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Diss Factsheets
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EC number: 701-307-9 | 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:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- boron nitride (cubic)
- EC Number:
- 701-307-9
- Cas Number:
- 10043-11-5
- Molecular formula:
- BN
- IUPAC Name:
- boron nitride (cubic)
- Test material form:
- solid: crystalline
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: Sage™ Labs, Boyertown, PA on February 15, 2011.- Age at study initiation: young adults (9-10 weeks). Females assigned to test were nulliparous and nonpregnant.- Weight at study initiation: males 228-243 grams and females 175-207 grams at experimental start- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Litter paper was placed beneath the cage and was changed at least three times per week.- Diet (e.g. ad libitum): Purina Rodent Chow #5012- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system except during exposure.- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-23°C- Humidity (%): 45-60%- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION- Exposure apparatus: Nose-Only Exposure Chamber (Mini-Nose Only Inhalation Chamber, ADG Developments LTD)- Exposure chamber volume: approximately 6.7 liters- Method of holding animals in test chamber: Animals were individually housed in polycarbonate holding tubes- Source and rate of air: air compressor ( JUN-AIR, Model #6-15); 28.4 Lpm- Method of conditioning air: 3.3Lpm of compressed mixing air. supplied using air from a compressed air tank (Airgas)- System of generating particulates/aerosols: modified Wright Dust Generator driven by a variable speed motor (Dayton, Model #4Z538A) D.C. speed control with 0-100 potentiometer- Method of particle size determination: eight-stage Andersen Cascade Impactor- Temperature, humidity in air chamber: 20-22 °C, 34-43%, TEST ATMOSPHERE- Brief description of analytical method used: gravimetric- Samples taken from breathing zone: yesTEST ATMOSPHERE (if not tabulated)- MMAD (Mass median aerodynamic diameter): MMAD average 2.3 µm
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.19 ± 0.68 mg/L
- No. of animals per sex per dose:
- 5 female and 5 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: 5 times in 14 days period- Necropsy of survivors performed: yes- Other examinations performed: body weight measured, clinical signs (daily)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.19 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 241 min
- Mortality:
- all animals survived
- Clinical signs:
- other: There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
- Body weight:
- Although all animals lost weight by Day 1, all animals showed a continued weight gain thereafter through Day 14.
- Gross pathology:
- No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationNo labelling requirement for acute toxicity inhalationCriteria used for interpretation of results: other: OECD GHS and CLP
- Conclusions:
- Under the conditions of this study, the single exposure acute inhalation LC50 of Synthetic Cubic Boron Nitride Grade 2 (2 rnicron) Powder, CAS No.: 10043-11-5 is greater than 5.19 mg,/L in male and female rats. In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC and according to Annex I of Regulation (EC) 1272/2008 and OECD-CHS (Globally Harmonized Classification System) the test item Synthetic cBN Grade 2 (2 micron) Powder has no labelling requirement for acute toxicity inhalation.
- Executive summary:
An acute inhalation toxicity test was conducted with rats to determine the potential for Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder, CAS No.: 10043-11-5 to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. Under the conditions of this study, the single exposure acute inhalation LC50 of the test substance is greater than 5.19 mg/L in male and female rats. After establishing the desired generation procedures during pre-test trials, ten healthy rats (5/sex) were exposed to the test atmosphere for 4 hours. Chamber concentration and particle size distributions of the test substance were determined periodically during the exposure period. The animals were observed for mortality, signs of gross toxicity, and behavioural 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.
All animals survived exposure to the test atmosphere. The gravimetric chamber concentration was 5.19 mg/L.
Following exposure and throughout the 14-day observation period, all animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. Although all animals lost weight by Day 1, all animals showed a continued weight gain thereafter through Day 14. No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.
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