Update: August 1995
Current Massachusetts Regulatory Limit
MMCL = 0.4 mg/L. ORS has adopted the MCL published by U.S. EPA (55 FR 30370 (7/25/90); 57 FR 31776 (7/17/92)).
Federal Regulatory Limit
The MCL is equal to the MCLG of 0.4 mg/L.
Basis for Criteria
The MCLG is derived based on the RfD presented below and assumes that a 70 kg adult ingests 2 L/day of drinking water. The MCLG incorporates a relative source contribution factor of 20% and a 10-fold uncertainty factor to account for potential carcinogenicity (55 FR 30370).
RfD: 6 x 10-1 mg/kg/day
UF: 300 (10 = interspecies; 10 = intraspecies; 3 = lack of multigenerational reproductive study, lack of data)
MF: 1 Confidence in RfD: Medium
The RfD is based on a NOAEL of 1800 ppm (corresponding to a dose of 170 mg/kg/day) identified from a teratogenicity study done in rats.
The oral RfD is based upon two studies that used dietary administration of DEHA to rats; one assessed the effects of DEHA on gestating females and their developing fetuses (ICI 1988a). The other study examined the effects on fertility, reproductive outcome and gross and histological parameter in parents of both sexes. (ICI, 1988b).
The designation of a class C carcinogen is based on an absence of human data and increased liver tumors on female mice (NTP, 1982). The MCLG of 0.4 mg/L corresponds to a theoretical cancer risk level of 1.3 x 105 (57 FR 31776).
PQL: 0.005 mg/L
U.S. EPA 506 CRID/GC
PQLs and analytical methods may have been updated since this guidance value was last revised. Updated analytical methods for drinking water and their associated PQLs may be found at http://www.epa.gov/safewater/methods/methods.html.
Other Regulatory Data
Any Health Advisories, Reference Doses (RfDs), cancer assessments or Cancer Potency Factors (CPFs) referenced in this document pertain to the derivation of the current guidance value. Updated information may be obtained from the following sources:
Health Advisories - The U.S. EPA provides guidance for shorter-term exposures for chemicals based on their non-cancer effects. Current health advisories may be more current than those used to derive MCLs and may be found at http://www.epa.gov/waterscience/drinking/standards/dwstandards.pdf.
RfDs, cancer assessments and CPFs - For specific information pertaining to derivation of drinking water criteria, consult the Federal Register notice that announces the availability of the most current guidance for that chemical. In addition, information on other current RfDs and CPFs as well as cancer assessments for specific chemicals may be found in the U.S. EPA Integrated Risk Information System (IRIS) at http://www.epa.gov/iris/. Please note that the information in IRIS may differ from that used in the derivation process as published in the Federal Register notice.
Federal Register. July 25, 1990. Part II. Environmental Protection Agency. 40 CFR Part 141 et al. National Primary and Secondary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; Proposed Rule. (55 FR 30370)
Federal Register. July 17, 1992. Part III. Environmental Protection Agency. 40 CFR Parts 141 and 142. National Primary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; Final Rule. (57 FR 31776).
ICI. (ICI Central Toxicology Laboratory). 1988a. Di(2-ethylhexyl)adipate teratogenic study in the rat. Report CTL/p/2118. Unpublished study.
ICI. (ICI Central Toxicology laboratory). 1988b). Di(2-ethylhexyl)adipate (DEHA) fertility study in rats. Report CTL/p/2229. Unpublished study.
NTP. (National Toxicology Program). 1982. Carcinogenesis Bioassay of di(2-ethylhexyl)adipate (CAS No. 102-23-10 IN f344 RATS B6C3F1 mice. NTP = 80-29. NIH Publication No. 81-1768.
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