Soni and Associates Inc.

Vero Beach, FL, United States

Soni and Associates Inc.

Vero Beach, FL, United States
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Kothari S.C.,Gateway Inc. | Shivarudraiah P.,Anthem Biosciences Pvt. Ltd. and 49 | Venkataramaiah S.B.,Anthem Biosciences Pvt. Ltd. and 49 | Gavara S.,Anthem Biosciences Pvt. Ltd. and 49 | And 2 more authors.
Food and Chemical Toxicology | Year: 2014

In western Cameroon, edible fruits and seeds from the plant Dichrostachys glomerata are commonly used as spices. Extract from the fruit pods has been reported as a good natural source of antioxidants and may provide health benefits. The objective of the present study was to investigate potential adverse effects, if any, of D. glomerata fruit pod extract (Dyglomera™) in a subchronic toxicity study and in genotoxicity studies. In the toxicity study, Sprague Dawley rats (20/sex/group) were gavaged with D. glomerata extract at dose levels of 0, 100, 1000 and 2500. mg/kg body weight (bw)/day for 90-days. Dyglomera™ administration did not result in mortality or show treatmentrelated changes in clinical signs of toxicity, body weights, body weight gain or feed consumption. Similarly, no toxicologically significant treatment-related changes in hematological, clinical chemistry, urine analysis parameters, and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. Mutagenic and clastogenic potentials as evaluated by Ames assay, in vitro and in vivo chromosomal aberration test and in vivo micronucleus test did not reveal any genotoxicity of the extract. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for D. glomerata extract as 2500. mg/kg bw/day, the highest dose tested. © 2014 Elsevier Ltd.


Chen S.N.,National Taiwan University | Nan F.H.,National Taiwan Ocean University | Chen S.,Super Beta Glucan Inc. | Wu J.F.,Cenzone Technology Inc. | And 2 more authors.
Food and Chemical Toxicology | Year: 2011

Mushroom β-glucan, a polymer of β-(1,3/1,6)-glucan, has been claimed for its health benefits. The objective of this study was to assess the safety in-use of mushroom β-glucan as dietary supplement and food ingredient. Hence, a subchronic toxicity and mutagenicity studies were conducted. In the subchronic toxicity study, Sprague Dawley rats (12/sex/group) were administered (gavage) mushroom β-glucan at dose levels of 0, 500, 1000 and 2000. mg/kg body weight (bw)/day for 90. days. As compared to control group, administration of β-glucan did not result in any toxicologically significant treatment-related changes in clinical observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No adverse effects of the β-glucan on the hematology, serum chemistry parameters, urinalysis or terminal necropsy (gross or histopathology findings) were noted. The results of mutagenicity studies as evaluated by gene mutations in Salmonella typhimurium, in vitro chromosome aberrations and in vivo micronucleus test in mouse did not reveal any genotoxicity of β-glucan. Based on the subchronic study, the no observed-adverse-effect level (NOAEL) for mushroom β-glucan was determined as 2000. mg/kg. bw/day, the highest dose tested. © 2011 Elsevier Ltd.


Dadhaniya P.,Cadila Pharmaceuticals Ltd. | Patel C.,Cadila Pharmaceuticals Ltd. | Muchhara J.,Cadila Pharmaceuticals Ltd. | Bhadja N.,Cadila Pharmaceuticals Ltd. | And 3 more authors.
Food and Chemical Toxicology | Year: 2011

Curcumin, a polyphenol, is obtained from turmeric, the ground rhizomes of Curcuma longa L. Extensive research over the past half century has revealed several health benefits of curcumin. The objective of the present study was to investigate potential adverse effects, if any, of a novel solid lipid curcumin particle (SLCP) preparation in rats following acute and subchronic administration. The oral LD50 of the preparation in rats as well as in mice was found to be greater than 2000mg/kg body weight (bw). In the subchronic toxicity study, Wistar rats (10/sex/group) were administered via oral gavage 0 (control), 180, 360, and 720mg/kg bw/day of SLCP preparation for 90days. Administration of the curcumin preparation did not result in any toxicologically significant treatment-related changes in clinical (including behavioral) observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No adverse effects of the curcumin preparation were noted on the hematology, serum chemistry parameters, and urinalysis. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for this standardized novel curcumin preparation was determined as 720mg/kg bw/day, the highest dose tested. © 2011 Elsevier Ltd.


