Sudan IV was of low acute oral toxicity in rats. In a limited study involving repeated oral administration, indications of liver injury and early death were seen in rats and liver damage occurred in rabbits treated by intravenous injection. Reproductive toxicity is undefined. Although there are no adequate studies of the carcinogenicity of Sudan IV, limited oral studies in mice and rats may have indicated some carcinogenic potential in the liver. Sudan IV itself was not mutagenic in the bacterium Salmonella typhimurium (Ames test) but a reduction product was active.
Solutions of Sudan IV were slightly irritant to the skin and eyes of rabbits. Sensitization has been reported in a number of individuals exposed dermally or following contact of Sudan IV with open wounds.
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