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EC number: 237-149-8 | CAS number: 13669-76-6
- 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
Endpoint summary
Administrative data
Description of key information
The LC50 (4 h) is 1210 mg/m3 in rats with boron trifluoride dihydrate (Rusch et al., 1986). Animals mainly exhibited typical clinical signs of respiratory distress. All respiratory effects were reversible.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- N/A to 1968-04-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study similar to OECD 423 with sufficient documentation on methods and results to evaluate data.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: SPF-Wistar K
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 80-134 g
- Fasting period before study: 12 hrs
- Diet: After application rats received the standard-ALTROMIN R feed
- Water: tap water
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% aqueous solution
- Amount of vehicle (if gavage): 0.8 to 5.0 mL/100g bw
- Doses:
- 0.8, 1.25, 2.0, 3.2, and 5.0 mL per 100 g body weight
- No. of animals per sex per dose:
- 10 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1.7 other: mL/100 g body weight
- Based on:
- test mat.
- Mortality:
- In the 0.8 mL/100 g-bw dose group there was no mortalities and in the 1.25 mL/100 g-bw group 2 of the 10 animals died. In the 2.00 mL/100 g-bw dose group 8 of the 10 animals died and in the 3.20 mL/100 g-bw and 5.0 mL/100 g-bw dose group all 10 of the animals died.
- Clinical signs:
- other: The animals died lying on tummy or flank, with breathing difficulties and cramps within 30 minutes to 24 hours after application.
- Gross pathology:
- The necropsy of the animals showed macroscopic strong chemical burns on the mucous membrane of the stomach.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 600 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with normal standard methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Labs (Portage, Mich.)
- Age at study initiation: approximately 7 weeks old
- Fasting period before study: no
- Housing: individually in suspended stainless-steel mesh cages
- Diet: ad libitum Purin Rat Chow 5001
- Water: ad libitum
- Acclimation period: for a minimum of 2 weeks - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- Exposure Chamber Designs and Operation
The acute exposure was conducted in 225-liter stainless-steel and glass exposure chambers, operated under negative pressure with filtered, conditioned air.
The total flow rate during the acute study was approximately 50 liters/min, providing a t99 equilibration time of 21 min.
Test Atmosphere Generation Procedures
Test atmospheres in the acute study were generated with a Solo-Sphere nebulizer (McGraw Respiratory Therapy, Irvine, CA.) operated with compressed, breathing-grade air. Exposure concentrations were controlled by regulating the airflow through the nebulizer, and thus the rate of aerosol generation.
Analysis of Chamber Concentrations
Nominal aerosol concentrations were determined daily by measuring the amount of test material consumed during the exposure and dividing this by the total airflow through the chamber. At hourly intervals, actual air concentration measurements were made by trapping aerosol samples of known volume in 15-mL impingers, using a flow-Gmiting orifice (Millipore XX50000014) with a pump (Gast DOA-122) and dry test meter (Singer DTM-115-3) for volume measurement. The aerosol was then dissolved in distilled water and analyzed for BF3 content by an ion-selective electrode technique. Sample volumes were varied to permit collection of roughly equal quantities of BF3.
Particle size measurements were made with an Anderson I ACFM particle sizing sampler (Anderson 2000, Inc., Atlanta, Ga.). Measurements were performed hourly during the acute exposures; three times/week during the subacute exposures; and twice each week during the subchronic exposures. The material collected on each stage was determined gravimetrically.
Mass median aerodynamic diameter: 1.8 µm - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1.01, 1.22, 1.32 and 1.54 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
Duration of observation: 14 days
- Clinical signs: examined just before exposure, at 15-minute intervals during the first hour then hourly for the remaining of exposure and daily until the completion of the study.
- Mortality: idem
- Body weight: measured on days 1, 2, 4, 7 and 14
- Necropsy:
macroscopic examination of the main organs: yes - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1 210 mg/m³ air
- Exp. duration:
- 4 h
- Mortality:
- Deaths occurred in all exposure groups: nine (out of 10) at 1.54 mg/L, eight at 1.32 mg/L, two at 1.22 mg/L, and three at 1.01 mg/L, ranging from the day of the exposure to 6 days post-exposure.
- Clinical signs:
- other: Clinical signs elicited by the exposures included dry and moist rales, gasping, excessive oral and nasal discharge, and lacrimation, indicative of respiratory distress and irritation. Recovery was apparent for the rats surviving beyond Day 6 of post-expo
- Body weight:
- A body weight decrease was recorded.
- Gross pathology:
- A decrease in liver and kidney weight was noted.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 210 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No experimental data with the complex are
available. Due to animal welfare reasons a studies on acute toxicity
should not be conducted with the complex. The test substance is composed
of boron trifluoride dihydrate and phosphoric acid. Both substances are
classified as skin and eye corrosive. The complex is therefore also
regarded as corrosive, which was confirmed in a Corrositex®
- Skin Corrosion Test (OECD Guideline 435) (see IUCLID chapter 7.3.1).
The following studies conducted with boron trifluoride dihydrate and
phosphoric acid further underline the corrosiveness of both constituents
of the complex.
acute oral toxicity
supporting information (phosphoric
acid)
In an acute oral toxicity study equivalent or similar to OECD
guideline 423, groups of fasted, female Wistar rats (10 per dosing
group) were given a single oral dose of the read across substance
phosphoric acid (CAS No 7664-38-2) at concentrations of 0.8, 1.25, 2.0,
3.2 and 5.0 mL per 100 g body weight (Farbwerke Hoechst, 1968). Animals
were then observed for 7 days.
