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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May-Juni 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- 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: The stability of test test item in the vehicle (0.05 and 200 mg/mL)for at least 7 days was confirmed by analysis
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The dosing preparations were prepared at room temperature and were well mixed prior administration. Before administration the dosing preparations were shortly heated up to 40°C in a cabinet.
- Final preparation of a solid: The test compound was heated to approximately 11 0°C for formulation and in orderto melt the amorphous mass so that an aliquot could be taken.
FORM AS APPLIED IN THE TEST (if different from that of starting material): Homogeneity (visual inspection): The formulations 0.5 mglml and 200 mglml are clear solutions after preparation and therefore homogeneous.
The 200 mg/ml formulation showed a slight turbidity after cooling down at room temperature which disappeared after heating shortly in a cabinet at 40°C.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, Horst, Netherlands
- Strain: HsdRCCHan:WIST
- Age at study initiation: approx. 8-12 weeks
- Weight at study initiation: 160-180 g
- Fasting period before study: 16-24 hours
- Housing: in groups
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Kolliphor HS 15 I Ethanol I Tap water (40/10/50)
- Details on oral exposure:
- - Application volume: 10 ml/kg bw
- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 x 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes - Statistics:
- none (limit test)
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All 6 animals survived the treatment.
- Clinical signs:
- No clinical signs were observed in 6/6 animals.
- Body weight:
- Body weight development was not affected.
- Gross pathology:
- No gross pathological findings were observed.
- Other findings:
- none
Applicant's summary and conclusion
- Executive summary:
A single oral dose of 2000 mg/kg bw in Kolliphor HS 15/Ethanol/Tap water (40/10/50) was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the LD50 oral of the test item is > 2000 mg/kg bw.
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