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EC number: 816-285-7 | CAS number: 1263133-33-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 1263133-33-0
- Test material form:
- solid
- Details on test material:
- Purity: 99.4%
Impurities: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Harlan Laboratories, Inc., Frederick, MD on November 6, 2013.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult (10-11 weeks)
- Weight at study initiation: 194-200 grams
- Fasting period before study: overnight
- Housing: The animals were individually housed in plastic solid bottom polycarbonate cages which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed in each cage. Corncob bedding (1/8 inch bed-o’cobs®) was used and was changed at least once per week.
- Diet (e.g. ad libitum): ad libitum, except during fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14-27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 43-55%
- Air changes (per hr): 13/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: test substance was 25% w/w in mixture
- Vehicle was a solution of 0.1% Tween-80 in 0.5% methylcellulose
- Amount of vehicle (if gavage): 4.5 mL for a dose level of 4,390 mg/kg and 5.3 mL for a dose level of 5000 mg/kg.
MAXIMUM DOSE VOLUME APPLIED: 5.3 mL.
DOSAGE PREPARATION (if unusual): At concentrations higher than 25% w/w, the viscosity was too high to be administered properly. Due to the high dose volume of the dose solution to be administered (23.11 and 26.32 ml/kg), each animal’s dose was divided into two approximately equal portions and administered two hours apart.
CLASS METHOD (if applicable)
- Based on the estimated LD50 (4,930 mg/kg) of the test substance a Main Test was conducted using a default starting dose level of 4,390 mg/kg which was administered to one healthy female rat by oral gavage. - Doses:
- One rat was dosed at 4,390 mg/kg (4.5 mL dose volume) and 3 rats were dosed at 5,000 mg/kg (5.3 dose volume).
Due to the high dose volume of the dose solution to be administered (23.11 and 26.32 ml/kg), each animal’s dose was divided into two approximately equal portions and administered two hours apart. - No. of animals per sex per dose:
- All rats were female. One rat was dosed at 4,390 mg/kg and 3 rats were dosed at 5,000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0, Day 7, and Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded before test substance administration (initial), on Day 7, and Day 14 (termination). Clinical signs were observed during the first several hours after dosing and at least once a daily thereafter for 14 days after dosing. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- Statistical analysis was limited to the mean density value for dosing.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Animals at both dose levels survived the 14-day observation period.
- Clinical signs:
- other: 4,390 mg/kg Dose Level - no clinical signs during 14-day observation period 5,000 mg/kg Dose Level - all animals exhibited reduced fecal volume but recovered by Day 3
- Gross pathology:
- At both dose levels no gross abnormalities were noted for when necropsied at the conclusion of the 14-day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of the test substance is greater than 5,000 milligrams per kilogram of body weight in female rats.
- Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for the test substance to produce toxicity from a single dose via the oral route following the test guidelines OPPTS 870.1100 and OECD 425. Under the conditions of this study, the acute oral LD50 of the test substance greater than 5,000 mg/kg of body weight in female rats.
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