Die Nahrungsmittelmafia > Die Produktions-Mafia
Nahrungsergänzungmittel aus Indien besteht zu 1/6 aus Quecksilber
(1/1)
Eulophon:
Nahrungsergänzungsmittel aus Indien besteht zu 1/6 aus Quecksilber. (164 Gramm pro Kilogramm!)
Wie die das geschafft haben, ist mir ein Rätsel. Ob ein Messfehler vorliegt?
https://webgate.ec.europa.eu/rasff-window/portal/?event=notificationDetail&NOTIF_REFERENCE=2019.3085
[*quote*]
European Commission
RASFF Portal
Notification details - 2019.3085
mercury (164000 mg/kg - ppm) in food supplements from India
Reference: 2019.3085
Notification type: food - information for attention - consumer complaint
Notification date: 30/08/2019
Action taken:
Last update: 30/08/2019
Distribution status: product traded online
Notification from: Czech Republic (CZ)
Product: food supplements
Classification: information for attention
Product category: dietetic foods, food supplements, fortified foods
Risk decision: serious
Published in RASFF Consumers' Portal: has never been published
Hazards
Substance / Hazard Category Analytical result Units Sampling date
mercury metals 164000 mg/kg - ppm 11/07/2019
Countries/organisations concerned (D = distribution, O = origin): Czech Republic INFOSAN India (O)
[*/quote*]
Eulophon:
Das RASFF Portal der EU Kommission hat eine Liste, deren neueste 100 Einträge hier veröffentlicht sind.
Aktuell steht dort am 3.9.2019:
https://webgate.ec.europa.eu/rasff-window/portal/?event=notificationsList&StartRow=1
[*quote*]
European Commission
RASFF Portal
Notifications list
New search
Export to...
Notifications list
First
Previous 100
Notifications 1 to 100 of 57508
Next 100
Last
Classification
Descending sort on notification date Date of case
Sorted by notification date downwards Reference
Notifying country
Subject
Product Category
Type
Risk decision
1. alert 03/09/2019 2019.3125 Netherlands sweetener E 951 - aspartame undeclared on energy drink from the Netherlands non-alcoholic beverages food serious Details
2. border rejection 03/09/2019 2019.3129 Netherlands Salmonella (presence /25g) in ffrozen salted chicken half breasts from Brazil poultry meat and poultry meat products food serious Details
3. information for follow-up 03/09/2019 2019.3130 Latvia salinomycin (70412 µg/kg - ppb) unauthorised in complete feed for laying quails from Lithuania compound feeds feed not serious Details
4. border rejection 03/09/2019 2019.3128 Spain high content of lead (> 500 mg/kg - ppm) in manganese oxide from India feed additives feed serious Details
5. information for attention 03/09/2019 2019.3127 Sweden unauthorised colour rhodamine B in pickled turnips from Lebanon fruits and vegetables food serious Details
6. alert 03/09/2019 2019.3126 Italy mercury (2.28 mg/kg - ppm) in thawed vacuum-packed swordfish loins from Spain fish and fish products food serious Details
7. border rejection 03/09/2019 2019.3121 Germany dead insects (presence) in sesame seed from Uganda nuts, nut products and seeds food not serious Details
8. information for attention 03/09/2019 2019.3124 Netherlands aliphatic hydrocarbons (1250 mg/kg - ppm) in pork fat from Germany feed materials feed not serious Details
9. border rejection 03/09/2019 2019.3123 Germany sesame seeds from Uganda infested with insects (Tribolium castaneum) nuts, nut products and seeds food not serious Details
10. border rejection 03/09/2019 2019.3122 United Kingdom unsuitable organoleptic characteristics of frozen half cut blue swimming crab from China crustaceans and products thereof food not serious Details
11. border rejection 02/09/2019 2019.3116 Lithuania presence of ruminant DNA in fish meal from Thailand feed materials feed not serious Details
12. alert 02/09/2019 2019.3120 France Listeria monocytogenes (<10 CFU/g) in poultry sausage from Poland poultry meat and poultry meat products food serious Details
13. alert 02/09/2019 2019.3113 Finland sulphite and wheat undeclared on pasta salad with peppers and fennel incorrectly labelled as potato salad with spring onion and french cream from Germany prepared dishes and snacks food serious Details
14. border rejection 02/09/2019 2019.3119 Spain poor temperature control - rupture of the cold chain - (-14.3, -13.9;-13.6; 13.5; 14.8 °C) of frozen swordfish from Chile fish and fish products food not serious Details
15. border rejection 02/09/2019 2019.3118 Germany sesame seeds from Uganda infested with insects (Tribolium castaneum) nuts, nut products and seeds food not serious Details
16. border rejection 02/09/2019 2019.3117 Bulgaria aflatoxins (B1 = 9.4 µg/kg - ppb) in hazelnut flour from Georgia nuts, nut products and seeds food serious Details
17. border rejection 02/09/2019 2019.3115 Germany sesame seeds from Uganda infested with insects (Tribolium castaneum) nuts, nut products and seeds food not serious Details
18. information for follow-up 02/09/2019 2019.3114 Italy Listeria monocytogenes (<10 CFU/g) in frozen cocked mussels from Spain bivalve molluscs and products thereof food not serious Details
19. alert 02/09/2019 2019.3112 France Salmonella (presence /25g) in chilled smoked bacon from Belgium meat and meat products (other than poultry) food serious Details
