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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- weight of evidence
- Study period:
- 2010-02-22 to 2010-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to Guidelines in a GLP certified laboratory on a read-across compound.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Genes in histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomal enzymes were routinely prepared from adult male Wister rats.
- Test concentrations with justification for top dose:
- Dose range finding concentrations: 100 to 5000 μg/plate.
First mutation assay concentration: 100 to 5000 μg/plate.
Independent repeat assay concentration: 100 to 5000 μg/plate. - Vehicle / solvent:
- Milli-Q water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: TA1535 - sodium azide (in Saline); TA1537 - 9-aminoacridine (in saline); TA98 - 2-nitrofluorene (in Milli-Q water); TA100 - methylmethanesulfonate (in DMSO); WP2uvrA - 4-nitroquinoline-N-oxide (in DMSO). With S9: 2-aminoanthracene
- Details on test system and experimental conditions:
- Test System: Salmonella typhimurium and Escherichia coli bacteria.
The Salmonella typhimurium strains were regularly checked to confirm their histidine-requirement, crystal violet sensitivity, ampicillin resistance (TA98 and TA100), UV-sensitivity and the number of spontaneous revertants.
The Escherichia coli WP2uvrA was regularly checked to confirm the tryptophan-requirement, UV-sensitivity and the number of spontaneous revertants.
Stock cultures of the five strains were stored in liquid nitrogen (-196 deg C). - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might have entered into the final evaluation decision. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
All bacterial strains (S. typhimuriumand E.coli) showed negative responses (i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments) at up to 5 mg/plate, with and without S9, indicating that TEA acetate is not mutagenic in this assay. - Executive summary:
Evaluation of the mutagenic activity of Triethanol amineacetate in the Salmonella typhimurium reverse mutation and the Escherichia coli reverse mutation assay (with independent repeat) was conducted according to OECD guidelines (and to GLP).
Triethanol amineacetate was tested in the S. typhimurium assay with histidine-requiring strains of S. typhimurium (TA1535, TA1537, TA98 and TA100) and in the E. coli reverse mutation assay with tryptophan-requiring strain of E. coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of Phenobarbital and β-naphthoflavone).
In the dose range finding test, Triethanol amineacetate was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. Triethanol amineacetate did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.
Based on the results of the dose range finding test, Triethanol amineacetate was tested in the first mutation assay at a concentration of range of 100 to 5000 μg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. In an independent repeat of the assay with additional parameters, Triethanol amineacetate was tested at the same concentration range as the first assay in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98 and WP2uvrA.
Cytotoxicity, as evidenced by a decrease of the bacterial background lawn, was observed in tester strain TA1537 in the presence of S9-mix (second mutation assay) at the highest tested concentration. In all tester strains, the bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.
Triethanol amineacetate did not induce a significant dose-related increase in the number of revertant (His*) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metbolic activation. These results were confirmed in an independently repeated experiment.
In this study, the negative and strain-specific positive control values were within the 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 in the S. typhimurium reverse mutation assay and in the E. coli reverse mutation assay.
Reference
Dose Finding Test
Triethanol amineacetate was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330, 5000 μg/plate in the absence and presence of S9-mix. This dose range finding test is reported as part of the first experiment of the mutation test (Table 1).
Precipitation of Triethanol amineacetate on the plates was not observed at the start or at the end of the incubation period in both tester strains.
No reduction in the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
In the dose range finding test, no increase in the number of revertants was observed upon treatment with Triethanol amineacetate under all conditions tested.
Mutation Assay
Based on the results of the dose range finding test, Triethanol amineacetate was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in two mutation assays. The first mutation experiment was performed with the strains TA1535, TA1537 and TA98 and the second mutation experiment was performed with the strains TA1535, TA1537, TA98, TA100 and WP2uvrA. The results are shown in Table 1 and 2.
Precipitation of Triethanol amineacetate on plates was not observed at the start or at the ends of the incubation period.
In both mutation assays, there was no reduction of the bacterial background lawn and no decrease in the number of revertants at any of the concentration tested in all tester strains in the absence and presence of S9-mix, except for a slight reduction of the bacterial background lawn at the concentration of 5000 μg/plate in the presence of S9-mix in tester strain TA1537 (second experiment).
In strain TA98, fluctuations in the number of revertant colonies below the laboratory historical control data range were observed. However, since no dose-relationship was observed, the reductions are not considered to be caused by toxicity of the test substance.
In both mutation assays, no increase in the number of revertants was observed upon treatment with Triethanol amineacetate under all conditions tested.
