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EC number: 478-910-6 | CAS number: -
- 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:
- 02.03.2007 - 27.03.2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Study according to OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive 2004/73/EC, B.1 tris
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Glyceryl Behenate/eicosandioate
- IUPAC Name:
- Glyceryl Behenate/eicosandioate
- Reference substance name:
- -
- EC Number:
- 478-910-6
- EC Name:
- -
- Cas Number:
- 215322-01-3
- Molecular formula:
- C114H218O12 for the stoichiometric product
- IUPAC Name:
- Reaction product of Eicosanedioic acid, Docosanoic acid and Glycerin
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Nomcort HKG
- Substance type: organic
- Physical state: solid
- Analytical purity: 100 %
- Lot/batch No.: 5-11-B
- Expiration date of the lot/batch: 29.04.2007
- Stability of test material: stable under storage condition
- Storage condition of test material: at room temperature (range of 20 +- 5 °C) away from direct sunlight
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH4414 Füllinsdorf, Switzerland
- Age at study initiation: 11 weaks
- Weight at study initiation: 175.7 - 205.8 g
- Fasting period before study: 18 hours
- Housing: in groups of 3 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: duration not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Corn oil was found to be asuitable vehicle
- Lot/batch no. (if required): 27572782
- Purity: not stated
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for clinical signs daily, for mortality/viability twice daily and body weights weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no staticitcal analysis was used
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: No signs of toxicity were observed. Mortality: No death occurred during the study. Clinical Signs: No clinical Signs were observed during the course of the study. Body Weights: The body weight of the animals was within the range co
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of Nomcort HK-G after single oral administration to female rats, observed over a period of 14 days is Ld50 greater than 2000 mg/kg body weight.
- Executive summary:
Two groups, each of three female Wistar rats, were treated with Nomcort HK-G by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (corn oil) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined dily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once dily during test days 2 - 15. Mortality/viability was recorded during the first 30 minutes and at approximately, 1, 2, 3 and 5 hours after administration on test day 1 (with clinical signs) and twice daily during days 2 - 15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
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