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Spiegel (1953) reported about 30-day testing using rats, mice, rabbits, cats, guinea pigs and dogs. Dimethyl ether boron trifluoride was tested via the inhalation route in concentrations of 0.13 and 0.25 mg/l (= 27 and 50 ppm) for 6 h/d and 6 d/wk (all species). Results rat study: Mortality 6 resp. 18%. Pathological examinations showed mild, pulmonary irritation and depletion of thyroid tissue (highest dose), no substance-related findings in liver, kidneys, spleen, intestinum, lymph nodes, bone marrow, gonads and adrenal glands. Dental pathology consisted in mild to moderate fluorosis at the highest dose level, but only mild bleaching in incisal enamel and complete histological normalcy at the lowest dose level. Results mouse study: Mortality 19 resp. 100%. In the highest dose level the body weights were reduced (about 16%). A mild irritation and depletion of the thyroid tissue was observed in the highest dose level. No substance-related findings were seen in liver, kidneys, spleen, intestinum, lymph nodes, bone marrow, gonads and adrenal glands. Results rabbit study: No mortalities. In the highest dose level mild irritation and depletion of the thyroid tissue was seen; one rabbit at this dose level showed rather severe pulmonary hemorrhage and edema. No substance-related effects were noted in liver, kidney, spleen, intestinum, lymph nodes, bone marrow, gonads and adrenal glands. Clinical chemistry and hematology showed no substance-related abnormalities. Results cat study: No mortalities. a mild irritation and depletion of the thyroid tissue was seen in the highest dose level. Liver, kidneys, intestinum, lymph nodes, bone marrow, gonads and adrenal glands showed no substance-related effects. Results guinea pig study: Mortality 7 resp. 77%. Mild irritation in the lungs and depletion of the thyroid tissue. No substance-related effects were seen in liver, kidneys, spleen, intestinum, lymph nodes, bone marrow, gonads and adrenal glands. Results dog study: No mortalities. A mild irritation and depletion of the thyroid tissue was observed. No substance-related effects were seen in liver, kidneys, spleen, intestinum, lymph nodes, bone marrow, gonads and adrenal glands.

Boron trifluoride (CAS:13319-75-0) was tested in a 13-week inhalation study (Rusch et al., 1986). The substance was tested in a dihydrate form which contained 63.87% of BF3. Aerosols of BF3 dihydrate were offered daily by inhalation to male and female Fischer 344 rats, 6 hrs/day, 5 days a week, at dose levels of 0, 2, 6, 17 mg/m3. At 17 mg/m3, one death was attributed to the test substance. No differences were observed between treated and control groups for body weight and haematology. Urine analysis and blood chemistry were affected by treatment. Clinical signs of respiratory irritation were seen, but without abnormal histological findings. An exposure-related depression of total protein concentrations accompanied by an exposure-related depression of globulin concentrations was observed. In urines, an exposure-related depression in calcium amounts and an exposure-related increase in urinary fluoride were noted. The decrease in calcium values was found to be reversible at the end of exposure, contrary to the decrease of urinary fluoride which was partially reversible. Serum fluoride concentration were markedly increased in all exposure groups (dose-related increase). A recovery was noted after the end of exposure. At necropsy, no differences for organ weight and macroscopic appearance were observed between treated and control groups. At microscopy examination, necrosis of the renal tubular epithelium was seen in the highest dose group and was the apparent cause of a death in one of the animals. Consequently, under the experimental conditions, the NOAEC was found to be 6 mg/m3 and the LOAEC was found to be 17 mg/m3 for effects on kidneys. The increase of fluorine amounts in serum and in urine are not considered as adverse since no signs of toxicity was associated and since it was reversible or partially reversible (as the recovery period was only 2 week, a full reversibility was not observed for urinary fluorine); nevertheless they are related to treatment.

Justification for classification or non-classification

Classification proposal: EU - T; R48/23; GHS: STOT Rep. Exp. 1 (H372).