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EC number: 203-057-1 | CAS number: 102-81-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline-Study with acceptable restrictions (original study report in japanese, english translation available).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted on July 21, 1997)
- Deviations:
- yes
- Remarks:
- (2-Aminoanthracene was used as sole positive control in tests with S9 mix)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-dibutylaminoethanol
- EC Number:
- 203-057-1
- EC Name:
- 2-dibutylaminoethanol
- Cas Number:
- 102-81-8
- Molecular formula:
- C10H23NO
- IUPAC Name:
- 2-(dibutylamino)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-(Di-n-butylamino)ethanol
- Physical state: yellow, transparent liquid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): 0.12% water as impurity
- Storage condition of test material: Kept protected from light at room temperature
Constituent 1
Method
- Target gene:
- his and trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9: rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- -S9 mix; 0, 156, 313, 625, 1250, 2500, 5000 μg/plate (all strains)
+S9 mix; 0, 19.5, 39.1, 78.1, 156, 313, 625 μg/plate (all strains) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance was insoluble in water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF2M; in DMSO; TA100, TA98, WP2 uvrA), sodium azide (SA; TA1535) and 9-aminoacridine (9AA; in DMSO; TA1537); +S9 mix; 2-Aminoanthracene (2AA; in DMSO; all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates; the test was conducted twice with regard to same dose
DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition
OTHER EXAMINATIONS: 0.1 mL of the test substance solution of highest dose and 0.5 mL of S9 mix were separately dropped onto the culture plate to check mixing-in of other bacteria at the end of culture.
OTHER: The number of revertant colonies produced was counted by a colony analyzer (System Science Co., CA-11) or visually. - Evaluation criteria:
- If the median of the number of revertant colonies in the plate containing the test substance from one sort or more strains out of 5 strains in total in the absence of S9 mix or in the presence of S9 mix increased twice or more than that of the negative control value and its increase had reproducibility and dose dependency, it shall be judged that the said bacteria has mutagenicity (positive) in the present test system.
- Statistics:
- No data.
Results and discussion
Test resultsopen allclose all
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Growth inhibition was observed at and above 2500 μg/plate without S9 mix, and at 625 μg/plate (highest dose) with S9 mix in all four S. typhimurium strains.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Growth inhibition was observed without S9 mix at 5000 μg/plate (highest dose) and at 625 μg/plate (highest dose) in the presence of S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation observed.
RANGE-FINDING/SCREENING STUDIES: conducted (concentrations: 50.0, 150, 500, 1500 and 5000 μg/plate), each 3 plates for negative and positive controls, and 1 plate for each dose were used; as a result, the grow inhibition was observed in the highest dose of 5000 μg/plate for all the test bacteria in the absence of S9 mix and in the doses of 500 μg/plate and more for all the test bacteria in the presence of S9 mix. In addition, precipitations from the test substance were not observed in all the doses used. From the said results, a dose of 5000 μg/plate was determined for all the test bacteria in the absence of S9 mix and a dose of 625 μg/plate was determined for all the test bacteria in the presence of S9 mix.
