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Diss Factsheets
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EC number: 607-952-1 | CAS number: 2653-16-9
- 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:
- 24 January - 26 February 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with an OECD guideline (see below).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- CDBE 0055 XX
- IUPAC Name:
- CDBE 0055 XX
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CDBE 0055 XX
- Physical state: solid
- Analytical purity: 99.05%
- Purity test date: 19 December 2001
- Lot/batch No.: PKLHUC00799
- Expiration date of the lot/batch: 21 Nov 2002
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CrlGlxBrlHan: WI(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: m: 189 - 234g, f: 140-153g
- Housing: housed in groups of 3 animals in Noryl cages, type IV.
- Acclimatisation period: at least 7 days
- Diet (e.g. ad libitum):pellets ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): max 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous hydroxyethyl cellulose 0.5%
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
no data were available. Therefore 2000 mg/kg bw were chosen as the starting dose for the study. - Doses:
- 2000 mg/kg
200 mg/kg - No. of animals per sex per dose:
- 3 males /3 femals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
twice a day on working days, on non-working days only once. body weights were checked on days 1, 2, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food & water consumption - Statistics:
- Statistics were performed using validated SAS based statistic programs.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD, approximate lethal dose
- Effect level:
- >= 200 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg goup: all females and one male died within 24 hrs after dosing. one male was found dead on study day 4. one male survived to the end of the observation period.
200 mg/kg group: no mortality was observed. - Clinical signs:
- other: 2000 mg/kg goup: after administration, diarrhea, cyanosis, slight sedation, shallow respiration, piloerection and emanciation were present. 200 mg/kg group: no clinical signs were observed.
- Gross pathology:
- 2000 mg/kg goup: at necropsy, dilated stomach, dark red coloured stomach and small intestine mucosa were found.
200 mg/kg group: no gross pathological findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results of the study, the ALD for CDBE 0055 XX in rats following single oral administration is between 200 - 2000 mg/kg bw.
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