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EC number: 237-997-9 | CAS number: 14154-09-7
- 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
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:
- 2015-02-25 to 2015-06-23
- 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:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- yes
- Remarks:
- historical control data incomplete (benzo(a)pyrene data missing; positive control data not clearly labelled); Preliminary results missing; strain charac. confirmations not fully described. Proficiency of the lab not comparable with other laboraotries.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trimanganese bis(orthophosphate)
- EC Number:
- 237-997-9
- EC Name:
- Trimanganese bis(orthophosphate)
- Cas Number:
- 14154-09-7
- Molecular formula:
- Mn3O8P2
- IUPAC Name:
- trimanganese bis(orthophosphate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation: pink solid powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature 15 - 25 °C
Method
- Target gene:
- TA1537: his C 3076
TA98: his D 3052
TA1535 & TA100: his G 46
E. coli WP2 uvrA: trp-
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (containing 10 % S9)
- Test concentrations with justification for top dose:
- Main test (preincubation method): 0.313, 0.625, 1.25, 2.5, and 5 mg/plate (with and without metabolic activation)
Confirmatory test (plate incorporation method): 0.313, 0.625, 1.25, 2.5, and 5 mg/plate (with and without metabolic activation)
In preliminary tests the highest concentration was determined considering the criteria solubility and cytotoxicity. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: this medium is not suspected of chemical reaction with the test substance and is compatible with the survival of the bacteria and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene / daunomycin
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191 acridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation (main test) and in agar (plate incorporation, confirmatory test);
MAIN TEST (preincubation with and without metabolic activation)
The test solution (0.1 mL) was preincubated with the test strain (0.1 mL, containing approx. 10E8 viable cells) and sterile buffer or the metabolic activation system (0.5 mL) for 20 minutes at 30 °C - 37 °C prior to mixing with the overlay agar (2.0) mL. Tubes were aerated during the pre-incubation by using a shaker.
The content of each tube was poured over the surface of a minimal agar plate. This overlay agar was allowed to solidify before incubation.
After a period of incubation (about 48 - 72 hours, 37 ± 1 °C) revertant colonies were counted and compared with the number of spontaneous revertants in an untreated and/or solvent control culture.
The bacterial colonies were counted using the photo system "Argus X1/Total Lab-software".
CONFIRMATORY TEST (plate incorporation with and without metabolic activation)
For the test without metabolic activation 0.1 mL of the test solutions, 0.1 mL of fresh bacterial culture and 0.5 mL of sterile buffer were mixed with the overlay agar.
For the assay with metabolic activation 0.5 mL of S9 mixture was mixed with the overlay agar (2.0 mL), together with the bacteria and test solution.
The content of each tube was mixed and poured over the surface of a minimal agar plate.
This overlay agar was allowed to solidify before incubation.
After a period of incubation (about 48 - 72 hours, 37 ± 1 °C) revertant colonies were counted and compared with the number of spontaneous revertants in an untreated and/or solvent control culture.
NUMBER OF REPLICATIONS: triplicate plating was used at each dose level
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
A preliminary experiment was conducted to determine cytotoxicity and solubility of the test substance. Starting with the test material concentration of 5 mg/plate and subsequent serial dilutions (ratio 1:2) following concentrations of test material were applied: 5, 2.5, 1.25, 0.625, 0.313, and 0.156 mg/plate on two bacteria strains (TA 98 and TA 1535) with different mutation type (frameshift and base-pair substitution) with and without metabolic activation. The highest concentration of that solution was chosen for the main test that caused low cytotoxicity and / or where the precipitate did not interfere with the scoring according to OECD 471. - Rationale for test conditions:
- A preliminary experiment was conducted to determine cytotoxicity and solubility of the test substance. The highest concentration of that solution was chosen for the main test that caused low cytotoxicity and / or where the precipitate did not interfere with the scoring according to OECD 471.
- Evaluation criteria:
- A 2 or 2.5-fold increase in the number of revertant colonies/plate over the background (spontaneous revertant frequency) is used as a criterion to distinguish active mutagens from non-mutagenic materials (MOLTOX Salmonella Mutagenicity Test Kit Instruction Manual, 2014). The presence of dose response is a further criterion for mutagenic materials.
- Statistics:
- Means of individual plate counts (triplicates) were calculated for test solutions and controls.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: slight precipitations were seen in all test material concentrations which did not influeunce the results of the assay.
MAIN TEST (preincubation)
No genotoxic activity caused by the test material was detected under the described test conditions. In addition, a presence of test dose response was not detected.
Please also refer to the field "Attached background material" below.
CONFIRMATORY TEST (plate incorporation)
No genotoxic activity caused by the test material was detected under the described test conditions. In addition, a presence of test dose response was not detected.
Please also refer to the field "Attached background material" below.
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:
The colony counts of negative and positive controls are in the dimensions of historical data and fulfil the requirements according to the MOLTOX Salmonella Mutagenicity Test Kit Instruction Manual (positive control frequencies are at least 2 times of negative control counts (spontaneous frequency)). The results of negative and positive controls confirm the sensitivity and accuracy of the test system.
Please also refer to tables 1 to 3 in the field "Any other information on results incl. tables" below.
Any other information on results incl. tables
Table 1: Historical data of colonies per plate (negative control preparations without metabolic activation)
Strain |
MIN |
MAX |
MEAN |
SD |
N |
TA98 |
13 |
54 |
29 |
16 |
5 |
TA100 |
62 |
246 |
112 |
78 |
5 |
TA1535 |
7 |
28 |
14 |
8 |
5 |
TA1537 |
3 |
8 |
5 |
2 |
4 |
WP2uvrA |
10 |
17 |
14 |
3 |
4 |
Table 2: Historical data of colonies per plate (negative control preparations with metabolic activation)
Strain |
MIN |
MAX |
MEAN |
SD |
N |
TA98 |
21 |
65 |
38 |
19 |
5 |
TA100 |
63 |
232 |
108 |
70 |
5 |
TA1535 |
8 |
20 |
11 |
5 |
5 |
TA1537 |
3 |
6 |
5 |
1 |
4 |
WP2uvrA |
10 |
20 |
15 |
5 |
4 |
Table 3: Historical data of colonies per plate (positive control preparations)
Strain |
Chemical |
MIN |
MAX |
N |
TA98 |
2-Aminoanthracene |
135 |
> 1000 |
5 |
Daunomycin |
198 |
> 500 |
5 |
|
TA100 |
2-Aminoanthracene |
326 |
> 500 |
5 |
Sodium Azide |
274 |
> 500 |
5 |
|
TA1535 |
2-Aminoanthracene |
67 |
> 300 |
5 |
Sodium Azide |
83 |
> 300 |
5 |
|
TA1537 |
2-Aminoanthracene |
107 |
210 |
4 |
ICR 191 Acridine |
82 |
2010 |
4 |
|
WP2uvrA |
2-Aminoanthracene |
309 |
407 |
4 |
4-Nitroquinoline-1-oxide |
839 |
1419 |
4 |
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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