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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Lifshitz, Y. Levi, L. Eyal, I. Cohen, T. Tessler, S. |
| Description | Author Affiliation: Lifshitz Y ( Nutrition R&D, Enzymotec, Migdal HaEmeq, Israel. Electronic address: yaell@enzymotec.com.); Levi L ( Nutrition R&D, Enzymotec, Migdal HaEmeq, Israel.); Eyal I ( Nutrition R&D, Enzymotec, Migdal HaEmeq, Israel.); Cohen T ( Nutrition R&D, Enzymotec, Migdal HaEmeq, Israel.); Tessler S ( Nutrition R&D, Enzymotec, Migdal HaEmeq, Israel.) |
| Abstract | The safety of fish phosphatidylserine (PS) conjugated to DHA (InCog™) was examined in a series of toxicology studies as first step to support future use in infants and general population using in vitro genotoxicity tests and in a sub-chronic toxicity study with an in-utero exposure phase. PS is a major lipid in the cell membrane, active in various membrane-mediated processes. PS-DHA, present in human milk, has been suggested to be important for early brain development. Rats were exposed to diets containing 1.5%, 3% or 4.5% InCog or two control diets. Parental (F0) animals were fed throughout mating, gestation and lactation. Subsequently, a subchronic, 13-week study was conducted on the F1 animals followed by 4 weeks of recovery. The genotoxicity tests showed no mutagenicity potential. No significant toxicological findings were found in the F0 rats or the F1 pups. In the 13-weeks study, an increase in the presence of renal minimal-mild multifocal corticomedullary mineralization was noted in nine females of the high-dose group. This change was not associated with any inflammatory or degenerative changes in the kidneys. The no-observed-adverse-effect level (NOAEL) in the present study was placed at 3% in the diet (mid-dose group), equivalent to an overall intake of at least 2.1 g InCog/kg bw/day in the F1 generation. |
| File Format | HTM / HTML |
| ISSN | 02786915 |
| Volume Number | 86 |
| e-ISSN | 18736351 |
| Journal | Food and Chemical Toxicology |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2015-12-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Toxicology__semicolon__nutritional Discipline Sciences Docosahexaenoic Acids Toxicity Maternal Exposure Phosphatidylserines Administration, Oral Adrenal Glands Drug Effects Pathology Animals Chemistry Dose-response Relationship, Drug Drug Administration Schedule Female Male Mutagenicity Tests Organ Size Pregnancy Prenatal Exposure Delayed Effects Random Allocation Rats Rats, Wistar Salmonella Typhimurium Genetics Spleen Journal Article Research Support, Non-u.s. Gov't |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Toxicology Food Science |
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