[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Notices]
[Pages 66055-66056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

    The HHS' National Toxicology Program announces the availability of 
the NTP Technical Report on the toxicology and carcinogenesis studies 
of codeine, which is used in a variety of pharmaceuticals including 
analgesics, sedatives, hypnotics, antiperistaltics, and antitussive 
agents.
    Toxicology and carcinogenicity studies were conducted by oral 
administration of codeine to groups of 60 F344/N rats of each sex at 0, 
400, 800, or 1,600 ppm and 60 B6C3F1 mice of each sex at 0, 750, 
1,500, or 3,000 ppm in feed for up to 106 weeks. In addition 9 or 10 
animals per group were evaluated at 15 months.
    Under the conditions of these 2-year feed studies, there was no 
evidence of carcinogenic activity \1\ of codeine in male or female 
F344/N rats exposed to 400, 800, or 1,600 ppm. There was no evidence of 
carcinogenic activity of codeine in male or female B6C3F1 mice 
exposed to 750, 1,500, or 3,000 ppm.
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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 
studies that cannot be evaluated because of major flaws 
(``inadequate study'').
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    Thyroid gland follicular cell hyperplasia was increased in exposed 
male and female mice.
    Decreased incidences of benign pheochromocytomas of the adrenal

[[Page 66056]]

medulla in male rats and mammary gland fibroadenomas and fibroadenomas 
or adenocarcinomas (combined) in female rats were related to codeine 
exposure.
    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 Codeine (CAS No. 
76-57-3) (TR-455) are available without charge from Central Data 
Management, NIEHS, MD E1-02, P.O. Box 12233, Research Triangle Park, NC 
27709; telphone (919) 541-3419.

    Dated: November 13, 1996.
Samuel H. Wilson,
Deputy Director, NIEHS.
[FR Doc. 96-31778 Filed 12-13-96; 8:45 am]
BILLING CODE 4140-01-M