title: Ninety-day toxicity study of alpha-iso-methylionone in rats.
abstract: Alpha-iso-methylionone (AIM), a fragrance ingredient, was evaluated for systemic toxicity in rats. Male and female Sprague Dawley rats were administered 0, 5, 30, or 500 mg/kg/d AIM via gavage for 90 days. Statistically significant changes in blood chemistry parameters (reduced aspartate aminotransferase [AST], and increased cholesterol, creatinine, and total protein) were observed in both sexes at 500 mg/kg/d. There were statistically significant increases in liver and kidney weights in both sexes and in spleen weights in males at 500 mg/kg/d. Adaptive hepatocyte enlargement was observed in both sexes at 500 mg/kg/d. Globular accumulations of eosinophilic material were observed in the renal tubular epithelium in males at ≥30 mg/kg/d. Thyroid and bone marrow histopathological changes were observed in males at 500 mg/kg/d. The no-observed-effect level was 5 mg/kg/d for males and 30 mg/kg/d for females. Based on histopathological changes in the kidney in males, the no-observed-adverse-effect level was 30 mg/kg/d.
authors.affiliation: Research Institute for Fragrance Materials, Inc, Woodcliff Lake, NJ 07677, USA.
authors.forename: Valerie T
authors.initials: VT
authors.lastname: Politano
authors.forename: Aurelia A
authors.initials: AA
authors.lastname: Lapczynski
authors.forename: Gretchen
authors.initials: G
authors.lastname: Ritacco
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Api
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001774:Blood Chemical Analysis; D001854:Bone Marrow Cells / Q000187:drug effects / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D007684:Kidney Tubules / Q000187:drug effects / Q000473:pathology; D008099:Liver / Q000187:drug effects; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D045792:Norisoprenoids / Q000633:toxicity*; D009929:Organ Size / Q000187:drug effects; D010476:Perfume / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D013154:Spleen / Q000187:drug effects; D013961:Thyroid Gland / Q000187:drug effects / Q000473:pathology; D059550:Toxicity Tests, Subchronic
chemical_list: D045792:Norisoprenoids; D010476:Perfume; C494862:alpha-isomethylionone