20. border rejection 02/09/2019 2019.3111 Italy migration of chromium (1 mg/kg - ppm) from fixed blade knife from China, manufactured in Hong Kong food contact materials FCM undecided Details
21. border rejection 02/09/2019 2019.3108 Poland parasitic infestation with Anisakis of frozen kingklip (Genypterus hubbsi) and argentine hake (Merluccius hubbsi) from Spain fish and fish products food not serious Details
22. alert 31/08/2019 2019.3104 United Kingdom mustard and celery undeclared on chilli cashew & peanut mix from the United Kingdom nuts, nut products and seeds food serious Details
23. information for follow-up 30/08/2019 2019.3087 Belgium migration of chromium (4.3 mg/kg - ppm) from egg whist from China, via Spain food contact materials FCM not serious Details
24. alert 30/08/2019 2019.3103 Netherlands oats undeclared on buns which were incorrect labelling as dark buns from the Netherlands cereals and bakery products food serious Details
25. alert 30/08/2019 2019.3093 Italy Salmonella (presence /25g) in ginger from Nigeria herbs and spices food serious Details
26. information for attention 30/08/2019 2019.3102 Italy too high content of sulphite (228 mg/kg - ppm) in thawed shrimp tails (Litopenaeus vannamei) from Italy, with raw material from Panama crustaceans and products thereof food not serious Details
27. border rejection 30/08/2019 2019.3101 Malta too high content of E 202 - potassium sorbate and E 316 - sodium erythorbate and E 223 - sodium metabisulphite unauthorised in various seasonings from South Africa herbs and spices food not serious Details
28. information for attention 30/08/2019 2019.3099 Italy norovirus (GII /25g) in frozen seaweed salad from Taiwan fruits and vegetables food serious Details
29. border rejection 30/08/2019 2019.3098 Germany aflatoxins (B1 = 65.3; Tot. = 92.4 µg/kg - ppb) in groundnut kernels from Argentina feed materials feed serious Details
30. border rejection 30/08/2019 2019.3097 France unauthorised substance hexaconazole (0.053 mg/kg - ppm) in green beans from Kenya fruits and vegetables food undecided Details
31. information for follow-up 30/08/2019 2019.3095 Latvia salinomycin (8.4 µg/kg - ppb) unauthorised in quail eggs from Latvia eggs and egg products food not serious Details
32. alert 30/08/2019 2019.3096 France Salmonella enterica ser. Enteritidis (presence /25g) in frozen chicken fillets from Poland poultry meat and poultry meat products food serious Details
33. border rejection 30/08/2019 2019.3094 Italy too high level of overall migration (28 mg/dm²) from plastic coated paper plates and cups from China food contact materials FCM undecided Details
34. border rejection 30/08/2019 2019.3092 Germany aflatoxins (B1 = 61.6 µg/kg - ppb) in blanched groundnuts for birdfeed from Argentina feed materials feed serious Details
35. border rejection 30/08/2019 2019.3091 Netherlands aflatoxins (B1 = 20; Tot. = 23 µg/kg - ppb) in peanuts from Egypt nuts, nut products and seeds food serious Details
36. border rejection 30/08/2019 2019.3090 Italy migration of chromium (3.5 mg/kg - ppm) from tea filter from China food contact materials FCM undecided Details
37. information for follow-up 30/08/2019 2019.3089 Netherlands Salmonella enterica ser. Gaminara (presence /25g) in pet food from Thailand pet food feed not serious Details
38. border rejection 30/08/2019 2019.3088 Netherlands aflatoxins (B1 = 6.5 µg/kg - ppb) in peanuts from the United States nuts, nut products and seeds food serious Details
39. information for attention 30/08/2019 2019.3085 Czech Republic mercury (164000 mg/kg - ppm) in food supplements from India dietetic foods, food supplements, fortified foods food serious Details
40. border rejection 30/08/2019 2019.3086 Italy migration of nickel (0.5 mg/kg - ppm) from chromed iron grid from Turkey food contact materials FCM undecided Details
41. border rejection 30/08/2019 2019.3084 Belgium aflatoxins (B1 = 49 µg/kg - ppb) in groundnuts from Bolivia feed materials feed serious Details
42. alert 29/08/2019 2019.3077 Netherlands prohibited substance DDT (0.37 mg/kg - ppm) in Japanese millet from Belgium, with raw material from India feed materials feed undecided Details
43. information for follow-up 29/08/2019 2019.3080 Germany Salmonella (present /25g) in feed for foals from Germany feed materials feed not serious Details
44. information for attention 29/08/2019 2019.3075 Netherlands wheat undeclared on instant pumpkin cereal from China other food product / mixed food serious Details
45. information for follow-up 29/08/2019 2019.3083 Poland insufficient information about freezing of frozen boned poultry thighs from Poland poultry meat and poultry meat products food not serious Details
46. information for follow-up 29/08/2019 2019.3078 Denmark baguettes from France infested with moulds (visible) cereals and bakery products food not serious Details
47. alert 29/08/2019 2019.3076 Germany too high intake of zinc (66 mg/day) from food supplement from the United States, via the United Kingdom dietetic foods, food supplements, fortified foods food serious Details
48. border rejection 29/08/2019 2019.3082 Netherlands Salmonella (presence /25g) in sesame seeds from Uganda nuts, nut products and seeds food serious Details
