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EC number: 268-638-4 | CAS number: 68132-46-7
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Version / remarks:
- Not stated
- Principles of method if other than guideline:
- Testing was performed as reported by Galloway et al. (1987). Triethanolamine was sent to the laboratory as a coded aliquot by Radian Corporation. It was tested in cultured Chinese hamster ovary (CHO) cells for induction of sister chromatid exchanges (SCEs) and chromosomal aberrations (Abs), both in the presence and absence of Aroclor 1254-induced male Sprague-Dawley rat liver S9 and cofactor mix. Cultures were handled under gold lights to prevent photolysis of bromodeoxyuridine-substituted DNA. Each test consisted of concurrent solvent and positive controls and of at least three doses of triethanolamine. In the trials conducted without S9, the high dose was limited by toxicity; in the trials with S9, the high dose was limited to 10,100 μg/mL. A single flask per dose was used, and tests yielding equivocal or positive results were
repeated.
In the chromosomal aberrations test without S9, cells were incubated in McCoy’s 5A medium with triethanolamine for 8.5 hours; Colcemid was added, and incubation continued for 2 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa. For the aberrations test with S9 (Arochlor 1254-induced male Sprague-Dawley rat liver S9), cells were treated with triethanolamine and S9 for 2 hours, after which the treatment medium was removed and the cells were incubated for 8.5 hours in fresh medium, with Colcemid present for the final 2 hours. Cells were harvested in the same manner as for the treatment without S9.
Cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 ± 2 chromosomes). All slides were scored blind and those from a single test were read by the same person. One hundred first-division metaphase cells were scored at each dose level. Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). - GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- Molecular formula:
- C6H15NO3
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- Not specified
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Cloned Chinese hamster ovary cells (CHO-W-B1)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254-induced male Sprague-Dawley rat liver S9 and cofactor mix
- Test concentrations with justification for top dose:
- For test with S9, concentrations were 6,040, 8,060 and 10,070 ug/mL. For test without S9, concentrations were 1,510, 2,010 and 4,030 ug/mL. The highest dose tested was 4,030 µg/mL. Initially, dose selection was based on a preliminary test of cell survival 24hr after treatment. The top doses selected for cytogenetics assays were those estimated to reduce growth by 50%.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl Sulfoxide (DMSO)
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- Mitomycin-C used as positive control absent S9. Cyclophosphamide used as positive control with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium (McCoy's 5A medium with 10% fetal calf serum, L-glutamine and antibiotics)
DURATION
- Exposure duration: Without S9, 10.5 hours. (8.5 hours + 2 hours colcimid, prior to harvest)
: With S9, 2 hours.(after which the treatment medium was removed, incubated for 8.5 hours + 2 hours Colcemid)
- Expression time (cells in growth medium): 10.5 hours in total
- Fixation time (start of exposure up to fixation or harvest of cells): 10.5 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: Not specified
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Not specified
NUMBER OF CELLS EVALUATED: 100 cells were scored from each of the three highest dose groups having sufficient metaphases for analysis
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): 100
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
- Any supplementary information relevant to cytotoxicity: Observations on cell growth and cell cycle kinetics from the Sister Chromatid Exchange (SCE) test were used to select the doses and fixation times for the chromosome aberration tests.
OTHER EXAMINATIONS:
- Determination of polyploidy: aberrations in polyploidy not scored
- Determination of endoreplication: recorded but not included in the totals
- OTHER: Cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 ± 2 chromosomes). All slides were scored blind and those from a single test were read by the same person. One hundred first-division metaphase cells were scored at each of the three highest dose groups having sufficient metaphases for analysis. Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). - Rationale for test conditions:
- Developed screening protocol for detecting chemically induced cytogenetic changes in vitro [Galloway et al, 1985]
Ref: Galloway SM, Bloom AD, Resnick M, Margolin BH, Nakamura F, Archer P, Zeiger E (1985): Development of a standard protocol for in vitro cytogenetic testing with Chinese hamster ovary cells: Comparison of results for 22 compounds in two laboratories. Environ Mutagen 7: 1-51. - Evaluation criteria:
- Cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 ± 2 chromosomes). All slides were scored blind and those from a single test were read by the same person. One hundred first-division metaphase cells were scored at each dose level. Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations).
