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.
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).
Hagiwara
Akihiro
A
Daiyu-kai Institute of Medical Science, 64 Goura, Nishiazai, Azai-cho, Ichinomiya 491-0113, Japan.
Sano
Masashi
M
Ichihara
Toshio
T
Yoshino
Hiroko
H
Miyata
Emiko
E
Tamano
Seiko
S
Aoki
Hiromitsu
H
Yukawa
Chiyoki
C
Koda
Takatoshi
T
Nakamura
Mikio
M
Shirai
Tomoyuki
T
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*
C453682:1-carboxyl-5,7-dibromo-6-hydroxy-2,3,4-trichloro-xanthone; D005505:Food Coloring Agents; D044004:Xanthones; D010697:Eosine I Bluish