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EC number: 425-380-9 | CAS number: 7397-46-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 425-380-9
- EC Name:
- -
- Cas Number:
- 7397-46-8
- Molecular formula:
- C5H13BO
- IUPAC Name:
- methyl diethylborinate
- Details on test material:
- - Name of test material (as cited in study report): DEMB
- Physical state: Water-white liquid
- Analytical purity: 99.4 %
- Lot/batch No.: 183
- Expiration date of the lot/batch: August 01, 1997
- Stability under test conditions: in the vehicle dry propylene glycol stable for 16-20 h
- Storage condition of test material: At room temperature in the dark
- Other: Density 0.76 g/ml
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar strain Crl:(WI) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: Approx. 6 or 8 weeks
- Weight at study initiation: males: 177 g; female: 138 g
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: 5 animals/cage (main study); single housing in the pilot study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on their physical and chemical properties.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): Because DEMB is a highly flammable liquid in open air, all procedures were carried out in a glove-box under nitrogen. The test substance was expelled from the original container into a clean vial. Immediately after weighing, the formulation was prepared on volume/volume basis by adding the appropriate amount of the vehicle (The formulations for the pilot study were prepared in propylene glycol and were used within 10 minutes after preparation. For the main study formulation (prepared approx. 18 hours prior to use), the propylene glycol was dried by addition of silica-gel at least several hours before use) and subsequently mixing to homogeneity. Adjustments were made for the specific gravity of the test substance and the vehicle. For the different dose levels, the concentration of the test substance in vehicle was varied to allow constant dosage volume in terms of ml/kg body weight. Homogeneity was accomplished to a visually acceptable level. - Doses:
- Pilot study: 2000, 500, 50 mg/kg bw
Main study: 50 mg/kg bw - No. of animals per sex per dose:
- Pilot study:
2000 mg/kg: 2 male/2 female
500 mg/kg: 1 male/1 female
50 mg/kg: 1 male/1 female
Main study:
50 mg/kg: 5 male/5 female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: twice daily; weighing in the pilot study: day 1 and 8 and in the main study: day 1,2,3,4,8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organs, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg: The two males died and the two female were killed in extremis within 1 hour after dosing.
500 mg/kg: The male and female died within 24 hours after dosing.
50 mg/kg: No mortality occurred in the pilot and the main study - Clinical signs:
- 50 mg/kg bw: hunched posture and uncoordinated movements were noted in all animals an day 1.
- Body weight:
- The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Executive summary:
According to Annex VI of EU Regulation (EC) N0. 1272/2008 (CLP) and Annex I of EU directive 67/548/EEC, DEMB is classified as harmful if swallowed Cat 4 and R22, respectively.
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