49. information for follow-up 29/08/2019 2019.3081 Germany high content of E 300 - ascorbic acid (1917 mg/kg - ppm) in frozen tuna loins from Spain fish and fish products food not serious Details
50. border rejection 29/08/2019 2019.3079 Italy migration of nickel (0.8 mg/kg - ppm) from chromed steel grid from Turkey food contact materials FCM undecided Details
51. information for attention 29/08/2019 2019.3074 Italy too high content of sulphite (273 mg/kg - ppm) in chilled cooked shrimps (Peaeus Vannamei) from Spain crustaceans and products thereof food not serious Details
52. alert 28/08/2019 2019.3067 Netherlands mercury (2.2 mg/kg - ppm) in frozen swordfish loins from Vietnam fish and fish products food serious Details
53. border rejection 28/08/2019 2019.3073 United Kingdom poor temperature control (-5.5 °C) of frozen Alaskan pollock (Theragra chalcogramma) from the United States fish and fish products food not serious Details
54. alert 28/08/2019 2019.3071 Germany polycyclic aromatic hydrocarbons (sum of PAH4: 115.2 µg/kg - ppb) in shredded parsley from Germany herbs and spices food serious Details
55. alert 28/08/2019 2019.3069 Netherlands foodborne outbreak suspected (Salmonella) to be caused by and Salmonella enterica ser. Enteritidis (present /25g) in eggs from Spain eggs and egg products food serious Details
56. information for attention 28/08/2019 2019.3072 Hungary foreign body (pieces of packaging material) in chilled minced beef from Poland, produced in Croatia meat and meat products (other than poultry) food undecided Details
57. border rejection 28/08/2019 2019.3064 Poland Salmonella (presence /25g) in sesame seeds from Nigeria nuts, nut products and seeds food serious Details
58. alert 28/08/2019 2019.3070 Hungary benzo(a)pyrene (20.73 µg/kg - ppb) and polycyclic aromatic hydrocarbons (91.58 µg/kg - ppb) in cocoa powder from Slovakia cocoa and cocoa preparations, coffee and tea food serious Details
59. alert 28/08/2019 2019.3065 Belgium Salmonella (present /25g) in chilled chicken fillet preparation from Belgium, with raw material from the Netherlands poultry meat and poultry meat products food serious Details
60. information for follow-up 28/08/2019 2019.3068 Romania unauthorised irradiation of chilli powder from China, via Latvia herbs and spices food not serious Details
61. border rejection 28/08/2019 2019.3066 United Kingdom absence of health certificate(s) for rice noodles from China cereals and bakery products food not serious Details
62. alert 28/08/2019 2019.3062 France Listeria monocytogenes (570 CFU/g) in vacuum packed cooked shrimps from France crustaceans and products thereof food serious Details
63. information for follow-up 28/08/2019 2019.3061 Germany unauthorised substance tetrahydrocannabinol (THC) (5.9 mg/kg - ppm) and unauthorised novel food ingredient cannabidiol (CBD) (155 mg/kg - ppm) in chocolate with hemp oil from the Netherlands cocoa and cocoa preparations, coffee and tea food undecided Details
64. alert 27/08/2019 2019.3049 Netherlands Salmonella (presence /25g) in broccoli from the Netherlands fruits and vegetables food serious Details
65. alert 27/08/2019 2019.3051 Italy Salmonella enterica ser. Typhimurium (presence /25g) in frozen ducks with offal from Hungary poultry meat and poultry meat products food serious Details
66. alert 27/08/2019 2019.3048 Austria Salmonella enterica ser. Brandenburg (in 2 out of 5 samples /25g), Salmonella enterica ser. London (in 1 out of 5 samples /25g), Salmonella enterica ser. Rissen (in 1 out of 5 samples /25g) and Salmonella enterica ser. Typhimurium monophasic (1 ,4, [5], 12:i:-) (in 1 out of 5 samples /25g) in chewing sticks from Germany pet food feed serious Details
67. border rejection 27/08/2019 2019.3056 Poland parasitic infestation (Trifur tortuosis and nematodes) of frozen hake from Uruguay fish and fish products food not serious Details
68. alert 27/08/2019 2019.3054 Italy mercury (1.46 mg/kg - ppm) in chilled vacuum packed swordfish fillet (Xiphias gladius) from Spain fish and fish products food serious Details
69. information for attention 27/08/2019 2019.3052 Sweden high count of Enterobacteriaceae (1550 CFU/g) in complete feed from China compound feeds feed not serious Details
70. information for attention 27/08/2019 2019.3055 Switzerland azaperone (10 µg/kg - ppb) and azaperol unauthorised (35 µg/kg - ppb) in chilled beef from the United States meat and meat products (other than poultry) food not serious Details
71. alert 27/08/2019 2019.3059 Poland Listeria monocytogenes (presence /25g) in gouda cheese from Poland milk and milk products food serious Details
72. information for follow-up 27/08/2019 2019.3053 Germany illegal trade (intended for human consumption) of frozen duck heads from Hungary, via Italy poultry meat and poultry meat products food undecided Details
73. alert 27/08/2019 2019.3050 Netherlands celery undeclared on steamed bread filled with chicken from the Netherlands mislabelled as steamed bread filled with beef other food product / mixed food serious Details
