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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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- yes
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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Inc.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult (9 weeks)
- Weight at study initiation: males 233-247 grams, females 170-193 grams
- Fasting period before study: not reported
- Housing: animals were individually housed in plastic solid bottom polycarbonate cages. Enrichment was placed in each cage. Corncob bedding was placed in cage and changed once a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 61-75%
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- 2.8 µm
- Geometric standard deviation (GSD):
- 2.17
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Mini-Nose-Only Inhalation Chamber
- Exposure chamber volume: 6.7 liters
- Method of holding animals in test chamber: individulal polycabronate holding
- Source and rate of air: 30.0 liters per minute supplied by air compressor
- System of generating particulates/aerosols: Wright Dust Generator
- Method of particle size determination: Eight-stage ACFM Andersen Ambient Particle Sizing Sampler
- Temperature, humidity, pressure in air chamber: Temp: 23-24°C, Hum: 28-62%, pressure: slightly negative
TEST ATMOSPHERE
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.04±0.16 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Prior to test substance administration, Day 1, Day 3, Day 7, and Day 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Not Applicable
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All animals survived
- Clinical signs:
- other: All animals exhibited irregular respiration after exposure but recovered by Day 3 and appeared healthy and active the remainder of the observation period.
- Body weight:
- 4 males and 4 females failed to gain weight after Day 1 but all animals showed continued weight gain thereafter through the exposure period.
- Gross pathology:
- No gross abnormalities were observed in any of the animals when necropsied at the conclusion of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the single exposure acute inhalation LC50 of the test substance is greater than 5.04 mg/L in male and female rats.
- Executive summary:
An acute inhalation toxicity test was conducted in accordace with OECD 403, OPPTS 870.1300, and EU Method B.2 to determine the potential for the test substance to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days following exposure. Body weights were recorded prior to exposure and again on Days 1, 3, 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.
The gravimetric chamber concentration was 5.04 ± 0.16 mg/L (mean ± SD). Based upon graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler, the mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) of the 5.04 mg/L atmosphere was 2.80 μm ± 2.17 (MMAD ± GSD).
All animals survived exposure to the test substance. Following exposure, all animals exhibited irregular respiration. However, the animals recovered from this symptom by Day 3 and appeared active and healthy for the remainder of the 14-day observation period. Although four males and four females lost or failed to gain body weight by Day 1, all animals showed a continued weight gain thereafter through Day 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day recovery period.
Under the conditions of this study, the single 4-hour inhalation medial lethal concentration (LC50) for the test substance is greater than 5.04 mg/L in male and female rats.
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