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EC number: 213-635-5 | CAS number: 996-35-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study/guideline study (results of TA 100 are missing in the standard plate test)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (only 2-Aminoanthracene as positive control with S9-mix)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-dimethylisopropylamine
- EC Number:
- 213-635-5
- EC Name:
- N,N-dimethylisopropylamine
- Cas Number:
- 996-35-0
- Molecular formula:
- C5H13N
- IUPAC Name:
- dimethyl(propan-2-yl)amine
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethylisopropylamine
- Physical state: colourless liquid
- Analytical purity: 99.8
- Lot/batch No.: tank 10
- Storage condition of test material: room temperature (N2 conditions)
- ZHT Test Substance No.: 96/134
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:
- The S9 fractions were prepared from the liver of Aroclor 1254-induced male Sprague-Dawley rats.
- Test concentrations with justification for top dose:
- standard plate test with and without S9-mix: 0; 20; 100; 500; 2500 and 5000 µg/plate.
preincubation test with and without S9-mix: 0; 4; 20; 100; 500 and 2500 µg/plate (Salmonella strains)/ 0; 20; 100; 500; 2500 and 5000 µg/plate (E. coli WP2 uvrA). - Vehicle / solvent:
- - Vehicle/solvent used: water
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water control
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: with S-9 mix: all strains 2-aminoanthracene; without S-9 mix: strains TA100, TA1535: N-methyl-N'-nitro-N-nitrosoguanidine; TA98: 4-nitro-o-phenylendiamine; TA1537: 9-aminoacridine; E.coli WP2 uvrA: N-ethyl-N'-nitro-N-nitrosoguanidine.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
METHOD OF APPLICATION: standard plate test
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction of His-positive revertants compared to control - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- bacteriotoxic effect was observed depending on the strain and test conditions at doses >= 2500 µg/plate.
- 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:
- cytotoxicity
- Remarks:
- bacteriotoxic effect was observed at doses >= 2500 µg/plate.
- 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'.
Any other information on results incl. tables
Standard Plate Test
Table 1: Mean values (without S9 mix)
|
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
|||||
Concentration (µg/plate) |
S9 |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
control |
minus |
27 |
|
d.m. |
d.m. |
23 |
|
11 |
|
56 |
|
20 |
minus |
23 |
0.8 |
d.m. |
d.m. |
18 |
0.8 |
9 |
0.8 |
49 |
0.9 |
100 |
minus |
21 |
0.8 |
d.m. |
d.m. |
18 |
0.8 |
6 |
0.5 |
58 |
1.0 |
500 |
minus |
22 |
0.8 |
d.m. |
d.m. |
13 |
0.6 |
7 |
0.6 |
56 |
1.0 |
2,500 |
minus |
21 |
0.8 |
d.m. |
d.m. |
8 |
0.4 |
5 |
0.5 |
46 |
0.8 |
5,000 |
minus |
5 |
0.2 |
d.m. |
d.m. |
4* |
0.2 |
4 |
0.4 |
42 |
0.7 |
positive control |
minus |
1005 |
36.8 |
d.m. |
d.m. |
929 |
41.0 |
505 |
45.9 |
571 |
10.1 |
Table 2: Mean values (with S9 mix)
|
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
|||||
Concentration (µg/plate) |
S9 |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
control |
yes |
42 |
|
d.m. |
d.m. |
20 |
|
8 |
|
37 |
|
20 |
yes |
41 |
1.0 |
d.m. |
d.m. |
20 |
1.0 |
7 |
0.9 |
44 |
1.2 |
100 |
yes |
30 |
0.7 |
d.m. |
d.m. |
17 |
0.8 |
6 |
0.7 |
43 |
1.2 |
500 |
yes |
20 |
0.5 |
d.m. |
d.m. |
11 |
0.5 |
6 |
0.8 |
40 |
1.1 |
2,500 |
yes |
19 |
0.5 |
d.m. |
d.m. |
14 |
0.7 |
11 |
1.4 |
42 |
1.2 |
5,000 |
yes |
20 |
0.5 |
d.m. |
d.m. |
0* |
|
8 |
1.0 |
38 |
1.0 |
positive control |
yes |
1023 |
24.4 |
d.m. |
d.m. |
125 |
6.2 |
106 |
13.2 |
161 |
4.4 |
Preincubation Test
Table 3: Mean values (without S9 mix)
|
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
|||||
Concentration (µg/plate) |
S9 |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
control |
minus |
28 |
|
123 |
|
20 |
|
10 |
|
48 |
|
4 |
minus |
23 |
0.8 |
109 |
0.9 |
14 |
0.7 |
8 |
0.8 |
- |
- |
20 |
minus |
19 |
0.7 |
124 |
1.0 |
20 |
1.0 |
10 |
1.0 |
42 |
0.9 |
100 |
minus |
24 |
0.8 |
111 |
0.9 |
16 |
0.8 |
5 |
0.5 |
42 |
0.9 |
500 |
minus |
27 |
0.9 |
113 |
0.9 |
14 |
0.7 |
8 |
0.8 |
49 |
1.0 |
2,500 |
minus |
0* |
|
24 |
0.2 |
5* |
0.3 |
0* |
|
26 |
0.5 |
5,000 |
minus |
- |
- |
- |
- |
- |
- |
- |
- |
0* |
|
positive control |
minus |
855 |
30.2 |
999 |
8.1 |
700 |
35.6 |
653 |
63.2 |
997 |
20.8 |
Table 4: Mean values (with S9 mix)
|
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
|||||
Concentration (µg/plate) |
S9 |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
X (n=3) |
revertant factor |
control |
yes |
39 |
|
119 |
|
20 |
|
11 |
|
52 |
|
4 |
yes |
39 |
1.0 |
125 |
1.1 |
18 |
0.9 |
10 |
0.9 |
- |
- |
20 |
yes |
35 |
0.9 |
103 |
0.9 |
16 |
0.8 |
12 |
1.1 |
45 |
0.9 |
100 |
yes |
38 |
1.0 |
92 |
0.8 |
16 |
0.8 |
10 |
0.9 |
45 |
0.9 |
500 |
yes |
30 |
0.8 |
99 |
0.8 |
13 |
0.7 |
9 |
0.8 |
50 |
0.9 |
2,500 |
yes |
30 |
0.8 |
92 |
0.8 |
12 |
0.6 |
9 |
0.8 |
40 |
0.8 |
5,000 |
yes |
- |
- |
- |
- |
- |
- |
- |
- |
29 |
0.5 |
positive control |
yes |
690 |
17.5 |
680 |
5.7 |
113 |
5.7 |
102 |
9.2 |
181 |
3.5 |
d.m.: data missing; *: reduced background
According to the results of the study, the test substance is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here. A cytotoxic effect can be seen in some strains in the highest concentration.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results
negative - Executive summary:
In an OECD Guideline 471/472 study, S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A were exposed to the N,N-dimethylisopropylamine in water at 0, 20, 100, 500, 2500 and 5000 µg/plate in the standard plate test with and without S9-mix, and at 0, 4, 20, 100, 500 and 2500 µg/plate (Salmonella strains) or 0, 20, 100, 500, 2500 and 5000 µg/plate (E. coli WP2 uvrA) in the preincubation test with and without S9-mix (Aroclor-induced rat liver S9 mix). Positive and negative (vehicle) controls were included in the study. N,N-dimethylisopropylamine did not induce revertants in any bacterial strains tested both with and without metabolic activation, a cytotoxic effect was seen in some strains in the highest concentration.
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