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EC number: 221-220-5 | CAS number: 3033-62-3
- 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
- Study period:
- 1982-07-21 - 1982-07-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study report included thorough methods and results sections, followed the internal laboratory protocol without any reported deviations, and generally followed the related OECD Method (OECD 476). The study was said to be conducted under GLP conditions but no certificate was provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Study did not include cross-linking mutagens (TA102) or a DNA repair-proficient strain of E. coli.
- Principles of method if other than guideline:
- An internal BRCC Laboratory protocol was followed with no deviations.
- GLP compliance:
- yes
- Remarks:
- As described in Section I. Quality Control (no certificate)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
- EC Number:
- 221-220-5
- EC Name:
- N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
- Cas Number:
- 3033-62-3
- Molecular formula:
- C8H20N2O
- IUPAC Name:
- {2-[2-(dimethylamino)ethoxy]ethyl}dimethylamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): NIAX Catalyst A-99
- Substance type: active substance
- Physical state: Liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: Room temperature
- Other: Storage location was chemical hood/Genetic Toxicology Department
- Lot/batch No.: 51-DKE-115
Method
- Target gene:
- Reverse mutations in the histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fraction of rat liver homogenate obtained from Arcolor 1254-treated Sprague Dawley male rats
- Test concentrations with justification for top dose:
- 0.003, 0.01, 0.03, 0.1, 0.3 µL/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water, deionized, sterile
- Justification for choice of solvent/vehicle: no data
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Preincubation period: Broth cultures are prepared by inoculating from the master plates into nutrient broth and incubated overnight with agitation.
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS: Each dose tested in triplicate and with all 5 bacterial strains
DETERMINATION OF CYTOTOXICITY
- Method: Inhibition of growth of background lawn
OTHER EXAMINATIONS: not applicable
OTHER: A preliminary toxicity test was performed using strain TA100 to determine the level of toxicity of the test substance. Ten doses were tested for toxicity with a plate assay performed in the manner used for mutagenicity determinations. Toxicity was assessed at 24 to 48 hours after treatment by either growth inhibition of the background lawn or a reduction in the number of spontaneous mutants. - Evaluation criteria:
- The spontaneous reversion for the solvent controls must be within the laboratory's historical range. The positive controls must demonstrate that the test systems are responsive with known mutagens. A test chemical is considered a bacterial mutagen if the number of revertant colonies is at least twice the solvent control for at least one dose level and there is evidence of a dose-related increase in the number of revertant colonies. If a test chemical produces a marginal or weak response that cannot be reproduced, the initial positive result loses significance. If there is no evidence of a dose-related increase in the number of revertant colonies and the number of revertant colonies is not twice the solvent control, then the test chemical is not considered to be a bacterial mutagen.
- Statistics:
- All plate counts and the respective means and standard deviations were provided. If the background lawn is sparse and the colony count is still recorded, that number is not used in the calculation of the mean number of colonies and its standard deviation.
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:
- Some toxicity was noted at the 0.3 uL dose.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Some toxicity was noted at the 0.3 uL dose.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not applicable
- Effects of osmolality: not applicable
- Evaporation from medium: not applicable
- Water solubility: not applicable
- Precipitation: not applicable
- Other confounding effects: Concurrently run sterility checks showed that the S9 mix, PBS, the test chemical and all solvents and controls were sterile.
RANGE-FINDING/SCREENING STUDIES: The top dose of the 50 uL/plate inhibited all growth, while the doses of 10, 3, 1, and 0.3 microliters per plate allowed only sparse growth.