74. alert 27/08/2019 2019.3060 France Listeria monocytogenes (<10 CFU/g) in serrano ham from Spain meat and meat products (other than poultry) food undecided Details
75. information for attention 27/08/2019 2019.3057 Estonia Salmonella enterica ser. Typhimurium (presence /25g) in chilled pork collar from Poland meat and meat products (other than poultry) food not serious Details
76. border rejection 27/08/2019 2019.3058 Greece Salmonella enterica ser. Amsterdam (presence /25g) in fish meal from Mauritania feed materials feed not serious Details
77. information for attention 27/08/2019 2019.3047 Denmark chlorpyrifos (0.12 mg/kg - ppm) in pennywort (Centella asiatica) from Thailand fruits and vegetables food undecided Details
78. information for attention 27/08/2019 2019.3046 Croatia Salmonella enterica ser. Enteritidis (presence /25g) in chilled chicken breast fillets from Poland poultry meat and poultry meat products food serious Details
79. alert 26/08/2019 2019.3033 United Kingdom milk ingredient undeclared on popcorn from the United Kingdom cereals and bakery products food serious Details
80. alert 26/08/2019 2019.3042 Italy Listeria monocytogenes (in 2 out of 5 samples /25g) in chilled stuffed veal cold cuts ("cima") from Italy meat and meat products (other than poultry) food serious Details
81. alert 26/08/2019 2019.3038 Germany glass fragments in canned vegetables from France fruits and vegetables food serious Details
82. alert 26/08/2019 2019.3045 France atropine (47 µg/kg - ppb) and scopolamine (30 µg/kg - ppb) in organic buckwheat flour from France cereals and bakery products food serious Details
83. information for follow-up 26/08/2019 2019.3043 Poland spoilage of chilled pork from Poland meat and meat products (other than poultry) food undecided Details
84. alert 26/08/2019 2019.3034 Netherlands milk ingredient undeclared on vegan margarine from Denmark fats and oils food serious Details
85. information for attention 26/08/2019 2019.3035 France Vibrio parahaemolyticus (TRH+ /25g) in live lobsters from the United States crustaceans and products thereof food serious Details
86. border rejection 26/08/2019 2019.3037 Spain migration of formaldehyde (71 mg/kg - ppm) from bamboo pots from China food contact materials FCM undecided Details
87. border rejection 26/08/2019 2019.3044 United Kingdom dead insects and live insects in glucosamine sulphate from China dietetic foods, food supplements, fortified foods food not serious Details
88. alert 26/08/2019 2019.3041 Italy mercury (1.4 mg/kg - ppm) in chilled swordfish fillets from Spain fish and fish products food serious Details
89. information for attention 26/08/2019 2019.3036 Denmark chlorpyrifos (0.017 mg/kg - ppm) in coriander roots from Thailand fruits and vegetables food undecided Details
90. alert 23/08/2019 2019.3015 Portugal dimethoate (0.04 mg/kg - ppm) and unauthorised substance omethoate (0.039 mg/kg - ppm) in peaches from Spain fruits and vegetables food serious Details
91. information for follow-up 23/08/2019 2019.3032 Czech Republic too high content of sulphite (84.8 mg/kg - ppm) in and insufficient labelling (only E number mentioned for sulphite) of pickled onions from the Czech Republic fruits and vegetables food not serious Details
92. alert 23/08/2019 2019.3025 Italy mercury (2.1 mg/kg - ppm) in little tunny (Euthynnus alletteratus) from Greece fish and fish products food serious Details
93. border rejection 23/08/2019 2019.3030 Germany aflatoxins (B1 = 27.2; Tot. = 37 µg/kg - ppb) in pistachios from the United States, dispatched from Turkey nuts, nut products and seeds food serious Details
94. information for attention 23/08/2019 2019.3026 Sweden glass fragments in pasta sauce in glass jars from Italy soups, broths, sauces and condiments food serious Details
95. alert 23/08/2019 2019.3013 Belgium gluten, soya and fish undeclared on andalouse sauce from Belgium mislabelled as banzai sauce soups, broths, sauces and condiments food serious Details
96. information for attention 23/08/2019 2019.3031 Denmark unauthorised substance prothiofos (10 mg/kg - ppm) in Chinese broccoli from Thailand fruits and vegetables food serious Details
97. alert 23/08/2019 2019.3020 Poland Salmonella enterica ser. Enteritidis (presence /25g) in chilled chicken meat from Poland poultry meat and poultry meat products food serious Details
98. information for follow-up 23/08/2019 2019.3028 Germany too high content of zinc (435 mg/kg - ppm), of selenium (1.56 mg/kg - ppm) and of manganese (291 mg/kg - ppm) and high content of copper (57.8 mg/kg - ppm) in supplementary feed for fattening pigs from Germany feed materials feed not serious Details
99. border rejection 23/08/2019 2019.3029 Poland improper certified analytical report (result exceeds legal limit for aflatoxin B1) for brown rice from Pakistan cereals and bakery products food undecided Details
100. border rejection 23/08/2019 2019.3016 Sweden dimethoate (0.016 mg/kg - ppm) and unauthorised substance omethoate (0.036 mg/kg - ppm) in green chili from Uganda fruits and vegetables food serious Details
[*/quote*]
Das mit der Lebenserwartung der heutigen Kinder kann man knicken. Bei der Giftbelastung werden die höchstens noch 60.
