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EC number: 203-640-0 | CAS number: 109-02-4
- 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:
- 1990-10-03 - 1990-11-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- 4-methylmorpholine
- EC Number:
- 203-640-0
- EC Name:
- 4-methylmorpholine
- Cas Number:
- 109-02-4
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 4-methylmorpholine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 6398-24-20, Project #90-005
- Appearance: clear colorless liquid
- Purity: responsibility of the sponsor
- Stability: there was no apparent change in the physical state of the test article during administration
- Other: Specific gravity: 0.92 g/mL; pH 10.8 (taken from MSDS)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, inc., Wilmington, Massachusetts, USA
- Age at study initiation: young adults
- Mean weight at study initiation (n=5 per group):
Males: 380.8 g (200 mg/kg dose group), 393.4 g (400 mg/kg dose group), 379.2 g (500 mg/kg dose group), 385.8 g (1000 mg/kg dose group), 344.6 g (1500 mg/kg dose group), 382.8 g (2000 mg/kg dose group)
Females: 221.6 g (200 mg/kg dose group), 233.4 g (400 mg/kg dose group), 226.2 g (500 mg/kg dose group), 224.8 (1000 mg/kg dose group), 244.4 g (1500 mg/kg dose group)
- Housing: Rats housed individually in stainless steel 1/2 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): Wayne Teklad Lab Blox, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging, and scattering
- Water (e.g. ad libitum): Availability - fresh tap water, ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3°C
- 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:
- Maximum dose volume did not exceed 10 ml/kg bw.
- Doses:
- Dose-range-finding study: 500, 2500 and 5000 mg/kg
Definitive LD50 study: 200, 400, 500, 1000, 1500 and 2000 mg/kg - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations:
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 LD50: The rats were observed at approximately 1, 4 and 24 hours after dosing and once daily through Day 14 for pharmacological and toxicological effects. Viability was checked daily. Body weights were recorded on Days 0, 7 and 14 or when found dead. All remaining rats were sacrificed by CO2 inhalation and gross necropsy performed. - Statistics:
- LD50 determinations were performed via Litchfield and Wilcoxon on Pharmacological Calculations System, version 4.1.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 442.3 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 137 - <= 1 829.4
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 723.2 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 454.9 - <= 2 040.9
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 212.4 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 933.9 - <= 1 574.1
- Mortality:
- None of the animals died at 200, 400 or 500 mg/kg dose levels. One (female) of ten animals died at the 1000 mg/kg dose level. Five (4 females, 1 male) of ten died at the 1500 mg/kg dose level and nine (5 females, 4 males) of ten animals died at the 2000 mg/kg dose level.
- Clinical signs:
- other: Signs included decreased activity, piloerection, salivation, abnormal gait, abnormal stance, ptosis, chromodacryorrhea, dyspnea and convulsions.
- Gross pathology:
- Necropsy of the animals dying on study revealed distended and/or fluid filled stomachs and intestines, dark liver, dark pitted, mottled and/or pale kidneys and fluid filled uterine horns. Terminal necropsy of the remaining animals revealed mottled kidneys.
Any other information on results incl. tables
Results dose range study:
Signs observed included decreased activity, piloerection, salivation, abnormal gait, abnormal stance, ptosis, chromodacryorrhea, dyspnea and convulsions. One of two animals died at the 500 mg/kg dose level. Two of two animals died at both the 2500 and 5000 mg/kg dose levels. Based upon these results, a definitive LD50 test was performed.
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 study in rats, the definitive acute oral LD50 in males and females for this substance was determined to be 1442.3 mg/kg with 95% confidence limits of 1137.0 to 1829.4 mg/kg. The substance is considered classified as acute oral toxicant category 4 according to the criteria laid down in the CLP Regulation.
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