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EC number: 263-503-6 | CAS number: 62314-25-4
- 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:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2-hydroxypropyl)trimethylammonium formate
- EC Number:
- 263-503-6
- EC Name:
- (2-hydroxypropyl)trimethylammonium formate
- Cas Number:
- 62314-25-4
- Molecular formula:
- C6H16NO.CHO2
- IUPAC Name:
- (2-hydroxypropyl)trimethylammonium formate
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Air Product & Chemicals, Inc- Corporate Toxicology Dept. / EHS, Allentown/790K13950
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool, Dry, Ventilated Storage
- Stability under storage conditions: Stable
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution: All strains were treated with the test substance at a concentration of 10 mg/ plate, since the test substance, based upon the results of the Range Finding Study, did not show toxicity at this concentration.
Method
- Target gene:
- his-, trp-
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: Other phenotypic characteristics were verfied by using crystal violet sensitivity and resistance to ampicillin and tetracycline methods
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: post-mitochondrial S9 fraction of rat liver homogenate obtained from Aroclor 1254 treated Sprague Dawley rats
- method of preparation of S9 mix: the S9 activation system, prepared fresh on the day of the assay and kept refrigerated or on ice, contained the following per 10 mL:
0.4 M MgC12/1.65M KCL 0.20 mL
1 M glucose-6-phosphate 0.05 mL
0.1 M NADP 0.40 mL
0.2 M phosphate buffer Type and composition of metabolic activation system:
- source of S9: post-mitochondrial S9 fraction of rat liver homogenate obtained from Aroclor 1254 treated Sprague Dawley rats
- method of preparation of S9 mix: the S9 activation system, prepared fresh on the day of the assay and kept refrigerated or on ice, contained the following per 10 mL:
0.4 M MgC12/1.65M KCL 0.20 mL
1 M glucose-6-phosphate 0.05 mL
0.1 M NADP 0.40 mL
0.2 M phosphate buffer pH=7.4 5.00 mL
USP Water for Injection 3.35 mL
S9 Fraction 1.00 mL - Test concentrations with justification for top dose:
- All strains were treated with the test substance at a concentration of 10 mg/plate, since the
test substance, based upon the results of the Range Finding Study, did not show toxicity at
this concentration. - Vehicle / solvent:
- NaCl
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- E.coli WP2 (20 Mg/mL) without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Salmonella typhimurium TA1537 (800 µg/mL) without metabolic activation.
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Salmonella typhimurium TA100 (100 µg/mL); Salmonella typhimurium TA1535 (5 µg/mL) without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Salmonella typhimurium TA98 (10 µg/mL), without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- Salmonella typhimurium TA98 (5 µg/mL); Salmonella typhimurium TA100 (10 µg/mL); Salmonella typhimurium TA1535 (20 µg/mL); Salmonella typhimurium TA1537 (30 µg/mL); E. coli WP2 (200 µg/mL) with metabolic activation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Plates were incubated at 37±2°C for 72 or 48 hours, checked for uniform background lawns, and revertant colonies counted.
- Test substance was administered in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: Plates were incubated at 37±2°C for 72 or 48 hours, checked for uniform background lawns, and revertant colonies counted. - Evaluation criteria:
- The test results were analyzed using a statistical program such as Tallarida, R. S. and R.B. Murray's Pharmacological Calculations Procedure, analysis of variance (ANOVA), and Newman-Keuls Test for confirmation of pairwise comparisons. The statistical method was determined if there was a significant (p < 0.05) increase in the mutation frequency of the test substance compared to the negative control substance. The results obtained for the mutation frequency at the various dose levels (wherever applicable) were analyzed by the method of Linear Regression using a program such as "Linear Regression I" by R.J. Tallarida and R.B. Murray, (Manual of Pharmacologic Calculations with Computer Programs, Springer-Verlag, New York, 1986, pp 10-13). This determined if there was a positive dose response.
