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EC number: 245-524-2 | CAS number: 23251-72-1
- 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 mammalian cells
- 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:
- 2010-02-23 to 2010-04-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to Guidelines in a GLP certified laboratory, on a structurally closely-related substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- 1. In the dose range-finding study, the test substance was tested at a concentration of above 0.01 M. 2. When culturing the cells, the humidity and temperature were occasionally outside the recommended range
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- See deviations above
- Qualifier:
- according to guideline
- Guideline:
- other: The recommendations of the "International Workshop on Genotoxicity Tests Workgroup", published in the literature (Clive et. al, 1995, Moore et al, 1999, 2000, 2002, 2003, 2006 and 2007)
- Deviations:
- yes
- Remarks:
- See deviations above
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Triethanolamine acetate
- IUPAC Name:
- Triethanolamine acetate
- Reference substance name:
- Tris(2-hydroxyethyl)ammonium acetate
- EC Number:
- 238-874-2
- EC Name:
- Tris(2-hydroxyethyl)ammonium acetate
- Cas Number:
- 14806-72-5
- IUPAC Name:
- 2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium acetate
- Test material form:
- other: solid
- Details on test material:
- Identification: Triethanol amineacetate
Molecular formula: C8H19NO5
Molecular weight: 209.24
CAS Number: 14806-72-5
Smiles notation N(CCO)(CCO)CCO.C(C)(=O)O
InChl UPCXAARSWVHVLY-UHFFFAOYSA-N
Structural formula attached as image file: see Fig. 1
Test substance storage: At room temperature protected from light under nitrogen
Stability under storage conditions: Stable
Constituent 1
Constituent 2
Method
- Target gene:
- Thymidine kinase gene
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- L5178Y/TK+/- 3.7.2C mouse lymphoma cells
Sourced from the American Type Culture Collection.
Stocks stored in liquid nitrogen until use.
Density was preferably kept below 1 x 10^6 cells/ml - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix: rat liver microsomal enzymes were routinely prepared from adult Wistar rats
- Test concentrations with justification for top dose:
- Dose range-finding concentrations: 0 (control), 33, 100, 333, 1000 and 2092 µg/ml
First and second mutation assay concentrations: 0 (control), 1, 3, 10, 33, 100, 333, 1000 and 2092 µg/ml - Vehicle / solvent:
- RPMI 1640 medium
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: MMS was used as the positive control in cultures without metabolic activation. Cyclophosphamide (CPA) was used as the positive control in cultures with metabolic activation
- Details on test system and experimental conditions:
- TEST SYSTEM: L5178Y/TK+/- 3.7.2C mouse lymphoma cells
METHOD OF APPLICATION: The test substance was dissolved in RPMI 1640 medium and filter sterilised. Triethanol amineacetate concentrations were added to the mouse lymphoma cells within 30 minutes of preparation.
DURATION
- Preincubation period: Prior to addition of the test substance, mouse lymphoma cells were grown for 1 day in HAT medium to reduce the amount of spontaneous mutants, followed by a recovery period of 2 days in RPMI 1640 medium containing hypoxanthine and thymidine only. Cells were then cultered in RPMI 1640 medium for at least 1 day before starting the experiment.
- Exposure duration: In experiment 1, cells were exposed to Triethanol amineacetate for 3 hours in the presence and absence of metabolic activation. In experiment 2, cells were exposed to Triethanol amineacetate for 3 hours in the presence of metabolic activation and 24 hours in the absence of metabolic activation.
- Expression time (cells in growth medium): Two days
- Selection time (if incubation with a selection agent): Eleven or twelve days in TFT selective medium
- Fixation time (start of exposure up to fixation or harvest of cells): Fourteen or fifteen days from start of treatment with test substance until analysis of cells
SELECTION AGENT (mutation assays): Trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: The experiment was performed in duplicate using eight concentrations of test substance
NUMBER OF CELLS EVALUATED: For determination of the mutation frequency, a total number of 9.6 x 10^5 cells/concentration were plated in five 96-well microtiter plates, with each well containing 2000 cells in TFT medium. At the end of the selection period, the plates were stained for 2 hours by adding 0.5 mg/ml MTT to each well. The plates were then scored with the naked eye or using a microscope for total cell count in each well.
DETERMINATION OF CYTOTOXICITY
- Method: The cytotoxicity of the test substance was measured by calculating the relative suspension growth of the cells treated with Triethanol amineacetate versus medium-treated control cultures. - Evaluation criteria:
- A test substance is considered positive in the mutation assay if it induces a mutation frequency (MF) of more than MF(controls) + 126 in a dose-dependent manner. An increase should be biologically relevant in comparison with the historical control range.
A test substance is considered equivocal in the mutation assay if no clear conclusion for positive or negative results can be made after an additional confirmation study.
