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EC number: 237-415-3 | CAS number: 13776-88-0
- 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 gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26/08/2014 - 04/12/2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- Performed in 2014. This study is now covered by the OECD 490 guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Version / remarks:
- Guideline was not available in 2014 when the study was performed
- GLP compliance:
- yes
- Type of assay:
- other: gene mutation in mammalian cells
Test material
- Reference substance name:
- Aluminium metaphosphate
- EC Number:
- 237-415-3
- EC Name:
- Aluminium metaphosphate
- Cas Number:
- 13776-88-0
- Molecular formula:
- Al.3HO3P
- IUPAC Name:
- aluminium metaphosphate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: C08567A
- Expiration date of the lot/batch: 23/01/2016
- Analytical purity: >95%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature 15-25°C
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: sterilised via gamma irradiation
FORM AS APPLIED IN THE TEST (if different from that of starting material)
In suspension
Method
- Target gene:
- Thymidine kinase (Tk1)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Bayer Schering Pharma AG cell line L5178Y TK+/- 3.7.2C
- Suitability of cells: Appropriate cells used in accordance with the guideline
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Cell culture medium (RPMI 1640) containing 10% v/v horse serum. 5% CO2.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 5 mg/l
1 mg/ml
0.2 mg/ml
0.04 mg/ml
0.008 mg/ml
0.0016 mg/ml
0.00032 mg/ml
Top dose is recommended by OECD GL 476. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: cell culture medium (RPMI 1640) containing 10% v/v horse serum
- Justification for choice of solvent/vehicle: medium is not suspected of chemical reaction with the test substance and is compatible with the survivial of the cells and the S9 activity.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
- Cell density at seeding (if applicable): 0.5 x 1E6/ml
DURATION
- Exposure duration: 3 hours (first test) 4 hours (confirmatory test)
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent):11-14 days (with TFT)
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: cloning efficiency
- Any supplementary information relevant to cytotoxicity: cloning for cloning effeciency was performed after the exposure time (CE1) and after the expression period (CE2).
CE1: each treated cell culture was diluted to 8 cells/ml = 1.6 cells per well with RPMI 1640 containing 20% v/v HS and cultivated in a humidified incubator with 5% CO2 in air at 37±1°C for 7 days.
CE2: An aliquot of each treated cell culture was diluted to 8 cells/ml - 1.6 cells per well with RPMI 1640 + 20% v/v HS and cultivated in a humidifier incubator with 5% CO2 in air at 37±1°C for 7 days. - Rationale for test conditions:
- Testing was performed in accordance with the guideline.
- Evaluation criteria:
- The cloning efficiency (CE) of cells and the spontaneous mutation frequency (MF) of negative controls should be within their limit valuesL CE ≥ 50%; MF (negative control) 50-300 x 10E-6.
The MF of positive controls should be increased 2x or more than the MF in corresponding negative controls in each experiment. - Statistics:
- Not specified
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight precipitations were seen in all test material concentrations ehich did not influence the results of the assay.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH did not change during the study
Mutation frequencies were determined from the number of wells without colonies, without big colonies(≥1/4 of well diameter, large and diffuse morphology), without small colonies (≤1/4 of the well diameter, compact morphology). A significant increase in mutation frequencies (2 x higher than the corresponding negative controls) was only found in positive controls.
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:
CE1:
Negative control (-S9): Min 0.88 - Max 1.25 (mean 0.84). SD: 0.15 Number of studies = 5
Negative control (+S9): Min 0.87 - Max 1.05 (mean 0.87). SD: 0.09 Number of studies = 5
Positive control (-S9): Min 0.63 - Max 1.01 (mean 1.04). SD: 0.14 Number of studies = 5
Positive control (+S9): Min 0.80 - Max 1.00 (mean 0.99). SD: 0.13 Number of studies = 5
CE2:
Negative control (-S9): Min 0.90 - Max 1.22 (mean 0.86). SD: 0.17 Number of studies = 5
Negative control (+S9): Min 0.93 - Max 1.24 (mean 0.85). SD: 0.16 Number of studies = 5
Positive control (-S9): Min 0.61 - Max 1.08 (mean 1.16). SD: 0.27 Number of studies = 5
Positive control (+S9): Min 0.73 - Max 1.12 (mean 1.06). SD: 0.11 Number of studies = 5
MF (big and small colonies):
Negative control (-S9): Min 61.13 - Max 115.14 (mean 676.57). SD: 168.46 Number of studies = 5
Negative control (+S9): Min 99.47 - Max 116.59 (mean 685.85). SD: 133.27 Number of studies = 5
Positive control (-S9): Min 496.35 - Max 900.51 (mean 94.05). SD: 19.75 Number of studies = 5
Positive control (+S9): Min 547.86 - Max 866.44 (mean 107.86). SD: 7.52 Number of studies = 5
Any other information on results incl. tables
MF (main test):
|
MF |
|
Big colonies |
Small colonies |
|
Negative control (-S9) |
109.93 |
64.38 |
Negative control (+S9) |
124.78 |
68.03 |
Positive control (-S9) |
329.11 |
1854.44 |
Positive control (+S9) |
313.13 |
501.96 |
Concentration 1 (-S9) |
106.04 |
87.39 |
Concentration 1 (+S9) |
113.14 |
100.13 |
Concentration 2 (-S9) |
115.50 |
88.29 |
Concentration 2 (+S9) |
124.31 |
65.67 |
|
MF |
|
Big colonies |
Small colonies |
|
Negative control (-S9) |
96.68 |
51.93 |
Negative control (+S9) |
76.79 |
39.62 |
Positive control (-S9) |
358.67 |
719.25 |
Positive control (+S9) |
205.27 |
419.71 |
Concentration 3 (-S9) |
91.98 |
48.45 |
Concentration 3 (+S9) |
93.99 |
70.05 |
Concentration 4 (-S9) |
93.11 |
44.58 |
Concentration 4 (+S9) |
102.78 |
46.75 |
MF confirmatory test
|
MF |
|
Big colonies |
Small colonies |
|
Negative control (-S9) |
94.33 |
72.65 |
Negative control (+S9) |
94.09 |
81.38 |
Positive control (-S9) |
443.45 |
1571.21 |
Positive control (+S9) |
195.30 |
227.77 |
Concentration 1 (-S9) |
79.73 |
58.03 |
Concentration 1 (+S9) |
99.79 |
57.48 |
Concentration 2 (-S9) |
92.75 |
70.09 |
Concentration 2 (+S9) |
118.78 |
52.94 |
Concentration 3 (-S9) |
88.45 |
58.94 |
Concentration 3 (+S9) |
102.01 |
59.38 |
Concentration 4 (-S9) |
104.23 |
58.96 |
Concentration 4 (+S9) |
111.06 |
62.99 |
The variability of the MF of all tested concentrations are as a result of biological variance of the test system and displayed not significant increase.
The presence of S9 had no effect on the results.
The distribution of smal and big colonies showed neither chromosome nor gene mutations.
Applicant's summary and conclusion
- Conclusions:
- Aluminium metaphosphate did not cause genotoxic reactions in L5178Y mouse lymphoma cells with and without metabolic activation.
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