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Diss Factsheets
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EC number: 619-856-7 | CAS number: 1056196-56-5
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health Consumer Protection, Directorate Notification Authority, Head: Dr. Dag Kappes.
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF SE, 33470-153 FK
- Expiration date of the lot/batch: Shelf life: unlimited.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:ambient temperature (RT), protected against moisture and daylight.
- Stability under test conditions: The stability of the test substance under Storage conditions over the test period was guaranteed by the sponsor.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test substance was diluted in corn oil
- Final dilution of a dissolved solid, stock liquid or gel: 500 mg/mL
FORM AS APPLIED IN THE TEST (if different from that of starting material): suspension in corn oil
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TECAM Animal Facility (S. Roque, SP).
- Age at study initiation: 9 weeks.
- Weight at study initiation: The weight variation of animals was not greater than 20 percent of the mean weight (196.2 g).
- Fasting period before study: Animals were fasted (food but not water was withheld ovemight) prior to the test substance administration.
- Housing: Animals were housed using conventional polypropilene rodent cages (Beiramar, CXBHG, 41 x 34 X 16 cm) with three animals per cage.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C.
- Humidity (%): 64%.
- Photoperiod (hrs dark / hrs light): 12 hours/day.
IN-LIFE DATES: From: 01 August 2007 To: 15 August 2007 and From: 02 August 2007 To: 16 August 2007.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Request of the Sponsor. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Remarks:
- not apllicable
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded shortly before administration, weekly thereafter and at the end of the study. Animals were observed individually after dosing during the first 24 hours with special attention given during the first 4 hours (day 1). Signs and symptoms were recorded at least once each workday for individual animals. A check for dead or moribund animals were made at least once each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No adverse effects observed.
- Mortality:
- No mortality was observed arnong the tested animals.
- Clinical signs:
- No treatment related signs were observed during the first 4 hours after a single administration of the test material or during the observation period (14 days).
- Body weight:
- Body weight changes were within the range of physiological variability.
- Gross pathology:
- No macroscopic changes were observed in any of the major Organs of the examined animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is considered to be not acute toxic by the oral route in the OECD 423 study. The LD50 of the test material was estimated to be > 2000mg/kg bw in rats.
- Executive summary:
The present study was carried out to assess acute toxicity following a single oral administration to rats of the test substance.Wistar rats were selected and maintained under controlled environmental conditions. Based on individual body weight, dosing of the test substance was calculated in mg/kg body weight (bw). Two groups of three female rats received 2000mg/kg bw of the test substance diluted in corn oil by oral gavage. No mortality or signs of evident toxicity were observed during the first 4 hours after test substance administration or during the observation period (14 days). Gross pathology examination was performed in all tested animals. No macroscopic alterations were observed in any of the major organs of the examined animals. According to the decision tree of the OECD-Guideline, the LD50oral of the test material was estimated to be > 2000mg/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.
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