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- Article] Studies of the Toxicological Potential of Capsinoids: IX. Teratology Studies of Dihydrocapsiate in Rats and Rabbits
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DocNo of ILP: 3968
Doc. Type: Article
Title: Studies of the Toxicological Potential of Capsinoids: IX. Teratology Studies of Dihydrocapsiate in Rats and Rabbits
Authors: Bernard, BK; Watanabe, E; Kodama, T; Tsubuku, S; Otabe, A; Ikeya, M; Matsuoka, T; Masuyama, T
Full Name of Authors: Bernard, Bruce K.; Watanabe, Eri; Kodama, Terutaka; Tsubuku, Shoji; Otabe, Akira; Ikeya, Masamichi; Matsuoka, Tetsuya; Masuyama, Takeshi
Keywords by Author: Capsiate; Capsinoids; Dihydrocapsiate; Teratogenicity
Keywords Plus: CAPSAICIN; CAPSICUM; TOXICITY
Abstract: In order to determine the safety of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS no. 205687-03-2), teratology studies were conducted in pregnant Sprague-Dawley rats (18 to 20 animals per group) and pregnant New Zealand white rabbits (20 to 21 animals per group). The test substance was administered by gavage for 11 days, from days 7 to 17 of gestation in rats, and for 13 days from days 6 to 18 of gestation in rabbits, at dose levels of 0 (vehicle), 100, 300, or 1000 mg/kg/day. 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 of implantations, index of implantations, index of embryofetal deaths, and number, sex ratio, or body weight of live fetuses at the end of the gestation period and there were no abnormalities in the placentae of live fetuses. There were no test substance-related abnormalities or variations in the external, skeletal, or visceral examinations of live fetuses. There were no abnormalities in ossification. En toto, it was concluded there were no teratogenic effects in the rat study. In the rabbit study, there were no test substance-related effects on clinical signs, body weight, food consumption, or necropsy findings in any group. There were neither test substance-related abortions nor test substance-related effects on the number of corpora lutea, number of implantations, or implantation index in any group. There were no test substance-related effects on the number of dead embryos/fetuses, the number, sex ratio, or body weight of live fetuses, or gross pathological finding of placentae. There were no test substance-related external abnormalities, or incidence of visceral or skeletal abnormalities or variations, and there were no test substance-related effects on the progress of ossification in any group. Based upon these data, the no observed adverse effect level (NOAEL) of dihydrocapsiate for general toxicity in dams, reproductive functions of dams, and embryofetal development was judged to be 1000 mg/kg/day both in rats and rabbits.
Cate of OECD: Basic medicine
Year of Publication: 2008
Business Area: other
Detail Business: medicine & science
Country: USA
Study Area:
Name of Journal: INTERNATIONAL JOURNAL OF TOXICOLOGY
Language: English
Country of Authors: [Bernard, Bruce K.] SRA Int Inc, Cambridge, MD 21613 USA; [Watanabe, Eri; Kodama, Terutaka; Tsubuku, Shoji; Otabe, Akira; Masuyama, Takeshi] Ajinomoto Co Inc, Nonclin Dev Res Dept, Pharmaceut Res Labs, Pharmaceut Co, Kanagawa, Japan; [Ikeya, Masamichi] Bozo Res Ctr Inc, Gotemba Lab, Shizuoka, Japan; [Matsuoka, Tetsuya] Bozo Res Ctr Inc, Kannami Lab, Shizuoka, Japan
Press Adress: Bernard, BK (reprint author), SRA Int Inc, 5235 Ragged Point Rd, Cambridge, MD 21613 USA.
Email Address: Bernard@sra-intl.com
Citaion:
Funding:
Lists of Citation: Akagi A, 1998, FOOD CHEM TOXICOL, V36, P1065, DOI 10.1016/S0278-6915(98)00077-5; AKAGI AN, 1998, FOOD CHEM TOXICOL, V36, P1069; Chanda S, 2006, INT J TOXICOL, V25, P205, DOI 10.1080/10915810600683317; Dawson AB, 1926, STAIN TECHNOL, V1, P123; DUNNETT CW, 1964, BIOMETRICS, V20, P482, DOI 10.2307/2528490; Hollander M, 1973, NONPARAMETRIC STAT M, P120; Kobata K, 1999, J NAT PROD, V62, P335, DOI 10.1021/np9803373; Kobata K, 2002, BIOSCI BIOTECH BIOCH, V66, P319, DOI 10.1271/bbb.66.319; KOBATA K, 1998, J AGR FOOD CHEM, V46, P1696; *MIN HLTH WELF ENV, 1996, 29 MIN HLTH WELF ENV; MONSEREENUSORN Y, 1983, RES COMMUN CHEM PATH, V41, P95; Nishimura K., 1974, C ANOM, V14, P23; OECD, 1996, OECD GUID TEST CHEM; Sokal RR, 1969, BIOMETRY, P370; Wilson JG, 1965, TERATOLOGY PRINCIPLE, P262; Yates F, 1934, JR STATIST SOC S, V1, P217, DOI DOI 10.2307/2983604; Yazawa S., 2004, CAPSICUM EGGPLANT NE, V23, P17
Number of Citaion: 17
Publication: SAGE PUBLICATIONS INC
City of Publication: THOUSAND OAKS
Address of Publication: 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
ISSN: 1091-5818
29-Character Source Abbreviation: INT J TOXICOL
ISO Source Abbreviation: Int. J. Toxicol.
Volume: 27
Version:
Start of File: 119
End of File: 136
DOI: 10.1080/10915810802513643
Number of Pages: 18
Web of Science Category: Pharmacology & Pharmacy; Toxicology
Subject Category: Pharmacology & Pharmacy; Toxicology
Document Delivery Number: 376OK
Unique Article Identifier: WOS:000261192700009
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