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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study (GLP; ATC method, dose steps: 2000, 500 and 200 mg/kg bw, respectively, instead of 2000, 300 and 50 mg/kg bw.)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method; Dec 29, 1992)
- Deviations:
- yes
- Remarks:
- dose steps: 2000, 500 and 200 mg/kg bw, respectively, instead of 2000, 300 and 50 mg/kg bw.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
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): N-Ethyldiisopropylamin (Lab test substance number: 96/479)
- Physical state: liquid, colourless
- Analytical purity: 99.3 %
- Lot/batch No.: K 79 PD
- Storage condition of test material: Refrigerator
- Stability under test conditions: the stability of the test substance in olive oil for a time period of 4 hours was confirmed by analysis. The stability of the test substance over the study period has not been investigated by reanalysis, because the study was terminated only about 4 weeks after the characterization. It can be assumed, that the test substance was stable for the duration of the study.
- Other: the test substance was homogeneous by visual inspection.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. THOMAE GMBH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 173 - 194 g (±20% of the mean weight)
- Fasting period before study: at least 16 h before administration, but water was available ad libitum
- Housing: single housing in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: KLIBA-LABORDIAET 343, Klingenthalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- DAB 10
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: test substance is unsoluble in water
- Concentration in vehicle: 4.0, 10.0 and 40.0 g/100 ml, respectively for the low, mid and high dose groups
MAXIMUM DOSE VOLUME APPLIED: 5 ml
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on the physical and chemical characteristics of the test substance and its composition no pronounced acute oral toxicity was expected. Therefore a starting dose of 2000 mg/kg bw was chosen in a first step with 3 female animals. As all animals died, 500 mg/kg bw were used with 3 female animals in a second step. Because 100% mortality occurred, 200 mg/kg bw were tested in a third step with 3 female rats. Because no mortality occurred in this third step, 3 male animals were treated in a fourth step with the same dose (200 mg/kg bw). - Doses:
- 200, 500, 2000 mg/kg
- No. of animals per sex per dose:
- 3 females (high and mid dose levels); 3 males and 3 females (low dose level)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: up to 14 days (depending on survival)
- Frequency of observations: clinical signs daily (several times on the day of administration, and at least once each workday); check for mortality and moribund animal twice each workday and once on Saturdays, Sundays and public holidays
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes; necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2, then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible.
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred at 200 mg/kg bw (3 male and 3 female animals), whereas 100% mortality was observed at 500 and 2000 mg/kg bw (only females)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 317 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 15 - 1 360
- Remarks on result:
- other: LD50 point estimate (re-calculated)
- Mortality:
- - 2000 mg/kg bw: all 3 animals died within 1 hour;
- 500 mg/kg bw: 1 animal died within 1 hour, the remaining 2 within 3 hours;
- 200 mg/kg bw: no mortality. - Clinical signs:
- other: - 200 mg/kg: impaired general state (day 2), poor general state (hour 0-day 1), dyspnoea (hour 0-day 2), apathy (hour 0-day1), staggering (hour 0-hour 5), piloerection (hour 0-day 2) in all male animals. Poor general state, dyspnoea, apathy, staggering, t
- Gross pathology:
- Animals that died:
- 2000 mg/kg bw: glandular stomach: slight hyperemia of the glandular stomach, moderate erythema of the small intestine;
- 500 mg/kg bw: slight thickening of fore stomach and glandular stomach walls;
- 200 mg/kg bw (sacrificed animals): organs without particular findings.
Any other information on results incl. tables
Mortality:
Dose (mg/kg bw) | Gender | 1 h | 3 h | 14 days |
200 | male | 0/3 | 0/3 | 0/3 |
200 | female | 0/3 | 0/3 | 0/3 |
500 | female | 1/3 | 3/3 | 3/3 |
2000 | female | 3/3 | 3/3 | 3/3 |
Weight (g):
Dose (mg/kg) |
Gender | day 0 | day 7 | day 14 | |||
200 | male | 181 | 243 | 283 | |||
200 | female | 176 | 210 | 224 | |||
500 | female | 188 | - | - | |||
2000 | female | 177 | - | - |
There is indication that the test substance causes local irritation to the exposed tissue.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 value is between 200 and 500 mg/kg and calculated to be 317 mg/kg bw.
. - Executive summary:
To assess the acute oral toxicity after a single oral administration of ethyldiisopropylamine, a GLP study according to the acute toxic class method was conducted.
None of the animals (0/6, m/f) died after administration of 200 mg/kg bw. However clinical symptoms of toxicity were observed (poor general state, dyspnoea, apathy, staggering, tremor and twitching). All animals (3/3, f) died after receiving a dose of 500 mg/kg or 2000 mg/kg bw. Clinical symptoms were the same as observed for the 200 mg/kg dose group. Necropsy of the animals that died revealed hyperemia of the gastro-intestinal tract pointing to the irritating/caustic properties of the test substance. The test substance was applied in olive oil, which might have influenced the resorption properties and necropsy findings of this caustic substance to some extend. The LD50 value is between 200 and 500 mg/kg and calculated to be 317 mg/kg bw.
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