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EC number: 418-140-1 | CAS number: 5117-12-4 ACRYLOYLMORPHOLIN
- 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
Endpoint summary
Administrative data
Description of key information
The acute median lethal oral dose LD50 of the substance to rats is estimated to be 588 mg/kg bw for males and females combined.
The acute median lethal dermal dose LD50 of the substance to rats was found to be greater than 2000 mg/kg bw.
The acute inhalation study with snout-only exposure resulted 4-hour LC50 of >5.28 mg/L.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 22 April to 15 May 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Batch number: 6032505
Purity: not specified - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 91 to 138 g
- Fasting period before study: overnight prior to and 4 hours after dosing
- Housing: housed in groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C, max 23°C
- Humidity (%): 57%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hour period - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.9 mL/kg
Treatment procedure: The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter. - Doses:
- 400, 500, 640, 1000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing, then at frequent intervals for remainder of day 1. On subsequent days the animals were observed once in the morning and again at end of experimental day. The following were recorded: approximate time of death of inidividual rats; the nature, severity, approximate time of onset and duration of each toxic sign; individual bodyweights of rats on days 1, 8 and 15 and at death.
- Necropsy of survivors performed: yes
Surviving animals were killed on day 15 by carbon dioxide asphyxiation. All animals that died during the study and those killed on day 15 were subjected to a macroscopic post mortem examination which consisted of opening the abdominal, thoracic and cranial cavities. The macroscopic appearance of abnormal organs when present was recorded. - Statistics:
- The acute median lethal oral dose (LD50) to male and female rats was calculated using the method of Finney (1971) Probit analysis (3rd edition) Cambridge University press.
- Preliminary study:
- A trial test was carried out to establish a dosing regimen using groups of two male and two female rats at three dose levels of 500, 1000 and 2500 mg/kg bodyweight.
Results indicated that the acute median lethal oral dose of the substance was between 500 and 1000 mg/kg bodyweight. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 588 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 524 - < 701
- Mortality:
- Mortalities occurred among male rats dosed at 500 mg/kg and above and among females dosed at 640 or 1000 mg/kg. Deaths occurred from five hours after dosing until day 4.
- Clinical signs:
- other: piloerection, abnormal body carriage, abnormal gait, lethargy, decreased respiratory rate, pallor of extremeties and increased salivation
- Body weight:
- other body weight observations
- Remarks:
- normal bodyweight gain for survival animals
- Gross pathology:
- The autopsy of the rats which died during the study showed
in almost all rats a pallor of kidneys, spleen and/or liver.
The autopsy of the animals sacrificed at the end of the
study did not show deviations. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose LD50 of the substance to rats is estimated to be 588 mg/kg bw for males and females combined.
- Executive summary:
The study is performed to assess the acute oral toxicity of the substance, according to OECD Guideline 401.
The acute median lethal oral dose LD50 of the substance to rats is estimated to be 588 mg/kg bw for males and females combined.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 588 mg/kg bw
- Quality of whole database:
- reliable without restrictions
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 to 24 July 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Specific details on test material used for the study:
- Lot No.: 06512330
Purity: 99.5% - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river UK Ltd
- Age at exposure: 8-12 weeks
- Weight at study initiation: ca 200 g
- Housing: the rats were housed by sex in groups of 5, the holding cages were made of stainless steel sheet and wire mesh and were suspended on a moveable rack.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50% - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- snout only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- >= 3.1 - <= 3.2 µm
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: snout-only exposure chamber (ADG developments)
- Exposure chamber volume: 30 L
- Source and rate of air (airflow): 0.15 mL/minute
- Method of conditioning air: A supply of clean dried air was connected to aerosol generator and supply pressure was adjusted to give a flow rate of 10 L/min measured at generator outlet tube.
- System of generating particulates/aerosols: The aerosol generator was designed to produce and maintain an atmosphere containing a high proportion of respirable droplets. All parts of the generator in contact with the test substance were made of stainless steel or glass. The test substance was supplied to the generator from a syringe driven at a constant rate by a syringe pump. The compressed air supply to the generator was dried, filtered and oil-free.
- Temperature, humidity, pressure in air chamber: Temperature (°C): 22°C, Humidity (%): 54-66%
TEST ATMOSPHERE
- Brief description of analytical method and equipment used: at least five air samples were taken from chamber during each 4-hour exposure and the collected material was weighed to determine the concentration of test substance in chamber air. Each air sample was withdrawn at 2 L/min, through a weighed Whatman GF/A glass fibre filter, held in an open face filter holder. The volume of air samples were measured with a wet-tupe gas meter. One or two additional air samples were taken during each exposure using a Marple cascade impactor, to determine particle size distribution.
