Document ID: chunk:federal_register_of_legislation:F2013C00288:reg:1:p7
Version: federal_register_of_legislation:F2013C00288
Segment Type: reg
Provision Reference: reg 1 (pt 7/10)
Character Range: 2753580–2756698

effects on the CNS, kidney, liver and endocrine system in inhalation studies where a point of departure (POD) of 38 mg/m3 was identified, and an uncertainty factor of 1000 adopted.
RIVM (2001)                   PTDI = 0.05 mg/kg/day          Provision threshold values derived for TCE due to limited data and an assumption that the genotoxic mechanism for TCE (numerical chromosome aberration in vivo) exhibits a threshold. The basis for these values is not listed here as the evaluation is considered dated.
                              PTC = 0.2 mg/m3
ATSDR (1997)                  No chronic MRLs derived        No chronic oral or inhalation MRL has been established.
New York State (NYS DH 2006)  GV = 0.005 mg/m3               An air guideline value (GV) of 0.01 mg/m3 was derived for non-carcinogenic effects (CNS effects in humans) is based on review of all available studies and associated end points. The lowest guideline value has been adopted and is noted to be protective of the general population including sensitive life stages of infants, children, the infirm and elderly. The GV resulted in carcinogenic risk estimates at the lower end of the risk range (1x10-6 to 1x10-4). The guideline value was then reduced by a factor of 2 based on the consideration of additional factors (data gaps, concern regarding methods for evaluating risks to children and concerns regarding human carcinogenicity) in addition to background levels and analytical capabilities. The resulting air guideline derived was 0.005 mg/m3.

US EPA (2011)                 SF = 0.05 (mg/kg/day)-1        Oral slope factor based on PBPK model-based route-to-route extrapolation from the inhalation value based on human kidney cancer risks. The value is also supported by data from oral bioassays.
                              UR = 4x10-6 (g/m3)-1          Inhalation unit risk derived on the basis of non-Hodgkin's lymphoma , renal cell carcinoma and liver tumours from a human inhalation (epidemiology) studies, adjusted (by a factor of 4) to address potential risk of tumours at multiple sites. The value is derived from linear extrapolation from the point of departure (LEC01). It is noted that even with the consideration of the 4-fold factor, the inhalation unit risk value derived is within the range of values derived from a wide range of studies.
                              RfD = 0.0005 mg/kg/day         Application of the ADAF for kidney cancer risks due to evidence supporting a mutagenic MoA is recommended.
                              RfC = 0.002 mg/m3              RfD based on critical effects of heart malformations (rats), adult immunological effects (mice) and developmental immunotoxicity (mice), which is further supported by an oral study for the toxic nephropathy (rats) and route extrapolation from an inhalation study.
                                                             RfC based on route-extrapolation from and oral studies for the critical effects of heart malformations in rats and immunotoxicity in mice, and incorporation of uncertainty factors ranging from 10 to 100.

For TCE the health