title: A 13-week subchronic toxicity study of sodium iron chlorophyllin in F344 rats.
abstract: Sodium iron chlorophyllin (SIC), a water-soluble chlorophyll derivative, has been used as a food additive for green coloration. In the present study, a subchronic toxicity study of SIC was performed in male and female F344 rats with oral administration in diet at concentrations of 0%, 0.2%, 1.0%, and 5.0% for 13 weeks. No mortalities, abnormal clinical signs, and hematological changes were observed in any of the groups during the experiment. Significant reduction of body weight gain was noted in 5.0% males. In serum biochemistry, serum transferrin levels were significantly increased in 5.0% males and females. Relative spleen weights of both sexes were markedly reduced with 5.0% SIC as compared to the controls, and absolute weights of spleen were also significantly decreased in males. On histopathological assessment, diffuse hypertrophy of acinar cells in the parotid gland was observed in all examined 5.0% males and females, but not in the other groups. Based on the histopathology of the parotid glands, the no-observed-adverse-effect level (NOAEL) of SIC in the present study was estimated to be 1.0% (609 mg/kg bw/day for males and 678 mg/kg bw/day for females).
authors.affiliation: Division of Pathology, National Institute of Health Sciences.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Toyoda
authors.forename: Young-Man
authors.initials: YM
authors.lastname: Cho
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Mizuta
authors.forename: Jun-ichi
authors.initials: J
authors.lastname: Akagi
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Nishikawa
authors.forename: Kumiko
authors.initials: K
authors.lastname: Ogawa
mesh_terms: D061354:Acinar Cells / Q000187:drug effects / Q000473:pathology; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002735:Chlorophyllides / Q000008:administration & dosage / Q000633:toxicity*; D005260:Female; D005505:Food Coloring Agents / Q000008:administration & dosage / Q000633:toxicity*; D006801:Humans; D006984:Hypertrophy; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010306:Parotid Gland / Q000166:cytology / Q000187:drug effects / Q000473:pathology; D011916:Rats, Inbred F344; D012727:Sex Characteristics; D013154:Spleen / Q000187:drug effects; D013997:Time Factors; D014168:Transferrin / Q000378:metabolism
chemical_list: D002735:Chlorophyllides; D005505:Food Coloring Agents; D014168:Transferrin; C007020:chlorophyllin