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EC number: 618-281-9 | CAS number: 895520-71-5
- 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:
- From 9 December 2003 to 5 December 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted : 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 618-281-9
- EC Number:
- 618-281-9
- Cas Number:
- 895520-71-5
- Molecular formula:
- C28 H29 N5 O5
- IUPAC Name:
- 618-281-9
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E-699-2003
- Expiration date of the lot/batch: 1 July 2004
- Purity test date: 27 and 28 October 2003
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: white to light beige powder stored at approximately 20°C in a fume cupboard
- Stability under test conditions: is guaranteed for 4 hours in dionized water by the sponsor (dated 04 December 2003)
- Solubility and stability of the test substance in the solvent/vehicle: is guaranteed for 4 hours in dionized water by the sponsor (dated 04 December 2003)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: DP-2 was suspended in the stated concentrations in deionozed water and distributed homogenously by means of magnetic stirrer
- Final dilution of a dissolved solid, stock liquid or gel: 10% w/v in vehicle for the high dose and 3% for the low dose
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SD
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: mean : 179g±10.9g (168 to 201 g)
- Fasting period before study: Fasted, no more details
- Housing: In transparent macrolon cages (type IV) on soft wood granulate in air conditionel room, 3 animals per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534) ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 50±20%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours of light / 12 hours of dark
IN-LIFE DATES: From: 9 December 2003 To: 5 December 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% w/v for 2000 mg/kg dose and 3% for 300 mg/kg dose level
- Amount of vehicle (if gavage): 10 ml/kg for 300 mg/kg and 2 x 10 ml/kg for high dose 2000 mg/kg
- Justification for choice of vehicle: not specified
- Purity: not specified
DURATION OF TREATMENT :
Single dose (300 mg/kg) and two applications in 30 minutes interval (2000 mg/kg)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 6 females for 300 mg/kg group and 3 for 2000 mg/kg dose group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms and lethality were recorded twice everyday. During this time, animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology (macroscopic examinations of organs)
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg : 3/3 animals died
300 mg/kg : 0/6 animals died - Clinical signs:
- 2000 mg/kg :
The following clinical signs were observed in female animals starting between 0 and 10 minutes after administration of DP-2 : stupor, moderate ataxia, hypoactivity, prone or lateral postion, forward crawling, straddled hind limbs, squatting posture, stilted gait, drawn in flanks, irregular respiration, bristling coat, narrowed palpebral fissures and dilated pupils, absent paw reflex to pinching, negative righing reflex and clonic convulsions.
300 mg/kg
The following clinical signs were observed in female animals starting 10 to 30 minutes after the treatment : stupor, hypoactivity, squatting posture, moderate ataxia, stilted or uncoordinated gait, drawn in flanks, irregular respiration, bristling coat, narrowed palpebral fissures and trembling. From day 3 until the end of the study no symptoms were observed - Body weight:
- Development of the body weight was not impaired in the surviving animals.
- Gross pathology:
- The decedent animals and the animals killed at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
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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