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  • 1
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    Studies of the Toxicological Potential of Capsinoids: V. Genotoxicity Studies of Dihydrocapsiate
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27, No. 3_suppl ( 2008-05), p. 59-72
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27, No. 3_suppl ( 2008-05), p. 59-72
    Abstract: A series of studies was performed to evaluate the safety of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS no. 205687-03-2). This study evaluated the potential genotoxicity of this compound using a variety of in vitro and in vivo test systems, including bacterial reverse mutation test, chromosomal aberration test, micronucleus test, gene mutation assay with transgenic rats, and single-cell gel (SCG) assay (Comet assay). In vitro tests (bacterial reverse mutation test and chromosomal aberration test) produced positive results in the absence of metabolic activation, but negative results in the presence of metabolic activation. The in vivo gene mutation assay (with transgenic rats) produced negative results, as did the in vivo mouse micronucleus assay, which failed to induce micronucleated polychromatic erythrocytes. Although the rat SCG assay produced statistically significant increases in the Olive tail moment and % tail DNA of the liver and intestine in the 2000 mg/kg group (compared with the negative-control group), a number of factors caused the authors to question the validity of these findings. Taken together, these results suggest that dihydrocapsiate has a low or extremely low likelihood of inducing genotoxicity.
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810802513536
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 2
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    Studies of the Toxicological Potential of Capsinoids: I. Single-Dose Toxicity Study and Genotoxicity Studies of CH-19 Sweet Extract
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27 ( 2008), p. 1-9
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27 ( 2008), p. 1-9
    Type of Medium: Online Resource
    ISSN: 1091-5818
    URL: Article
    DOI: 10.1080/10915810802513361
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 3
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    Studies of the Toxicological Potential of Capsinoids: VIII. A 13-Week Toxicity Study of Commercial-Grade Dihydrocapsiate in Rats
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27, No. 3_suppl ( 2008-05), p. 101-118
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27, No. 3_suppl ( 2008-05), p. 101-118
    Abstract: Dihydrocapsiate, (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS No. 205687-03-2) is a naturally occurring capsinoid compound found in nonpungent chili peppers. Although the safety of synthetically produced dihydrocapsiate has been previously evaluated, the purpose of this 13-week gavage toxicity study is to evaluate dihydrocapsiate produced with a slightly modified manufacturing process. Sprague-Dawley rats, 10 rats/sex/group, 6 weeks of age at study initiation, were administered the dihydrocapsiate daily by gavage at dose levels of 0 (vehicle), 100,300, or 1000 mg/kg/day. The rats were observed for antimortem and postmortem signs of toxicity, including 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. There were no changes observed in clinical signs, body weight, food consumption, water intake, ophthalmology, urinalysis, hematology, or blood chemistry that were attributable to the administration of dihydrocapsiate. The only change observed attributable to the dihydrocapsiate administration involved the liver and that change occurred only at the high dose (1000 mg/kg). Both sexes had an increase in organ weights, but this increase correlated with a change in histopathology (i.e., hepatocyte hypertrophy) only in the males. No dihydrocapsiate-related histopathological changes were observed in males at doses ≤300 mg/kg or in females at any of the doses tested (≤1000 mg/kg). It was concluded that the no observed adverse effect level (NOAEL) of dihydrocapsiate was 300 mg/kg/day for male rats and 1000 mg/kg/day for female rats in this 13 week gavage study.
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810802513619
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 4
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    Thirteen-Week Oral Toxicity Study of Branched-Chain Amino Acids in Rats
    SAGE Publications ; 2004
    In:  International Journal of Toxicology Vol. 23, No. 2 ( 2004-03), p. 119-126
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 23, No. 2 ( 2004-03), p. 119-126
    Abstract: Branched-chain amino acids (l-isoleucine, l-valine, and l-leucine) are being increasingly used in sport supplements. This study evaluated toxicological and behavioral effects of l-isoleucine (Ile), l-valine (Val), and l-leucine (Leu) during a dosing study with male and female Sprague-Dawley rats. The amino acids were incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% ( w/ w). A control group of rats received a standard diet. All diets were administered ad libitum for 13 consecutive weeks. To examine stability of any potential effects, the administration period was followed by a 5-week recovery period, during which only the standard diet was provided to all animals. No significant, dose-related effects on body weight were found in rats fed a Leu-and Ile-supplemented diet. Val mixed into a diet at 5.0% ( w/ w) decreased slightly, but significantly body weight gain in females, but not males. Ile (5.0% w/ w) affected the urine electrolytes, protein, ketone bodies, urine glucose, and urobilinogen in both genders, yet the observed changes remained mostly within the range observed in controls. The random findings in hepatology and ophthalmology at the 13-week sacrifice were not considered toxicologically relevant to effects of the tested amino acids. No significant changes in organ weights were recorded. We estimate the no-observed-adverse-effect level (NOAEL) for Ile at 2.5% for both genders (male, 1.565 ± 0.060 g/kg/day; females, 1.646 ± 0.095 g/kg/day), Val at 5.0% for males (3.225 ± 0.135 g/kg/day) and 2.5% for females (1.853 ± 0.060 g/kg/day), and Leu at 5.0% for both genders (males, 3.333 ± 0.101 g/kg/day: females, 3.835 ± 0.257 g/kg/day).
