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EC number: 207-856-6
CAS number: 498-15-7
Table 1. Summary of pre-test exposure trials
Table 2. Exposure conditions
*Total air = compressed generator air + compressed mixing air. ²Time for 90% equilibration of the chamber atmosphere. #Time for 99% equilibration of the chamber atmosphere.
Table 3. Characteristics of the achieved atmosphere
Table 4. Nominal Chamber Concentration:
Table 5. Body weights monitored during the study
Table 6. Mortality data summary:
In an acute inhalation toxicity study (Acute Toxic Class Method) performed in accordance with GLP and OECD guideline 436, groups (3/sex) of Sprague Dawley rats were exposed by inhalation route for 4 hours to nose-only at a single exposure. After establishing the desired generation procedures during the pre-test trials,twelve healthy rats were selected for test and equally distributed into two exposure groups (3 males and 3 females per exposure): one exposure group with vapour concentation of 5.07 mg/L and second exposure group at 1.05 mg/L. Chamber concentration and particle size distributions of the test atmosphere were determined periodically during the exposure period.
Animals were then observed for mortality and clinical signs, gross toxicity and behavioral changes at least once daily for 14 days following exposure or until death occured. Bodyweights were recoeded prior to exposure (initial) and again on Days 1, 3, 7 and 14 (terminal) or after death. Necropsies were performed in all animals for macroscopical examination.
At the high dose level, the gravimetric chamber and nominal chamber concentrations were 5.07 mg/L and 82.90 mg/L, respectively. The average mass median aerodynamic diameter was estimated to be 2.28 µm based on graphic analysis of the particle size distribution as measured with a 1 ACFM Andersen Ambient Particle Sizing Sampler with an avergae geometric standard deviation of 2.49.One female rat was found dead at chamber removal and the remaining five animals were euthanized for humane reasons following exposure to the test atmosphere. Prior to death, the euthanized animals were hypoactive and exhibited abnormal respiration, prone posture, and clonic convulsions. Gross necropsy of the decedents revealed discoloration of the lungs and/or distention of the intestines.
At the low dose level, the gravimetric chamber and nominal chamber concentrations were 1.05 mg/L and 15.62 mg/L, respectively. The average mass median aerodynamic diameter was estimated to be 2.32 µm based on graphic analysis of the particle size distribution as measured with a 1 ACFM Andersen Ambient Particle Sizing Sampler with an avergae geometric standard deviation of 1.98. All animals survived at the test item exposure and gained body weight during the study. Four rats were hypoactive and all animals exhibited abnormal respiration and/or ano-genital staining. However, all animals recovered by Day 3 and appeared active and healthy for the remainder of the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Thus, the inhalation LC50 (male/female) is between 1.05 mg/L and 5.07 mg/L (LC50 cut-off of 5 mg/L). Therefore, the test material is classified in Category 4 (H332: Harmful if inhaled) according to Regulation (EC) No. 1272/2008 and the GHS as the LC50 value is comprised between 1 and 5 mg/L/4h.
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