FOUR-WEEK ORAL TOXICITY STUDY OF 1-CARBOXY-5,7-DIBROMO-6-HYDROXY-2,3,4-TRICHLOROXANTHONE (HXCA), AN IMPURITY OF PHLOXINE B, IN F344 RATS

Akihiro HAGIWARA, Masashi SANO, Toshio ICHIHARA, Hiroko YOSHINO, Emiko MIYATA, Seiko TAMANO, Hiromitsu AOKI, Chiyoki YUKAWA, Takatoshi KODA, Mikio NAKAMURA, Tomoyuki SHIRAI
2003 Journal of Toxicological Sciences  
This study was designed to evaluate and characterize any subacute toxicity of 1-carboxy-5,7-dibromo-6-hydroxy-2,3,4-trichloroxanthone (HXCA), an impurity of Phloxine B (Food Red No. 104 in Japan, D&C Red No. 28 in the USA), when administered to both sexes of F344 rats at dietary levels of 0 (control), 0.005, 0.05 and 0.5%. During the study, the treatment had no effects on clinical signs, survival, urinalysis or ophthalmology. Hematology, blood biochemistry, gross pathology, organ weights, organ
more » ... to body weight ratios and histopathology exhibited no differences of toxicological significance between control and treated rats. Reactions to treatment may be summarized as follows: there was a tendency for increased food and water consumption and decreased food efficiency in both sexes of the 0.5% group. Thus, these results indicated the no-observed-adverse-effect level (NOAEL) of HXCA to be 0.05% (39.3 mg/kg/day for males, and 41.0 mg/kg/day for females).
doi:10.2131/jts.28.445 pmid:14746348 fatcat:vrlcv3sh55dunojemac7en4ss4