International Agency for Research on Cancer (IARC) - Summaries & Evaluations

D&C RED No. 9 (CI Pigment Red 53:1)
(Group 3)

For definition of Groups, see Preamble Evaluation.

VOL.: 57 (1993) (p. 203)
CAS No.: 5160-02-1
Chem. Abstr. Name: 5-Chloro-2-[(2-hydroxy-1-naphthalenyl)azo]-4-methyl benzenesulfonic acid, barium salt (2:1)

5. Summary of Data Reported and Evaluation

5.1 Exposure data

D&C Red No. 9 (a certified grade of CI Pigment Red 53:1) is used in lipsticks, mouthwashes, dentifrices and drugs in some countries. CI Pigment Red 53:1 has been used extensively since the 1940s as a pigment in printing inks, coated papers, crayons, rubber and baking enamels.

5.2 Human carcinogenicity data

No data were available to the Working Group.

5.3 Animal carcinogenicity data

D&C Red No. 9 was tested for carcinogenicity by administration in the diet in one study in mice and in two studies in rats and by skin painting in one study in mice. In one study, it produced splenic sarcomas in male rats and increased the incidence of neoplastic liver nodules in animals of each sex. No treatment-related increase in the incidence of tumours was observed in mice.

5.4 Other relevant data

D&C Red No. 9 caused splenic toxicity in rats and mice.

D&C Red No. 9 was inactive in all studies in which it was tested, including assays for gene mutation in bacteria and in cultured mammalian cells, DNA damage in cultured mammalian cells and in rodents in vivo, sister chromatid exchange and chromosomal aberrations in cultured mammalian cells and micronucleus formation in the bone marrow of rats treated orally.

5.5 Evaluation

There is inadequate evidence in humans for the carcinogenicity of D&C Red No. 9.

There is limited evidence in experimental animals for the carcinogenicity of D&C Red No. 9.

Overall evaluation

D&C Red No. 9 is not classifiable as to its carcinogenicity to humans (Group 3).

For definition of the italicized terms, see Preamble Evaluation.

Previous evaluation: Suppl. 7 (1987) (p. 61)


Last updated 08/22/1997

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