A test substance is considered negative in the mutation assay if:
a) None of the tested concentrations reach a mutation frequency of MF(controls) + 126 AND
b) The results are confirmed in an independently repeated test. - Statistics:
- No statistical analysis was required.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The spontaneous mutation frequencies in the vehicle-treated control cultures were between the minimum and maximum values of the historical control range
The results of the gene mutation assay were confirmed through an independent confirmatory assay. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Preliminary cytotoxicity test
The initial dose range-finding test conducted on Triethanol amineacetate indicated that the test substance was not toxic up to and including the highest test substance concentration of 2902 µg/ml, either with or without metabolic activation. In the presence of S9-mix, the relative suspension growth was 91 % at the test substance concentration of 2902 µg/ml, and in the absence of S9-mix, the relative suspension growth was 55 % at 2902 µg/ml compared to that of the solvent control.
Triethanol amineacetate did not precipitate in the exposure medium at any of the concentrations tested.
Mutagenic assays
In experiments I and II, no toxicity was observed at any dose level, either in the presence or absence of metabolic activation.
In experiment I, the concentration of S9-mix in the exposure medium was 8 % (v/v). No significant increase in the number of mutant colonies was observed after treatment with Triethanol amineacetate in either the presence or absence of S9-mix.
In experiment II, the concentration of S9-mix in the exposure medium was increased to 12 % (v/v). The cells were treated with the test substance for 3 hours in the presence of S9-mix, or 24 hours in the absence of S9-mix. No significant increase in the number of mutant colonies was observed after treatment with Triethanol amineacetate in either the presence or absence of S9-mix.
MMS and CPA were used as positive controls for cells treated in the absence and presence of S9-mix respectively. These substances significantly increased the mutation frequency at the TK locus, indicating that the assay was appropriate for the detection of a mutagenic response and that the metabolic activation system (S9-mix) functioned properly. Furthermore, the observed mutation frequencies of the positive control substances were within the acceptability criteria of this assay.
Table 1: Cytotoxicity data from dose-range finding test
Concentration (µg/ml) |
S9 Mix |
Treatment period (h) |
Number of cells at 3 h (cells/ml x 106) |
Number of cells/ml at 24 h (cells/ml x 106) |
Number of cells/ml at 48 h (cells/ml x 106) |
SG (x 105cells/ml) |
RSG (%) |
0* |
- |
3 |
5.2 |
7.0 |
6.1 |
141 |
100 |
33 |
- |
3 |
5.5 |
6.9 |
5.7 |
139 |
99 |
100 |
- |
3 |
5.2 |
7.0 |
5.9 |
136 |
97 |
333 |
- |
3 |
5.2 |
6.6 |
6.0 |
131 |
9. |
1000 |
- |
3 |
5.3 |
6.7 |
5.4 |
124 |
88 |
2902 |
- |
3 |
4.7 |
7.9 |
5.2 |
122 |
87 |
0* |
+ |
3 |
4.8 |
6.7 |
6.8 |
141 |
100 |
33 |
+ |
3 |
4.8 |
7.0 |
6.0 |
128 |
91 |
100 |
+ |
3 |
4.9 |
6.1 |
6.4 |
122 |
87 |
333 |
+ |
3 |
4.4 |
7.6 |
6.3 |
134 |
95 |
1000 |
+ |
3 |
4.2 |
7.8 |
6.0 |
126 |
89 |
2902 |
+ |
3 |
5.1 |
6.8 |
5.8 |
128 |
91 |
0* |
- |
24 |
- |
6.8 |
4.7 |
25 |
100 |
33 |
- |
24 |
- |
7.4 |
4.2 |
25 |
97 |
100 |
- |
24 |
- |
7.4 |
4.0 |
24 |
93 |
333 |
- |
24 |
- |
7.8 |
3.6 |
23 |
89 |
1000 |
- |
24 |
- |
7.0 |
3.6 |
20 |
79 |
2902 |
- |
24 |
- |
5.8 |
3.0 |
14 |
55 |
* = solvent control
SG = suspension growth
RSG = relative suspension growth
Table 2: Cytotoxic and mutagenic response of Triethanol amineacetate in experiment I
Dose
(µg/ml) |
Relative suspension growth (%) |
Cloning efficiency
(day 2) |
Relative Survival
(day 2) |
Relative total growth
(%) |
Mutation frequency per 106cells |
||
Total |
Small |
Large |
|||||
Without metabolic activation 3 hours treatment |
|||||||
SC1 |
100 |
77 |
100 |
100 |
72 |
38 |
32 |
SC2 |
100 |
74 |
100 |
100 |
58 |
26 |
30 |
1 |
103 |
67 |
89 |
92 |
77 |
24 |
51 |
3 |
106 |
62 |
83 |
87 |
101 |
50 |
48 |
10 |
103 |
52 |
69 |
71 |
92 |
56 |
35 |
33 |
95 |
70 |
94 |
88 |
72 |
49 |
21 |
100 |
119 |
56 |
74 |
88 |
101 |
48 |
50 |
333 |
114 |
58 |
76 |
87 |
80 |
22 |
56 |
1000 |
117 |
67 |
89 |
104 |
60 |
30 |
28 |
2092 |