- Statistics:
- Data Evaluation: The statistical procedures for evaluation of the test data and the assessment of the results have been modified from those described in detail by Galloway et al [1985] Ref: Galloway SM, Bloom AD, Resnick M, Margolin BH, Nakamura F, Archer P, Zeiger E (1985): Development of a standard protocol for in vitro cytogenetic testing with Chinese hamster ovary cells: Comparison of results for 22 compounds in two laboratories. Environ Mutagen 7: 1-51 and Margolin et al [1986]. Ref: Margolin BH, Resnick MA, Rimpo JY, Archer P, Galloway SM, Bloom AD, Zeiger E (1986).. Briefly, the analyses examined the evidence for a dose relation and the absolute increase over the solvent control at each dose.
For chromosome aberrations, linear regression analysis of the percentage of cells with aberrations vs the log-dose was used as the test for trend. To examine absolute increases over control levels at each dose, a binomial sampling assumption (as opposed to Poisson) was used, and the test was that described by Margolin et a1 [1983, pp 714-7151. The P values were adjusted by Dunnett’s method to take into account the multiple dose comparisons. For data analysis, we used the “total” aberration category, and the criterion for a positive response was that the adjusted P value be < 0.05.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At highest dose test (4,030 μg/mL), only 56 metaphases analysed
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: No induction of aberrations were observed with or without S9 (Galloway et al., 1987).
Any other information on results incl. tables
Induction of Chromosomal Aberrations in Chinese Hamster Ovary Cells by Triethanolamine
Without S9
Dose (μg/mL) |
Total Cells Scored | Number of Aberrations | Aberrations/cells | % cells with abberations |
|
Dimethyl Sulfoxide (solvent control) |
- | 100 | 7 | 0.07 | 5.0 |
Mitomycin-C (positive control) |
0.5 | 100 | 24 | 0.24 | 20.0 |
Triethanolamine | 1,510 | 100 | 2 | 0.02 | 2.0 |
2,010 | 100 | 1 | 0.01 | 1.0 | |
4,030 | 56 | 2 | 0.00 | 1.0 | |
P = 0.985 (Significance of percent cells with aberrations tested by the linear regression trend test versus log of the dose) |
With S9
|
Applicant's summary and conclusion
- Conclusions:
- An in vitro mammalian chromosome aberration test was perfomormed on cultured Chinese Hamster Ovary (CHO) cells using the test item triethanolamine with and without metabolic activation. Each test consisted of concurrent solvent and positive controls. Cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 +/- 2 chromosomes). Cytotoxicity was noted at the highest dose tested (4,030 µg/mL) in the aberration test without metabolic activation. No induction of aberrations was observed with or without matabolic activation.
- Executive summary:
Triethanolamine (TEA) was tested for Chromosome Aberrations in Chinese Hamster Ovary Cells as an evaluatuion of 108 Chemicals. All chemicals were tested with and without exogenous metabolic activation, using a developed screening protocol for detecting chemically induced cytogenetic changes in vitro [Galloway et al, 1985] .The protocol was designed to allow testing up to toxic doses and concentrations evaluated were from 1,510 - 4,030 µg/mL (with S9) and 6,040 -10,100 µg/mL (without S9) . 100 metaphase cells were scored from each of the three highest dose groups having sufficient metaphases for analysis and from positive and solvent controls. The results were negative even up to doses that induced toxicity (with and without S9). TEA was therefore negative for structural chromosomal aberrations in this in vitro test system. GLP is not specified, however there is clear methodology and reference to evaluation of criteria for a positive response. The study is considered reliable and comparable to a guideline study.
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