Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-518-3 | CAS number: 4394-85-8
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Jan 2016 - 26 Mar 2016
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-morpholinecarbaldehyde
- EC Number:
- 224-518-3
- EC Name:
- 4-morpholinecarbaldehyde
- Cas Number:
- 4394-85-8
- Molecular formula:
- C5H9NO2
- IUPAC Name:
- morpholine-4-carbaldehyde
- Test material form:
- aerosol dispenser: not specified
- Remarks:
- migrated information: aerosol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 93973556P0
- Expiration date of the lot/batch: 08 Apr 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room termparture
- Stability under test conditions: The stability of the test substance under storage conditions over the test
period was guarenteed by the sponsol.
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 11 weeks
- Weight at study initiation: female 200,5 g; male 239,5 g
- Housing: air-conditioned rooms; TYP III polycarbonate cages; wooden gnowing blocks as
enrichment, single housing or up to 5 animals, dust-free wooden bedding
- Diet: Kliba laboratory diet, mouse/rat maintenance "GLP" 12mm pellets ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes : 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- Test-substance preparation:
The test substance was dosed unchanged.
The test substance was stirred in its container before a sample for aerosol generation was taken.
Equipment: Two-component atomizer Mod. 970 (stainless steel, Schlick) Continuous infusion pumps PHD Ultra (Harvard Apparatus, Inc., Holliston, Massachusetts, U.S.A.)
Generation technique: A liquid aerosol was generated.
The aerosol was produced by continuously pumping amounts of the test substance into the two-component atomizer. Using compressed air, the aerosol was generated with the atomizer inside the exposure system.
Nose-only inhalation system INA 20 (glass-steel construction, BASF SE, volume V 55 L): the animals were restrained in glass tubes and their snouts projected into the inhalation system.
The homogenous distribution of test substance atmosphere in this inhalation system has been verified with model aerosols.
Conditioned air:
The central air conditioning system provides cold air of about 15°C. This cold air passes through an activated charcoal filter, is adjusted to room temperature of 20 to 24°C and passes through a second particle filter (H13 (HEPA) Camfil Farr, Germany). The so generated conditioned air was used to generate inhalation atmospheres.
Compressed air:
Compressed air was produced by an oil-free compressor (HT 6, Josef Mehrer GmbH & Co KG, Germany). For this purpose, air is filtered by an inlet air strainer and introduced into the compressor. After passing through a second ultra-filter (SMF 5/3, 108 mm, Donalson), the compressed air (15 bar) is stored in a storage of 1500
or 5000 L. The compressed air is conducted to the laboratories via pipes, where the pressure is reduced to 6 bar. In the laboratory, the compressed air can be taken as required.
Exhaust air:
The exhaust air was filtered and conducted into the exhaust air of the building.
The exposure system was located inside an exhaust cabin in an air-conditioned laboratory. During exposure, the following scheduled parameters were recorded four times at about 1-hour intervals:
Supply air flow (compressed air): (from a central air-conditioning system) 1.5 m³/h
The flow was adjusted and continuously measured with a flowmeter (Yokogawa).
Exhaust air flow: 1.3 m³/h
The flow was adjusted and continuously measured with a flowmeter (Yokogawa).
The lower amount of exhaust air, which was adjusted by means of a separate exhaust air system, achieved a positive pressure inside the exposure system. This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals.
An air change of about 27 times per hour can be calculated by dividing the supply air flows by the volume of the inhalation system.
The animals were exposed to the inhalation atmosphere for 4 hours plus equilibration time of
the inhalation systems (t99 about 10 min).
No surveillance of the oxygen content in the inhalation system was performed. The air change was judged to be sufficient to prevent oxygen depletion by the breathing of the animals, and the concentration of the test substance used could not have a substantial influence on oxygen partial pressure.
Temperature: The temperature in the inhalation system was measured with a digital thermometer (Testo).
Relative humidity: The relative humidity in the inhalation system was measured with a dielectric probe (Testo).
Particle size analysie
EACD 50% (effective aerodynamic cutoff diameter 50%) defines the separation characteristic of each impactor stage. 50% of particles with the EACD given are deposited in the pertinent impactor stage; the remainder has reached one of the following stages.
MMAD (mass median aerodynamic diameter) is the calculated aerodynamic diameter which divides the size distribution in half when measured by mass.
Geometrical standard deviation (GSD) is the ratio of the estimated 84 percentile to the 50 percentile and indicates the slope of the cumulative particle size distribution curve.
Sample 1 MMAD (μm) 2,7 GSD 3.0
Sample 2 MMAD (µm) 3.0 GSD 3.0 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5,319 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Feed and Water: A check for the presence of feed and drinking water was made twice a day on workdays and once daily on weekends and public holidays.
- Body weight determination: Individual body weights once during the acclimatization period, shortly before exposure (day 0) and at least on days 1, 3 and 7,
and before the sacrifice of the animals at the end of the observation period.
- Signs: Clinical observations were recorded for each animal before exposure, separately several times during exposure (usually hourly) and after exposure. At least once daily on the preexposure day and during the post exposure observation period.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Pathology: At the end of the observation period the animals were sacrificed with CO2-inhalation in a chamber with increasing concentration over time, and were subjected to gross-pathological examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 5.319 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- no mortality occurred
- Clinical signs:
- other: abdominal respiriation, intermittent respiration indicating local irritation effect, piloerection and substance contaminated fur
- Body weight:
- the mean body weights decreased on the first post exposure observation day but decreased thereafter.
- Gross pathology:
- no gross pathological abnormalities were detected during necropsy in the animals at the termination of the study
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the current study conditions, the LC50 value was > 5.3 mg/l in male and female rats after 4 hour inhalation to liquid aerosol of the test-substance.
- Executive summary:
Based on the results observed and by applying the evaluation criteria it was concluded that N-formylmorpholine don´t need to be classified as toxic after single inhalation application according to Regulation 1272/2008/EC. (BASF, 2016).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.