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EC number: 231-837-1 | CAS number: 7758-23-8
- 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 Feb - 9 Jul 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pentacalcium hydroxide tris(orthophosphate)
- EC Number:
- 235-330-6
- EC Name:
- Pentacalcium hydroxide tris(orthophosphate)
- Cas Number:
- 12167-74-7
- Molecular formula:
- Ca5HO13P3
- IUPAC Name:
- tricalcium diphosphate
- Reference substance name:
- tricalcium phosphate
- IUPAC Name:
- tricalcium phosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Method
- Target gene:
- his operon (S. typhimurium strains)
trp operon (E. coli strain)
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- First and second experiment: 313, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: the vehicle is not suspected of chemical reaction with the test substance and is compatible with the survival of the bacteria and the S9 activity
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- with and without metabolic activation
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene, ICR 191 acridine, daunomycin
- Remarks:
- -S9: sodium azide, 1.5 µg/plate, TA100, TA1535; ICR 191 acridine, 1 µg/plate, TA1537; daunomycine, 6 µg/plate, TA98; 4-nitroquinoline-1-oxide, 2 µg/plate, E. coli; +S9: 2-aminoanthracene, 10 or 50 µg/plate, all strains; B(a)P, 20 µg/plate, TA98, TA100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: preincubation; experiment 2: in agar (plate incorporation)
DURATION
- Preincubation period: 20 min (experiment 1)
- Exposure duration: 48 - 72 h (incubation period, experiment 1 and 2)
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn - Evaluation criteria:
- A 2 or 2.5 fold increase in the number of revertant colonies per plate over the background (spontaneous revertant frequency) is used as a criterion to distinguish active mutagens from non-mutagenic materials. The presence of dose-response is a further criterion for mutagenic materials.
- Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: slight precipitation was noted at all concentration levels in all strains, however, this did not interfere with the scoring.
RANGE-FINDING/SCREENING STUDIES: A range-finding study was performed to determine the cytotoxicity and solubilty of the test substance. TA 98 and TA 100 were tested at concentrations of 156, 313, 625, 1250, 2500 and 5000 µg/plate, with and without metabolic activation. The highest concentration that showed low cytotoxicity and/or for which precipitation did not interfere with the scoring, was selected as the highest concentration in the main study.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes. Incidentally the mean results fell outside the range of the historical negative and positive control values. In these cases the scores fell within the standard deviation of the mean value.
Any other information on results incl. tables
Table 1: Experiment 1
EXPERIMENT 1 (preincubation test) |
|||||
S9-mix |
Without |
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
Vehicle control |
17 ± 4 |
83 ± 2 |
13 ± 6 |
5 ± 4 |
17 ± 2 |
313 |
18 ± 4 |
71 ±7 |
12 ± 5 |
5 ± 3 |
14 ± 4 |
625 |
16 ± 4 |
77 ± 8 |
13 ± 3 |
4 ± 1 |
16 ± 2 |
1250 |
21 ± 6 |
86 ± 7 |
11 ± 3 |
4 ± 1 |
15 ± 4 |
2500 |
18 ± 3 |
84 ± 4 |
7 ± 3 |
5 ± 3 |
22 ± 9 |
5000 |
18 ± 4 |
91 ± 3 |
10 ± 1 |
6 ± 1 |
21 ± 6 |
DNM |
925 ± 180 |
- |
- |
- |
- |
SA |
- |
388 ± 24 |
383 ± 42 |
- |
- |
4NQO |
- |
- |
- |
- |
1337 ± 236 |
ICR 191 |
- |
- |
- |
2096 ± 59 |
- |
S9-mix |
With |
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
Vehicle control |
23 ± 7 |
76 ± 3 |
7 ± 2 |
6 ± 2 |
20 ± 5 |
313 |
21 ± 5 |
84 ± 18 |
9 ± 3 |
8 ± 1 |
17 ± 2 |
625 |
22 ± 3 |
87 ± 15 |
13 ± 2 |
6 ± 1 |
12 ± 6 |
1250 |
15 ± 2 |
83 ± 21 |
5 ± 1 |
5 ± 1 |
15 ± 4 |
2500 |
22 ± 5 |
84 ± 4 |
8 ± 3 |
6 ± 4 |
16 ± 3 |
5000 |
22 ± 4 |
91 ± 3 |
7 ± 2 |
5 ± 1 |
13 ± 2 |
2AA |
1991 ± 26 |
1377 ± 24 |
52 ± 8 |
138 ± 26 |
291 ± 16 |
B(a)P |
173 ± 12 |
667 ± 71 |
- |
- |
- |
Vehicle control = distilled water DNM: daunomycine SA: sodium azide 4NQO: 4-nitroquinoline-N-oxide ICR191: ICR 191 acridine 2AA: 2-aminoanthracene B(a)P: benzo(a)pyrene |
Table 2: Experiment 2
EXPERIMENT 2 (direct incorporation test) |
|||||
S9-mix |
Without |
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
Vehicle control |
10 ± 3 |
80 ± 14 |
7 ± 3 |
13 ± 6 |
17 ± 2 |
313 |
14 ± 4 |
76 ± 4 |
7 ± 2 |
9 ± 4 |
14 ± 4 |
625 |
15 ± 3 |
76 ± 8 |
8 ± 2 |
11 ± 5 |
16 ± 2 |
1250 |
13 ± 2 |
80 ± 8 |
8 ± 3 |
10 ± 5 |
15 ± 4 |
2500 |
17 ± 6 |
80 ± 14 |
7 ± 1 |
8 ± 3 |
22 ± 9 |
5000 |
15 ± 5 |
82 ± 6 |
9 ± 2 |
7 ± 2 |
21 ± 6 |
DNM |
713 ± 293 |
- |
- |
- |
- |
SA |
- |
381 ± 15 |
278 ± 131 |
- |
- |
4NQO |
- |
- |
- |
- |
1337 ± 236 |
ICR 191 |
- |
- |
- |
97 ± 17 |
- |
S9-mix |
With |
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
Vehicle control |
17 ± 3 |
88 ± 7 |
8 ± 3 |
7 ± 3 |
14 ± 5 |
313 |
18 ± 4 |
70 ± 10 |
9 ± 2 |
5 ± 3 |
16 ± 5 |
625 |
17 ± 1 |
90 ± 9 |
9 ± 2 |
10 ± 2 |
19 ± 2 |
1250 |
20 ± 2 |
62 ± 20 |
5 ± 3 |
6 ± 2 |
16 ± 3 |
2500 |
21 ± 5 |
71 ± 6 |
6 ± 2 |
9 ± 3 |
21 ± 3 |
5000 |
18 ± 2 |
75 ± 9 |
7 ± 2 |
5 ± 2 |
19 ± 4 |
2AA |
2057 ± 88 |
1024 ± 197 |
41 ± 6 |
96 ± 22 |
506 ± 26 |
B(a)P |
203 ± 8 |
509 ± 39 |
- |
- |
- |
Vehicle control = distilled water DNM: daunomycine SA: sodium azide 4NQO: 4-nitroquinoline-N-oxide ICR191: ICR 191 acridine 2AA: 2-aminoanthracene B(a)P: benzo(a)pyrene |
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test.
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