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EC number: 906-891-0 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- January 6, 1987 - January 9, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to methods similar to OECD471 but strain E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium TA102 was not included. Negative results were not confirmed by an independent repeat.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- - The study was performed according to methods similar to OECD471 but strain E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium TA102 is not included.
- Negative results were not confirmed by an independent repeat. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trientine
- EC Number:
- 203-950-6
- EC Name:
- Trientine
- Cas Number:
- 112-24-3
- Molecular formula:
- C6H18N4
- IUPAC Name:
- N,N'-bis(2-aminoethyl)ethane-1,2-diamine
- Details on test material:
- Chemical Rame: Triethylenetetramine - Sample A
Chemical Synonyms: TETA
I. D a #/ : 36-ARB-31-8
BRRC Sample #: 49-424
BRRC Account R: 86-22-18120
Sample No.: 798-95-1
Purity 95.7%
9.71% TAEA
56.41% L-TETA
17.68% DAEP
11.88% PEEDA
0.125% AEEA
0.31% AE-TAEA
0.156% 4 unknowns
0.72% unknown
1.04% unknown
1.18% unknown
0.42% unknown
0.14% unknown
Other impurities < 0.1%
Constituent 1
Method
- Target gene:
- histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: r-factor (ampilicin resistance) (TA100 and TA98), uvrB-, rfa-
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: uvrB-, rfa-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- without S9 0.03, 0.1, 0.3, 1 and 2 mg/plate
with S9 0.1, 0.3, 1, 3 and 5 mg/plate - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Preincubation period: none
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplcate
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- The spontaneous reversion for the solvent controls should be within this laboratory's historical range. The positive controls should demonstrate that the test systems are responsive with known mutagens. A test chemical is considered to be a bacterial mutagen if the number of revertant colonies is at least twice the solvent control for at least one dose level and there is evidence of a dose-related increase in the number of revertant colonies. If a test chemical produces a marginal or weak response that cannot be reproduced in a second test, the test result will be considered negative, If there is no evidence of a dose-related increase in the number of revertant colonies and the number of revertant colonies is not twice the solvent control, then the test chemical is not considered to be a bacterial mutagen.
- Statistics:
- none
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA100, TA98, TA1537, TA1538
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- increases in number of revertant colonies: TA98 6.6-fold, TA100 4.3-fold, TA1538 2.6-fold, TA1537 3-fold
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2mg/plate in all strains except TA100
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- maximun 5-fold increase
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1537, TA1538
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Range finding study:
In preliminary tests to determine cytotoxicity, ten concentrations of TETA-Sample B ranging from 0.01 to 98 mglplate were tested with and without the presence of an S9 metabolic activation system. Cytotoxicity was defined as either a reduction in the number of revertant colonies or an inhibition of growth of the background lawn. Dose levels ranging from 3.0 to 98 -/plate produced complete absence of growth of the background lawn in the test without S9. A lower dose of 1.0 mg/plate produced no evidence of cytotoxicity, allowing confluent growth of the background lawn. In addition the 1.0 mg/plate dose level produced a 4.3-fold increase in relative numbers of revertant colonies indicating that a biologically effective dose level had been attained. In the preliminary test performed with activation, dose levels ranging from 10 to 98 mg/plate produced absence of growth of the background lawn and a dose of 5 mg/plate produced cytotoxicity evident by sparse growth of the background lawn. In addition, this dose produced a 5.3-fold increase in revertant colonies while a lower dose of 1 and 3 mg/plate produced a 7.1-fold and 6.2-fold increase above control levels, repsectively.
Based on the results of these preliminary toxicity tests, 5 doses ranging from 0.03 to 2.0 mg/plate were tested without S9 and 5 doses ranging from 0.1 to 5 mg/plate were tested in the presence of S9 in definitive mutagenicity experiments using triplicate cultures at each dose level.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
TETA-Sample A was considered to be mutagenic in this vitro bacterial assay. - Executive summary:
Triethylenetetramine - Sample A (TETA-Sample A) was tested for potential mutagenic activity using the Salmonella/microsome bacterial mutagenicity assay (Ames test). Test doses for the Ames test were chosen from data obtained in a preliminary study with strain TA100. Tests without a rat liver S9 activation system indicated that a concentration of 3.0 mg/glate was cytotoxic and produced absence of growth of the bacterial lawn. A slightly lower dose of 1.0 mg/plate allowed confluent growth of the background lawn. In the test with S9, a dose of 5 mg/plate produced cytotoxicity evident by sparse growth of the bacterial lawn. Higher doses produced complete absence of the background lawn. Based on these results, five doses ranging from 0.03 to 2.0 mg/plate were tested in the definitive test without S9 and a slightly higher range of 0.1 to 5 mg/plate were tested in the presence of the S9 metabolic activation system, These concentrations were rested with five different strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, and TA1538) using triplicate cultures at each dose level for each strain.
In the test without S9, dose-related mutagenic activity was observed with all five strains except TA1535. In tests performed in the presence of a
rat-liver S9 metabolic activation system, strains TA98, TA100 and TA1535 had highly positive and dose related increases in numbers of revertant colonies. Thus, TETA-Sample A was considered to be mutagenic in this in vitro bacterial assay.
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