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Studies of the toxicological potential of capsinoids: III. A two-generation reproduction study of CH-19 Sweet extract in rats.
Int J Toxicol. 2008; 27 Suppl 3:29-39.IJ

Abstract

CH-19 Sweet extract, containing 66.5 to 75.05 mg/ml capsinoids, was administered once daily by gavage, to two generations of male and female Sprague-Dawley rats, at dose levels of 0 (vehicle), 1.25, 2.5, and 5.0 ml/kg/day (83.13 to 93.81, 166.25 to 187.63, and 332.50 to 375.25 mg/kg as capsinoids, respectively) in order to determine its potential reproductive effects. In the first generation (F(0)) males and females, there were no test substance-related deaths, toxic changes, gross pathological findings, or adverse findings in clinical signs, body weight, or food consumption. There were no test substance-related effects on estrous cycles, copulation index, days required for copulation, fertility index, number of implantations, gestation period, number of liveborn pups, delivery index, stillbirth index, livebirth index, or lactation or nursing. In the second generation (F(1)), there were no test substance-related changes observed in clinical signs, body weights, sex ratios at birth, external abnormalities, differences in survival at any point from birth to weaning, and no deaths after weaning. There were no changes suggestive of adverse test substance-induced effects on body weight, food consumption, or external differentiation after birth, and there was no test substance-related damage on sensory/reflex functions. As with the first generation, there were no test substance-related effects on reproductive indices, in the offspring, no untoward effects on development, viability during the lactation period, body weight, external differentiation, or sensory/reflex functions, and there were no gross morphological abnormalities. Based on these results, the no observed adverse effect level (NOAEL) of CH-19 Sweet extract on the reproductive function and growth of offspring in this two generation study was judged to be 5.0 ml/kg/day (332.50 to 375.25 mg/kg as capsinoids).

Authors+Show Affiliations

Toxicology and Pathology, Nonclinical Developmental Research Department, Pharmaceutical Research Laboratories, Pharmaceutical Company, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan. terutaka kodama@ajinomoto.comNo 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

19037797

Citation

Kodama, Terutaka, et al. "Studies of the Toxicological Potential of Capsinoids: III. a Two-generation Reproduction Study of CH-19 Sweet Extract in Rats." International Journal of Toxicology, vol. 27 Suppl 3, 2008, pp. 29-39.
Kodama T, Watanabe E, Masuyama T, et al. Studies of the toxicological potential of capsinoids: III. A two-generation reproduction study of CH-19 Sweet extract in rats. Int J Toxicol. 2008;27 Suppl 3:29-39.
Kodama, T., Watanabe, E., Masuyama, T., Tsubuku, S., Otabe, A., Katsumata, Y., & Bernard, B. K. (2008). Studies of the toxicological potential of capsinoids: III. A two-generation reproduction study of CH-19 Sweet extract in rats. International Journal of Toxicology, 27 Suppl 3, 29-39. https://doi.org/10.1080/10915810802513403
Kodama T, et al. Studies of the Toxicological Potential of Capsinoids: III. a Two-generation Reproduction Study of CH-19 Sweet Extract in Rats. Int J Toxicol. 2008;27 Suppl 3:29-39. PubMed PMID: 19037797.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Studies of the toxicological potential of capsinoids: III. A two-generation reproduction study of CH-19 Sweet extract in rats. AU - Kodama,Terutaka, AU - Watanabe,Eri, AU - Masuyama,Takeshi, AU - Tsubuku,Shoji, AU - Otabe,Akira, AU - Katsumata,Yoshihiro, AU - Bernard,Bruce K, PY - 2008/12/17/pubmed PY - 2009/3/11/medline PY - 2008/12/17/entrez SP - 29 EP - 39 JF - International journal of toxicology JO - Int J Toxicol VL - 27 Suppl 3 N2 - CH-19 Sweet extract, containing 66.5 to 75.05 mg/ml capsinoids, was administered once daily by gavage, to two generations of male and female Sprague-Dawley rats, at dose levels of 0 (vehicle), 1.25, 2.5, and 5.0 ml/kg/day (83.13 to 93.81, 166.25 to 187.63, and 332.50 to 375.25 mg/kg as capsinoids, respectively) in order to determine its potential reproductive effects. In the first generation (F(0)) males and females, there were no test substance-related deaths, toxic changes, gross pathological findings, or adverse findings in clinical signs, body weight, or food consumption. There were no test substance-related effects on estrous cycles, copulation index, days required for copulation, fertility index, number of implantations, gestation period, number of liveborn pups, delivery index, stillbirth index, livebirth index, or lactation or nursing. In the second generation (F(1)), there were no test substance-related changes observed in clinical signs, body weights, sex ratios at birth, external abnormalities, differences in survival at any point from birth to weaning, and no deaths after weaning. There were no changes suggestive of adverse test substance-induced effects on body weight, food consumption, or external differentiation after birth, and there was no test substance-related damage on sensory/reflex functions. As with the first generation, there were no test substance-related effects on reproductive indices, in the offspring, no untoward effects on development, viability during the lactation period, body weight, external differentiation, or sensory/reflex functions, and there were no gross morphological abnormalities. Based on these results, the no observed adverse effect level (NOAEL) of CH-19 Sweet extract on the reproductive function and growth of offspring in this two generation study was judged to be 5.0 ml/kg/day (332.50 to 375.25 mg/kg as capsinoids). SN - 1092-874X UR - https://www.unboundmedicine.com/medline/citation/19037797/Studies_of_the_toxicological_potential_of_capsinoids:_III__A_two_generation_reproduction_study_of_CH_19_Sweet_extract_in_rats_ L2 - https://journals.sagepub.com/doi/10.1080/10915810802513403?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -