Technical Basis
A review of available sources identified OEL-STEL exposure limits, and multiple mouse and rat acute toxicity data (LC50, LD50) for various routes (inhalation, oral, intravenous, intraperitoneal). 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 3.3.1, 3.3.2, and evaluated using factors in Tables 3.2, 3.3, and 3.4. Inhalation exposures were scaled to 60-minute equivalents using the ten Berge equation (Section 3.3.4). Of the available data, the most preferred data type, two rat LC50 (86 mg/m3/4H and 150 mg/m3/4H) were considered for the TEEL-3 basis. The study of the lower dose (86 mg/m3/4H) yielded more conservative values and was selected as the TEEL-3 basis. The TEEL-2 value was derived according to Table 3.5, and the OEL-STEL of the lowest amount, Germany (ADG/DFG), (15-minute, skin designation) was selected as the TEEL-1.
• TEEL-1 = OEL-STEL (Germany, skin, 0.0152 mg/m3)
• TEEL-2 = TEEL-3/6
• TEEL-3 = Rat LC50 (86 mg/m3/4H)
This review generated TEEL values inconsistent with Rev. 29A. The Rev. 29A TEEL-3 basis was rat LC50 (175.5 mg/m3/4H), which was derived by taking the average LC50 from male and female rats. The analysts did not use this value since more conservative rat LC50 data was found and because LC50 is supposed to be a median value, not an average. The Rev. 29A TEEL-2 basis, a rat oral TDLo, was not found during the current review; therefore, the recommended TEEL-2 was derived according to Table 3.5. The recommended TEEL-1 is the OEL-STEL (Germany) instead of being derived from Table 3.5 as in Rev. 29A.
A review of available sources identified OEL-STEL exposure limits, and multiple mouse and rat acute toxicity data (LC50, LD50) for various routes (inhalation, oral, intravenous, intraperitoneal). 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 3.3.1, 3.3.2, and evaluated using factors in Tables 3.2, 3.3, and 3.4. Inhalation exposures were scaled to 60-minute equivalents using the ten Berge equation (Section 3.3.4). Of the available data, the most preferred data type, two rat LC50 (86 mg/m3/4H and 150 mg/m3/4H) were considered for the TEEL-3 basis. The study of the lower dose (86 mg/m3/4H) yielded more conservative values and was selected as the TEEL-3 basis. The TEEL-2 value was derived according to Table 3.5, and the OEL-STEL of the lowest amount, Germany (ADG/DFG), (15-minute, skin designation) was selected as the TEEL-1.
• TEEL-1 = OEL-STEL (Germany, skin, 0.0152 mg/m3)
• TEEL-2 = TEEL-3/6
• TEEL-3 = Rat LC50 (86 mg/m3/4H)
This review generated TEEL values inconsistent with Rev. 29A. The Rev. 29A TEEL-3 basis was rat LC50 (175.5 mg/m3/4H), which was derived by taking the average LC50 from male and female rats. The analysts did not use this value since more conservative rat LC50 data was found and because LC50 is supposed to be a median value, not an average. The Rev. 29A TEEL-2 basis, a rat oral TDLo, was not found during the current review; therefore, the recommended TEEL-2 was derived according to Table 3.5. The recommended TEEL-1 is the OEL-STEL (Germany) instead of being derived from Table 3.5 as in Rev. 29A.