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EC number: 231-203-4 | CAS number: 7446-26-6
- 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:
- 25 Jan 2016-18 Feb 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dizinc pyrophosphate
- EC Number:
- 231-203-4
- EC Name:
- Dizinc pyrophosphate
- Cas Number:
- 7446-26-6
- Molecular formula:
- H4O7P2.2Zn
- IUPAC Name:
- dizinc(2+) (phosphonooxy)phosphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment (plate incorporation method): 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg/plate with and without metabolic activation
Second experiment (preincubation method): 31.6, 100, 316, 1000, 3160 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 0.05 M HCl
- Justification for choice of solvent/vehicle: The test item was not soluble in any of the solvents recommended: water, dimethylsulfoxide (DMSO), ethanol or acetone, but was completely soluble at 3.16 mg/mL 0.05 M HCl in preliminary solution tests. For concentrations lower than or equal to 316 μg/plate, the test item was completely dissolved. For concentrations of 1000, 3160 and 5000 μg/plate the test material was suspended in 0.05 M HCl solution.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.05 M HCl
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 2 replications each in 2 independent experiements
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn. Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the vehicle control and/or a scarce background lawn. - Evaluation criteria:
- A test item is considered to show a positive response if:
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537, and 1.5-fold of the solvent control for TA102 in both independent experiments.
- in addition, a significant (p ≤ 0.05) concentration (log value)-related effect (Spearman's rank correlation coefficient) is observed.
- positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
Biological relevance of the results should be considered first. A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the AMES test. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the top concentration of 5000 μg/plate in all test strains
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test material precipitation was noted in all experiments at concentrations of 3160 and 5000 μg/plate.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
- Negative (solvent/vehicle) historical control data:
Negative Reference Item
Strain TA 98 TA 100 TA 102 TA 1535 TA 1537
S9-mix -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9
Mean 29.9 31.3 148.5 149.2 275.5 279.8 19.4 19.2 6.4 6.5
SD 5.7 5.9 18.1 18.2 15.5 16.2 4.4 4.4 1.8 1.9
Min 19 14 103 106 240 245 10 8 2 0
Max 49 49 191 195 319 319 34 42 10 10
Positive Reference Item
Strain TA 98 TA 100 TA 102 TA 1535 TA 1537
S9-mix -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9
2-nitro- Benzo[a] Sodium 2-amino- Mitomycin Benzo[a] Sodium 2-amino- 9-amino- Benzo[a]
fluorene pyrene azide anthracene C pyrene azide anthracene acridine pyrene
Mean 148.4 147.3 928.7 937.9 1014.6 1008.9 133.2 133.3 81.1 81.5
SD 33.6 33.7 107.8 99.8 121.4 109.5 28.9 29.5 28.8 28.9
Min 91 91 463 703 756 757 51 49 26 28
Max 305 315 1209 1181 1637 1571 220 271 178 189
Any other information on results incl. tables
Dizinc pyrophosphate
EXPERIMENT 1(Standard Plate Test, SPT) |
|||||
