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EC number: - | CAS number: -
- 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- 2009
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Brown DYHY 0331/0334
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: Beijing Vital River Laboratory Animal Technology Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 54 to 60 days
- Weight at study initiation: 185 to 233 g for male rats and 165 to 173 g for female rats
- Fasting period before study: NA
- Housing: One or two animals were housed per cage during the acclimatization period. Animals were housed individually after exposure
- Diet (ad libitum): rodent complete nutrition pellet diet supplied by Beijing keaoxieli Feed CO., LTD. (Batch numbers: 18053211; 18073231)
- Water (ad libitum): purified tap water using the HT-R01000 purity system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1°C to 24.6°C (Target value: 19°C to 25°C)
- Humidity (%): 46% to 75% (Target value: 40% to 70%)
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 31, 2018 to August 14, 2018
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- >= 1 - <= 4 µm
- Geometric standard deviation (GSD):
- >= 1.5 - <= 3
- Details on inhalation exposure:
- Equipment: HOPE-MED 8052H dynamic snout only dust inhalation instrument was used.
Exposure Method
Before exposure, each rat was restrained in a confined transparent polyacrylic tube. The exposure tubes were installed in the portholes of the inhalation chamber and the chamber was sealed up. Filtered and compressed air was mixed quantitatively with test item and the aerosol was sent to the exposure chamber (0.04 m³). The test item moving speed and exposure airflow rate had been adjusted to provide the selected target concentration. The aerosol was continuously generated by the generation system on the top of the chamber with an aerosol producer. A slight negative pressure was maintained in the outer plenum of the chamber to prevent leakage of the test substance into the surrounding area. The exhausted air was removed from the outlet at the bottom of the chamber and led to the absorption unit.
The actual concentrations, particle size distribution at the animals’ breathing zone, chamber airflow, chamber temperature, relative humidity and oxygen concentration were determined during the exposure period. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Designed dose (mg/m³): 5000
Actual concentration (mg/m³): 5030 - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were recorded once during the exposure and twice (with about one hour interval) after exposure on the exposure day and then once daily for up to the end of the observation period.
Mortality inspections were made twice daily, morning and afternoon, during normal working days and once daily at weekends and public holidays.
The animals were weighed within the first 24 hours after arrival, on the day of exposure prior to exposure (day 0), and on day 1, day 3, day 7 and day 14.
- Necropsy of survivors performed: yes - Statistics:
- The mean and standard deviation of body weight and body weight gains at different times were calculated.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 000 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
- Clinical signs:
- other: none
- Body weight:
- no effects
- Gross pathology:
- no effects
- Other findings:
- Actual Concentration
Actual mean concentration in the cabinet for four times measurement was 5030±58 mg/m³.
Nominal concentration in the cabinet was 53827 mg/m³.
Exposure Chamber Parameters
The air flow rate was 1.08 m³/h.
Temperature, humidity, oxygen and carbon dioxide concentration all met the acceptance criteria.
Particle Size Distribution
The mass median aerodynamic diameters (MMAD) for two measurements were 1.88 μm and 2.04 μm.
The geometric standard deviations (GSD) were 2.29 and 2.35, respectively.
The aerodynamic particle sizes less than 4 micron (mass %) for two measurements were 99.75% and 99.74%, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, the acute inhalation LC50 in SD rats for Reactive Brown DYHY 0331/0334 is higher than 5030±58 mg/m³ and it is classified as “unclassified” according to GHS classification.
- Executive summary:
The study was designed to assess the acute inhalation toxicity of Reactive Brown DYHY 0331/0334 after being snout only administrated to SD rats for 4 hours and to make GHS classification.
The method was designed to meet the OECD Guideline for the testing of chemicals: Acute Inhalation Toxicity – Acute Toxic Class Method (No.436, 07 September 2009). 6 animals (3 males and 3 females) were exposed for 4 hours using a snout-only exposure system to 5030 mg/m³ test item. Clinical observations were made once during exposure and twice after exposure on the dosing day and then once daily in 14 days observation period. Body weights were weighed on day 0, day 1, day 3, day 7 and day 14. Concentrations were analysed four times and particle size distributions were measured two times during exposure. Gross necropsy was made to all animals at the end of observation.
No animals were found dead during test period and the mortality was zero. No abnormalities were found during the whole observation period. The body weight development of male and female animals during the observation period was regular. No abnormalities were found in female and male animals at the gross necropsy.
Actual mean concentration in the cabinet resulting from the four times measurement was 5030±58 mg/m³. The mass median aerodynamic diameters (MMAD) from the two measurements were 1.88 μm and 2.04 μm. The geometric standard deviations (GSD) were 2.29 and 2.35, respectively. The aerodynamic particle sizes less than 4 micron (mass %) for the two measurements were 99.75% and 99.74%, respectively.
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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