Document ID: chunk:federal_register_of_legislation:F2013C00288:reg:4:p3
Version: federal_register_of_legislation:F2013C00288
Segment Type: reg
Provision Reference: reg 4 (pt 3/5)
Character Range: 2506808–2509728

which is more conservative that the current dietary survey indicates. On this basis a background intake of 30% is considered appropriate for deriving a soil HIL for endosulfan.

4.4              Identification of Toxicity Reference Values

4.4.1         Classification
The International Agency for Research on Cancer (IARC) and US EPA have not classified endosulfan with respect to human carcinogenicity.

4.4.2         Review of Available Values/Information
Limited data is available to assess carcinogenicity of endosulfan. Evaluation of the WHO DWG (WHO 2011) referenced JMPR (WHO 1998), who concluded that endosulfan is not genotoxic and no carcinogenic effects have been noted in long-term studies in rats and mice. This is also noted, in the NRA (1998) review. Review by APVMA (2005) has reassessed the potential for endosulfan to be an endocrine disruptor. The review concluded that the endocrine-disrupting potential of the compound was not a significant risk to public health under the existing management controls and health standards.

On the basis of the available information, it is considered appropriate that a threshold doseresponse approach be adopted for endosulfan and that no additional consideration is required to address endocrine-disrupting effects. The following are available from Level 1 Australian and International sources:
Source                       Value                       Basis/Comments
Australian
ADWG (NHMRC, 2011)           TDI = 0.006 mg/kg/day       The NHMRC derived a guideline of 0.02 mg/L from a TDI of 0.006 mg/kg/day that is based on a NOEL of 0.57 mg/kg/day from a 1-year dietary study in dogs, and an uncertainty factor of 100.
OCS (2012) and FSANZ (2011)  ADI = 0.006 mg/kg/day       ADI was set in May 1997 and based on a NOEL of 0.6 mg/kg/day from a 78-week dietary study in mice, 13-week dietary study in rats, 1-year dietary study in dogs and a developmental study in rats. The ADI is currently used by FSANZ in the assessment of endosulfan residues in food.
NRA (1998)                   ADI – 0.006 mg/kg/day       As noted above from OCS (2012).
International
WHO (2011)                   ADI = 0.006 mg/kg/day       No guideline is currently set in WHO (2011) as concentrations in drinking water occur well below those of health concern. However the review has noted that a health-based value of 0.02 mg/L can be derived on the basis of an ADI of 0.006 mg/kg/day derived from a 2-year dietary study in rats, supported by a 78-week study in mice, a 1 -ear study in dogs and a developmental study in rats.
ATSDR (2000)                 Oral MRL = 0.002 mg/kg/day  Chronic oral MRL based on a NOAEL of 0.18 mg/kg/day associated with liver effects in a dog study, and an uncertainty factor of 100.
US EPA (IRIS 2012)           RfD = 0.006 mg/kg/day       Oral RfD (last reviewed in 1994) is based on a NOAEL of 0.6/0.7 (M/F) mg/kg/day associated with kidney effects