111 |
58 |
78 |
87 |
69 |
31 |
36 |
MMS |
30 |
49 |
65 |
20 |
1064 |
474 |
453 |
With metabolic activation 3 hours treatment |
|||||||
SC1 |
100 |
102 |
100 |
100 |
63 |
27 |
34 |
SC2 |
100 |
105 |
100 |
100 |
52 |
29 |
22 |
1 |
96 |
104 |
100 |
96 |
59 |
34 |
23 |
3 |
121 |
93 |
89 |
108 |
90 |
46 |
41 |
10 |
91 |
102 |
99 |
90 |
47 |
25 |
21 |
33 |
112 |
74 |
71 |
79 |
131 |
75 |
50 |
100 |
102 |
102 |
99 |
100 |
70 |
39 |
28 |
333 |
89 |
107 |
103 |
92 |
58 |
16 |
41 |
1000 |
97 |
108 |
104 |
101 |
68 |
35 |
31 |
2092 |
105 |
83 |
84 |
84 |
119 |
49 |
65 |
CP |
42 |
44 |
18 |
18 |
1487 |
623 |
626 |
Table 3: Cytotoxic and mutagenic response of Triethanol amineacetate in experiment II
Dose
(µg/ml) |
Relative suspension growth (%) |
Cloning efficiency
(day 2) |
Relative Survival
(day 2) |
Relative total growth
(%) |
Mutation frequency per 106cells |
||
Total |
Small |
Large |
|||||
Without metabolic activation 3 hours treatment |
|||||||
SC1 |
100 |
89 |
100 |
100 |
70 |
45 |
23 |
SC2 |
100 |
90 |
100 |
100 |
65 |
32 |
31 |
1 |
94 |
91 |
102 |
96 |
96 |
61 |
30 |
3 |
107 |
85 |
95 |
101 |
67 |
31 |
34 |
10 |
102 |
94 |
105 |
107 |
80 |
40 |
37 |
33 |
108 |
78 |
87 |
94 |
66 |
33 |
31 |
100 |
106 |
80 |
90 |
95 |
83 |
47 |
33 |
333 |
104 |
88 |
98 |
102 |
78 |
55 |
21 |
1000 |
81 |
99 |
111 |
90 |
56 |
27 |
28 |
2092 |
69 |
81 |
91 |
63 |
95 |
51 |
41 |
MMS |
74 |
64 |
72 |
53 |
803 |
519 |
199 |
With metabolic activation 3 hours treatment |
|||||||
SC1 |
100 |
93 |
100 |
100 |
66 |
37 |
26 |
SC2 |
100 |
108 |
100 |
100 |
77 |
52 |
23 |
1 |
102 |
111 |
111 |
113 |
54 |
30 |
22 |
3 |
95 |
91 |
91 |
86 |
86 |
46 |
37 |
10 |
83 |
107 |
106 |
88 |
75 |
49 |
23 |
33 |
102 |
115 |
114 |
116 |
76 |
56 |
18 |
100 |
98 |
85 |
85 |
83 |
119 |
73 |
41 |
333 |
97 |
120 |
119 |
116 |
71 |
41 |
27 |
1000 |
106 |
111 |
111 |
118 |
65 |
43 |
20 |
2092 |
100 |
104 |
103 |
104 |
83 |
50 |
30 |
CP |
74 |
88 |
87 |
64 |
878 |
474 |
250 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No significant increase in the mutation frequency at the TK locus was observed in mouse lymphoma L5278Y cells after treatment with Triethanol amineacetateat non-toxic concentraitons of up to 2092 ug/ml, with and with without S9. - Executive summary:
The objective of this guideline (GLP) study was to assess the ability of Triethanol amineacetate to induce mutations at the TK locus on chromosome 11 of mouse lymphoma L5178Y cells, in both the presence and absence of a metabolic activation system (S9). A preliminary test was performed to determine the cytotoxicity of the test substance. L5278Y cells were exposed to the test item at concentrations of between 33 and 2092 µg/ml for 3 hours with and 3 and 24 hours without S9. At the end of this treatment period the cloning efficiency and relative suspension growth were determined.
To assess the capacity of Triethanol amineacetate to induce mutations at the TK locus, a mutation assay was performed in two independent experiments. In both experiments, L5178Y cells were treated with 1, 3, 10, 33, 100, 333, 1000 and 2092 µg/ml. In experiment I, cells were exposed to the test item for 3 hours with and 3 and 24 hours without metabolic activation using 8 % v/v S9-mix. In experiment II, cells were exposed to the test item for 3 hours with and 3 and 24 hours without metabolic activation using 12 % v/v S9-mix. Cultures treated with medium only were used as solvent controls. MMS was used as a positive control substance in cultures without metabolic activation, while CPA was used as a positive control substance in cultures with metabolic activation using S9 mix. The TFT-resistant mutant frequency per 106 cloneable cells was used to determine the potential mutagenic effects of the test substance.
Treatment of mouse lymphoma L5278Y cells with Triethanol amineacetate did not induce toxicity as measured by relative suspension growth. No significant increase in the mutation frequency at the TK locus was observed after treatment with the test substance at any of the concentrations tested. The negative and positive control values were within laboratory historical control data ranges, indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that Triethanol amineacetate is not mutagenic at the TK locus of mouse lymphoma L5178Y cells.
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