title: 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.
abstract: 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 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).
authors.affiliation: Daiyu-kai Institute of Medical Science, 64 Goura, Nishiazai, Azai-cho, Ichinomiya 491-0113, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Hagiwara
authors.forename: Masashi
authors.initials: M
authors.lastname: Sano
authors.forename: Toshio
authors.initials: T
authors.lastname: Ichihara
authors.forename: Hiroko
authors.initials: H
authors.lastname: Yoshino
authors.forename: Emiko
authors.initials: E
authors.lastname: Miyata
authors.forename: Seiko
authors.initials: S
authors.lastname: Tamano
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Aoki
authors.forename: Chiyoki
authors.initials: C
authors.lastname: Yukawa
authors.forename: Takatoshi
authors.initials: T
authors.lastname: Koda
authors.forename: Mikio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Shirai
mesh_terms: D000818:Animals; D003257:Consumer Product Safety; D004032:Diet; D004305:Dose-Response Relationship, Drug; D004326:Drinking / Q000187:drug effects; D004340:Drug Contamination; D004435:Eating / Q000187:drug effects; D010697:Eosine I Bluish / Q000737:chemistry / Q000633:toxicity*; D005260:Female; D005505:Food Coloring Agents / Q000633:toxicity*; D006863:Hydrogen-Ion Concentration; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D011916:Rats, Inbred F344; D013997:Time Factors; D018675:Toxicity Tests; D014556:Urine / Q000737:chemistry; D044004:Xanthones / Q000737:chemistry / Q000378:metabolism / Q000633:toxicity*
chemical_list: C453682:1-carboxyl-5,7-dibromo-6-hydroxy-2,3,4-trichloro-xanthone; D005505:Food Coloring Agents; D044004:Xanthones; D010697:Eosine I Bluish