Julian:
Diese indischen Schweine soll der Teufel holen! Das ist alles noch weit schlimmer als befürchtet.
Schon im April 2019 hat die Verbraucher-Schutzstelle Niedersachsen vor den indischen Giftmischern gewarnt:
http://verbraucherschutzstelle.org/Bruhat.htm
[*quote*]
Verbraucher Schutzstelle Niedersachsen
Warnung vor indischem Nahrungsergänzungsmittel
BRUHAT VATA CHINTAMANI RASA
Gefahr durch enorme Quecksilberkonzentration!
8.4.2019: Die tschechische Aufsichtsbehörde für Landwirtschaft und Lebensmittel (SZPI) warnt die Verbraucher eindringlich vor dem Verbrauch von
BRUHAT VATA CHINTAMANI RASA
mit einer enormen Menge an Quecksilber und anderen Verunreinigungen (Blei, Nickel, Arsen). Der zulässige Quecksilbergehalt für Nahrungsergänzungsmittel beträgt 0,1 mg / kg. Das Produkt enthielt insgesamt 72 200 mg Quecksilber pro kg-Probe.
SZPI erhielt Informationen über ein gefährliches Produkt vom Medizinischen Institut in Ostrava, das auf Kundenwunsch eine Laboranalyse durchführte.
Das Produkt wird über das Internetauktionshaus eBay (https://www.ebay.com), und Amazon Indien (https://www.amazon.in). angeboten. Es ist zudem nicht ausgeschlossen, dass es zusätzlich in weiteren Online-Shops international angeboten wird.
Hersteller ist das indische Unternehmen
Shree Dhootapapeshwar Ltd.
135 Nanubhai Desai Road
Khetwadi, Mumbai 400004
Maharashtra, Indien
Tel.: +91 22 2388 1308
Tel. +91 1800 2 29874
healthcare@sdlindia.com
Das Produkt sollte auf keinen Fall konsumiert werden.
[*/quote*]
Die Warnung der tschechischen Behörde:
https://www.szpi.gov.cz/clanek/szpi-varuje-pred-zdravi-ohrozujicimi-doplnky-stravy-z-indie-nabizenymi-pres-ebay-s-cca-1-5-milion-x-prekrocenym-limitem-pro-obsah-rtuti.aspx
[*quote*]
SZPI varuje před zdraví ohrožujícími doplňky stravy z Indie nabízenými přes eBay s cca 1,5 milion x překročeným limitem pro obsah rtuti
30. 08. 2019
Státní zemědělská a potravinářská inspekce (SZPI) důrazně varuje spotřebitele před nákupem potravin a zejména doplňků stravy na internetu z neověřených zdrojů.
Inspektoři SZPI objednali prostřednictvím internetové aukční síně společnosti eBay dva doplňky stravy: (1.) Bruhat Vata Chintamani Rasa STANDARD Quality Suvaranakalpa, 10 tablet a (2.) Bruhat Vata Chintamani Rasa PREMIUM Quality Suvaranakalpa, 10 tablet. Výrobcem je dle etikety indická společnost Shree Dhootapapeshwar Ltd., 135, Nanubhai Desai Road, Khetwani, Mumbai 400 004, Maharashtra, Indie, prodávající subjekt na www.ebay.com figuroval pod označením „saurabh-enterprises“, jde o společnost: „saurabh sonavane, navdurga rahivasi seva sangh, gandhi nagar, galli no-6 Near shiv sena shaka, kurar village, mumbai - 400097, Maharashtra, India“.
