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EC number: 257-913-4
CAS number: 52434-90-9
To assess the toxic effects of AP 729, an acute inhalation toxicity study was conducted on Wistar rats according to Annex 3d of OECD Guideline 436, with a treatment group (G1, limit test).
A technical pre-test was conducted without animals to check the feasibility of generating adequate test atmosphere (test item concentration, particle size distribution, O2 content, CO2 content, temperature and relative humidity) after chamber equilibrium using a solid dust aerosol generation system.
The inhalation toxicity study was performed in 3 male and 3 female Wistar rats by nose-only exposure to test item AP 729 as a dust aerosol generated at the same exposure conditions adopted during the technical pre-test.The animals were housed in special rat restrainers and continuously exposed to the test item aerosol for 4 hours in an inhalation exposure chamber (nose-only, dynamic state). The post treatment observation period was 14 days.
The dust aerosol was sampled from the inhalation chamber to determine particle size distribution, Mass Median Aerodynamic Diameter (MMAD) and Geometric Standard Deviation (GSD). Particle size of the aerosol generated in the chamber air was determined two times i.e., during the first and fourth hour of the exposure period using any one port. The MMAD and GSD were calculated using Seven Stage Cascade Impactor. The overall mean MMAD of 2.31 µm and GSD of 1.71 were observed for G1 group.
The test item concentration at the animals’ breathing zone was also determined using gravimetric filter analysis method. The average actual concentration of AP 729 was 5.03 mg/L of chamber air.
All animals were normal after the 4 hours exposure period. All rats gained bodyweight throughout the experiment period and no clinical signs were detected. There were no pre-terminal mortalities observed during the experimental period and no abnormalities were detected at necropsy at the end of the 14 days observation period.
The acute inhalation (4 hours) Median Lethal Concentration (LC50) value of AP 729 is greater than 5.03 mg/L of chamber air in both male and female Wistar rats.
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