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EC number: 200-834-7 | CAS number: 75-04-7
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- only 4 strains were tested
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals
- Author:
- Mortelmans, K., et al.
- Year:
- 1 986
- Bibliographic source:
- Environmental Mutagenesis, 7: 1-119
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was assayed for mutagenicity in the Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program [see also Haworth et al, 1983].
To the 13 X 100-mm test tube maintained at 37°C the following substances were added:
0.5 ml of S-9 mix or 0.1 M PO4 buffer (pH 7.4), 0.05 ml of the overnight culture, and 0.05 ml of solvent or chemical dilution.
The mixture was mixed and allowed to incubate without shaking at 37°C for 20 min, at which time 2.0 ml of molten (45°C) top agar supplemented with 0.5 mM L-histidine and 0.5 mM D-biotin were added. The contents of the tubes were mixed and poured onto 25 ml of minimal glucose bottom agar [Vogel and Bonner, 1956] in 15 X 100-mm plastic petri dishes (Falcon Muta-Assay, 1028). When the top agar had solidified, the plates were inverted and incubated at 37°C for 48 hr. Concurrent solvent and positive controls were tested with and without the metabolic activation systems. Five dose levels of the test substance was tested, with three plates per dose level in four strains. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethylamine
- EC Number:
- 200-834-7
- EC Name:
- Ethylamine
- Cas Number:
- 75-04-7
- Molecular formula:
- C2H5NH2
- IUPAC Name:
- ethanamine
- Details on test material:
- - Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data
Constituent 1
- Specific details on test material used for the study:
- - Supplier: Fluka Chemical Co.
- Testing lab: SRI
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Male Sprague-Dawley rats and male syrian hamsters; liver S9
- method of preparation of S9 mix: Aroclor 1254 (200 mg/ml in corn oil) was administered ip at 500 mg/kg 5 days prior to decapitation (EGG, SRI) or cervical dislocation (CWR). The animals were deprived of food 12-24 hr immediately preceding death; otherwise food and water were provided ad libitum. The livers were removed aseptically, washed in ice-cold 0.15 M KCl, and minced and homogenized (3 ml of 0.15 M KC1 per gm of wet tissue) in a Potter-Elvehjem apparatus with a Teflon pestle. CWR initially used a Waring blender, but switched to a Potter-Elvehjem apparatus. The S-9 fraction was obtained by centrifugation of the liver homogenate for 10 min at 9,000 g at 4°C. The S-9 mix was prepared immediately prior to each assay.
- Volumes of S9 mix:
Per milliliter:
S-9 fraction 0.10 ml
0.04 M MgC12 0.02 ml
1.65 M KC1 0.02 ml
0.04 M NADP 0.10 ml
0.05 M glucose-6-phosphate 0.10 ml
1.0 M NaH2P04, (pH 7.4) 0.10 ml
Distilled water 0.56 ml - Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333, 10000 ug/plate
- Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Potassium chloride
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: -4-nitro-o-phenylenediamine for TA98; - with metabolic activation: 2-aminoanthracene (all strains).
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 3
METHOD OF TREATMENT/ EXPOSURE:
- preincubation test
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 20 min
- Exposure duration: 48 h
FOR GENE MUTATION:
- Ames test - Evaluation criteria:
- 1) Mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold
2) nomutagenic response: when no increase in the number of revertants was elicited by the chemical
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible;
or when the response was of insufficient magnitude to support a determination of mutagenicity
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 10000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 10000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 10000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 10000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXIC EFFECTS:
- With metabolic activation: negative
- Without metabolic activation: negative
PRECIPITATION CONCENTRATION:
- No precipitate observed
CYTOTOXIC CONCENTRATION:
- With metabolic activation: 10000 ug/plate
- Without metabolic activation: 10000 ug/plate
Any other information on results incl. tables
Strain: TA1535
Dose |
No Activation |
10% HLI |
10% RLI |
|||
Protocol |
Preincubation |
Preincubation |
Preincubation |
|||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
33 |
2.3 |
11 |
2.6 |
15 |
0.3 |
100 |
30 |
4.9 |
10 |
2.3 |
10 |
3 |
333 |
25 |
3.5 |
9 |
1.7 |
11 |
3.8 |
1000 |
30 |
2.7 |
11 |
2 |
10 |
0.9 |
3333 |
7s |
4.1 |
15 |
3.5 |
18 |
1.7 |
10000 |
0s |
0 |
0s |
0 |
0s |
0 |
Positive Control |
342 |
42.1 |
245 |
10.7 |
178 |
24.1 |
Strain: TA100
Dose |
No Activation |
10% HLI |
10% RLI |
|||
Protocol |
Preincubation |
Preincubation |
Preincubation |
|||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
146 |
10.4 |
121 |
2.7 |
121 |
6.5 |
100 |
118 |
5.1 |
114 |
8.6 |
136 |
11.5 |
333 |
129 |
9.4 |
132 |
5.7 |
116 |
10.3 |
1000 |
108 |
5.2 |
143 |
9.4 |
108 |
9.3 |
3333 |
118 |
9 |
121 |
16.9 |
94 |
11.1 |
10000 |
0s |
0 |
0s |
0 |
41s |
20.5 |
Positive Control |
377 |
8.7 |
966 |
42.3 |
456 |
24.8 |
Strain: TA98
Dose |
No Activation |
10% HLI |
10% RLI |
|||
Protocol |
Preincubation |
Preincubation |
Preincubation |
|||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
16 |
2 |
26 |
5.7 |
25 |
1.9 |
100 |
17 |
1.7 |
32 |
2.3 |
27 |
3.5 |
333 |
13 |
3.1 |
32 |
3.2 |
25 |
0.6 |
1000 |
12 |
3.2 |
34 |
4.7 |
32 |
2.3 |
3333 |
8s |
4.3 |
0s |
0 |
23 |
4.5 |
10000 |
t |
|
t |
|
0s |
0 |
Positive Control |
475 |
108.7 |
764 |
21.3 |
326 |
10.7 |
Strain: TA1537
Dose |
No Activation |
10% HLI |
10% RLI |
|||
Protocol |
Preincubation |
Preincubation |
Preincubation |
|||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
5 |
1.5 |
5 |
1.5 |
6 |
1.7 |
100 |
11 |
2.1 |
7 |
1.2 |
6 |
1 |
333 |
5 |
1.3 |
4 |
1 |
7 |
1.2 |
1000 |
6 |
3.2 |
7 |
1.2 |
4 |
0.7 |
3333 |
4 |
1.7 |
0s |
0 |
3 |
0.7 |
10000 |
0s |
0 |
t |
|
0s |
0 |
Positive Control |
350 |
41.7 |
406 |
11.5 |
135 |
8.7 |
Abbreviations:
RLI =
induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and
Precipitate; T = Toxic; c = Contamination
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this publication, the test substance is negative in the Salmonella/microsome preincubation assay with and without metabolic activation.
- Executive summary:
The test substance was evaluated for mutagenicity in the Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program. Doses of 0, 100, 333, 1000, 3333 and 10000 ug/plate were tested in four Salmonella typhimurium strains (TA98, TA100, TA1535, and TA1537) in the presence and absence of Aroclor-induced rat or hamster liver S9. The test substance was evaulated as negative in all experiments.
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