- Statistics:
- Statistical analysis performed are : analysis of variance (ANOVA), and Newman-Keuls Test for confirmation of pairwise comparisons.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Positive controls validity:
- valid
- 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES (if applicable):
No toxicity was observed with the test article in the Range Finding Assay
STUDY RESULTS
- Concurrent vehicle negative and positive control data:
All positive controls exhibited a statistically significant increase in the number of mutants as
compared to the corresponding negative control, demonstrating that the test system was
functional with known mutagens.
Any other information on results incl. tables
Table 4. Confirmatory test Reverse Mutation Assay without Microsomal Activation
Strain | Controls | Test Article | |
Positive Control | Negative Control | Dose Level 10 mg/plate | |
TA 98 | 135.3 ± 9.3 | 27.0 ± 7.0 | 25.7 ± 3.5 |
TA 100 | 502.0± 52.4 | 109.3 ± 17.4 | 109.0 ± 7.8 |
TA 1535 | 117.0 ± 30.1 | 24.7 ± 11.6 | 16.7 ± 2.3 |
TA 1537 | 146.3 ± 18.3 | 10.7 ± 2.5 | 7.7 ± 2.1 |
WP2 | 394.7 ± 10.3 | 130.7 ± 6.1 | 123.0 ± 4.4 |
Table 3. Confirmatory test Reverse Mutation Assay with Microsomal Activation
Strain | Controls | Test Article | |
Positive Control | Negative Control | Dose Level | |
TA 98 | 137.3 ± 26.0 | 27.3 ± 9.1 | 33.3 ± 5.9 |
TA 100 | 440± 85.0 | 121.3 ± 10.5 | 107.3 ± 19.3 |
TA 1535 | 144 ± 9.9 | 18.3 ± 3.8 | 17.3 ± 5.1 |
TA 1537 | 152 ± 24.5 | 14.0 ± 4.6 | 9.7 ± 1.5 |
WP2 | 428.7 ± 2.9 | 129.3 ± 4.0 | 124.7 ± 5.7 |
Table 2. Reverse Mutation Assay without Microsomal Activation
Strain | Controls | Test Article | |
Positive Control | Negative Control | Dose Level | |
TA 98 | 135.3 ± 9.3 | 27.0 ± 7.0 | 20.7 ± 2.5 |
TA 100 | 502.0± 52.4 | 109.3 ± 17.4 | 100.7 ± 11.09 |
TA 1535 | 117.0 ± 30.1 | 24.7 ± 11.6 | 20.3 ± 7.4 |
TA 1537 | 146.3 ± 18.3 | 10.7 ± 2.5 | 11.7 ± 3.5 |
WP2 | 394.7 ± 10.3 | 130.7 ± 6.1 | 133.0 ± 4.6 |
Table 1. Reverse Mutation Assay with Microsomal Activation
Strain | Controls | Test Article | |
Positive Control | Negative Control | Dose Level | |
TA 98 | 137.3 ± 26.0 | 27.3 ± 9.1 | 31.7 ± 7.1 |
TA 100 | 440± 85.0 | 121.3 ± 10.5 | 122.3 ± 26.0 |
TA 1535 | 144 ± 9.9 | 18.3 ± 3.8 | 16.0 ± 4.6 |
TA 1537 | 152 ± 24.5 | 14.0 ± 4.6 | 10.3 ± 4.9 |
WP2 | 428.7 ± 2.9 | 129.3 ± 4.0 | 126.7 ± 3.5 |
Applicant's summary and conclusion
- Conclusions:
- The Salmonella typhimurium and Escherichia coli Reverse Mutation Assay (Ames Assay) evaluated the potential of the test substance, Hydroxypropyl, 2-, trimethylammonium formate, to induce histidine (his)reversion (his- to his+) and tryptophan (tryp) reversion (tryp- to tryp+) in the genomes of these respective organisms. This direct plate incorporation assay was conducted with four strains of Salmonella typhimurium (S. typhimurium) and one strain of Escherichia coli (E. coli) in the presence and absence of an exogenous mammalian activation system. A confirmatory assay was performed in order to verify the results of the Reverse Mutation Assay. Based on the criteria of the study protocol, the test substance is considered non-mutagenic
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