Miraglia N.,Gnosis S.p.A. | Bianchi D.,Gnosis S.p.A. | Trentin A.,Gnosis S.p.A. | Volpi N.,University of Modena and Reggio Emilia | Soni M.G.,Soni and Associates Inc.
Food and Chemical Toxicology | Year: 2016

Chondroitin sulfate, an amino sugar polymer made of glucuronic acid and N-acetyl-galactosamine, is used in dietary supplements to promote joint health. Commonly used chondroitin sulfate is of animal origin and can pose potential safety problems including bovine spongiform encephalopathy (BSE). The objective of the present study was to investigate potential adverse effects, if any, of microbial derived chondroitin sulfate sodium (CSS) in subchronic toxicity, genotoxicity and bioavailability studies. In the toxicity study, Sprague Dawley rats (10/sex/group) were gavaged with CSS at dose levels of 0, 250, 500 and 1000 mg/kg body weight (bw)/day for 90-days. No mortality or significant changes in clinical signs, body weights, body weight gain or feed consumption were noted. Similarly, no toxicologically relevant treatment-related changes in hematological, clinical chemistry, urinalysis and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. In vitro mutagenic and clastogenic potentials as evaluated by Ames assay, chromosomal aberration test and micronucleus assay did not reveal genotoxicity of CSS. In pharmacokinetic study in human, CSS showed higher absorption as compared to chondroitin sulfate of animal origin. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for CSS as 1000 mg/kg bw/day, the highest dose tested. © 2016 Elsevier Ltd.


Kothari S.C.,Gateway Inc. | Shivarudraiah P.,Anthem Biosciences Pvt. Ltd. | Venkataramaiah S.B.,Anthem Biosciences Pvt. Ltd. | Gavara S.,Anthem Biosciences Pvt. Ltd. | Soni M.G.,Soni and Associates Inc.
Food and Chemical Toxicology | Year: 2012

African Bush Mango from Irvingia gabonensis is a West African culinary fruit and the mucilage from this fruit seed is used to make traditional soups and sauces. Extract from the kernel (IGOB131) has been claimed for its health benefits. In the present investigations, potential adverse effects, if any, of IGOB131 were investigated in dose-response 90-day study and genotoxicity studies. In the subchronic study, Sprague Dawley rats (20/sex/group) were gavaged with I. gabonensis extract (IGOB131) at dose levels of 0, 100, 1000 and 2500. mg/kg body weight (bw)/day for 90-days. No treatment-related changes in clinical signs, functional observations, mortality, ophthalmologic observations, body weights, body weight gain or feed consumption were noted. Similarly, hematological, clinical chemistry, urine analysis parameters, and organ weights did not reveal any toxicologically significant treatment-related changes. No treatment-related macroscopic and microscopic abnormalities were noted at the end of treatment period. The mutagenicity as evaluated by Ames assay, in vitro and in vivo chromosomal aberration test and in vivo micronucleus assay did not reveal any genotoxicity of IGOB131. The results of subchronic toxicity study suggest the no-observed-adverse-effect level (NOAEL) for I. gabonensis extract (IGOB131) as ≥2500. mg/kg bw/day, the highest dose tested. © 2012 Elsevier Ltd.


Moran D.L.,Quincy Bioscience | Marone P.A.,Eurofins | Bauter M.R.,Eurofins | Soni M.G.,Soni and Associates Inc.
Food and Chemical Toxicology | Year: 2013

Apoaequorin, a calcium-binding protein originally isolated from jellyfish is available commercially as a dietary supplement. The objective of the present study was to investigate potential adverse effects, if any, of Apoaequorin, a recombinant protein preparation, in rats following subchronic administration. For this study, Sprague-Dawley (Hsd:SD®) rats (10/sex/group) were administered via oral gavage 0 (control), 92.6, 462.9, and 926.0. mg/kg body weight (bw)/day of Apoaequorin preparation, for 90. days. The corresponding amount of Apoaequorin protein was 0, 66.7, 333.3 and 666.7. mg/kg bw/day, respectively. Administration of the Apoaequorin preparation did not result in any mortality. There were no clinical or ophthalmological signs, body weight, body weight gain, food consumption, food efficiency, clinical pathology or histopathological changes attributable to administration of Apoaequorin. Any changes noted were incidental and in agreement with those historically observed in the age and strain of rats used in this study. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for Apoaequorin was determined as 666.7. mg/kg bw/day, the highest dose tested. © 2013 Elsevier Ltd.


Kothari S.C.,Gateway Inc. | Shivarudraiah P.,Anthem Biosciences Pvt. Ltd. | Venkataramaiah S.B.,Anthem Biosciences Pvt. Ltd. | Koppolu K.P.,Anthem Biosciences Pvt. Ltd. | And 5 more authors.
Food and Chemical Toxicology | Year: 2011

Cissus quadrangularis has been used for centuries for therapeutic and culinary purposes. Extract from this plant (CQR-300) has been claimed for its health benefits. The objective of present investigation was to delineate adverse effects, if any, of CQR-300 in subchronic toxicity, and gentotoxicity studies. In the subchronic study, Sprague Dawley rats (20/sex/group) were administered (gavage) C. quadrangularis extract (CQR-300) at dose levels of 0, 100, 1000, and 2500. mg/kg body weight (bw)/day for 90. days. No treatment related clinical signs of toxicity, mortality or changes in body weights, body weight gain or food consumption were noted. Functional observation tests and ophthalmological examination did not reveal any changes. No toxicologically significant treatment related changes in hematological, clinical chemistry, urine analysis parameters, and organ weights were noted. No treatment related macroscopic and microscopic abnormalities were noted at the end of treatment period. The results of mutagenicity studies as evaluated by Ames assay, in vitro chromosomal aberration and in vivo micronucleus assay did not reveal any genotoxicity of CQR-300. Based on the subchronic study, the no-observed-adverse-effect level (NOAEL) for C. quadrangularis extract (CQR-300) determined as 2500. mg/kg. bw/day, the highest dose tested. © 2011 Elsevier Ltd.


