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Studies of the toxicological potential of capsinoids: VII. A 13-week toxicity study of dihydrocapsiate in rats.
Int J Toxicol. 2008; 27 Suppl 3:79-100.IJ

Abstract

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.

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

19037801

Citation

Kodama, Terutaka, et al. "Studies of the Toxicological Potential of Capsinoids: VII. a 13-week Toxicity Study of Dihydrocapsiate in Rats." International Journal of Toxicology, vol. 27 Suppl 3, 2008, pp. 79-100.
Kodama T, Watanabe E, Tsubuku S, et al. Studies of the toxicological potential of capsinoids: VII. A 13-week toxicity study of dihydrocapsiate in rats. Int J Toxicol. 2008;27 Suppl 3:79-100.
Kodama, T., Watanabe, E., Tsubuku, S., Otabe, A., Mochizuki, M., Masuyama, T., & Bernard, B. K. (2008). Studies of the toxicological potential of capsinoids: VII. A 13-week toxicity study of dihydrocapsiate in rats. International Journal of Toxicology, 27 Suppl 3, 79-100. https://doi.org/10.1080/10915810802513585
Kodama T, et al. Studies of the Toxicological Potential of Capsinoids: VII. a 13-week Toxicity Study of Dihydrocapsiate in Rats. Int J Toxicol. 2008;27 Suppl 3:79-100. PubMed PMID: 19037801.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Studies of the toxicological potential of capsinoids: VII. A 13-week toxicity study of dihydrocapsiate in rats. AU - Kodama,Terutaka, AU - Watanabe,Eri, AU - Tsubuku,Shoji, AU - Otabe,Akira, AU - Mochizuki,Masahiro, AU - Masuyama,Takeshi, AU - Bernard,Bruce K, PY - 2008/12/17/pubmed PY - 2009/3/11/medline PY - 2008/12/17/entrez SP - 79 EP - 100 JF - International journal of toxicology JO - Int J Toxicol VL - 27 Suppl 3 N2 - 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. SN - 1092-874X UR - https://www.unboundmedicine.com/medline/citation/19037801/Studies_of_the_toxicological_potential_of_capsinoids:_VII__A_13_week_toxicity_study_of_dihydrocapsiate_in_rats_ L2 - https://journals.sagepub.com/doi/10.1080/10915810802513585?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -