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EC number: 276-470-8 | CAS number: 72208-20-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non mutagenic in bacterial reverse mutation assay (Ames test).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from July 7 to August 26, 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2000)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Standard plate test
1) TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA: 0, 60, 300, 1500, 7500, 15000 µg/plate.
2) TA 100: 0, 200, 400, 600, 800, 1000 µg/plate
3) TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA: 0, 1000, 2000, 3000, 4000 and 5000 µg/plate.
Preincubation test
4) TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA: 0, 30, 100, 300, 1000, 3000 µg/plate.
5) TA 100: 0, 500, 1000, 1500, 2000, 2500 µg/plate. - Vehicle / solvent:
- - Vehicle: water.
- Justification for choice of solvent/vehicle: good solubility of test substance in water. - Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene, 4-nitro-o-phenylendiamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation method
Test tubes containing 2-mI portions of soft agar (overlay agar, i.e. 100 ml agar (0.8 % agar + 0.6 % NaCI) and 10 ml amino acid solution (minimal aminoacid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at about 42 - 45 °C, and the remaining components are added in order:
0.1 ml test solution or vehicle
0.1 ml fresh bacterial culture
0.5 ml S9 mix (in tests with metabolic activation)
or
0.5 ml phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within ca. 30 seconds.
Composition of the minimal glucose agar for Salmonella Typhimurium:
980 ml aqua dest.
20 ml Vogel-Bonner E medium
15 g Difco bacto agar
20 g D-glucose, monohydrate.
After incubation at 37 °C for 48 - 72 hours in the dark, the bacterial colonies (his+ revertants) are counted.
Composition of the minimal glucose agar for Escherichia coli:
300 ml solution B (agar)
100 ml solution A (saline solution)
8 ml solution C (glucose solution)
10 ml solution D (casein solution)
After incubation at 37 °C for 48 - 72 hours in the dark, the bacterial colonies (trp+ revertants) are counted.
METHOD OF APPLICATION: preincubation test
0.1 ml test solution or vehicle, 0.1 ml bacterial suspension and 0.5 ml S9 mix or phosphate buffer are incubated at 37 °C for the duration of about 20 minutes using a shaker. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the agar plates within ca. 30 seconds.
After incubation at 37 °C for 48 - 72 hours in the dark, the bacterial colonies are counted. - Evaluation criteria:
- The test substance is considered positive in this assay if a dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either with or without S9 mix, is noted.
A test substance is generally considered nonmutagenic in this test if the number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in standard plate test (from 3000 µg/plate), in preincubation test (from 1000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- precipitation: no test substance precipitation was found. As long as precipitation does not interfere with the colony scoring, 5 mg/plate is selected and analysed (if not toxic) as the maximum dose.
COMPARISON WITH HISTORICAL CONTROL DATA: at non cytotoxic levels, test results are in the range of historical control data, except for TA 100 strain with metabolic activation. Further investigation on ths specific strain did not confirm this results, which was then considered as accidental.
ADDITIONAL INFORMATION ON CYTOTOXICITY
- bacteriotoxic effect (reduced his- and trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in titer) was observed in the standard plate test depending on the strain and test conditions from about 3000 to 5000 µg/plate onward.
- in preincubation assay, batteriotoxicity (reduced his- and trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in titer) was obserevd depending on the strain and test conditions at doses ≥ 1000 µg/plate. - Conclusions:
- Under these experimental conditions, the substance is not a mutagenic agent in bacterial reverse mutation assay with Salmonella typhimurium and Escherichia coli strains. The occasionally observed slight increase in the number of revertant colonies using TA 100 with S9 mix both in the standard plate test and in the preincubation assay could not be confirmed in additional studies and is therefore regarded as incidental and not as indication of a point mutagenic activity of test substance.
- Executive summary:
Method
Bacterial reverse mutation assay (Ames test) with Salmonella typhimurium (TA 1535, TA 100, TA 1537 and TA 98) and Escherichia coli (WP2 uvrA) without or with metabolic activation (S9 mix). Two methods were used for the assays: standard plate and preincubation methods. Water was used as vehicle due to the high solubility of test substance in water. In standard plate test, doses ranged between 60 and 15000 µg/plate; in preincubation test, doses were between 30 and 3000 µg/plate. Solvent controls, sterility controls and positive controls were used.
Results
Based on negative responses under test conditions, the substance is considered as non mutagenic. Indeed the number of revertant colonies was found to be within historical control ranges. Depending on strain and test conditions, from ca. 3000 - 5000 µg/plate onward the substance was cytotoxic in the standard plate test, while at doses ≥ 1000 µg/plate the substance showed cytotoxicity in preincubation test. Slight increase in revertant colonies using TA 100 with S9 mix was not confirmed in further studies with this strain; therefore, it was considered as accidental.
