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EC number: 230-392-0 | CAS number: 7087-68-5
- 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:
- end 2008-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, OECD 471 (1997 July 21st)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Ethyldiisopropylamine
- EC Number:
- 230-392-0
- EC Name:
- Ethyldiisopropylamine
- Cas Number:
- 7087-68-5
- Molecular formula:
- C8H19N
- IUPAC Name:
- ethylbis(propan-2-yl)amine
- Details on test material:
- - Name of test material (as cited in study report): Ethyldiisopropylamine
- Physical state: liquid
- Analytical purity: 99.89%
- Purity test date: 2006-11-29
- Lot/batch No.: 2811061
- Stability under test conditions: no data
- Storage condition of test material: protected from moisture and at temperature <50°C
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 312.5, 625, 1250, 2500, and 5000µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (Batch V61963106L, Carlo Erba, Val de Reuil, France)
- Justification for choice of solvent/vehicle: solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: NaN3 1µg/plate (TA1535-TA100), 9-AA 50 µg/plate (TA1537), 2-NF 0.5µg/plate (TA98), MMC 0.5µg/plate (TA102) +S9: 2-anthramine 2µg/plate (TA 1535-TA1537-TA98), Benzo(a)pyrene5µg/plate (TA100), 2-anthramine 10µg/plate (TA102)
- Details on test system and experimental conditions:
- METHODS OF APPLICATION:
Plate incorporation (both experiments without S9 mix, and the first experiment with S9mix);
test item solution (0.025mL),
+/-S9mix or phosphate buffer pH7.4 (0.5mL)
bacterial suspension (0.1mL)
2mL of overlay agar
preincubation (the second experiment with S9mix)
DURATION : 60min at 37°C
test item solution (0.025mL),
S9mix(0.5mL)
bacterial suspension (0.1mL)
after preincubation: 2mL of overlay agar
READING after 48 to 72hours incubation at 37°C
DETERMINATION OF CYTOTOXICITY
- Method: number of revertants - Evaluation criteria:
- A reproductible 2-fold increase (TA98, TA100, TA102) or 3-fold increase (TA1535, TA1537) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of dose-relationship was considered as positive result.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at doses > 2500µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
Since the test item was freely soluble and non-toxic, the highest dose-level was 5000 µg/plate, according to the criteria specified in the international guidelines.
The selected treatment-levels were 312.5, 625, 1250 2500 and 5000 µg/plate, for both mutagenicity experiments with and without S9 mix.
Without S9 mix, no toxicity was induced in any of the five strains tested, in either experiment.
With S9 mix, using the direct plate incorporation method, no toxicity was induced in any of the five strains tested.
In the preincubation method, moderate to strong toxicity was induced at dose-levels = 2500 µg/plate, in all tester strains tested.
The test item did not induce any noteworthy increase in the number of revertants, either with or without S9 mix, in any of the five strains. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Ethyldiisopropylamine did not show any mutagenic activity in the bacterial reverse mutation test with S. typhimurium. - Executive summary:
The genotoxic activity of ethyldiisopropylamine EDIPA is evaluated in the Ames test on Salmonella typhimurium according to the OECD 471 guideline (Haddouk, 2008). Doses of 312.5, 625, 1250, 2500, and 5000µg/plate are tested on five strains (TA 98, TA 100, TA 102, TA 1535 and TA 1537) according to two methods: direct plate incorporation (the first experiment and the second without S9mix) and the preincubation method (60 min at 37°C - second experiment with S9mix). The number of revertants colonies is evaluated 48 to 72 hours later. Cytotoxicity was observed for the highest doses (2500µg/plate and higher) with and without metabolic activation in any strain. No genotoxic activity was observed for all doses with and without metabolic activation on the 5 tested strains. Ethyldiisopropylamine did not induce genotoxicity in the Ames test on Salmonella typhimurium in the absence and presence of metabolic activation.
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