Technical Basis
A review of available sources identified the multiple acute toxicity studies (LD50). Data sources were selected according to the hierarchy listed in Table 3.1. Toxicity data were selected according to type of exposure, species, and route according to the hierarchies stated in Sections 3.6.3, 3.6.4, and evaluated using factors in Tables 3.2, 3.3, and 3.4. Of the available studies, a monkey inhalation LD50 was selected as the TEEL-3 basis. TEEL-2 and TEEL-1 values were derived according to Table 3.5.
• TEEL-1 = TEEL-2/11
• TEEL-2 = TEEL-3/6
• TEEL-3 = LD50 inhalation monkey (17 ng/kg)
This review generated TEEL values that are less conservative than Rev. 29A. The Rev. 29A TEEL-3 basis was a mouse intraperitoneal LD50 not found in the current review. Instead, the current TEEL-3 basis, a monkey LD50, is a more preferred species and route (Sections 3.3.2, 3.6.3, 3.6.4). The Rev. 29A and current TEEL-2 and TEEL-1 values were derived using the same methodology (Table 3.5), with differences due to the change in TEEL-3.
References
Rhesus macaques LD50; refer to Section 3.4.3. Popoff, M., Connan, C. (2014). Absorption and Transport of Botulinum Neurotoxins. In: Foster, K. (eds) Molecular Aspects of Botulinum Neurotoxin. Current Topics in Neurotoxicity, vol 4. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9454-6_3