title: Prenatal effects of natural calcium supplement on Wistar rats during organogenesis period of pregnancy.
abstract: The potential of oral exposure to calcium and magnesium citrate, a natural product obtained from dolomite, to initiate teratogenesis was analyzed in Wistar rats. Animals received calcium and magnesium citrate oral doses of 250, 500 and 1000 mg/kg during the period of gestation from day 6 to 17 post conception. Maternal, embryo and fetal toxicity was evaluated. Calcium and magnesium citrate exposure did not produce maternal toxicity assessed by clinical observations, body weight gain, food intake, hematology, biochemical parameters and necropsy finding. Signs of embryo-fetal toxicity were not observed. Skeletal and visceral malformations were seen occasionally in all drug-treated and control groups. Skeletal and visceral variations were similar in control and drug-treated groups except for incomplete ossification rib. These finding was spontaneous and unrelated to the drug. In conclusion, in this study we found that the oral exposure to rats of up to 1000 mg/kg of calcium and magnesium citrate during organogenesis did not induce significant maternal and embryo-fetal toxicity. The experimentally derived NOAEL for developmental toxicity was 1000 mg/kg.
authors.affiliation: Drug Research and Development Center, CIDEM, 17 No. 6208 e/62 y 64, Playa, Código Postal 11300, Ciudad Habana, Havana City, Cuba. alicialp@infomed.sld.cu
authors.forename: Alicia
authors.initials: A
authors.lastname: Lagarto
authors.forename: Addis
authors.initials: A
authors.lastname: Bellma
authors.forename: Micaela
authors.initials: M
authors.lastname: Couret
authors.forename: Tatiana
authors.initials: T
authors.lastname: Gabilondo
authors.forename: Raisel
authors.initials: R
authors.lastname: López
authors.forename: Viviana
authors.initials: V
authors.lastname: Bueno
authors.forename: Isbel
authors.initials: I
authors.lastname: Guerra
authors.forename: Jorge
authors.initials: J
authors.lastname: Rodríguez
mesh_terms: D000818:Animals; D002119:Calcium Carbonate / Q000737:chemistry; D019355:Calcium Citrate / Q000302:isolation & purification / Q000633:toxicity*; D019343:Citric Acid / Q000302:isolation & purification / Q000633:toxicity*; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D047108:Embryonic Development / Q000187:drug effects; D023381:Endpoint Determination; D005260:Female; D047109:Fetal Development / Q000187:drug effects; D008274:Magnesium / Q000737:chemistry; D018811:Maternal Exposure / Q000009:adverse effects*; D009139:Musculoskeletal Abnormalities / Q000139:chemically induced / Q000196:embryology; D019055:No-Observed-Adverse-Effect Level; D038081:Organogenesis / Q000187:drug effects*; D009942:Organometallic Compounds / Q000302:isolation & purification / Q000633:toxicity*; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced*; D051381:Rats; D017208:Rats, Wistar; D012272:Ribs / Q000002:abnormalities / Q000187:drug effects / Q000196:embryology
chemical_list: D009942:Organometallic Compounds; D019343:Citric Acid; D002119:Calcium Carbonate; D008274:Magnesium; D019355:Calcium Citrate; C110422:magnesium citrate; C028042:calcium magnesium carbonate