COMPARISON WITH HISTORICAL CONTROL DATA: The spontaneous reversion rate of the negative controls was within the historical range at the laboratory.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxicity, observed as a reduction of the background lawn, was obtained with at least one plate for each strain at the 0.3 uL per plate dose in both tests. Those plate counts were not used to calculate the means.
See Tables 1 and 2 below for full results.
Any other information on results incl. tables
Table 1. Results of the Salmonella Mutagenicity Assay. NIAX Catalyst A-99, Without Activation
Test Agent | Dose per Plate | Plate Counts | Average | Std. Dev. | ||
1 | 2 | 3 | ||||
Strain TA98 | ||||||
Solvent | 100 µL | 20 | 15 | 16 | 17 | 2.6 |
POS: 01 | 10 µg | 810 | 869 | 840 | 840 | 29.5 |
Test Substance | 0.3 µL | 15 | 21 | 16 (T) | 18 | 4.2 |
0.1 µL | 15 | 18 | 14 | 16 | 2.1 | |
0.03 µL | 20 | 21 | 14 | 16 | 3.8 | |
0.01 µL | 15 | 7 | 13 | 12 | 4.2 | |
0.003 µL | 12 | 15 | 7 | 11 | 4.0 | |
Strain TA100 | ||||||
Solvent | 100 µL | 161 | 148 | 143 | 151 | 9.3 |
POS: 02 | 10 µg | 1338 | 1172 | 869 | 1126 | 237.8 |
Test Substance | 0.3 µL | 155 | 140 (T) | 149 (T) | 155 | ---- |
0.1 µL | 136 | 158 | 141 | 145 | 11.5 | |
0.03 µL | 115 | 156 | 143 | 138 | 21.0 | |
0.01 µL | 123 | 160 | 144 | 142 | 18.6 | |
0.003 µL | 132 | 158 | 145 | 145 | 13.0 | |
Strain TA1535 | ||||||
Solvent | 100 µL | 51 | 37 | 36 | 41 | 8.4 |
POS: 02 | 10 µg | 1341 | 1344 | 1371 | 1352 | 16.5 |
Test Substance | 0.3 µL | 43 | 42 | 28 (T) | 42 | 0.7 |
0.1 µL | 21 | 28 | 55 | 35 | 18.0 | |
0.03 µL | 45 | 42 | 41 | 43 | 2.1 | |
0.01 µL | 42 | 37 | 43 | 41 | 3.2 | |
0.003 µL | 34 | 50 | 24 | 36 | 13.1 | |
Strain TA1537 | ||||||
Solvent | 100 µL | 4 | 7 | 6 | 6 | 1.5 |
POS: 03 | 60 µg | 332 | 350 | 328 | 337 | 11.7 |
Test Substance | 0.3 µL | 6 | 9 | 3 (T) | 8 | 2.1 |
0.1 µL | 2 | 7 | 4 | 4 | 2.5 | |
0.03 µL | 3 | 4 | 10 | 6 | 3.8 | |
0.01 µL | 5 | 4 | 6 | 5 | 1.0 | |
0.003 µL | 4 | 4 | 7 | 5 | 1.7 | |
Strain TA1538 | ||||||
Solvent | 100 µL | 6 | 5 | 5 | 5 | 0.6 |
POS: 01 | 10 µg | 1155 | 1229 | 1249 | 1211 | 49.5 |
Test Substance | 0.3 µL | 6 | 3 (T) | 2 (T) | 6 | ---- |
0.1 µL | 12 | 8 | 12 | 11 | 2.3 | |
0.03 µL | 5 | 8 | 7 | 7 | 1.5 | |
0.01 µL | 5 | 7 | 4 | 5 | 1.5 | |
0.003 µL | 5 | 4 | 3 | 4 | 1.0 |
T: Toxic
POS: Positive Controls: 01: 4-nitro-o-phenylenediamine; 02: Sodium azide; 03: 9-aminoacridine; 04: 2-aminoanthracene
Table 2. Results of the Salmonella Mutagenicity Assay, NIAX Catalyst A-99, With Activation
Test Agent | Plate Counts | Average | Std. Dev. | |||
Dose per Plate | 1 | 2 | 3 | |||
Strain TA98 | ||||||
Solvent | 100 µL | 39 | 32 | 33 | 35 | 3.8 |
POS: 04 | 10 µg | 1793 | 1549 | 1431 | 1591 | 184.6 |
Test Substance | 0.3 µL | 32 | 33 | 28 (T) | 32 | 0.7 |
0.1 µL | 24 | 32 | 22 | 26 | 5.3 | |
0.03 µL | 28 | 33 | 28 | 30 | 2.9 | |
0.01 µL | 25 | 28 | 13 | 22 | 7.9 | |
0.003 µL | 25 | 21 | 31 | 26 | 5.0 | |
Strain TA100 | ||||||
Solvent | 100 µL | 97 | 101 | 108 | 102 | 5.6 |
POS: 04 | 10 µg | 1429 | 1226 | 1299 | 1318 | 102.8 |
Test Agent | 0.3 µL | 93 (T) | 90 (T) | 96 | 96 | --- |
0.1 µL | 102 | 110 | 125 | 112 | 11.7 | |
0.03 µL | 113 | 89 | 90 | 97 | 13.6 | |
0.01 µL | 117 | 110 | 89 | 105 | 14.6 | |
0.003 µL | 112 | 110 | 97 | 106 | 8.1 | |
Strain TA1535 | ||||||
Solvent | 100 µL | 15 | 9 | 14 | 13 | 3.2 |
POS: 04 | 10 µg | 99 | 88 | 98 | 95 | 6.1 |
Test Substance | 0.3 µL | 8 (T) | 15 | 12 (T) | 15 | --- |
0.1 µL | 16 | 9 | 14 | 13 | 3.6 | |
0.03 µL | 4 | 17 | 8 | 10 | 6.7 | |
0.01 µL | 12 | 7 | 9 | 9 | 2.5 | |
0.003 µL | 5 | 11 | 7 | 8 | 3.1 | |
Strain TA1537 | ||||||
Solvent | 100 µL | 3 | 9 | 6 | 6 | 3.0 |
POS: 04 | 10 µg | 139 | 117 | 181 | 146 | 32.5 |
Test Substance | 0.3 µL | 2 (T) | 3 (T) | 2 (T) | --- | --- |
0.1 µL | 9 | 4 | 9 | 7 | 2.9 | |
0.03 µL | 8 | 5 | 10 | 8 | 2.5 | |
0.01 µL | 2 | 9 | 6 | 6 | 3.5 | |
0.003 µL | 10 | 4 | 8 | 7 | 3.1 | |
Strain TA1538 | ||||||
Solvent | 100 µL | 14 | 29 | 17 | 20 | 7.9 |
POS: 04 | 10 µg | 543 | 789 | 294 | 542 | 247.5 |
Test Substance | 0.3 µL | 10 | 26 | 7 (T) | 18 | 11.3 |
0.1 µL | 9 | 15 | 15 | 13 | 3.5 | |
0.03 µL | 17 | 13 | 26 | 19 | 6.7 | |
0.01 µL | 16 | 24 | 8 | 16 | 8.0 | |
0.003 µL | 18 | 12 | 17 | 16 | 3.2 |
T: Toxic
POS: Positive Controls - 01: 4-nitro-o-phenylenediamine; 02: Sodium azide; 03: 9-aminoacridine; 04: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- NIAX Catalyst A-99 did not produce a dose-dependent mutagenic response in any of the Salmonella typhimurium strains. Under the conditions of this assay, NIAX Catalyst A-99 was not mutagenic at 0.003, 0.01, 0.03, 0.1, and 0.3 uL/plate in the Salmonella/microsome mutagenicity assay.
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