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Diss Factsheets

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
Reference
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.
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
Reference
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.
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)