U.S. Department of Health and Human Services Find Blue No.2 is Toxic

U.S.  DEPARTMENT OF HEALTH  AND  HUMAN  SERVICES

Toxicology and carcinogenesis studies ofHC Blue No.2 (approximately 98% pure), a semipermanent
hair dye, were conducted by  administering the test chemical in feed for  103 weeks to groups of 50
F3441N rats of each sex and for 104 weeks to groups of 50 B6C3F 1 mice of each sex.  The dietary con­
centrations used were 0, 5,000, or 10,000 ppm for male rats and male mice and 0,  10,000, or 20,000
ppm for female rats and female mice.  These concentrations were selected on the basis of results from
single-administration  gavage  and  14-day  and  13-week feed  studies.  For  the  2-year studies,  the
average daily doses were  approximately 195  and 390 mg!kg in male rats,  465  and  1,000 mglkg in
female rats, 1,320 and 2,240 mglkg in male mice, and 2,330 and 5,600 mg/kg in female mice.
The survival ofhigh dose male rats and male mice was better than that for controls, and the survival
ofdosed female rats was comparable to that of the controls.  The survival of high dose female mice was
reduced (P<0.05) relative to that of the controls (control, 35/50; low dose, 27/50; high dose 19/50); this
reduced survival was attributed to a reproductive tract infection.  Final mean body weights relative
to those ofthe controls were depressed less than 10% in dosed male rats, whereas depressions of 13%
and 22% were observed in the low dose and high dose groups of female rats.  Final mean body weights
for dosed male mice were within 5% ofcontrol values, but final mean body weights for dosed females
were 15% (low dose) and 22% (high dose) lower than that of controls.
A dose-related increase in the incidence of hyperostosis of the skull was detected in rats (male, 5/50,
8150,  25/49; female,  2/50, 19/50, 49/50)  and in 1149 high dose male and 4/50 high dose female mice.
Mixed mesenchymal neoplasms of the kidney were detected in 2150 high dose female rats; none was
observed in any other group offemale or male rats.  This tumor is considered uncommon and has not
been found in 1,863 historical control female F344/N rats.  A negative trend in fibroadenomas of the
mammary gland was seen in female rats (20/50, 10/50, 4/50).
A marginal (P=0.05) positive trend occurred in the inci,dence oflymphomas in male mice (1150; 5/48;
8149); the incidences in the dosed groups were not significantly greater than that in the controls when
survival differences were taken into account.

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