Ravikrishnan R.,RCC Laboratories India Pvt. Ltd. | Rusia S.,RCC Laboratories India Pvt. Ltd. | Ilamurugan G.,RCC Laboratories India Pvt. Ltd. | Salunkhe U.,OmniActive Health Technologies Ltd. | And 4 more authors.
Food and Chemical Toxicology | Year: 2011

Lutein and zeaxanthin, naturally occurring carotenoids, have shown to reduce the risk of cataracts and age-related macular degeneration. Lutemax™ 2020 is a lutein and zeaxanthin (including meso-isomer) enriched product obtained from Marigold flowers (Tagetes erecta L). The objective of the present study was to investigate adverse effects, if any, of Lutemax 2020™ in acute and subchronic toxicity, and mutagenicity studies. In acute toxicity study in rats no lethality was noted at 2000. mg Lutemax 2020™/kg body weight (bw). In the subchronic study, Wistar rats (10/sex/group) were administered (gavage) lutein/zeaxanthin concentrate at dose levels of 0, 4, 40 and 400. mg/kg bw/day for 90-days. Compared with the control group, administration of lutein/zeaxanthin concentrate did not result in any toxicologically significant treatment-related changes in clinical observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No toxicologically relevant findings were noted in urinalysis, hematology or clinical biochemistry parameters at the end of the treatment or recovery period. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. The results of mutagenicity testing in Salmonella typhimurium did not reveal any genotoxicity. The no observed-adverse-effect level (NOAEL) for lutein/zeaxanthin concentrate was determined as 400. mg/kg bw/day, the highest dose tested. © 2011 Elsevier Ltd.


PubMed | University of Modena and Reggio Emilia, Gnosis S.p.A. and Soni and Associates Inc.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2016

Chondroitin sulfate, an amino sugar polymer made of glucuronic acid and N-acetyl-galactosamine, is used in dietary supplements to promote joint health. Commonly used chondroitin sulfate is of animal origin and can pose potential safety problems including bovine spongiform encephalopathy (BSE). The objective of the present study was to investigate potential adverse effects, if any, of microbial derived chondroitin sulfate sodium (CSS) in subchronic toxicity, genotoxicity and bioavailability studies. In the toxicity study, Sprague Dawley rats (10/sex/group) were gavaged with CSS at dose levels of 0, 250, 500 and 1000mg/kg body weight (bw)/day for 90-days. No mortality or significant changes in clinical signs, body weights, body weight gain or feed consumption were noted. Similarly, no toxicologically relevant treatment-related changes in hematological, clinical chemistry, urinalysis and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. Invitro mutagenic and clastogenic potentials as evaluated by Ames assay, chromosomal aberration test and micronucleus assay did not reveal genotoxicity of CSS. In pharmacokinetic study in human, CSS showed higher absorption as compared to chondroitin sulfate of animal origin. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for CSS as 1000mg/kg bw/day, the highest dose tested.


PubMed | OmniActive Health Technologies Ltd., BIONEEDS, OmniActive Health Technologies Inc. and Soni and Associates Inc.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2014

The available evidence suggests a beneficial effect of zeaxanthin against the progression of age-related macular degeneration (AMD). The objective of the present study was to investigate potential adverse effects of OmniXan, a RR-zeaxanthin (65%) enriched product obtained from paprika (Capsicum annum fruits) in subchronic toxicity and mutagenicity studies. The oral LD50 of OmniXan(TM) in rats was greater than 2000 mg/kgbody weight (bw)/day. For the subchronic toxicity study, Wistar rats (10/sex/group) were gavaged daily with zeaxanthin concentrate at doses of 0, 4, 40 and 400 mg/kg bw/day for 90-days. No treatment related clinical signs and mortalities observed. Similarly, no treatment related toxicologically significant changes in body weight, feed consumption; ophthalmoscopic examination, neurological examination, hematology, urine analysis and organ weights were observed. Statistically significant changes observed in some clinical chemistry parameters were considered toxicologically and biologically insignificant and nonadverse. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. The results of mutagenicity testing using Salmonella typhimurium did not reveal any genotoxicity. The no observed-adverse-effect level (NOAEL) for zeaxanthin concentrate (OmniXan(TM)) was determined as 400 mg/kg bw/day, the highest dose tested. The findings of this subchronic toxicity and mutagenicity studies support safety of zeaxanthin concentrate.

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