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810490444424
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2004
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  • 5
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    Studies of the Toxicological Potential of Capsinoids: III. A Two-Generation Reproduction Study of CH-19 Sweet Extract in Rats
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27, No. 3_suppl ( 2008-05), p. 29-39
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27, No. 3_suppl ( 2008-05), p. 29-39
    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).
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810802513403
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 6
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    Studies of the Toxicological Potential of Capsinoids: II. A 26-Week Daily Gavage Dosing Toxicity Study of CH-19 Sweet Extract in Rats
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27, No. 3_suppl ( 2008-05), p. 11-27
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27, No. 3_suppl ( 2008-05), p. 11-27
    Abstract: A 26-week oral toxicity study of capsinoids-containing CH-19 Sweet extract was conducted in Sprague-Dawley rats (20 males and 20 females per group) at 6 weeks of age. The test substance was administered by gavage for 26 weeks at dose levels of 0 (vehicle), 1.25, 2.5, and 5.0 ml/kg/day. The concentration of capsinoids in the CH-19 Sweet extract employed was 71.25 to 73.15 mg/ml, resulting in dose levels of capsinoids of 89.06 to 91.44, 178.13 to 182.88, and 356.25 to 365.75 mg/kg, respectively. Adverse test article–related changes were only observed in males, not in females, and within the males, only at the high dose (5.0 ml/kg). Within that group (high-dose males), increases were observed in the numbers of segmented neutrophils, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and lactate dehydrogenase (LDH) activities, liver weights, and in the incidence and severity of hepatocellular focal necrosis. No test substance–related changes were detected in clinical signs, body weight, food consumption, water intake, ophthalmology, or urinalysis. No adverse test article–related changes were observed in low- or mid-dose males or in females at any dose. Based on the results of this chronic gavage study, the target organ was the liver and the no observed adverse effect level (NOAEL) for CH-19 Sweet extract in the rat was 2.5 ml/kg/day in males and 5.0 ml/kg/day in females (178.13 to 182.88 mg/kg and 356.25 to 365.75 mg/kg as capsinoids, respectively).
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810802513379
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 7
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    Thirteen-Week Oral Toxicity Study of l -Glutamine in Rats
    SAGE Publications ; 2004
    In:  International Journal of Toxicology Vol. 23, No. 2 ( 2004-03), p. 107-112
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 23, No. 2 ( 2004-03), p. 107-112
    Abstract: l-Glutamine (Gln) is a semiessential amino acid used in enteral feeding in critically ill patients, and is contained in numerous dietary supplements available to the general public. This study evaluated toxicological effects of Gln in male and female Sprague-Dawley rats. Gln produced by Ajinomoto Co. (Tokyo, Japan) was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% ( w/ w), respectivelly. A control group of rats received only a standard diet. All diets were administered ad libitum for 13 consecutive weeks. To examine recoverability of any potential effects, the administration period was followed by a 5-week recovery period, during which only the standard diet was provided to all animals. Throughout the administration and recovery periods, no deaths were observed, and no changes in diet consumption, ophthalmologic findings, gross pathology, and histopathology were detected. Several changes in urine parameters (total protein, urine pH, and a positive incidence (±) of ketone bodies) were observed in the 2.5% and 5.0% groups at the end of the administration period. Minor increases were found in hematology parameters for the 5.0% group (platelet count, γ-globulin, lactate dehydrogenase [LDH]), but all changes were within physiological range. No effects of administration were observed in the 1.25% group. The no-observed-adverse-effect level (NOAEL) for Gln was estimated at 1.25% for both genders (males 0.83 ± 0.01 g/kg/day; females, 0.96 ± 0.06 g/kg/day).
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810490435677
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2004
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  • 8
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    Studies of the Toxicological Potential of Capsinoids: X. Safety Assessment and Pharmacokinetics of Capsinoids in Healthy Male Volunteers after a Single Oral Ingestion of CH-19 Sweet Extract
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27, No. 3_suppl ( 2008-05), p. 137-147
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27, No. 3_suppl ( 2008-05), p. 137-147
    Abstract: The safety and pharmacokinetics of capsinoids, physiologically active ingredients of CH-19 Sweet extract, were investigated in 16 healthy male volunteers following a single oral ingestion of CH-19 Sweet extract. The study subjects consumed soft gel capsules containing either capsinoids (15 or 30 mg/person) or placebo. Capsinoids were well tolerated, and no clinically significant changes in physical examinations, blood pressure, heart rate, body temperature, electrocardiogram, hematology, blood chemistry, and urinalysis were observed at either the 15 or 30 mg dose. Body temperature tended to increase after the ingestion of capsinoids, but remained within the normal range. Plasma levels of capsinoids and their metabolite, vanillyl alcohol, were below the lower limit of quantitation. In addition, some study subjects showed increases in urinary excretion of 3-methoxy-4-hydroxyphenylglycol that, when compared to the group receiving the placebo, did not achieve statistical significance.
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810802514476
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 9
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    Thirteen-Week Oral Toxicity Study of l -Arginine in Rats
    SAGE Publications ; 2004
    In:  International Journal of Toxicology Vol. 23, No. 2 ( 2004-03), p. 101-105
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 23, No. 2 ( 2004-03), p. 101-105
    Abstract: The amino acid l-arginine (Arg) has been used extensively in dietary and pharmacological products. This study evaluated toxicological and behavioral effects of Arg produced by Ajinomoto Co. (Tokyo, Japan) during a dosing study with male and female Sprague-Dawley rats. The amino acid was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% ( w/w). A control group of rats received only a standard diet. All diets were administered ad libitum for 13 continuous weeks. To examine recoverability of any potential effects, the administration period was followed by a 5-week-long recovery, during which only a standard diet was provided. In male and female rats in each concentration group, treatment-related changes were not observed for clinical signs, body weights, diet consumption, ophthalmology, gross pathology, organ weight, or histopathology. An elevated level of plasma glucose was detected in some male rats (5.0%, w/ w) during the analysis conducted in the fifth week of administration; however, the degree of the change was within the physiological range, and no changes were observed at the end of the administration period. In the same group, an increase in hemoglobin, together with a tendency toward an increase in the red blood cell counts, was found, but the change was considered toxicologically insignificant. The no-observed-adverse-effect level (NOAEL) for Arg was estimated at 5.0% ( w/w) for both genders (males, 3.3 ±0.1 g/kg/day; females, 3.9 ±0.2 g/kg/day).
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810490435622
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2004
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  • 10
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    Studies of the Toxicological Potential of Capsinoids: VI. Single-Dose Toxicity Study and Micronucleus Test of Commercial-Grade Dihydrocapsiate
    SAGE Publications ; 2008
    In:  International Journal of Toxicology Vol. 27, No. 3_suppl ( 2008-05), p. 73-77
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 27, No. 3_suppl ( 2008-05), p. 73-77
    Abstract: A single-dose oral toxicity study was conducted to examine the qualitative and quantitative toxicity of a commercial-grade batch of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS No. 205687-03-2). Dihydrocapsiate was administered once by gavage to ICR mice at dose levels of 0 (vehicle) or 5000 mg/kg/day. No mortality was observed during the 14 day observation period following test article administration. During the 2 h immediately following dosing, mice of both sexes treated with dihydrocapsiate were observed to exhibit one or more of the following: staggered gait, decreased spontaneous movement, increased time in the prone position, tremors, gasping, or red-brownish urine. All mice had completely recovered by the 6 h observation interval. No effects on body weights or necropsy findings were observed as a result of dihydrocapsiate administration. These results suggested that the lethal dose of dihydrocapsiate was 〉 5000 mg/kg. In an in vivo micronucleus test using BDF 1 male mice, a commercial grade of dihydrocapsiate neither increased the incidence of micronucleated polychromatic erythrocytes (MNPCEs) nor decreased the ratio of polychromatic erythrocytes (PCEs) in any of the treatment groups. The results suggest that commercial-grade dihydrocapsiate is unlikely to be an in vivo clastogen.
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1080/10915810802513569
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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