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Safety studies of pseudo-ceramide SLE66. Part 3: Effects on embryo/fetal development in rats
- Source :
- Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 47(4)
- Publication Year :
- 2008
-
Abstract
- SLE66 a synthetic pseudo-ceramide, has been shown to reduce dryness/scaling/itching of human skin. Naturally occurring ceramides have been claimed to play a crucial role in cell proliferation, differentiation, and apoptosis including processes important for embryogenesis. The objective of this study was to evaluate the potential maternal and fetal effects of SLE66. SLE66 was administered orally (gavage) to mated female Crl:CD®(SD)IGS BR rats (25/group) once daily from gestation day 6 through 19, at dose levels of 0 (control), 150, 400 or 1000 mg/kg/day. No treatment-related clinical or internal (macroscopic) findings were noted and all animals survived to the scheduled necropsy on gestation day 20. SLE66 administration did not affect mean maternal body weights, body weight gains, net body weights, net body weight gains, gravid uterine weights, or feed consumption. Similarly, SLE66 administration did not affect intrauterine growth and survival related parameters such as viable fetuses, pre-implantation loss, early and late resorptions, fetal weight and fetal sex. No SLE66-related fetal malformations or developmental variations were noted. Based on the results of this study, a dose level of 1000 mg/kg/day (highest dose used) was considered as the no-observed-adverse-effect level (NOAEL) for both maternal and developmental toxicity.
- Subjects :
- medicine.medical_specialty
Ceramide
Developmental toxicity
Physiology
Embryonic Development
Biology
Toxicology
Ceramides
Fetal Development
Rats, Sprague-Dawley
chemistry.chemical_compound
Internal medicine
medicine
Animals
Fetus
No-Observed-Adverse-Effect Level
Dose-Response Relationship, Drug
Embryogenesis
Body Weight
Abnormalities, Drug-Induced
Embryo
General Medicine
Rats
Endocrinology
chemistry
Apoptosis
Gestation
Itching
Female
medicine.symptom
Food Science
Subjects
Details
- ISSN :
- 18736351
- Volume :
- 47
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association
- Accession number :
- edsair.doi.dedup.....4f808e43203ae4a601b30207af18bc1e