[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17746]


[[Page Unknown]]

[Federal Register: July 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

National Toxicology Program; Availability of Technical Report on 
Toxicology and Carcinogenesis Studies of p-Nitroaniline

    The HHS' National Toxicology Program announces the availability of 
the NTP Technical Report on the toxicology and carcinogenesis studies 
of p-nitroaniline, an intermediate in the preparation of several azo 
dyes used for coloring consumer products.
    Two-year toxicology and carcinogenesis studies were conducted by 
administering to both sexes of B6C3F1 mice doses of 0, 3, 30, or 
100 mg p-nitroaniline per kg body weight in corn oil by gavage 5 days 
per week for up to 103 weeks.
    Under the conditions of these 2-year gavage studies, there was 
equivocal evidence of carcinogenic activity* of p-nitroaniline in male 
B6C3F1 mice based on the increased incidences of hemangiosarcoma 
of the liver and hemangioma or hemangiosarcoma (combined) at all sites. 
There was no evidence of carcinogenic activity of p-nitroaniline in 
female B6C3F1 mice receiving doses of 3, 30, 0r 100 mg/kg.
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    *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 
no observable effect (``no evidence''), and 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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    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 p-Nitroaniline 
(CAS No. 100-01-6) in B6C3F1 Mice (Gavage Studies) (TR-418) are 
available without charge from Central Data Management, NIEHS, M.D. AO-
01, P.O. Box 12233, Research Triangle Park, NC 27709; telephone (919) 
541-3419.

    Dated: July 12, 1994.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 94-17746 Filed 7-18-94; 8:45 am]
BILLING CODE 4140-01-M