP 25 (µg/ml) |
Total |
200 |
24 |
13 |
1 |
4 |
0 |
1 |
42 |
18 |
30*** |
17*** |
1.70 |
X = > 10 aberrations per cell (not included in total aberrations)
*** = p < 0.001
Applicant's summary and conclusion
- Conclusions:
- In an in vitro cytogenicity / chromosome aberration study in mammalian cells, ATMP-N-oxide-xK was tested according to OECD TG 473 and in compliance with GLP. No increase in the number of cells with aberrations was observed when peripheral human lymphocytes were tested up to cytotoxic concentrations. Exposure lasted for 4 hours in the presence of metabolic activation and for 20 hours in the absence of metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of the test.
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