- Samples taken from breathing zone: yes/no
- Time needed for equilibrium of exposure concentration before animal exposure: 7 minutes is theoretical time required for concentration of aerosol in chamber to reach 90% of its final value - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2.3, 5.28 mg/L
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed continuously during exposure for signs of reaction to test substance and at least twice daily during observation period. All rats were weighed daily from day of delivery until end of observation period. Food and water comsumption were determined daily for each cage of rats by weight loss from the food hoppers and water bottles.
- Necropsy of survivors performed: At the end of 14-day observation period rats were anaesthetised by intraperitoneal injection of pentobarbitone sodium and killed by exsanguination. Rats were subjected to a detailed macroscopic examination. The lungs were removed, dissected clear of surrounding tissue and weighed in order to calculate lung weight to bodyweight ratio. The lungs were infused with and preserved in buffered 10% formalin together with samples of liver and kidneys for possible future microscopic examination. - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.28 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- There were no death.
- Clinical signs:
- other: no treatment-related signs during exposure, soiling of fur with excreta was seen in all test and control rats during exposure; immediately following exposure fascicular tremors were seen in rats together with exaggerated respiratory movements
- Body weight:
- Small bodyweight loss were recorded at 3 days following exposure for 4 hours.
- Gross pathology:
- All animals were within normal limits.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The 4-hour LC50 for the substance is determined as in excess of 5.28 mg/L.
- Executive summary:
The acute inhalation toxicity of the substance was assessed by exposing groups of rats, with snout-only exposure. The 4-hour LC50 for the substance is determined as in excess of 5.28 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 5.28 mg/L air
- Physical form:
- inhalation: aerosol
- Quality of whole database:
- reliable without restrictions
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 16 April to 13 May 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Lot No.: 6032505
Purity: not specified - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200 to 250 g
- Housing: housed individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C, max 23°C
- Humidity (%): 57%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hour period - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsolumbar region of each rat
- % coverage: 10% of total body surface
- Type of wrap if used: gauze was held in place with an impermeable dressing encircled firmly around trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water and blotted dry with absorbent paper
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.87 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 1260, 2000, 3200 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing, then at frequent intervals for remainder of day 1. On subsequent days the animals were observed once in the morning and again at end of experimental day. The treated areas of skin were examined daily for sign of dermal irritation and assessed.
The following were recorded: approximate time of death of inidividual rats; the nature, severity, approximate time of onset and duration of each toxic sign; individual bodyweights of rats on days 1, 8 and 15 and at death.
- Necropsy of survivors performed: yes
Surviving animals were killed on day 15 by cervical dislocation. All animals that died during the study and those killed on day 15 were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two female rats dosed at 2000 mg/kg bw were found dead on day 2. There was no death in groups of rats dosed at 1260 and 3200 mg/kg bw.
- Clinical signs:
- other: no signs of systemic reaction to treatment
- Body weight:
- other body weight observations
- Remarks:
- Body weight gains were reduced on day 8 in most of theanimals, especially in that which received 2000 or 3200mg/kg.
- Gross pathology:
- In the animals which died during the study: unregullar areas of pallor in the liver.
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal dermal dose LD50 of the substance to rats was found to be greater than 2000 mg/kg bw.
- Executive summary:
The study is performed to assess the acute dermal toxicity of the substance, according to OECD Guideline 402.
The acute median lethal dermal dose LD50 of the substance to rats was found to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- reliable without restrictions
Additional information
Justification for classification or non-classification
Acute toxicity:
Oral LD50 is 588 mg/kg body weight;
Dermal LD50 > 2000 mg/kg bw;
Inhalation LC50: >5.28 mg/L.
Therefore, in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1, this substance should be classified as Cat 4 for acute oral endpoint, and should not be classified for acute inhalation and dermal endpoints.
Specific target organ toxicity-single exposure:
Oral:
Pallor of kidneys, spleen and/or liver showed in almost all died animals, while normal in all survived animals.
Inhalation:
Stowed lungs showed in all died animals, while normal in all survived animals.
As there were no effects considered to support classification for Category 1 and 2 observed. Therefore, in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should not be classified.
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