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EC number: 235-979-5 | CAS number: 13078-36-9
- 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
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:
- 11 June 2001 to 19 July 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- and OECD 472
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate
- EC Number:
- 235-979-5
- EC Name:
- Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate
- Cas Number:
- 13078-36-9
- Molecular formula:
- C14H23N3O10.3Na
- IUPAC Name:
- Trisodium N-carboxymethyliminobis(ethylenenitrilo) tetraacetic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot No.1Y31L, 1% aqueous purity.
Method
Species / strain
- 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:
- No information
- Test concentrations with justification for top dose:
- Preliminary study
48.8, 195, 781, 3125, 12500 and 50000 μg/mL without S9 mix
48.8, 195, 781, 3125, 12500 and 50000 μg/mL with S9 mix
Main study
1563, 3125, 6250, 12500, 25000 and 50000 μg/mL without S9 mix
1563, 3125, 6250, 12500, 25000 and 50000 μg/mL with S9 mix - Vehicle / solvent:
- Purified water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2_Aminoanthracine
- Details on test system and experimental conditions:
- The study was performed by the preincubation method. Two plates were used for each test, and each dose level.
1)Dose setting study and main study
In the dose setting study, bacterial suspensions of respective strains dispensed and stored frozen were thawed and 20 μL each was inoculated in 10 mL of nutrient broth culture solution and incubated by shaking (65 reciprocations/minute) at 37°C in a dark room for 12 hours. A 0.1-mL aliquot of this culture solution, 0.5 mL of S9 mix (0.5 mL of 0.1M sodium phosphate buffer, pH 7.4, when S9 mix was not used) and 0.1 mL of 48.8, 195, 781, 3125, 12500 or 50000 μg/mL test substance solution (4.88, 19.5, 78.1, 312.5, 1250 or 5000 μg/plate) were measured in a sterilized test tube and preincubated at 37°C for 20 minutes. Then, 2 mL of the overlay agar containing amino acid was added, mixed to spread over the minimum glucose agar plate medium, and incubated at 37°C for 48 hours. After incubation, reverse mutant colonies were counted macroscopically and bacterial growth inhibition was observed under a stereomicroscope.
The main study was conducted in the same manner as in the dose setting study. Based on the results of the dose setting study, 6 concentrations (156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate) were provided with 50000 μg/mL (= 5000 μg/plate) as the highest concentration and common ratio of 2.
A vehicle control and a positive control were provided for each bacterial strain and tested in the same manner.
2)Sterility tests for S9 mix and the test substance solution
On a plate of normal agar plate medium (20 mL) prepared using the normal agar plate medium (Eiken Chemical Co., Ltd., pH 7.2), 0.1 mL each of S9 mix, 0.1M sodium phosphate buffer, 2 types of overlay agar and the test substance solution of each concentration were spread and incubated at 37°C for 48 hours. - Evaluation criteria:
- When the mean value of 2 plates obtained with the test substance is compared to the data obtained with the vehicle control and the positive control, the result is judged as positive if the number of reverse mutant colonies is twice or more that of the vehicle control and the result is dose-dependence and reproducible.
- Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
The number of reverse mutant colonies in the positive control substance was twice or more that in the vehicle control for all strains both without S9 mix system and with S9 mix in the dose setting study and the main study, demonstrating mutagenicity.
In the sterility test, microbial contamination was not detected in any of the test solutions.
The dose setting study was conducted at six dose levels with 5000 μg/plate at the highest dose level and common ratio of four for both without S9 mix and with S9 mix. Growth inhibition was observed at 5000 μg/plate for all bacterial strains except for TA98 in wihtout S9 mix and for TA100, WP2uvrA and TA1537 with S9 mix. The number of reverse mutant colonies was not twice or more than that of the vehicle control.
The main study was conducted at six dose levels with 5000 μg/plate at the highest dose level and common ratio of two for both without S9 mix and with S9 mix, based on the results of the dose setting study. Growth inhibition was observed at 5000 μg/plate for TA100 and TA1537 without S9 mix and for TA100, WP2uvrA and TA1537 with S9 mix. The number of reverse mutant colonies was not twice or more than that of the vehicle control for all bacterial strains
Applicant's summary and conclusion
- Conclusions:
- The bacterial reverse mutation study of DTPA did not show the number of reverse mutant colonies twice or more that in the vehicle control even at the highest dose level of 5000 μg/plate in the dose setting study and the main study with or without metabolic activation. Growth inhibition was noted in some of the bacterial strains.
Based on the above results, it was concluded that the test substance was not mutagenic.
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