Toxicological evaluation of ammonium 4,8-dioxa-3H-perfluorononanoate, a new emulsifier to replace ammonium perfluorooctanoate in fluoropolymer manufacturing.
Ammonium 4,8-dioxa-3H-perfluorononanoate (ADONA) was developed to replace ammonium perfluorooctanoate (APFO) as an emulsifier in the manufacture of fluoropolymers. The toxicity of ADONA was evaluated in acute and repeat-dose studies of up to 90-days duration, and in eye and skin irritation, dermal sensitization, genotoxicity, and developmental toxicity studies. ADONA was also evaluated as a peroxisome proliferator-activated receptor alpha (PPARα) agonist in rats. ADONA was moderately toxic orally and practically non-toxic dermally in acute studies in rats. It was a mild skin irritant and a moderate to severe eye irritant in rabbits. It was a weak dermal sensitizer in local lymph node assays in mice. ADONA was not genotoxic based on the weight of evidence from five assays. It was not developmentally toxic in rats except at maternally toxic doses. ADONA was a possible PPARα agonist in male rats. The liver was the primary target organ in male rats and the kidney was the primary target organ in female rats. NOAELs in 28- and 90-day oral studies in rats were 10mg/kg/day for males and 100mg/kg/day for females. These findings demonstrate that the toxicity profile for ADONA is acceptable for its intended use and is superior to that of APFO.
Gordon
Steven C
SC
3M Company, Toxicology Assessment and Compliance Assurance, St. Paul, MN 55144, USA. scgordon@mmm.com
D000818:Animals; D001853:Bone Marrow / Q000187:drug effects / Q000473:pathology; D002210:Caprylates / Q000008:administration & dosage / Q000633:toxicity*; D002478:Cells, Cultured; D002869:Chromosome Aberrations / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D045703:Emulsifying Agents / Q000008:administration & dosage / Q000633:toxicity*; D005123:Eye / Q000187:drug effects / Q000473:pathology; D005260:Female; D047109:Fetal Development / Q000187:drug effects; D005466:Fluorocarbons / Q000008:administration & dosage / Q000633:toxicity*; D006801:Humans; D023441:Local Lymph Node Assay; D008297:Male; D008420:Manufactured Materials / Q000633:toxicity*; D051379:Mice; D008808:Mice, Inbred CBA; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D009154:Mutation; D019055:No-Observed-Adverse-Effect Level; D047493:PPAR alpha / Q000819:agonists; D000644:Quaternary Ammonium Compounds / Q000008:administration & dosage / Q000633:toxicity*; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D017208:Rats, Wistar; D018570:Risk Assessment; D012867:Skin / Q000187:drug effects / Q000473:pathology; D023422:Skin Irritancy Tests; D013997:Time Factors; D018675:Toxicity Tests
D002210:Caprylates; D045703:Emulsifying Agents; D005466:Fluorocarbons; D047493:PPAR alpha; D000644:Quaternary Ammonium Compounds; C558144:ammonium 4,8-dioxa-3H-perfluorononanoate; C023036:perfluorooctanoic acid