Laboratorní rozbor u předmětných doplňků stravy prokázal přítomnost rtuti ve zcela ojedinělé výši: v případě produktu Bruhat Vata Chintamani Rasa STANDARD Quality rozbor potvrdil přítomnost rtuti ve výši 164000 mg/kg (rtuť tak představovala 16,4% obsahu výrobku), v případě produktu Bruhat Vata Chintamani Rasa PREMIUM Quality rozbor potvrdil přítomnost rtuti ve výši 76500 mg/kg (rtuť tak představovala 7,7% obsahu výrobku). Limit pro maximální přípustnou přítomnost rtuti stanovuje evropský předpis na 0,10 mg/kg.
SZPI vložila informaci do evropského systému varování před nebezpečnými potravinami RASFF a požádá o stažení nabídky předmětných výrobků z aukční síně eBay.
Inspektoři SZPI odebrali vzorek na základě podnětu, jehož prostřednictvím Inspekce varovala veřejnost již v tiskové zprávě ze dne 8. 4. 2019.
Zpracoval: Mgr. Pavel Kopřiva - tiskový mluvčí, tel.: +420 542 426 633
https://www.szpi.gov.cz/SCRIPT/ViewImage.aspx?id=23405&ext=.jpg
https://www.szpi.gov.cz/SCRIPT/ViewImage.aspx?id=23407&ext=.jpg
https://www.szpi.gov.cz/SCRIPT/ViewImage.aspx?id=23409&ext=.jpg
https://www.szpi.gov.cz/SCRIPT/ViewImage.aspx?id=23411&ext=.jpg
https://www.szpi.gov.cz/SCRIPT/ViewImage.aspx?id=23413&ext=.jpg
[*/quote*]
Google-Trans Englisch:
[*quote*]
2497/5000
Go to:
go to content
go to the menu
| Comments News | | |
Foodstuffs
Establishments
Risk sites
Thematic checks
www
Homepage Press Releases PR 2019 CAFIA warns against health-threatening food supplements from India offered via eBay with about 1.5 million times the mercury content limit exceeded
MENU
CAFIA warns against health-threatening food supplements from India offered via eBay with about 1.5 million times the mercury content limit exceeded
30. 08. 201X
The Czech Agriculture and Food Inspection Authority (CAFIA) strongly warns consumers against buying food and especially food supplements on the Internet from unauthorized sources.
CAFIA inspectors ordered two food supplements through eBay's Internet Auction Room: (1) Bruhat Vata Chintamani Rasa STANDARD Quality Suvaranakalpa, 10 tablets and (2.) Bruhat Vata Chintamani Rasa PREMIUM Quality Suvaranakalpa, 10 tablets. According to the label, the manufacturer is Indian company Shree Dhootapapeshwar Ltd., 135, Nanubhai Desai Road, Khetwani, Mumbai 400 004, Maharashtra, India, selling entity at www.ebay.com under the designation "saurabh-enterprises", it is: "saurabh sonavane, navdurga rahivasi seva sangh, gandhi nagar, galli no-6 Near shiv sena shaka, kurar village, mumbai - 400097, Maharashtra, India ".
The laboratory analysis of the food supplements in question showed the presence of mercury in a very rare amount: in the case of Bruhat Vata Chintamani Rasa STANDARD Quality the analysis confirmed the presence of mercury of 164000 mg / kg (mercury thus represented 16.4% of the product) Chintamani Rasa PREMIUM Quality analysis confirmed the presence of mercury of 76500 mg / kg (mercury thus represented 7.7% of the product content). The limit for the maximum permitted mercury presence is set by the European regulation at 0.10 mg / kg.
CAFIA entered the information into the European Dangerous Food Warning System RASFF and asks to withdraw the offer of the products in question from the eBay auction house.
CAFIA inspectors took a sample based on a complaint through which the CAFIA warned the public in a press release dated April 8, 2019.
Prepared by: Mgr. Pavel Kopřiva - spokesperson, tel .: +420 542 426 633
Pages archived by National Library of the Czech Republic [opened in new window]
ISO 9001: 2000 certificate
© Czech Agriculture and Food Inspection Authority 2019.
Květná 15, 603 00 Brno, Czech Republic, epodatelnaszpi.gov.cz
Data box ID: avraiqg
IČO: 75014149, DIČ: CZ75014149
Declaration of accessibility Privacy Policy
Send feedback
History
Saved
Community
[*/quote*]
Google-Trans Deutsch:
[*quote*]
CAFIA warnt vor gesundheitsgefährdenden Nahrungsergänzungsmitteln aus Indien, die über eBay angeboten werden und deren Quecksilbergehalt 1,5 Millionen Mal überschritten wurde
30. 08. 201X
Die tschechische Aufsichtsbehörde für Landwirtschaft und Lebensmittel (CAFIA) warnt die Verbraucher nachdrücklich vor dem Kauf von Lebensmitteln und insbesondere Nahrungsergänzungsmitteln im Internet aus nicht genehmigten Quellen.