No mortality was observed in the lowest dosing group. 2/10 and 8/10
animals died in the 1.25 and 2.00 mL/100 g group, respectively. A
mortality rate of 100% was observed in the two highest dosing groups.
Animals that died showed unbalanced movements. They were lying on tummy
or flank with breathing difficulties and cramps. The animals died within
30 min to 24 hours. During necropsy strong chemical burns on the mucous
membrane of the stomach were observed. The LD50 for a 10% solution of
75.4% phosphoric acid in rats was determined to be 1.70 mL/100 g body
weight (approximately 2600 mg/kg bw).
supporting information (boron trifluoride dihydrate)
In a scientifically acceptable non-guideline study (BASF, 1978), boron trifluoride dihydrate (CAS 13319 -75 -0) was administered to male and female Sprague-Dawley rats (5 per sex and dose) orally via gavage at 2.15, 3.16, 4.64 and 6.81 % (v/v) in Lutrol (corresponding to approx. 351, 515, 756 and 1110 mg/kg bw/d). The animals were then observed for 14 days.
Mortality was observed at 351 mg/kg (6/10
after 14 d), 515, 756, and 1110 mg/kg (all: 10/10 after 14 d). Observed clinical
signs comprised dyspnea, apathy, staggering, exciccosis and diarrhea. Gross
pathology revealed the following findings: heart: acute dilatation
bilateral, acute congestive hyperemia; stomach: dilated, liquid content;
urinary bladder: in several animals remarkable filling; intestinal
mucosa: slight reddened, atonic, diarrheic content. The LD50 was calculated
to be 320 mg/kg bw/d.
acute inhalation toxicity (boron trifluoride dihydrate)
key
In a publication of Rusch et al. from 1986, groups (5/sex) of
Fischer 344 rats (approx. 7 weeks old) were treated whole body via
inhalation route with the read across substance boron trifluoride
dihydrate (CAS No. 13319-75-0). Animals were exposed for 4 hours at
concentrations of 1.01, 1.22, 1.32 and 1.54 mg/L. Animals were then
observed for 14 days. All animals were examined at the end of the
chamber equilibration period, at 0.25, 0.5, 0.75 and 1h during exposure,
at 0, 1, 2 and 24 h post exposure and daily during the 14-day
post-exposure observation period. Body weights were recorded on days 1,
2, 4, 7 and 14. Necropsy was performed on all animals.
Mortality was observed in all dosing groups: 3/10 (1.01 mg/L), 2/10
(1.22 mg/L), 8/10 (1.32 mg/L) and 9/10 (1.54 mg/L). Observed clinical
signs included dry and moist rales, gasping, excessive oral and nasal
discharge, and lacrimation, indicative of respiratory distress and
irritation. Recovery was apparent for the rats surviving beyond study
day 6 post exposure.
The LC50 (4 h) was calculated to be around 1210 mg/m3 when rats were
whole body exposed by inhalation to aerosols of BF3 dihydrate.
supporting
The acute inhalation toxicity of the read across substance boron
trifluoride dihydrate (CAS No. 13319-75-0) was evaluated in a 4-hour,
single-exposure study in rats according to a protocol comparable to the
OECD Guideline 403 (Rusch et al., 2008). The test substance was
initially administered to a single group of ten male and ten female
Sprague Dawley rats via whole-body exposure at concentrations of 0, 10,
30, 100 mg/m3 (nominal) (8.53±2.83, 24.6±10.3 and 74.4±11.9 mg/m3
(analytical)). All animals were examined at the end of the chamber
equilibration period, at 0.25, 0.5, and 1h during exposure, at 0, 1, 2
and 24 h post exposure and twice daily during the 14-day post-exposure
observation period for those animals not sacrificed 24 h post exposure.
Body weights were recorded daily from pretreatment until sacrifice.
There were no unscheduled deaths. There were no effects on body weight
or body weight gain. The larynx showed treatment-related
histopathological findings in rats in the 74.4-mg/m3 exposure level
group. Based on the results of this study, the LC50 of BF3 was higher
than 74.4+/-11.9 mg/m3 when male and female rats were exposed for a
single, 4-hour period.
Quite similar LC50 ranges were reported in other publications: LC50 (4
h) of 1180 mg/m3 (Kasparov et al. 1972) and LC50 (1 h) of 899.34
-1439.56 mg/m3 (Vernot et al. 1977), indicating that the substance has a
high potential of acute toxicity by inhalation.
The NOAEL for respiratory irritation following a single exposure of 4
hours to low dose levels was estimated around 24.6 mg/m3 (Rusch et al.,
2008).
Justification for classification or non-classification
Due to the corrosivity of phosphoric acid boron trifluoride, testing regarding acute oral, dermal and inhalation toxicity is not meaningful.
Dangerous Substance Directive (67/548/EEC)
The structure-related test compound boron trifluoride is classified with T+ and R26. For test compound boron trifluoride dihydrate proposal for classification is Xn, R20/22.
Classification proposal based on the available data of BF3 dihydrate: Xn; R20/22.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The structure-related test compound boron trifluoride is classified with Acute Tox. Cat. 2, H 330 (GHS). For test compound boron trifluoride dihydrate proposal for classification is Acute Tox. Cat. 4, H332 and H302.
Classification proposal based on the available data of BF3 dihydrate: Acute Tox. 4 (H302 and H332)
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