S9-Mix |
Without |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA 100 |
TA 102 |
TA 1535 |
TA 98 |
TA 1537 |
|
VC |
135.0±9.2 |
268.3±5.5 |
17.3±1.5 |
31.7±6.1 |
5.7±1.5 |
31.6 |
149.3±3.5 |
264.7±3.8 |
14.3±0.6 |
31.3±8.3 |
4.0±0.0 |
100 |
167.7±9.0 |
263.0±1.0 |
16.3±1.5 |
29.7±4.9 |
7.0±1.7 |
316 |
150.7±20.8 |
267.0±1.0 |
16.7±1.5 |
32.7±4.9 |
4.7±1.5 |
1000 |
126.3±7.6 |
276.7±9.5 |
15.0±1.0 |
32.7±1.5 |
6.7±3.5 |
3160 |
164.7±13.3 |
268.0±7.8 |
15.0±1.0 |
30.7±7.1 |
5.0±1.0 |
5000 |
17.3±4.0 |
21.7±1.5 |
6.3±1.5 |
9.0±1.0 |
1.3±0.6 |
PC (mg/plate) |
NaN3(10) |
MMC (10) |
NaN3(10) |
2NF (10) |
AAC (100) |
916.3±10.7 |
1018.3±9.5 |
143.3±1.5 |
177.0±3.0 |
51.70±3.1 |
|
S9-Mix |
With |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA 102 |
TA 1535 |
TA98 |
TA1537 |
|
VC |
149.7±3.8 |
251.7±1.5 |
22.0±0.0 |
36.0±2.6 |
6.0±1.0 |
31.6 |
166.3±10.2 |
259.0±0.0 |
18.0±0.0 |
29.0±2.0 |
6.7±3.1 |
100 |
145.7±9.0 |
270.7±9.2 |
17.3±1.5 |
32.0±3.6 |
5.3±1.5 |
316 |
142.3±8.1 |
297.0±19.1 |
14.7±0.6 |
25.7±3.8 |
6.0±1.0 |
1000 |
134.7±7.6 |
253.7±5.5 |
16.0±2.6 |
27.3±6.0 |
5.7±1.5 |
3160 |
150.0±14.0 |
256.3±3.2 |
16.0±2.6 |
24.7±3.1 |
6.0±1.0 |
5000 |
27.3±5.7 |
24.7±6.4 |
5.7±1.2 |
8.0±1.0 |
1.0±0.0 |
PC (mg/plate) |
AAN (2) |
B[a]P (10) |
AAN (2) |
B[a]P (10) |
B[a]P (10) |
878.0±37.6 |
1022.3±26.3 |
141.7±1.2 |
177.0±2.0 |
52.7±3.1 |
VC = Vehicle control; PC = Positive control
NaN3= Sodium azide
2NF = 2-Nitrofluorene
MMC = Mitomycin C
AAC = 9-Aminoacridine
AAN = 2-Aminoanthracene
B[a]P = Benzo[a]pyrene
EXPERIMENT 2(Standard Plate Test with Incubation) |
|||||
S9-Mix |
Without |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA 102 |
TA 1535 |
TA98 |
TA1537 |
|
VC |
145.0±20.0 |
281.7±23.5 |
21.7±8.1 |
23.7±2.1 |
8.3±0.6 |
31.6 |
155.7±4.9 |
254.7±1.2 |
20.0±1.7 |
28.3±1.5 |
6.3±0.6 |
100 |
141.0±21.1 |
254.3±2.1 |
18.3±0.6 |
27.0±3.5 |
5.7±1.5 |
316 |
138.3±15.5 |
282.3±22.8 |
16.0±1.7 |
27.7±3.2 |
8.3±1.2 |
1000 |
151.7±4.9 |
260.7±15.6 |
15.0±1.0 |
25.3±3.2 |
6.0±1.7 |
3160 |
135.7±12.4 |
268.0±2.6 |
22.3±5.9 |
26.3±1.2 |
6.3±0.6 |
5000 |
32.0±10.5 |
104.70±3.5 |
6.3±1.2 |
8.3±1.5 |
1.3±0.6 |
PC (mg/plate) |
NaN3(10) |
MMC (10) |
NaN3(10) |
2NF (10) |
AAC (100) |
974.3±62.3 |
991.7±2.5 |
114.3±11.7 |
186.7±14.3 |
68.0±0.0 |
|
S9-Mix |
With |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA 102 |
TA 1535 |
TA98 |
TA1537 |
|
VC |
166.3±2.5 |
295.0±4.0 |
18.0±2.0 |
28.7±0.6 |
7.7±2.1 |
31.6 |
135.0±11.3 |
278.0±3.0 |
15.7±0.6 |
30.7±3.1 |
9.0±1.0 |
100 |
138.7±9.3 |
267.3±13.2 |
16.0±1.0 |
27.0±1.0 |
6.7±2.9 |
316 |
142.3±23.1 |
255.7±2.1 |
20.3±3.1 |
25.3±0.6 |
7.0±1.7 |
1000 |
126.3±14.5 |
270.0±26.9 |
15.7±0.6 |
25.7±6.0 |
7.3±2.5 |
3160 |
141.0±7.2 |
270.3±7.8 |
15.7±2.5 |
34.3±0.6 |
4.3±0.6 |
5000 |
32.3±3.5 |
93.3±2.1 |
7.3±1.2 |
8.3±0.6 |
1.7±0.6 |
PC (mg/plate) |
AAN (2) |
B[a]P (10) |
AAN (2) |
B[a]P (10) |
B[a]P (10) |
935.0±69.4 |
1026.0±72.5 |
133.0±24.3 |
185.0±6.0 |
64.3±0.6 |
VC = Vehicle control; PC = Positive control
NaN3= Sodium azide
2NF = 2-Nitrofluorene
MMC = Mitomycin C
AAC = 9-Aminoacridine
AAN = 2-Aminoanthracene
B[a]P = Benzo[a]pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: the test material dizinc pyrophosphate is negative for mutagenicity (non-mutagenic) with and without metabolic activation.
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