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EC number: 239-018-0 | CAS number: 14940-41-1
- 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:
- weight of evidence
- Study period:
- 2015-12-15 to 2016-01-14
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2014-05-14
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triiron bis(orthophosphate)
- EC Number:
- 239-018-0
- EC Name:
- Triiron bis(orthophosphate)
- Cas Number:
- 14940-41-1
- Molecular formula:
- Fe.2/3H3O4P or Fe3(PO4)2
- IUPAC Name:
- triiron bis(orthophosphate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation: light grey powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +10°C to +25°C, in a tightly closed container and store in a cool, dry and well-ventilated place.
Method
- Target gene:
- TA1537: his C 3076
TA98: his D 3052
TA1535 & TA100: his G 46
TA102: his G428
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:
- S9-mix (containing 5 % S9): 0.4 M MgCl2 + 1.65 M KCl salt solution (2 mL); glucose-6-phosphate (141.0 mg); NADP (306.5 mg; phosphate buffer (pH 7.4; 50 mL); fill up to a total of 100.0 mL with sterile aqua ad iniectabilia
- Test concentrations with justification for top dose:
- Plate incorporation test: 31.6, 100, 316, 1000, 3160, and 5000 µg/plate (with and without metabolic activation)
Preincubation test: 31.6, 100, 316, 1000, 3160, and 5000 µg/plate (with and without metabolic activation)
The test concentrations were chosed based on a preliminary cytotoxicity test, which indicted no cytotoxicity up to a concentration of 5000 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 0.05 M HCl solution
- Justification for choice of solvent/vehicle: the test item was not soluble in any of the solvents recommended: water, dimethylsulfoxide (DMSO), ethanol or acetone. The test item was completely soluble at 100 μg/mL 0.05 M HCl solution. Hence, the test item was suspended in 0.05 M HCl solution for concentrations of 31.6, 100, 316, 1000, 3160, or 5000 μg/plate. For concentrations lower than 10.0 μg/plate, which were used in the preliminary cytotoxicity test, the test item was completely dissolved. Fresh preparations of the test item were used for the treatment in all experimental parts.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.05 M HCl solution
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation; independent experiment 1) and preincubation (independent experiment 2)
MAIN EXPERIMENT (two independent experiments with and without metabolic activation)
1) plate incorporation method (independent experiment 1)
2 mL of top agar were distributed into culture tubes. 0.1 mL of Salmonella cell suspension (containing approximately 10^8 viable cells in the late exponential or early stationary phase) 0.1 mL of test item (or 0.1 mL solvent or 0.1 mL positive control) and 0.5 mL of S9 mix were added to these culture tubes. In the assay without metabolic activation, the S9 mix was substituted with 0.5 mL phosphate buffer.
The test components were mixed and then poured onto a minimal glucose agar plate (Minimal Glucose Agar medium E).
The plates were inverted and placed in a dark 37°C incubator for 48 to 72 hours. The revertant colonies on the test plates and on the control plates were counted with a colony counter.
2) Preincubation method (independent experiment 2)
The test item was preincubated with the test strain (containing approximately 10^8 viable cells in the late exponential or early stationary phase) and sterile buffer (0.5 mL) or the metabolic activation system (0.5 mL) for 20 minutes at 37°C prior to mixing with the overlay agar and pouring onto the surface of a minimal agar plate. 0.1 mL of test item (or 0.1 mL solvent or 0.1 mL positive control), 0.1 mL of bacteria, and 0.5 mL of S9 mix or sterile buffer, were mixed with 2 mL of overlay agar. Tubes were aerated during preincubation by using a shaker. The remaining steps were the same as described for the plate incorporation method.
NUMBER OF REPLICATIONS: 3 replicates for each experimental point
DETERMINATION OF CYTOTOXICITY
Prior to the main test two preliminary cytotoxicity tests (plate incorporation test, with and without metabolic activation) were carried out in test strain TA100. The following concentrations were tested: 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160, and 5000 µg/plate - Rationale for test conditions:
- The test concentrations were chosen based on a preliminary cytotoxicity test, which indicted no cytotoxicity up to a concentration of 5000 µg/plate. Precipitation was observed for a concentration of 1000 µg/plate and higher.
- 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:
- U-test according to MANN and WHITNEY and Spearman’s rank correlation coefficient
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA98, TA100, TA102, TA1535, and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- please refer to the field "Additional information on results" below
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- please refer to the field "Additional information on results" below
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
- test item precipitation was noted at concentrations of 1000 to 5000 μg/plate in both experiments.
- no signs of cytotoxicity were noted.
MAIN STUDY (2 independent experiments)
1) Test-specific confounding factors:
- Precipitation: test item precipitation was noted in both experiments, each carried out without and with metabolic activation, at concentrations of 1000 μg/plate and higher in all test strains.
2) Cytotoxicity:
- cytotoxicity (reduction of the number of revertants by more than 50%) was noted in both experiments with metabolic activation in test strain TA1537 at 5000 μg/plate.
3) Genotoxicity:
- no increase in revertant colony numbers as compared with control counts was observed for the test item in any of the two independent experiments without and with metabolic activation.
- positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
Please also refer to the field "Attached background material" below.
HISTORICAL CONTROL DATA
- Positive historical control data / Negative (solvent/vehicle) historical control data: please refer to Table 1 in the field "Any other information on results incl. tables" below.
Any other information on results incl. tables
Table 1: History profile of negative and positive control values of the years 2013 to 2015 (n=83 studies) - Data obtained from plate incorporation and preincubation tests
Negative Reference Item
Strain S9-Mix |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
-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 S9-Mix |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
2-nitrofluorene |
Benzo [a] pyrene |
Sodium azide |
2-aminoanthracene |
Mitomycin C |
Benzo [a] pyrene |
Sodium azide |
2-amino-anthracene |
9-amino-acridine |
Benzo [a] 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 |
Applicant's summary and conclusion
- Conclusions:
- The substance tested non-mutagenic under the conditions of the study.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance should not be considered to have a mutagenic potential.
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