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Diss Factsheets
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EC number: 456-880-5 | CAS number: 439685-79-7
- 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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 8 - 22 April 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pH and osmolarity of the dosage form preparations were not measured
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Groups of Sprague-Dawley rats (5/sex/dose) were administered with a single subcutaneous dose of test item at 0 (vehicle) and 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: see confidential details on test material
- Physical state: viscous brown liquid
- Lot/batch No.: see confidential details on test material
- Date of receipt: 20 February 2004
- Storage condition of test material: Stored at at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 309 ± 11 g for the males and 206 ± 12 g for the females
- Housing: Animals were housed in polycarbonate cages with stainless steel lid. Each cage contained 1-7 rats/sex during the acclimation period and 5 rats/sex/group during the treatment period.
- Diet: A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- other: 60/40 (w/w) mixture of purified water/propylene glycol
- Details on exposure:
- - Approximately 24 h before administration, the back area of the animals was clipped free of hair, as close to the skin as possible, using an electric clipper.
- Dosage form preparation was administered to the animals under a volume of 2.5 mL/kg bw.
- The test item was prepared freshly after mixing with the vehicle and then sterile filtered (with a 0.22 μm filter) under a laminar air-flow cabinet. Test item administration was performed in a single dose, by subcutaneous route using a single-use needle (0.50 mm x 16 mm) fitted to a 1 mL plastic syringe (0.01 mL graduations). - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until Day 15.
Bodyweight was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: Yes; all animals were killed by carbon dioxide asphyxiation on Day 15 and all animals were subjected to a macroscopic examination. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: maximal non-lethal dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No mortality was observed.
- Clinical signs:
- - No systemic clinical signs were observed.
- Crusts were noted on the back of 1/5 females of the control group from Days 8-15. - Body weight:
- - Body weight gain of treated animals was similar to that of control animals.
- Gross pathology:
- - No macroscopic abnormalities were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the maximal non-lethal dose of test item was considered to be higher than 2000 mg/kg bw in rats.
- Executive summary:
In an acute subcutaneous toxicity study performed in compliance with GLP, groups of Sprague-Dawley Crl CD® (SD) IGS BR rats (5/sex/dose) were administered with a single subcutaneous dose of test item at 0 (vehicle) and 2000 mg/kg bw as a solution in the vehicle (purified water/propylene glycol, 60/40 w/w) with the dose volume of 2.5 mL/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination..
No systemic clinical signs and no deaths were observed during the study. Crusts were noted on the back of 1/5 females of the control group from Days 8 to 15. The overall body weight gain of treated animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal.
Under the test conditions, the maximal non-lethal dose of test item was considered to be higher than 2000 mg/kg bw in 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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