title: The teratology testing of food additives.
abstract: The developmental and reproductive toxicity testing (including teratogenicity) of new foods and food additives is performed worldwide according to the guidelines given in the FDA Redbook. These studies are not required for substances that are generally recognized as safe, according to the FDA inventory. The anticipated cumulated human exposure level above which developmental or reproduction studies are required depends on the structure-alert category. For food additives of concern, both developmental (prenatal) and reproduction (multigeneration) studies are required. The developmental studies are performed in two species, usually the rat and the rabbit. The reproduction study is generally performed in the rat. The two rat studies are preferably combined into a single experimental design, if possible. The test methods described in the FDA Redbook are similar to those specified by the OECD for the reproductive toxicity testing of chemicals.
authors.affiliation: CiToxLAB, Evreux, France. paul.barrow@citox.com
authors.forename: Paul C
authors.initials: PC
authors.lastname: Barrow
authors.forename: François
authors.initials: F
authors.lastname: Spézia
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical; D004305:Dose-Response Relationship, Drug; D004333:Drug Administration Routes; D023381:Endpoint Determination; D005260:Female; D047109:Fetal Development / Q000187:drug effects; D005503:Food Additives / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D033161:Government Regulation; D006801:Humans; D008297:Male; D009035:Mothers; D011247:Pregnancy; D011817:Rabbits; D051381:Rats; D012098:Reproduction / Q000187:drug effects; D013045:Species Specificity; D018600:Teratology / Q000331:legislation & jurisprudence / Q000379:methods*; D018675:Toxicity Tests / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D005503:Food Additives