Reference
Standard plate test
historical data | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA |
without S9-mix | 11-25 | 82-155 | 6-16 | 17-44 | 25-51 |
with S9-mix | 12-25 | 88-156 | 6-19 | 20-49 | 25-56 |
µg/plate | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA | |||||
without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | |
0 | 18 | 17 | 111 | 112 | 12 | 13 | 28 | 43 | 34 | 40 |
60 | 18 | 16 | 106 | 168 | 13 | 8 | 28 | 45 | 36 | 46 |
300 | 18 | 16 | 105 | 212 | 11 | 15 | 26 | 44 | 40 | 43 |
1500 | 15 | 18 | 103 | 170 | 9 | 15 | 30 | 35 | 40 | 44 |
7500 | 2 | 2 | 13 | 11 | 0 | 2 | 4 | 13 | 14 | 18 |
15000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 5 |
µg/plate | TA 100 |
with S9-mix | |
0 | 112 |
200 | 152 |
400 | 138 |
600 | 150 |
800 | 149 |
1000 | 119 |
µg/plate | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA | |||||
without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | |
0 | 18 | 19 | 103 | 124 | 10 | 12 | 31 | 38 | 36 | 38 |
1000 | 17 | 20 | 111 | 130 | 11 | 9 | 28 | 38 | 32 | 41 |
2000 | 17 | 21 | 105 | 147 | 11 | 8 | 26 | 36 | 34 | 39 |
3000 | 13 | 22 | 62 | 78 | 4 | 6 | 23 | 39 | 35 | 33 |
4000 | 7 | 19 | 14 | 30 | 1 | 2 | 17 | 22 | 29 | 26 |
5000 | 1 | 8 | 9 | 10 | 0 | 1 | 8 | 12 | 21 | 18 |
Preincubation test
historical data | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA |
without S9-mix | 13 -25 | 90 -160 | 5 -19 | 18 -44 | 25-54 |
with S9-mix | 11-25 | 92 -159 | 6 -20 | 17 -50 | 25-59 |
µg/plate | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA | |||||
without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | without S9-mix | with S9-mix | |
0 | 17 | 17 | 118 | 111 | 10 | 13 | 29 | 36 | 35 | 43 |
30 | 18 | 17 | 110 | 145 | 12 | 10 | 24 | 30 | 47 | 36 |
100 | 16 | 17 | 100 | 144 | 8 | 9 | 24 | 41 | 40 | 35 |
300 | 15 | 14 | 118 | 137 | 9 | 11 | 31 | 28 | 42 | 35 |
1000 | 9 | 20 | 29 | 189 | 3 | 4 | 13 | 30 | 22 | 42 |
3000 | 0 | 10 | 0 | 56 | 0 | 3 | 0 | 20 | 7 | 23 |
µg/plate | TA 100 |
with S9-mix | |
0 | 111 |
500 | 136 |
1000 | 131 |
1500 | 110 |
2000 | 99 |
2500 | 88 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data on the substance in itself (phosphate salification) was available, thus a read across approach was followed, using data on a different salification (acetate). Details on the read across are available in section 13.
Bacterial reverse mutation test (AMES test) was conducted with five different strains, namely TA 1535, TA 1537, TA98 and TA100 of Salmonella typhimurium and WP2 uvrA of Escherichia coli, according to OECD guideline 471 (1997), using standard plate and preincubation methods.
No genotoxic effects, evident as substantial increase in revertant colony numbers of any of the tester strains, were seen following treatment with substance at any dose level, neither in presence nor in absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations.
Cytotoxic effects, evident as a reduction in the number of revertants, were seen at high concentrations (3000 - 5000 µg/plate onward in standard plate test and 1000 µg/plate onward in preincubation test) with and without metabolic activation, depending on the strain.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), a mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known.
The more general terms ‘genotoxic’ and ‘genotoxicity’ apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non- physiological manner (temporarily) alter its replication.
For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories:
Category 1: substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.
Category 1A: based on positive evidence from human epidemiological studies.
Category 1B: based on:
- positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or
- positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells.
- positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.
Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans, based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
- somatic cell mutagenicity tests in vivo, in mammals; or
- other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays
Based on negative result in the available study, relying on a read across approach, a mutagenic potential to bacteria was excluded for Basic Red 014 phosphate.
Accordingly, the substance is not classified under the CLP Regulation (EC 1272/2008).
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