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EC number: 423-300-7 | CAS number: 128554-52-9
- 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:
- 2007-01-31 to 2007-03-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: data from ELINCS notification validity criteria of guideline fulfilled
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 423-300-7
- EC Name:
- -
- Cas Number:
- 128554-52-9
- Molecular formula:
- Not available
- IUPAC Name:
- Reaction products of 12-hydroxyoctadecanoic acid and octadecanoic acid and 1,3-phenylenedimethanamine
- Details on test material:
- - Name of test material (as cited in study report): WAX#700
- Physical state: solid
- Lot/batch No.: 001
- Storage condition of test material: Room temperature (permissible range: 10°-30°C, actual value: 17.3°-21.8°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 8 weeks
- Weight at study initiation: from 175 to 179 g
- Fasting period before study: about 18 h
- Housing:
- Diet (e.g. ad libitum): ad libitum; Pellet feed for experimental animals (MF, Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): ad libitum; Tap water filtered through a 5-flm filter and irradiated by UV light
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 - 22.8 °C
- Humidity (%): 46.3 - 63.8 %
- Air changes (per hr): 6 to 20 times
- Photoperiod (hrs dark / hrs light): 12/12 h/d
Administration / exposure
- Route of administration:
- other: forced oral administration using a disposable syringe equipped with a gastric tube
- Vehicle:
- other: 0.5 w/v% CMC-Na solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL for the 300 mg/kg group and 200 mg/mL for the 2000 mg/kg group
- Amount of vehicle (if gavage): 10mL/kg - Doses:
- Group Number of Animals
First dosing group 3 females
300 mg/kg
Second dosing group 3 females
300 mg/kg
Third dosing group 3 females
2000 mg/kg
Fourth dosing group 3 females
2000 mg/kg - No. of animals per sex per dose:
- 300 mg/kg 6 females
2000 mg/kg 6 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observation:
All animals were observed for their mortality and clinical signs before dosing, 10 and 30 minutes, 1,3, and
6 hours after dosing (6 times in total) on the day of the administration
and were observed once daily for 14 days thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths at any dose
- Clinical signs:
- No abnormalities in clinical signs were noted in any animals at any dose.
- Body weight:
- No abnormalities in body weight gain were noted in any animals at any dose.
- Gross pathology:
- No abnormalities in necropsy findings were noted in any animals at any dose.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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