[Federal Register Volume 59, Number 178 (Thursday, September 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22812]


[[Page Unknown]]

[Federal Register: September 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

National Toxicology Program; Availability of Technical Report on 
Toxicology and Carcinogenesis; Studies of C.I. Direct Blue 218

    The HHS' National Toxicology Program announces the availability of 
the NTP Technical Report on the toxicology and carcinogenesis studies 
of C.I. Direct Blue 218, a copper chelated dye used for cellulose, 
acetate, nylon, silk, wool, tissue, papers, and textile goods with a 
urea-formaldehyde finish. C.I. Direct Blue 218 is one of five 
chemicals/dyes that are part of the National Toxicology Program's 
Benzidine Dye Initiative, established to determine the toxicity and 
carcinogenicity of representative benzidine congeners, congener-derived 
dyes, and benzidine derived dyes.
    Two year toxicology and carcinogenesis studies were conducted by 
administering C.I. Direct Blue 218 in feed to groups of 60 male and 
female F344/N rats and B6C3F1 mice at doses 0, 1,000, 3,000, or 
10,000 ppm.
    Under the conditions of these 2-year feed studies, there was some 
evidence of carcinogenic activity\1\ of C.I. Direct Blue 218 in male 
F344/N rats based on the occurrence of pharyngeal neoplasms. Squamous 
cell neoplasms of the forestomach may have been chemical related. There 
was no evidence of carcinogenic activity of C.I. Direct Blue 218 in 
female F344/N rats given 1,000, 3,000, or 10,000 ppm. There was clear 
evidence of carcinogenic activity of C.I. Direct Blue 218 in male and 
female B6C3F1 mice based on increased incidences of hepatocellular 
adenomas and carcinomas. The occurrence of a few neoplasms of the 
kidney and small intestine in male mice may have been related to C.I. 
Direct Blue 218 treatment.
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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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    The administration of C.I. Direct Blue 218 produced an increased 
incidence of forestomach basal cell hyperplasia in rats and 
hepatocellular foci of cytologic alteration in mice.
    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 C.I. Direct Blue 
218 (CAS No. 28407-37-6 in F344/N Rats and B6C3F1 Mice) (TR-430) 
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: September 8, 1994.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 94-22812 Filed 9-14-94; 8:45 am]
BILLING CODE 4140-01-M