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EC number: 237-222-4 | CAS number: 13701-59-2
- 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
- Study period:
- 1 July - 5 August, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted prior to GLP. No information on the purity of the test sample. No clear information on the conditions of exposure but it seems to be whole body. Thes test was carried out at he maximum achievable concentration.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Busan 11-M1
- IUPAC Name:
- Busan 11-M1
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Busan 11-M1
- Substance type: No data
- Physical state: White powder
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 6-5606
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: 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 Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: males 45 - 53 days, females 71 - 85 days (upon arrival)
- Weight at study initiation: Males mean group weight range 233.6 - 241.0 g, Females mean group 221.4 - 241.6
- Fasting period before study: No data
- Housing: Individually in stainless steel wire-mesh cages
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow at libitum during nonexposure periods
- Water (e.g. ad libitum): Tap water ad libitum during nonexposure periods
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.67 - 25.56 °C
- Humidity (%): 61 - 84% during study, 42 - 49% during exposure
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 01/07/1983 To: 05/08/1983
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass chamber (control group), glass and stainless steel chambers (exposed groups)
- Exposure chamber volume: 100L
- Method of holding animals in test chamber: in cages
- Source and rate of air: Generation system and accessory chamber, total chamber airflow 16.7 L/min.
- Method of conditioning air: Wright dust feeds (2) generating into the tangential input duct on the turret top
- System of generating particulates/aerosols: Wright dust feeds (2)
- Method of particle size determination: samples obtained using Andersen Mini Sampler Cascade Impactor placed inside the chamber on top of animal cages
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: temperature 23.33 - 23.89, humidity 42 - 49% , no data on pressure
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric concentrations were determined as outlined in "Any other information on materials and methods" below
- Samples taken from breathing zone: yes
VEHICLE
No data
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter): Group 2: Mean = 3.4, S.D. = 0.28; Group 3: Mean 2.8, S.D = 0.14
- GSD (Geometric st. dev.): Group 2: Mean = 1.8, S.D. = 0.13; Group 3: Mean 1.9, S.D = 0.05 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric concentrations
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal: Group 2 = 14.52 mg/L, Group 3 = 21.70 mg/L
Mean gravimetric concnetrations: Group 2 = 2.98 mg/L (S.D. = 0.15), group 3 = 3.54 mg/L (S.D. = 1.394) - No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed prior to exposure, at the start of exposure and at 30 minute intervals during exposure. The animals were observed twice daily for 14 days post exposure. Body weights of all animals were recorded immediately prior to exposure and on Days 2, 3, 4, 7 and 14 post exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: Special attention was paid to lungs and respiratory tract during necropsy. The lungs, lever, kidneys and any other organs exhibiting gross pathologic changes were removed and fixed for histopathology. - Statistics:
- No data
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 21.7 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Maximum attainable concentration
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 3.54 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Maximum attainable concentration
- Mortality:
- One Group 2 male was found dead on Day 2 and one Group 3 female was found dead on Day 1 of exposure.
- Clinical signs:
- other: During exposure, all Group 2 and 3 animals appeared languid from 30 min through 4 hours. Group 2 animals showed slight dyspnea from hour 2 through 4. Group 2 animals showed rhinorrhea from hour 1 through 4. Dust covered the fur of all Group 2 and 3 animal
- Body weight:
- Mean body weights of the Group 1 (control) females decrease slightly on days 2 and 4 post exposure. Mean body weights of both sexes of test groups decrease markedly on Day 2 and increased steadily thereafter with the exception of a decrease in the Group 2 female mean body weight on day 14.
- Gross pathology:
- 7 Group 1 (control) animals, 7 of the Group 2 animals and 8 of the group 3 animals had no gross pathology observations.
The lungs of one Group 1 (control) animal showed scattered pinpoint red areas. The lobes of the lung of the Group 2 animal found dead were dark red, and those of the Group 3 animal found dead failed to collapse when thoracic cavity was opened. One or both renal pelves were dilated in one Group 1 (control) female, one Group 2 female and one Group 2 male. The uterine horns of two Group 1 (control) females and one group 3 females were distended with clear fluid. - Other findings:
- No further data
Any other information on results incl. tables
No further data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The inhalation LC50 was found to be >3.54mg/L air (analytical) the maximum attainable concentration. Therefore it does not warrent classification of acute inhalation toxicity according to EU legislation
- Executive summary:
In a study conducted by Coate (1983), the test substance, Busan 11-M1, was examined for its ability to cause toxicity when administered via whole-body inhalation to male and female Sprague-Dawley rats. The test animals were exposed to nominal concentrations of the test substance 14.52 mg/L and 21.70 mg/L. The test animals were exposed to the test substance via whole-body inhalation for a period of up to 4 hours. They were then observed for 14 days following treatment to determine the effects. Under the conditions of this study, there were no test substance related mortalities observed and no test substance related adverse effects recorded. The LC50 is greater than >3.54mg/L air (analytical) the maximum attainable concentration. Based on this result, the test substance does not require classification for acute inhalation toxicity according to Regulation EC No. 1272/2008.
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