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EC number: 614-406-6 | CAS number: 68308-61-2
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-04-01 to 2008-04-17
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- esterification products of castor oil and polyphosphoric acids
- EC Number:
- 614-406-6
- Cas Number:
- 68308-61-2
- Molecular formula:
- C57H107P3O18
- IUPAC Name:
- esterification products of castor oil and polyphosphoric acids
- Reference substance name:
- Polyphosphoric acids, esters with caster oil
- IUPAC Name:
- Polyphosphoric acids, esters with caster oil
- Details on test material:
- - Name of test material (as cited in study report): GARDO TP10451
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: 2939R
- Expiration date of the lot/batch: 2010-02-18
Constituent 1
Constituent 2
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- => his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA 1535, TA 100) and frameshift (TA 1537, TA 98) mutations. The Escherichia coli WP2 uvrA (trp) reversion system measures trp– => trp+ reversions. The Escherichia coli WP2 uvrA detect mutagens that cause other base-pair substitutions (AT to GC).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9 mix.
- Test concentrations with justification for top dose:
- The test concentratoins were: 5000; 1581.1; 500; 158.1; 50 and 15.81 µg/plate
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation; Strain S. typhimurium: TA 100; TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation; Strain S. typhimurium: TA 1537
Migrated to IUCLID6: 9AA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation; Strain E. coli WP2uvrA
Migrated to IUCLID6: MMS
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Name 4 -Nitro-1,2-phenylenediamine, 4-NOPD (or NPD)
- Remarks:
- Without metabolic activation; Strain S. typhimurium: TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- With metabolic activation; Strains S. typhimurium: TA 100; TA 98; TA1535; TA 1537 and E. coli WP2uvrA
- Details on test system and experimental conditions:
- Preparation of bacteria:
The frozen cultures were thawed at room temperature and a measured amount was used for inoculating the over-night cultures in the assay. 200 μL inoculum was used for each 50 mL of broth. The bacterial strains were grown up in nutrient broth. The cultures were incubated for 10-14 h at 37°C up to the late exponential or early stationary growth phase (approx. 109 cells/mL) in a Gyrotory Water Bath Shaker. The nutrient broth contained 25 g Nutrient Broth No 2. per litre.
Agar Plates:
Ready-to-use minimal agar plates obtained from Merck (Merckoplate) were used in the experiments.
Overlay Agar:
Histidine- Biotin overlay agar (for Salmonella typhimurium strains) contains per litre: Agar Bacteriological 3.6 g; NaCl 4.5 g; D-Biotin (F.W. 244.3) 12.2 mg; L-Histidine·HCl H2O (F.W. 209.63) 10.5 mg. The agar solution was sterilised at 121 °C in an autoclave, and the Histidine – Biotin solution (0.5 mM) was sterilised by filtration through a 0.22 m membrane filter.
Tryptophan overlay agar (for Escherichia coli strain) contains per litre: Agar Bacteriological 3.79 g; NaCl 4.74 g; Nutrient Broth (see "Preparation of Bacteria") 50.0 mL; L-Tryptophan (F.W. 204.23) 5.0 mg. The agar solution and the nutrient broth was sterilised at 121 °C in an autoclave. The Tryptophan solution (2 mg/mL) was sterilised by filtration through a 0.22 m membrane filter.
Experimental Performance:
As an initial mutation test the standard plate incorporation procedure was performed. Bacteria (cultured in Nutrient Broth No. 2.) were exposed to the test item both in the presence and absence of an appropriate metabolic activation system.
Counting of Colonies:
Revertant colonies were counted manually. - Evaluation criteria:
- The colony numbers on the control, positive control and the test plates will be determined, the mean values and appropriate standard deviations will be calculated.
- Statistics:
- NA
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- Salmonella typhimurium TA 100 minor increases numbers were detected at the concentration of 2500 μg/plate furthermore in the concentration range of 316.23-10 g/plate with metabolic activation (+S9 Mix).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Five bacterial strains, Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA were used to investigate the mutagenic potential of GARDO TP10451 in two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). In general, the pre-incubation method is more sensitive than the plate incorporation assay. Each assay was conducted with and without metabolic activation (S9 Mix). The concentrations, including the controls, were tested in triplicate (positive and negative controls were run concurrently). Following concentrations of GARDO TP10451 were tested in experiment I (the concentrationswere chosen based on results obtained in the pre-experiment for toxicity):
5000; 1581.1; 500; 158.1; 50 and 15.81 g/plate.
The examined concentration levels were 5000; 1581.1; 500; 158.1; 50; 15.81 and 5 μg/plate in the experiment II (the additional concentration level, 5 μg/plate was investigated based on the results of the experiment I.
In experiment I and experiment II most of the observed revertant colony number increases were of minor intensity, not dose related, without any biological significance (i.e. below the respective biological threshold value) and in the historical control range.
The highest revertant rate was observed in the experiment I in case of Salmonella typhimurium TA 1535 at 15.81 μg/plate (MF=1.55), without metabolic activation (–S9 Mix). There were no additional dose-dependent relationship and these values were well below the biological threshold value.
In case of Salmonella typhimurium TA 98, TA 1535, TA 1537 and Escherichia coli WP2 uvrA at different concentration levels sporadically lower revertant colony numbers compared to the revertant colony numbers of the solvent control plates were detected in the performed experiments.
Because of the minor intensity of these variations (increases and decreases in the historical control range), the observed changes should be considered as reflecting the biological variability of the test.
After 48 hours incubation microdrops were observed at the concentration of 5000 g/plate ( S9 Mix), using plate incorporation method, and at the concentrations of 5000 and 1581.1 g/plate ( S9 Mix), using the pre-incubation method.
Positive and negative controls were run concurrently. The revertant colony numbers of solvent control plates without S9 Mix were within the historical control data range. The reference mutagens showed a distinct increase of induced revertant colonies. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
no remarks
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
GARDO TP10451 is classified as non mutagenic - Executive summary:
The reported data of this mutagenicity assay shows, that under the experimental conditions described, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the strains used. Therefore, GARDO TP10451 is considered non-mutagenic in this bacterial reverse mutation assay.
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