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EC number: 204-590-2 | CAS number: 123-00-2
- 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:
- 1992-07-13 to 1992-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-morpholinopropylamine
- EC Number:
- 204-590-2
- EC Name:
- 3-morpholinopropylamine
- Cas Number:
- 123-00-2
- Molecular formula:
- C7H16N2O
- IUPAC Name:
- 3-morpholin-4-ylpropan-1-amine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: no data
- Expiration date of the lot/batch: The identity, purity, strength and stability of the test article were the responsibility of the Sponsor.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data, there was no apparent change in the physical state of the test article during storage or administration.
- Solubility and stability of the test substance in the solvent/vehicle: no data
OTHER SPECIFICS:
Specific gravity: 0.9888 gm/mL
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Riv:er Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: 6-10 weeks
- Fasting : yes
- Weight at study initiation: 180-294 grams (dose-range finding test); definitive test: 168-247 grams
- Fasting period before study: no data, however animals were fasted
- Housing: Rats were housed individually in stainless steel " wire mesh cages, sized in accordance with the "Guide for the care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research council.
- Diet (e.g. ad libitum): Harlan Teklad Lab Blox@, ad libitum, checked daily and added or replaced as needed.
- Water (e.g. ad libitum): Water was monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.
- Acclimation period: Minimum of five (5) days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 3°
- Humidity (%): 30 to 70%.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test article was dosed as received using specific gravity calculations.
- Doses:
- dose-range finding study: 500, 2500 and 5000 mg/kg
definitive study: 800, 1250 and 2000 mg/kg - No. of animals per sex per dose:
- Dose-range finding study: 1
Definitive study: 5 - Control animals:
- no
- Details on study design:
- Dose-range finding study:
The rats were observed at approximately 1, 4, 24, 48 and 72 hours after dosing for pharmacological and toxicological effects.
Definitive study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Pharmacological and toxicological effects - at approximately 1, 4 and 24 hours after dosing and once daily through Day 14
Viability - daily
Body weights - at study initiation, Days 7 and 14 or when found dead
- Necropsy of survivors performed: yes
All surviving rats were sacrificed by CO2 inhalation and a gross necropsy was performed at termination of the study - Statistics:
- By the method of Litchfield and Wilcoxon via Innovative Programming Associates, LABCAT Module Version 4.22.
Results and discussion
- Preliminary study:
- Signs observed included decreased activity, abnormal gait, abnormal stance, dyspnea and prostration. None of the animals died at the 500 mg/kg dose level. Two of two animals died both at the 2500 and 5000 mg/kg dose levels.
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 790.9 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 888.2 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the main study one of ten animals died at the 800 mg/kg dose level.
None of the animals died at the 1250 mg/kg dose level and seven of ten animals died at 2000 mg/kg. - Clinical signs:
- In the main study the effects observed included decreased activity, abnormal gait, abnormal stance, salivation, red urine, dyspnea, poor grooming and decreased muscle tone.
- Body weight:
- With the exception of a slight decrease in body weight of one male in the 2000 mg/kg dose level, there was an apparent increase in body weight of all surviving animals.
- Gross pathology:
- Necropsy of the animals dying on study revealed fluid-filled and/or distended stomachs and intestines.
No visible lesions were observed in any animal at terminal necropsy.
Any other information on results incl. tables
The data generated for the acute LD50 in females did not lend itself to the statistical method employed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results from the Acute Exposure Oral Toxicity in rats, the, definitive acute oral LD 50 for males and combined sexes for the test item was determined to be 2888.2 mg/kg and 1790.9 mg/kg. Based on the LD50 for combined sexes and the criteria of the CLP Regulation, the test item is classified for acute oral toxicity category 4.
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