CAFIA-Inspektoren bestellten zwei Nahrungsergänzungsmittel über den Internet-Auktionsraum von eBay: (1) Bruhat Vata Chintamani Rasa-Standardqualität Suvaranakalpa, 10 Tabletten und (2.) Bruhat Vata Chintamani Rasa-Premiumqualität Suvaranakalpa, 10 Tabletten. Laut dem Label ist der Hersteller das indische Unternehmen Shree Dhootapapeshwar Ltd., 135, Nanubhai Desai Road, Khetwani, Mumbai 400 004, Maharashtra, Indien, Verkaufseinheit bei www.ebay.com unter der Bezeichnung "saurabh-enterprises", es ist: "saurabh" Sonavane, Navdurga Rahivasi Seva Sangh, Gandhi Nagar, Galli No-6 In der Nähe von Shiv Sena Shaka, Kurar Dorf, Mumbai - 400097, Maharashtra, Indien ".
Die Laboranalyse der fraglichen Nahrungsergänzungsmittel ergab das Vorhandensein von Quecksilber in einer sehr seltenen Menge: Im Fall von Bruhat Vata Chintamani Rasa STANDARD Quality bestätigte die Analyse das Vorhandensein von 164000 mg Quecksilber / kg (Quecksilber machte somit 16,4% des Produkts aus). Die Qualitätsanalyse von Chintamani Rasa PREMIUM bestätigte das Vorhandensein von 76500 mg Quecksilber / kg (Quecksilber entsprach somit 7,7% des Produktgehalts). Der Grenzwert für das maximal zulässige Vorhandensein von Quecksilber ist in der europäischen Verordnung auf 0,10 mg / kg festgelegt.
CAFIA hat die Informationen in das Europäische Warnsystem für gefährliche Lebensmittel RASFF eingegeben und bittet darum, das Angebot der betreffenden Produkte aus dem eBay-Auktionshaus zurückzuziehen.
CAFIA-Inspektoren nahmen eine Stichprobe auf der Grundlage einer Beschwerde, mit der die CAFIA die Öffentlichkeit in einer Pressemitteilung vom 8. April 2019 gewarnt hatte.
Vorbereitet von: Mgr. Pavel Kopřiva - Sprecher, Tel .: +420 542 426 633
[*/quote*]
Google ist eine so dämliche Scheiße, es spottet jeder Beschreibung.
Der Originaltext lautet:
[*quote*]
SZPI varuje před zdraví ohrožujícími doplňky stravy z Indie nabízenými přes eBay s cca 1,5 milion x překročeným limitem pro obsah rtuti
30. 08. 2019
[...]
[*/quote*]
Aber Google fälscht! Google fälscht bei den Übersetzungen reproduzierbar, auch in mehreren Sprachen, und macht aus dem Datum 30.8.2019 das Datum 30.8.2018. Etwas dermaßen dreistes und idiotisches findet man wirklich selten.
Von Google gefälschte englische Übersetzung:
[*quote*]
CAFIA warns against health-threatening food supplements from India offered via eBay with about 1.5 million times the mercury content limit exceeded
30. 08. 2018
[...]
[*/quote*]
Von Google gefälschte deutsche Übersetzung:
[*quote*]
AFIA warnt vor gesundheitsgefährdenden Nahrungsergänzungsmitteln aus Indien, die über eBay angeboten werden und deren Quecksilbergehalt 1,5 Millionen Mal überschritten wurde
30. 08. 2018
[...]
[*/quote*]
Perverserweise ist das an einer zweiten Stelle vorkommende Datum NICHT gefälscht:
[*quote*]
CAFIA inspectors took a sample based on a complaint through which the CAFIA warned the public in a press release dated April 8, 2019.
[*/quote*]
[*quote*]
CAFIA-Inspektoren nahmen eine Stichprobe auf der Grundlage einer Beschwerde, mit der die CAFIA die Öffentlichkeit in einer Pressemitteilung vom 8. April 2019 gewarnt hatte.
[*/quote*]
Daß Google Namen fälscht, war bereits bekannt. Aber daß Google auch Zahlen fälscht... Man sollte Google auf der Stelle zerschlagen, auflösen, und die gesamte Führungsetage geschlossen für die nächsten 100 Jahre im Knast einbunkern. Es reicht!
Auch eine andere Führungsgruppe gehört in den Knast: die von Ebay. Die Gifttabletten werden bei Ebay angeboten. Unter anderem hier:
https://www.ebay.com/sch/i.html?_nkw=bruhat%20vata
[*quote*]
Dhootapapeshwar Bruhat Vata Chintamani Rasa Premium 10 tablet with free shipping
Brand New
$32.70
From India
Buy It Now
Free International Shipping
Watch
Dhootapapeshwar Bruhat Vata Chintamani Rasa Premium Quality Suvarnakalpa 30 Tab
Brand New
$65.99
From India
Buy It Now
Free International Shipping
Only 1 left!
1 Watching
Watch
Dhootapapeshwar Bruhat Vata Chintamani Rasa Premium Quality Suvarnakalpa 30 tab
Brand New
$53.00 to $195.00
From India
Buy It Now
Free International Shipping
Dhootapapeshwar Bruhat Vata Chintamani Rasa Premium 10 tablet with free shipping
Brand New
$32.70
From India
Buy It Now
Free International Shipping
Watch
[*/quote*]
Wie kann Ebay es wagen, diesen lebensgefährliche Scheiße anzubieten!?