ADDITIONAL INFORMATION ON CYTOTOXICITY: As a result, the grow inhibition was observed in a dose of 2500 μg/plate or more in the test bacteria TA100, TA1535, TA98 and TA1537 in the absence of S9 mix, in the highest dose of 5000 μg/plate in WP2 uvrA and in a dose of 625 μg/plate in all the test bacteria in the presence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results of experiment 1 (preincubation test).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
E. coli WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 |
142 ± 10 |
9 ± 1 |
21 ± 3 |
25 ± 3 |
7 ± 2 |
– |
156 |
136 ± 1 |
7 ± 2 |
24 ± 5 |
26 ± 3 |
8 ± 1 |
– |
313 |
145 ± 40 |
7 ± 2 |
26 ± 3 |
24 ± 4 |
7 ± 1 |
– |
625 |
163 ± 10 |
7 ± 1 |
24 ± 6 |
29 ± 1 |
10 ± 1 |
– |
1250 |
150 ± 11 |
6 ± 4 |
22 ± 1 |
27 ± 5 |
9 ± 3 |
– |
2500 |
163* ± 11 |
7* ± 3 |
23 ± 8 |
26* ± 5 |
7* ± 2 |
– |
5000 |
0* ± 0 |
0* ± 0 |
0* ± 0 |
0* ± 0 |
0* ± 0 |
Positive controls, –S9 |
Name |
AF2 |
SA |
AF2 |
AF2 |
9AA |
Concentrations (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
602 ± 24 |
627 ± 18 |
178 ± 12 |
380 ± 48 |
226 ± 4 |
|
+ |
0 |
160 ± 12 |
10 ± 4 |
34 ± 3 |
40 ± 3 |
14 ± 2 |
+ |
19.5 |
149 ± 22 |
8 ± 0 |
26 ± 3 |
35 ± 9 |
12 ± 1 |
+ |
39.1 |
163 ± 4 |
10 ± 2 |
28 ± 2 |
35 ± 4 |
14 ± 2 |
+ |
78.1 |
176 ± 29 |
7 ± 1 |
28 ± 6 |
35 ± 6 |
15 ± 3 |
+ |
156 |
162 ± 13 |
11 ± 3 |
25 ± 4 |
35 ± 2 |
12 ± 4 |
+ |
313 |
162 ± 9 |
9 ± 5 |
31 ± 2 |
34 ± 10 |
13 ± 4 |
+ |
625 |
151* ± 14 |
9* ± 5 |
29* ± 1 |
47* ± 9 |
11* ± 1 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
821 ± 22 |
338 ± 24 |
796 ± 60 |
441 ± 46 |
268 ± 8 |
*growth inhibition was observed
AF2: 2-(2-FuryI)-3-(5-nitro-2-furyl)acrylamide, SA: Sodium azide, 9AA: 9-Aminoacridine, 2AA: 2-Aminoanthracene
Table 2. Test results of experiment 2 (preincubation test).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
E. coli WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 |
118 ± 12 |
8 ± 3 |
41 ± 5 |
23 ± 5 |
12 ± 3 |
– |
156 |
117 ± 12 |
9 ± 4 |
42 ± 8 |
24 ± 5 |
8 ± 1 |
– |
313 |
124 ± 17 |
8 ± 3 |
53± 9 |
23 ± 5 |
12 ± 3 |
– |
625 |
125 ± 8 |
8 ± 3 |
42 ± 7 |
23 ± 4 |
8 ± 2 |
– |
1250 |
123 ± 2 |
9 ± 2 |
38 ± 3 |
23 ± 4 |
6 ± 3 |
– |
2500 |
137* ± 4 |
7* ± 2 |
42 ± 10 |
20* ± 7 |
7* ± 3 |
– |
5000 |
0* ± 0 |
0* ± 0 |
0* ± 0 |
0* ± 0 |
0* ± 0 |
Positive controls, –S9 |
Name |
AF2 |
SA |
AF2 |
AF2 |
9AA |
Concentrations (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
431 ± 47 |
601 ± 1 |
176 ± 21 |
422 ± 38 |
313 ± 97 |
|
+ |
0 |
128 ± 7 |
8 ± 3 |
46 ± 4 |
40 ± 4 |
13 ± 1 |
+ |
19.5 |
132 ± 9 |
8 ± 3 |
44 ± 5 |
35 ± 3 |
12 ± 6 |
+ |
39.1 |
131 ± 23 |
8 ± 3 |
53 ± 5 |
31 ± 5 |
14 ± 4 |
+ |
78.1 |
130 ± 6 |
6 ± 3 |
44 ± 4 |
38 ± 3 |
13 ± 5 |
+ |
156 |
124 ± 8 |
9 ± 2 |
49 ± 5 |
38 ± 1 |
13 ± 2 |
+ |
313 |
142 ± 9 |
5 ± 2 |
46 ± 3 |
33 ± 6 |
12 ± 5 |
+ |
625 |
132* ± 6 |
7* ± 1 |
48* ± 3 |
35* ± 6 |
14* ± 2 |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
770 ± 27 |
345 ± 24 |
777 ± 57 |
434 ± 14 |
253 ± 20 |
*growth inhibition was observed
AF2: 2-(2-FuryI)-3-(5-nitro-2-furyl)acrylamide, SA: Sodium azide, 9AA: 9-Aminoacridine, 2AA: 2-Aminoanthracene
Applicant's summary and conclusion
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