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EC number: 231-391-8 | CAS number: 7529-22-8
- 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:
- From September 9, 1981 through September 28, 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
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 4-oxide, monohydrate
- EC Number:
- 231-391-8
- EC Name:
- 4-methylmorpholine 4-oxide, monohydrate
- Cas Number:
- 7529-22-8
- Molecular formula:
- C5H11NO2
- IUPAC Name:
- 4-methyl-4λ⁵-morpholin-4-one
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4236-43-5, Order #J-85
- Substance type: yellow liquid
- Purity: responsibility of the sponsor. It is confirmed by the Sponsor that the test has been performed with a 50% aqueous solution.
- Stability: There was no apparent change in the physical state of the test article during administration
- Other: Specific gravity = 1.136 g/mL
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Blue Spruce Farms, Altamont, New York
- Weight at study initiation: 180 - 360 grams after fasting. The weight variation in animals or between groups did not exceed +/- 20%
- Housing: Separate isolation by test system; rats were housed individually in stainless steel wire mesh cages. Size in accordance with Guide for the Care and Use of Laboratory Animals of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Lab Blox, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, briding, and scattering
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using an automatic watering system supplied by Edstrom Industries Inc., Waterford, Wisconsin
- Acclimation period: Five days
- Fasting period before study: 18 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 7000, 8000, 9000 and 10000 mg/kg
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed approximately at one, two, four and twenty-four hours after dosing and twice daily for fourteen days for pharmacotoxic, CNS effects and mortality. On the seventh and fourteenth day body weights were recorded.
- Necropsy of survivors performed: yes: The surviving rats were sacrificed by CO2 inhalation and a gross necropsy performed. - Statistics:
- no details
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 9 200 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 8 200 - <= 10 300
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 9 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 8 800 - <= 10 900
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 9 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 7 800 - <= 11 200
- Mortality:
- None of the animals died at the 7000 mg/kg dose level, two of the ten died at the 8000 mg/kg dose level (2 females), three of ten died at the 9000 mg/kg dose level (1 male, 2 females) and seven of ten died at the 10000 mg/kg dose level (3 males and 4 females).
- Clinical signs:
- other: Diarrhea, piloerection, abnormal gait, abnormal stance, decreased body tone, decreased activity and orange discoloration around the nose and genital areas.
- Gross pathology:
- Necropsy revealed distended fluid-filled stomachs and intestines (clear, tan, green, white or orange), mottled lungs, darkened thymuses and darkened lymph nodes. Terminal necropsy revealed no visible lesions in any of the remaining rats.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The calculated acute oral LD50 for male and female rats treated with the substance, was determined to be 9200 mg/kg with 95% confidence limits of 8200 to 10300 mg/kg. The test solution used was a 50% aqueous solution of NMMO. The LD50 of the pure NMMO is therefore considered to be 4600 mg/kg. Based on the study results and the criteria of the CLP Regulation, this substance should not be classified for oral toxicity.
- Executive summary:
In an acute oral toxicity study which was performed equivalent/similar to OECD TG 401, groups of five Sprague-Dawley rats/sex were given a single oral dose of 4-methylmorpholine 4-oxide (50% aqueous solution) by oral gavage at doses of 7000, 8000, 9000 and 10000 mg/kg bw. Animals were then observed for 14 days.
None of the animals died at the 7000 mg/kg dose level, two of the ten died at the 8000 mg/kg dose level (2 females), three of ten died at the 9000 mg/kg dose level (1 male, 2 females) and seven of ten died at the 10000 mg/kg dose level (3 males and 4 females). Necropsy revealed distended fluid-filled stomachs and intestines (clear, tan, green, white or orange), mottled lungs, darkened thymuses and darkened lymph nodes. Terminal necropsy revealed no visible lesions in any of the remaining rats. Clinical signs included Diarrhea, piloerection, abnormal gait, abnormal stance, decreased body tone, decreased activity and orange discoloration around the nose and genital areas.
The oral LD50 was calculated to be 9800 mg/kg bw for males and 9300 mg/kg bw for females. The combined oral LD50 was calculated to be 9200 mg/kg bw/day.
As a 50% aqueous solution is used, the combined LD50 for the pure NMMO is considered to be 4600 mg/kg bw. Based on the results of this study and according to the criteria of the CLP Regulation, the substance should not be classified for acute oral toxicity.
This acute oral study is classified as acceptable. It satisfies the guideline requirements for an acute oral toxicity study. Dose levels exceeded the current standards of oral toxicity testing.
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