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Diss Factsheets
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EC number: 919-003-1 | CAS number: 1174335-83-1
- 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:
- 2 February - 23 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 423) and in compliance with GLP.
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)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- PD 283 XX
- IUPAC Name:
- PD 283 XX
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PD 283 XX
- Physical state: yellow powder
- Analytical purity: 97.6 % (HPLC)
- Analysis test date: 12 january 2006
- Purity to be retested: january 2007
- Lot/batch No.: V12TFA00072
- Storage condition of test material: 20°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han), SPF quality
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, via Biological Laboratory Services, Boehringer Ingelheim
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: males 148 g to 157 g, females 126 g to 137 g
- Fasting period before study: Prior to administration, the rats were kept over night without food
- Housing:
- Diet (e.g. ad libitum): pelleted dry food, ad libitum
- Water (e.g. ad libitum): Municipal tap drinking water, ad libitum
- Acclimation period: 5- to 7-days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45% - 75%
- Air changes (per hr): minimum of 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxyethylcellulose
- Doses:
- 200, 2000 mg/kg
- No. of animals per sex per dose:
- 3 femals / 200 mg/kg
3 males/ 3 femals 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Results and discussion
- Preliminary study:
- JUSTIFICATION OF DOSE LEVELS:
In the absence of prior experience, 200 mg/kg body weight was chosen as the initial dose.
The second dose was selected based on the animals’ response to 200 mg/kg.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD (approximate lethal dose)
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed subsequent to a single oral administration of 200 mg/kg and 2000 mg/kg, respectively.
- Clinical signs:
- other: Piloerection was observed at both doses as the only clinical sign on day 1.
- Gross pathology:
- No necropsy findings were noted in females treated with 200 mg/kg and 2000 mg/kg, respectively, as well as in one male at the latter dose.
Following 2000 mg/kg, necropsy of two males revealed disseminated, dark red discolorations up to the size of a pin tip on the surface of the lungs.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, which was designed to evaluate in rats the acute toxicity
of PD 283 XX subsequent to a single oral administration by gavage, no mortality was seen
subsequent to oral administration of 200 mg/kg and 2000 mg/kg, respectively.
Thus, the approximate lethal dose (ALD) for PD 283 XX, is set above 2000 mg/kg for male and female rats.
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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