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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-01-31 to 1997-02-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This experiment was performed in accordance with OECD 401 without deviations. A few minor details were not described in the report (randomization of animals and assignment to treatment group, weight variation among animals at study initiation, etc.) but all report elements required by the guideline were present. Further, a dose response relationship was established via this experiment.
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 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
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): A-99
- Physical state: Liquid
- Analytical purity: 99.2%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: N/A
- Isomers composition: N/A
- Purity test date: 1997-03-12
- Expiration date of the lot/batch: No data
- Storage condition of test material: Original container at room temperature
- Other: A sufficient amount of test material was transferred from the original container to a labeled storage vessel. A stir bar was added, and the test material was maintained on a magnetic stir plate throughout the dosing procedures.
- Lot/batch No.: T208121896
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, MI
- Age at study initiation: N/A (Young adult)
- Weight at study initiation: 206 to 259 grams at initiation of dosing
- Fasting period before study: Approximately 18-20 hours prior to dosing
- Housing: Individual wire mesh cages
- Diet (e.g. ad libitum): PMI Feeds, Inc. Certified Rodent LabDiet 5002 was provided ad libitum
- Water (e.g. ad libitum): Municipal water was provided ad libitum
- Acclimation period: Minimum of 7 days prior to initiation of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.06 to 22.84
- Humidity (%): 35.9 to 46.7
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Substance used neat
- Amount of vehicle (if gavage): Substance used neat
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 1.22 mL/kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose range-finding studies - Doses:
- 500, 720 and 1037 mg/kg (0.59, 0.85 and 1.22 mL/kg, respectively)
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality at approximately 1.0, 3.0 and 4.0 hours post dosing on day 0 and twice daily (morning and afternoon) thereafter for 14 days; clinical observations at approximately 1.0, 3.0 and 4.0 hours post dosing on day 0 and once daily thereafter for 14 days; Body weights at days -1, 0 (initiation), 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: None - Statistics:
- Litchfield and Wilcoxon
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 708 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 652 - 769
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 603 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 527 - 689
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 677 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 636 - 722
- Mortality:
- At the 500 mg/kg dose level, 0/5 males and 0/5 females died. At the 720 mg/kg dose level, 3/5 males and 5/5 females died. At the 1037 mg/kg dose level, 5/5 males and 5/5 females died. The majority of deaths (17/18) occurred between days 0-2. One male in the 720 mg/kg group died on day 8.
- Clinical signs:
- other: Clinical findings were noted in all dose groups. Wet and/or dried red, yellow and/or clear staining/matting/material (around the nose, mouth, eye(s), forepaw(s) and/or urogenital area) was noted for 23 rats. Nineteen animals were hypoactive. Rales and
- Gross pathology:
- Of the animals found dead, 17/18 animals had gastrointestinal abnormalities (a distended stomach, red fluid and/or dark red contents, reddened mucosa, dark red area(s) in the intestine and/or stomach). Small seminal vesicles, a hemorrhagic thymus gland and dilated renal pelvis were noted for one male rat each. Seven animals had various external matting (yellow, red and/or brown matting around the eyes, nose, mouth, urogenital and/or anogenital area). There were no other gross necropsy findings for all other animals found dead. There were no findings for animals which survived to the scheduled necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test substance was found to be 677 mg/kg with 95% confidence limits of 636-722 mg/kg when administered once orally via gastric intubation to fasted male and female albino rats. Based on these results and according to the CLP Regulation, the test substance is to be classified as acute oral toxicant category 4.
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