Studies of the Toxicological Potential of Capsinoids: I. Single-Dose Toxicity Study and Genotoxicity Studies of CH-19 Sweet Extract

Watanabe, Eri; Kodama, Terutaka; Masuyama, Takeshi; Tsubuku, Shoji; Otabe, Akira; Mochizuki, Masahiro; Nakajima, Masahiro; Masumori, Shoji; Bernard, Bruce K.

doi:10.1080/10915810802513361

Cited by 18 publications

(32 citation statements)

References 11 publications

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“…However, in general, the results reported herein suggest the capsinoids, in the form of CH-19 Sweet extract, are relatively nontoxic when it comes to teratogenicity (or general toxicity). This is consistent with the findings of Watanabe et al (2008) who reported low single-dose acute toxicity in rats limited to transient salivation or decreased spontaneous movement immediately following gavage administration 10 ml/kg body weight (BW) and an LD 50 >20 ml/kg as CH-19 Sweet extract (>1425 mg/kg or >285 mg/kg as capsinoids or dihydrocapsiate, respectively).…”

Section: Table 13 Observations Made During Skeletal Examinations Of Fsupporting

confidence: 92%

Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits

et al. 2008

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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.

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Section: Table 13 Observations Made During Skeletal Examinations Of Fsupporting

confidence: 92%

Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits

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“…In comparison, Watanabe et al (2008c) reported significantly higher acute oral LD 50 values for rats. In that study, CH-19 Sweet extract was administered as a single gavage dose at levels of 0 (vehicle), 5, 10, or 20 ml/kg of body weight (BW).…”

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confidence: 78%

“…Genotoxicity for CH-19 Sweet extract (Watanabe et al 2008c) and dihydrocapsiate ) are both negative.…”

Section: Malesmentioning

confidence: 94%

“…Capsaicin and chili extracts were mutagenic with metabolic activation in the reverse-mutation test using Salmonella typhimurium, and in the micronucleus test in mice, capsaicin was positive at 7.5 mg/kg (Nagabhushan and Bhide 1985). However, in Watanabe et al (2008c), in a bacterial reverse-mutation test performed employing S. typhimurium and Escherichia coli, CH-19 Sweet extract did not increase the number of revertant colonies either in the presence (+S9) or absence (−S9) of metabolic activation. A second test reported in that same publication, an in vitro chromosome aberration test conducted using Chinese hamster lung cultured cells (CHL/IU), was similarly negative for chromosome aberrations in both short-term and continuous treatment Dose (mg/kg/day) 5.5 6.0 6.5 7.0 7.5 8.0 8.5 − ± + ++ + + + − ± + ++ + + + + + ++ − + − + + + + Table 3 for more details.…”

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Studies of the Toxicological Potential of Capsinoids: VII. A 13-Week Toxicity Study of Dihydrocapsiate in Rats

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To evaluate the safety of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS No. 205687-03-2), a 13-week gavage toxicity study was conducted in Sprague-Dawley rats (10/sex/group). Test subjects received either dihydrocapsiate, 100, 300, or 1000 mg/kg/day, or vehicle by gavage and were observed for antemortem and postmortem signs of toxicity, which included changes in clinical signs, body weights, food consumption, water intake, ophthalmology, clinical pathology (clinical chemistry, hematology, urinalysis), tissue findings (macroscopic and microscopic examination), as well as organ weights. No changes attributable to the test article were observed in clinical signs, body weights, food consumption, water intake, ophthalmology, urinalysis, hematology, or histopathology. A number of sporadic blood chemistry differences were observed at the high dose between treated and controls, but were not of toxicological significance and were not attributable to the test article. These included increased alanine aminotransferase (ALT) activity in males; increased total protein in males and females; increased calcium, percentage of albumin fraction, and A/G (albumin/globulin) ratio and decreased percentage of gamma-globulin fraction in female rats. An effect, which was attributable to the test article, was increases in both absolute and relative liver weights in the high dose (both sexes). In the absence of histopathological changes attributable to the test article, the liver weight changes were considered adaptive (physiological) in nature and not of toxicological significance. It was concluded that the no observed adverse effect level (NOAEL) of dihydrocapsiate was 1000 mg/kg/day for both male and female rats in this 13-week gavage study.

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“…The acute oral toxicity of CH-19 Sweet extract containing capsinoids was examined following a single gavage administration to Sprague-Dawley rats (Watanabe et al 2008). At dose levels of 0 (vehicle), 5, 10, or 20 ml/kg of body weight (BW) of CH-19 Sweet extract, rats received 356.25, 712.5, and 1425 mg capsinoids/kg BW, respectively.…”

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confidence: 99%

Studies of the Toxicological Potential of Capsinoids: III. A Two-Generation Reproduction Study of CH-19 Sweet Extract in Rats

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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).

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Studies of the Toxicological Potential of Capsinoids: I. Single-Dose Toxicity Study and Genotoxicity Studies of CH-19 Sweet Extract

Cited by 18 publications

References 11 publications

Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits

Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits

Studies of the Toxicological Potential of Capsinoids: VII. A 13-Week Toxicity Study of Dihydrocapsiate in Rats

Studies of the Toxicological Potential of Capsinoids: III. A Two-Generation Reproduction Study of CH-19 Sweet Extract in Rats

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