[Federal Register Volume 59, Number 7 (Tuesday, January 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-535]


[[Page Unknown]]

[Federal Register: January 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

 

National Toxicology Program; Availability of Technical Report on 
Toxicology and Carcinogenesis Studies of Ethylene Glycol

    The HHS' National Toxicology Program announces the availability of 
the NTP Technical Report on the toxicology and carcinogenesis studies 
of Ethylene Glycol, a major constituent of motor vehicle antifreeze-
coolant fluids and also in other commercial products including 
hydraulic brake fluids, adhesives, printer's inks, and wood stains. It 
is also used in the manufacturer of polyester films and fibers, 
polyethylene terephthalate (PET) solid state resins, plasticizers, 
elastomers, cellophane, and other products.
    Two year toxicology and carcinogenesis studies were conducted by 
administering ethylene glycol in the diet of 60 male mice (0, 6,200, 
12,500, or 25,000 ppm) and 60 female mice (0, 12,500, 25,000, or 50,000 
ppm) for up to 103 weeks. These concentrations correspond to daily 
doses of approximately 1,500, 3,000, or 6,000 mg/kg body weight for 
male mice and 3,000, 6,000, or 12,000 mg/kg for females.
    Under the conditions of these 2-year feed studies, there was no 
evidence of carcinogenic activity\1\ of ethylene glycol in male B6C3F1 
mice receiving 6,250, 12,500, or 25,000 ppm, or in female B6C3F1 mice 
receiving 12,500, 25,000, or 50,000 ppm. Administration of ethylene 
glycol resulted in hepatocellular hyaline degeneration in male mice fed 
diets containing 12,500 or 25,000 ppm and in female mice fed diets 
containing 50,000 ppm. An increased incidence of medial hyperplasia of 
small pulmonary arteries and arterioles occurred in female mice fed 
diets containing 12,500, 25,000, or 50,000 ppm ethylene glycol.
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    \1\The NTP uses five categories of evidence of carcinogenic 
activity observed in each animal study: two categories for positive 
results (``clear evidence'' and `'some evidence''), one category for 
uncertain findings (``equivocal evidence''), one category for no 
observable effect (``no evidence''), and one category for studies 
that cannot be evaluated because of major flaws (``inadequate 
study'').
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    Questions or comments about the Technical Report should be directed 
to Central Data Management at P.O. Box 12233, Research Triangle Park, 
NC 27709 or telephone (919) 541-3419.
    Copies of Toxicology and Carcinogenesis Studies of Ethylene Glycol 
(Cas No. 107-21-1) in B6C3F1 Mice (Feed Studies) (TR-413) are available 
without charge from Central Data Management, NIEHS, MD A0-01, P.O. Box 
12233, Research Triangle Park, NC 27709; telephone (919) 541-3419.

    Dated: January 3, 1994.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 94-535 Filed 1-10-94; 8:45 am]
BILLING CODE 4140-01-M