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Studies of the toxicological potential of capsinoids: IV. Teratology studies of CH-19 Sweet extract in rats and rabbits.
Int J Toxicol. 2008; 27 Suppl 3:41-57.IJ

Abstract

In order to evaluate the safety of CH-19 Sweet extract that contains capsinoids, teratology studies were conducted in pregnant Sprague-Dawley rats (20 rats per group) and pregnant New Zealand white rabbits (17 to 22 animals per group). The test substance was administered to rats by gavage for 11 days on gestation days 7 to 17 at doses of 0 (vehicle), 1.25, 2.5, and 5.0 ml/kg and to rabbits for 13 days on gestation days 6 to 18 at doses of 0 (vehicle), 0.25, 0.5, and 1.0 ml/kg. As the concentration of capsinoids in CH-19 Sweet extract was 72.2 to 75.05 mg/ml, the resulting dose of capsinoids administered to rats was 90.25, 180.5, and 361 mg/kg, and to rabbits was 18.76, 37.53, and 75.05 mg/kg in the vehicle, low-, mid-, and high-dose groups, respectively. In the rat study, no deaths occurred in any group and there were no test substance-related changes or abnormalities in clinical signs, body weight, food consumption, or gross pathological findings. There were no test substance-related changes in the number of corpora lutea, number or index of implantations, index of embryofetal deaths, number of live fetuses, sex ratio, fetal body weight at the end of the gestation period, or abnormalities in the placenta of live fetuses. There were no test substance-related abnormalities or variations in the external, skeletal, or visceral examinations of live fetuses. It was concluded that the test article caused neither teratogenic effects nor abnormalities in the progression of ossification. In the rabbit study, there were no test substance-related effects on clinical signs, body weight, food consumption, or necropsy findings. There were neither test substance-related abortions nor test substance-related effects on the number of corpora lutea, or number or index of implantations. There were no test substance-related effects on the number of dead embryos/fetuses, the number of live fetuses, sex ratio, body weight of live fetuses, or gross pathological finding in the placentas. There were no test substance-related external abnormalities or incidences of visceral or skeletal abnormalities or variations, and there were no test substance-related effects on the progress of ossification in any group. The authors concluded the no observed adverse effect level (NOAEL) of CH-19 Sweet extract containing capsinoids on pregnant animals and fetal development/growth was > 5.0 ml/kg/day (> 361 mg/kg/day as capsinoids) in rats and > 1.0 ml/kg/day (> 75.05 mg/kg/day as capsinoids) in rabbits.

Authors+Show Affiliations

SRA International, Inc., Cambridge, Maryland 21613, USA. bernard@sra-intl.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19037798

Citation

Bernard, Bruce K., et al. "Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits." International Journal of Toxicology, vol. 27 Suppl 3, 2008, pp. 41-57.
Bernard BK, Watanabe E, Kodama T, et al. Studies of the toxicological potential of capsinoids: IV. Teratology studies of CH-19 Sweet extract in rats and rabbits. Int J Toxicol. 2008;27 Suppl 3:41-57.
Bernard, B. K., Watanabe, E., Kodama, T., Tsubuku, S., Otabe, A., Katsumata, Y., Matsuoka, T., & Masuyama, T. (2008). Studies of the toxicological potential of capsinoids: IV. Teratology studies of CH-19 Sweet extract in rats and rabbits. International Journal of Toxicology, 27 Suppl 3, 41-57. https://doi.org/10.1080/10915810802513502
Bernard BK, et al. Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits. Int J Toxicol. 2008;27 Suppl 3:41-57. PubMed PMID: 19037798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Studies of the toxicological potential of capsinoids: IV. Teratology studies of CH-19 Sweet extract in rats and rabbits. AU - Bernard,Bruce K, AU - Watanabe,Eri, AU - Kodama,Terutaka, AU - Tsubuku,Shoji, AU - Otabe,Akira, AU - Katsumata,Yoshihiro, AU - Matsuoka,Tetsuya, AU - Masuyama,Takeshi, PY - 2008/12/17/pubmed PY - 2009/3/11/medline PY - 2008/12/17/entrez SP - 41 EP - 57 JF - International journal of toxicology JO - Int J Toxicol VL - 27 Suppl 3 N2 - In order to evaluate the safety of CH-19 Sweet extract that contains capsinoids, teratology studies were conducted in pregnant Sprague-Dawley rats (20 rats per group) and pregnant New Zealand white rabbits (17 to 22 animals per group). The test substance was administered to rats by gavage for 11 days on gestation days 7 to 17 at doses of 0 (vehicle), 1.25, 2.5, and 5.0 ml/kg and to rabbits for 13 days on gestation days 6 to 18 at doses of 0 (vehicle), 0.25, 0.5, and 1.0 ml/kg. As the concentration of capsinoids in CH-19 Sweet extract was 72.2 to 75.05 mg/ml, the resulting dose of capsinoids administered to rats was 90.25, 180.5, and 361 mg/kg, and to rabbits was 18.76, 37.53, and 75.05 mg/kg in the vehicle, low-, mid-, and high-dose groups, respectively. In the rat study, no deaths occurred in any group and there were no test substance-related changes or abnormalities in clinical signs, body weight, food consumption, or gross pathological findings. There were no test substance-related changes in the number of corpora lutea, number or index of implantations, index of embryofetal deaths, number of live fetuses, sex ratio, fetal body weight at the end of the gestation period, or abnormalities in the placenta of live fetuses. There were no test substance-related abnormalities or variations in the external, skeletal, or visceral examinations of live fetuses. It was concluded that the test article caused neither teratogenic effects nor abnormalities in the progression of ossification. In the rabbit study, there were no test substance-related effects on clinical signs, body weight, food consumption, or necropsy findings. There were neither test substance-related abortions nor test substance-related effects on the number of corpora lutea, or number or index of implantations. There were no test substance-related effects on the number of dead embryos/fetuses, the number of live fetuses, sex ratio, body weight of live fetuses, or gross pathological finding in the placentas. There were no test substance-related external abnormalities or incidences of visceral or skeletal abnormalities or variations, and there were no test substance-related effects on the progress of ossification in any group. The authors concluded the no observed adverse effect level (NOAEL) of CH-19 Sweet extract containing capsinoids on pregnant animals and fetal development/growth was > 5.0 ml/kg/day (> 361 mg/kg/day as capsinoids) in rats and > 1.0 ml/kg/day (> 75.05 mg/kg/day as capsinoids) in rabbits. SN - 1092-874X UR - https://www.unboundmedicine.com/medline/citation/19037798/Studies_of_the_toxicological_potential_of_capsinoids:_IV__Teratology_studies_of_CH_19_Sweet_extract_in_rats_and_rabbits_ L2 - https://journals.sagepub.com/doi/10.1080/10915810802513502?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -