96-10832. National Toxicology Program; Availability of Technical Report on Toxicology and Carcinogenesis Studies of t-Butyl Alcohol

[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Notices]
[Page 19305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10832]



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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 t-Butyl Alcohol

    The HHS' National Toxicology Program announces the availability of 
the NTP Technical Report on the toxicology and carcinogenesis studies 
of t-butyl alcohol. t-Butyl alcohol is widely used in the manufacture 
of perfumes and a variety of cosmetics.
    Toxicology and carcinogenicity studies were conducted by 
administration of t-butyl alcohol, in drinking water to groups of 60 
F344/N rats of each sex at doses of 0, 1.25, 2.5, or 5 mg/mL for males 
and 0, 2.5, 5, or 10 mg/mL for females. Groups of 60 
B6C3F1 mice of each sex received t-butyl alcohol in 
drinking water at does of 0, 5, 10, or 20 mg/mL.
    Under the conditions of these 2-year drinking water studies, there 
was some evidence of carcinogenic activity \1\ of t-butyl alcohol in 
male F344/N rats based on increased incidences of renal tubule adenoma 
or carcinoma (combined). There was no evidence of carcinogenic activity 
of t-butyl alcohol in female F344/N rats receiving 2.5, 5 or 10 mg/mL. 
There was equivocal evidence of carcinogenic activity in male 
B6C3F1 mice based on marginally increased incidences of 
follicular cell adenoma or carcinoma (combined) of the thyroid gland. 
There was some evidence of carcinogenic activity of t-butyl alcohol in 
female B6C3F1 mice based on increased incidences of 
follicular cell adenoma of the thyroid gland.
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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 [phone].
    Copies of Toxicology and Carcinogenesis Studies of t-Butyl Alcohol 
(CAS No. 75-65-0) (TR-436) are available without charge from Central 
Data Management, NIEHS, MD E1-02, P.O. Box 12233, Research Triangle 
Park, NC 27709; telephone [phone].

    Dated: April 27, 1996.

Kenneth Olden,

Director, National Toxicology Program.

[FR Doc. 96-10832 Filed 4-30-96; 8:45 am]

BILLING CODE 4140-01-M