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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25.7.1985 - 3.9.1985
- 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
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA. Office of pesticides and Toxic Substances, Office of Toxic Substances (TS-792). Primary dermal irritation. In: Health effects test guidelines. Washigton, DC: EPA, August 1982, EPA 560/6-82-001
- Deviations:
- yes
- Remarks:
- See Overall remarks
- Qualifier:
- according to guideline
- Guideline:
- other: Primary dermal irritation study. LAIR Standard Operating Procedure OP-STX-34. Presidio of San Francisco, CA: Letterman Army institute of Research, 19 March 1982
- Deviations:
- yes
- Remarks:
- See Overall remarks
- GLP compliance:
- yes
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): diethylene Glycol Dinitrate (DEGDN)
- The DEGDN was shipped containing 18% acetone (a desensitizer).
- Analytical purity: 96.6.%
- Impurities (identity and concentrations): The impurities were not identified.
- Lot/batch No.: RAD84MOO1S214
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry, 5265 Starr Way, Watsonville, CA 95076
- Age at study initiation: Young Adults
- Weight at study initiation: 3.0 - 3.6. kg
- Housing: individually in stainless steel, battery-type cages with screened floors and automatically flushing dumptanks.
- Diet (e.g. ad libitum): 150 g/day of Certified Purina Chow Diet 5322 (Ralston Purina Company, St Louis, MO
- Water (e.g. ad libitum): continuous drip from a central line
- Acclimation period: 15 days ???
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 - 20°C
- Humidity relative (%): 42 - 60%, with occasional spikes to 35% during room cleaning
- Photoperiod (hrs dark / hrs light): 12 hours of light per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Preparation: The DEGDN was received as a solution containing 18% acetone. The acetone was removed by evaporation before study. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removal of the patches
- Number of animals:
- Six males and two females were assigned to study. One female was submitted for quality necropsy during quarantine. One male was sacrificed due to traumatic ulcerative pododermatitis before start dosing.
The remaining six animals - 5 males and 1 female were dosed. - Details on study design:
- TEST SITE
- The shaved backs of rabbits were divided into four quadrants. Two sites were treated with the test compound. One site was a sham control (no treatment) and one site was a sham gauze patch control.
- Area of exposure: 1-inch square
- Type of wrap if used: Blenderm, a semiimpervious hypoallergenic surgical tape, was used to hold the patches in place. Vetrap was then wrapped securely around the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was gently wiped if the test material adhered to it.
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Topically apllied DEGDN produced neither edema nor erytheme at any test site on six rabbits. Also, all sham sites were negative for dermal reactions.
The six dosed animals were submitted for gross necropsy. There were no signs of skin irritation in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DEGDN should be classified as anonirritant since it causes no grossly detectable dermal reactions under conditions of this study.
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