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Diss Factsheets
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EC number: 947-618-5 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- range-finding study for the OECD TG 421 study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Jan.-Feb. 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- - Principle of test: daily oral (gavage) administration to the rat for 7 days and to provide the basis for selection of dose levels for a subsequent OECD TG 421
- Parameters analysed / observed: Assessment of toxicity was based on clinical signs, body weight, food consumption and anatomic pathology evaluations. Full necropsies were performed on all animals with a recording of macroscopic observations and organ weights (kidney, liver, testis and epididymis). - GLP compliance:
- yes
Test material
- Reference substance name:
- N,N''-hexane-1,6-diylbis[N'-(2-hydroxyethyl)-N'-methylurea]
- EC Number:
- 253-281-9
- EC Name:
- N,N''-hexane-1,6-diylbis[N'-(2-hydroxyethyl)-N'-methylurea]
- Cas Number:
- 36938-15-5
- Molecular formula:
- C14H30N4O4
- IUPAC Name:
- 2-(3-{6-[3-(2-Hydroxyethyl)-3-methylureido]hexyl}-1-methylureido)ethanol
- Reference substance name:
- 6-[3-(2-Hydroxyethyl)-3-methylureido]hexylamino 3-(methylamino)propionate
- Molecular formula:
- C14H30N4O4
- IUPAC Name:
- 6-[3-(2-Hydroxyethyl)-3-methylureido]hexylamino 3-(methylamino)propionate
- Test material form:
- solid: bulk
- Details on test material:
- - Batch no.: EGGE 2806-1
- Currenta sample no.: 2187
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: Suspensions of 0.5 and 200 mg/mL were found to be stable and homogenous for seven days at room temperature
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Kolliphor HS15/ethanol/water (40/10/50) (v/v/v)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Assessment of toxicity was based on clinical signs, body weight, food consumption and anatomic pathology evaluations.
- Sacrifice and pathology:
- Full necropsies were performed on all animals with a recording of macroscopic observations and organ weights (kidney, liver, testis and epididymis).
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Any other information on results incl. tables
Daily administration of EGGE 2806-1 to rats at levels of 0, 100, 300 and 1000 mg/kg/day for 7 days resulted in no toxicological findings.
Applicant's summary and conclusion
- Executive summary:
Groups of 5 rats per sex of the Crl:WI(Han) strain were dosed with 0, 100, 300, 1000 mg/kg bw and day for 7 consecutive days. Assessment of toxicity was based on clinical signs, body weight, food consumption and anatomic pathology evaluations. Full necropsies were performed on all animals with a recording of macroscopic observations and organ weights. Daily administration of EGGE 2806-1 to rats at levels of 0, 100, 300 and 1000 mg/kg/day for 7 days resulted in no toxicological findings. Based on this the No Observed Effect Level (NOEL) is considered to be 1000 mg/kg/day.
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