Table1 Experiment 1: Mutagenic response of Triethanol amineaceate in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|
Without S9 -mix |
|||||
positive control |
735± 16 |
312± 40 |
1109± 31 |
1033± 50 |
955± 164 |
solvent control |
10± 5 |
3± 1 |
15± 2 |
112± 9 |
22± 6 |
|
|
|
|
|
|
3 |
|
|
|
102± 2 |
26± 1 |
10 |
|
|
|
117± 7 |
32± 3 |
33 |
|
|
|
114± 2 |
21± 8 |
100 |
8± 1 |
3± 0 |
15± 4 |
109± 6 |
19± 3 |
333 |
6± 3 |
3± 1 |
17± 3 |
110± 4 |
19± 4 |
1000 |
6± 3 |
3± 0 |
12± 2 |
111± 12 |
21± 6 |
3330 |
7± 1 |
3± 1 |
11± 4 |
106± 10 |
22± 2 |
5000 |
9± 1 |
3± 1 |
14± 4 |
102± 4 |
19± 2 |
With S9 –mix |
|||||
positive control |
274± 9 |
187± 30 |
1204± 19 |
1421± 45 |
421± 21 |
solvent control |
8± 2 |
3± 1 |
17± 4 |
83± 13 |
23± 2 |
|
|
|
|
|
|
3 |
|
|
|
88± 14 |
28± 23 |
10 |
|
|
|
115± 10 |
28± 3 |
33 |
|
|
|
124± 2 |
30± 1 |
100 |
5± 2 |
3± 0 |
14± 3 |
113± 4 |
18± 3 |
333 |
5± 3 |
3± 0 |
16± 2 |
114± 14 |
17± 4 |
1000 |
4± 1 |
3± 1 |
18± 3 |
113± 11 |
19± 3 |
3330 |
4± 1 |
3± 1 |
20± 1 |
95± 11 |
20± 2 |
5000 |
4± 2 |
4± 1 |
14± 4 |
105± 13 |
15± 5 |
Table 2 Experiment 2: Mutagenic response of Triethanol amineacetate in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonells typhimurium and one Escherichia coli strain |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|
Without S9 -mix |
|||||
positive control |
894± 39 |
298± 12 |
1105± 44 |
977± 45 |
1206± 65 |
solvent control |
13± 3 |
6± 2 |
20± 4 |
107± 5 |
26± 4 |
|
|
|
|
|
|
100 |
9± 2 |
6± 2 |
22± 1 |
100± 10 |
21± 3 |
333 |
15± 5 |
6± 2 |
18± 5 |
109± 10 |
23± 4 |
1000 |
12± 3 |
5± 1 |
17± 4 |
110± 12 |
18± 2 |
3330 |
13± 3 |
5± 3 |
20± 3 |
100± 11 |
20± 2 |
5000 |
13± 2 |
5± 2 |
15± 1 |
101± 5 |
19± 4 |
With S9 –mix |
|||||
positive control |
143± 5 |
341± 94 |
597± 26 |
1153± 76 |
219± 46 |
solvent control |
9± 3 |
4± 1 |
19± 3 |
66± 4 |
18± 2 |
|
|
|
|
|
|
100 |
8± 3 |
4± 2 |
25± 4 |
61± 2 |
25± 4 |
333 |
7± 1 |
4± 1 |
25± 1 |
65± 4 |
19± 1 |
1000 |
7± 4 |
4± 1 |
23± 1 |
65± 4 |
24± 1 |
3330 |
9± 4 |
3± 1 |
23± 6 |
63± 2 |
18± 3 |
5000 |
9± 1 |
4± 2 |
29± 6 |
59± 5 |
23± 6 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No data are available on the genetic toxicity of DEA acetate, but a number of guideline, GLP, studies are available on structurally-related read-across compounds.
TEA acetate was not mutagenic in a bacterial reverse mutation assay in Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100, and Escherichia coli strain WP2uvrA, at up to 5000 μg/plate, in the presence and absence of metabolic activation (S9) (Verspeek-Rip, 2010a). RA2 was not mutagenic in S. typhimurium strains TA1535, TA1537, TA98 and TA100, at up to 10,000 μg/plate, with or without S9 (Prezioso, 1996c). In mouse lymphoma (L5178Y) cells, TEA acetate was not mutagenic when tested at up to 2092 μg/ml, with or without S9 (Verspeek-Rip, 2010b).
No clastogenic activity (chromosome aberration) or polyploidy was seen in Chinese hamster lung (V79) fibroblast cells incubated with RA1 or RA2 at up to 5000 μg/ml, in the presence or absence of S9 (Czich, 1997, 2000).
As no positive findings were seen in any of the in vitro assays, in vivo studies were not required according to Regulation (EC) No 1907/2006.
Justification for selection of genetic toxicity endpoint
GLP, OECD guideline study (reliability 2).
Justification for classification or non-classification
According to Regulation (EC) No. 1272/2008, a substance is to be classified as a germ cell mutagen based on a weight of the evidence approach, evaluating data including in vitro tests on somatic cells. No evidence of mutagenicity was seen in read-across in vitro tests on S. typhimurium, E coli or mouse lymphoma cells (Prezioso, 1996c; Verspeek-Rip, 2010a, b). Similarly, no evidence of chromosome aberrations were seen in Chinese hamster cells in vitro (Czich, 1997, 2000). On the basis of this data, on structurally-related read-across compounds, DEA acetate does not require classification.
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