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EC number: 211-745-8 | CAS number: 693-21-0
- 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:
- 1.5. - 5.6.1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Acute exposure, oral toxicity. In: Health effects test guidelines. Washington, DC: EPA, Aug 1982, EPA 560/6-82-001
- Deviations:
- yes
- Remarks:
- See Overall remarks
- Qualifier:
- according to guideline
- Guideline:
- other: Acute oral toxicity study (ADL and LD50). LAIR Standard Operating Procedure OP-STX-36, Letterman Army Institute of Research, Presidio of San Francisco, CA. 15 Jun 1984
- Deviations:
- yes
- Remarks:
- See Overall remarks
- GLP compliance:
- yes
- Test type:
- other: modified up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Oxydiethylene dinitrate
- EC Number:
- 211-745-8
- EC Name:
- Oxydiethylene dinitrate
- Cas Number:
- 693-21-0
- Molecular formula:
- C4H8N2O7
- IUPAC Name:
- 2-[2-(nitrooxy)ethoxy]ethyl nitrate
- Details on test material:
- - Name of test material (as cited in study report): Diethyleneglycol Dinitrate (DEGDN)
- Physical state: pale yellow liquid
- Analytical purity: 96.6%
- Impurities (identity and concentrations): not identified
- Lot/batch No.: RAD84MOO1S214
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman, Inc, Fremont, CA
- Weight at study initiation: 168 - 279 g
- Fasting period before study: overnight
- Housing:individually in stainless steel wire mesh cages in racks equipped with automatic flushing dumptanks, no bedding was used
- Diet (e.g. ad libitum): Certified Purina Rodent Chow Diet 5002 (Ralston Purina Company, St Louis, MO)
- Water (e.g. ad libitum): from central line
- Acclimation period: 12-19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3 - 25.6 °C
- Humidity (%): 41 - 55%
- Photoperiod (hrs dark / hrs light): 12 hours of light per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/ kg b.w. (1.98-2.79 ml/males, 1.68-2.4 ml/females)
DOSAGE PREPARATION (if unusual): DEGDN was received as a solution containing 18% acetone. The acetone was removed with a rotary evaporator. DEGDN was then suspended in corn oil to form a viscous yellow oily suspension.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The results of an approximate lethal dose (ALD) determination suggested that the median lethal dose (MLD) was between 500 and 1000 mg/kg. Based on these data, test doses were selected. - Doses:
- Males: 794, 891, 1000, 1120, 1260 mg/kg
Females: 631, 794, 891, 1000, 1260 mg/kg - No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
- mortality and signs of acute toxicity: on the day of dosing 1, 2, 4, 6 hours after dosing and then daily
- weighting: weekly
- Necropsy of survivors performed: yes - Statistics:
- The LD10, LD50 and LD90 were derived by probit analysis using the maximum likelihood method. The program, PROBIT, Model MV8000 was used to plot the probit curve and lethal dose values.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 990 mg/kg bw
- 95% CL:
- 924 - 1 060
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 753 mg/kg bw
- 95% CL:
- 654 - 826
- Mortality:
- Forty-eight animals died as a result of the dosing. Twenty-five deaths (52.1%) occured within 24 hours of dosing. Fifteen deaths (31.2%) occured between 24 and 48 hours after dosing. The remaining 8 deaths (16.7%) occured between 18 and 120 hours after dosing.
- Clinical signs:
- other: Behavioral disturbances (73 of 79 animals) - inactivity, twitching, tremors, hypertonia, irritability, jumping and ataxia. They were first observed 1 to 3 hours after dosing and, with exception of inactivity and irritability, were no longer observed 72 ho
- Gross pathology:
- The mortalities which occured after dosing appear to have been caused by the test compound.
A dose-response effect on deaths was apparent in both male and female rats.
Multifocal necrohemorrhagic gastritis - probably treatment related.
Liver vacuolization - maybe related to treatment or maybe not
Renal autolysis, renal autolysis and renal necrosis
Applicant's summary and conclusion
- Conclusions:
- Diethyleneglycol dinitrate produces signs of neurotoxicity in addition to standard symptoms of nitrate ester poisoning. Calculated MLD values
were 990.4 ± 30.0 mg/kg in male Sprague-Dawley rats and 753.1 ± 35.9 mg/kg in female Sprague-Dawley rats. - Executive summary:
The acute oral toxicity of the nitrate ester, diethyleneglycol dinitrate (DEGDN), was determined in male and female Sprague-Dawley rats by using the oral gavage single-dose method. The median lethal dose (MDL) was 990.4 +/- 30 mg/kg for male rats and 753.1 +/- 35.9 mg/kg for female rats. Clinical signs produced by DEGDN included twitching, tremors, hypertonia, squinting, lacrimation, depression of grasping and righting reflexes, jumping, increased startle reflex, ataxia, cyamosis, inactivity, and prostration. The extent of the neurotoxic component of this clinical signs profile suggests that DEGDN possesses additional pharmacological properties to those routinely associated with the nitrate esters. The duration of clinical signs was acute. Most animals were exhibiting signs by 2 hours after dosing and had either died or cleared by 72 hours after dosing.
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