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EC number: 220-284-1 | CAS number: 2700-30-3
- 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 March 02, 2021to March 19, 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N,N-bis(1-methylethyl)formamide
- EC Number:
- 220-284-1
- EC Name:
- N,N-bis(1-methylethyl)formamide
- Cas Number:
- 2700-30-3
- Molecular formula:
- C7H15NO
- IUPAC Name:
- N,N-Diisopropylformamide
Constituent 1
- Specific details on test material used for the study:
- Batch No.: M-O303190723301F
Purity: 99.68%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: SPF(Beijing) Biotechnology Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: 51-60 days on arrival, in the range of 57-70 days at the commencement of each animal’s dosing.
- Weight at study initiation: The body weight range was 231-241 g at grouping
- Fasting period before study: overnight prior to dosing
- Housing: Animals were housed in Room D130 of the facility’s barrier system. Animals were raised in suspended, stainless steel cages. Animals were housed in groups during the adaption period. Animals were housed individually during the test.
- Historical data:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3-22.2
- Humidity (%): 50%-68%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30, 5 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: because the test item has no solubility and hydrolysis information according to the MSDS provided by sponsor, to prevent its hydrolysis in water, corn oil was used as the vehicle.
- Lot/batch no. (if required): 20201204
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): For the purpose of 300 and 50 mg/kg b.w. dose level, the test item was freshly prepared with the vehicle. Calculated the theoretical amounts of test item and weighed it in a grinding jar. Put a small amount of vehicle into the grinding jar, and then stirred with a glass rod, and subsequently diluted the test item with vehicle to the scale mark. The prepared formulations were fully stirred and labeled for use.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: According to OECD Guideline for Testing of Chemicals “Acute Oral Toxicity-Acute Toxic Class Method” (TG 423, adopted 2001) and the dose level of 300 mg/kg b.w. is selected as the starting dose from one of four fixed dose levels (5, 50, 300, 2000 mg/kg) - Doses:
- 300 and 50 mg/kg b.w.
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Inspections were made twice daily, in the morning and afternoon, during normal working days (except that it was made once on the dosing and necropsy days), and once daily at weekends and public holiday. Clinical observations were performed once during the first 30 minutes and at 1, 2 and 4 hours after application approximately, and then once each day for up to 14 days. Individual weights of animals were determined within 24 hours after arrival, at the end of adaption period , at grouping (the day before each animal's dosing day), on Day 0 (day of dosing), Day 7 and Day 14. Dead animals were weighed during the test.
- Necropsy of survivors performed: Animals surviving to the end of the study were anesthetized by CO2 and bled by abdominal aorta to death. A gross necropsy was performed on all animals under test. The necropsy included carefully eye examinations of the abdominal, thoracic organs and their contents of all animals.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level-The first dosing (300 mg/kg b.w.): All animals dead.
Dose Level-The second dosing (50 mg/kg b.w.): There were no deaths or moribund status of any of the animals during the test.
Dose Level-The third dosing (50 mg/kg b.w.): There were no deaths or moribund status of any of the animals during the test. - Clinical signs:
- Dose Level-The first dosing (300 mg/kg b.w.): All animals showed jump, blood discharge of mouth, tachypnea and dead after administration.
Dose Level-The second dosing (50 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The third dosing (50 mg/kg b.w.): All animals showed no abnormal symptoms during the test. - Body weight:
- All of the surviving animals gained body weights during the test.
- Gross pathology:
- All animals under test showed no abnormalities at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral LD50 in rats for the test item was estimated to be between 300 and 50 mg/kg b.w. and the cut-off value of LD50 was estimated to be 200 mg/kg b.w.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test item in Sprague Dawley rats. The method was designed to meet the OECD Guideline 423 under GLP.
The acute oral LD50 in rats for the test item was estimated to be between 300 and 50 mg/kg b.w. and the cut-off value of LD50 was estimated to be 200 mg/kg b.w.
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