For definition of Groups, see Preamble Evaluation.
VOL.: 57 (1993) (p. 129)
Chem. Abstr. Name: 2,2'-([4-(Methylamino)-3-nitrophenyl]imino)bis(ethanol)
HC Blue No. 1 was used as a semipermanent hair dye until the mid-1980s, when its production and use were discontinued.
No data were available to the Working Group.
HC Blue No. 1 was tested for carcinogenicity by administration in the diet in two studies in mice, one of which was restricted to females, and in one study in male and female rats. In one study in male and female mice and in several experiments in the study of females, it significantly increased the incidence of hepatocellular adenomas and/or carcinomas in mice of each sex and increased the incidence of thyroid follicular-cell adenomas in males. An increase in the combined incidence of pulmonary adenomas and carcinomas was seen in female but not in male rats.
Commercial samples of HC Blue No. 1 bound to DNA and induced mutation in bacteria. They induced DNA damage, gene mutation and chromosomal anomalies and inhibited intercellular communication in cultured mammalian cells.
Purified samples of HC Blue No. 1 did not bind to DNA or induce mutation in bacteria. They did not induce mitotic recombination in yeasts and did not induce mutation in insects. They induced DNA damage, sister chromatid exchange and, weakly, gene mutation but not chromosomal aberrations in cultured mammalian cells. DNA damage was not induced in cultured human cells (HeLa). Micronuclei were induced in the bone marrow of female mice of one strain exposed in vivo.
There is inadequate evidence in humans for the carcinogenicity of HC Blue No. 1.
There is sufficient evidence in experimental animals for the carcinogenicity of HC Blue No. 1.
HC Blue No. 1 is possibly carcinogenic to humans (Group 2B).
For definition of the italicized terms, see Preamble Evaluation.
See Also: Toxicological Abbreviations