Ebay ist hier in der Haftung, und das in vollem Umfang.
Julian:
Die indischen Giftmischer wissen genau, was sie tun. Hier die Mengenangabe:
http://sdlindia.com/media/attachment/file/b/r/bruhat_vata_chintamani_rasa_tablet_pre_.pdf
Zitat:
[*quote*]
BRUHAT VATA CHINTAMANI RASA (Tablet)
Average weight: 157mg +/- 7,5%
Mercury (Hg): 12 - 17 mg
[*/quote*]
Das sind bei dieser Art Tabletten 7,6 bis 10,8 Gewichtsprozent Quecksilber!
Das indische Giftmischergesindel behauptet trotzdem volldreist, seine Giftmischung sei ungiftig und harmlos:
http://sdlindia.com/media/attachment/file/a/c/acute-toxicity-of-bruhat-vata-chintamani-rasa.pdf
[*quote*]
Abstract Report
ACUTE ORAL TOXICITY STUDY OF BRUHAT VATA CHINTAMANI RASA IN MICE
Shree Dhootapapeshwar Ayurvedic Research Foundation (SDARF), Panvel, Raigad,
Maharashtra-410206.
ABSTRACT
Objective: The aim of present study was to evaluate the acute toxicity of Bruhat Vata Chintamani Rasa in
mice.
Material and Method: In this study Bruhat Vata Chintamani Rasa 406.5 mg/kg was administered orally for
14 days.
Result: The oral administration of Bruhat Vata Chintamani Rasa at the highest dose resulted in no
mortalities or evidence of adverse effects implying that Bruhat Vata Chintamani Rasa is non toxic.
Throughout 14 days of the treatment no changes in behavioral pattern and body weight of mice in both
control and treatment groups. There was no cynosis, blanching or Inflammation of nasal tips, paws, eyes,
ears & tail. Also, No abnormal secretion from mouth, eyes & nose was seen.
Conclusion: Overall, the results suggest that, the oral administration of Bruhat Vata Chintamani Rasa did
not produce any significant toxic effect in mice
Keywords: Bruhat Vata Chintamani Rasa, Acute Toxicity, body weight, cyanosis, non-toxic etc.
No part of this publication can be reproduced or transmitted in any form or by any means, electronic, print or by
other mechanical process, including photocopying, recording, or by any information storage and retrieval system
without permission in writing from the Managing Director of Shree Dhootapapeshwar Ltd.
[*/quote*]
Die indischen Giftmischer meinen auch noch, das Urheberrecht für ihre Mordversuche mißbrauchen zu dürfen:
http://sdlindia.com/media/attachment/file/c/h/chronic-toxicity-of-bruhat-vat-chintamani.pdf
[*quote*]
Abstract Report
PATHOLOGICAL EVALUATION OF REPEATED DOSE ORAL TOXICITY STUDY OF BRUHAT
VATA CHINTAMANI IN WISTAR RATS.
Institute for Toxicological Studies (INTOX), Shivaji Nagar Pune, Maharashtra -411 005.
Shree Dhootapapeshwar Ayurvedic Research Foundation (SDARF), Panvel, Raigad,
Maharashtra-410206.
ABSTRACT
Ethnopharmacological Relevance: Bruhat Vata Chintamani Rasa is an Ayurvedic formulation, indicated for
the treatment of Vata Dosha imbalance diseases such as paralysis, hemiplegia, facial palsy, tremors etc. This
Ayurvedic formulation is composed of heavy metal ingredients.
Objective: To study pathological evaluation of repeated dose of Bruhat Vata Chintamani Rasa (BVC) in rats
Method: Two treatment group animals were given with Therapeutic Dose (TD) and twice of Therapeutic
Dose (2TD) for consecutive days, which were 1 and 2 times the proposed human therapeutic dose (HTD).
The 3rd group or control group, receive Carboxy Methyl Cellulose (CMC). The rats were fasted overnight
prior to the terminal necropsy and their body weights were recorded. Blood samples were obtained for
laboratory investigations from all the animals before necropsy. Weights of certain organs were recorded.
Histopathological evaluation was performed on brain, heart, kidney, lung, spleen, liver, adrenals, uterus and
ovaries in all rats from all groups.
Results: Animals were evaluated using functional observation battery (FOB), and no remarkable changes
were observed in gross and clinical symptoms throughout the study period. Body weights, feed, water intake
in all treated animals were not significant as compare to control group animals. In present study no treatment
related gross pathological changes were observed in animals from different treatment groups.
Conclusion: Based on these outcomes of the present chronic study, the NOEL (No Observed Effect Level)
for BVC in Wistar rats could be concluded at that of doubled of human dose.
Keywords: Bruhat Vata Chintamani Rasa, Heavy metals, Ayurvedic Formulation,Chronic toxicity study, No
observed effect level (NOEL) etc
No part of this publication can be reproduced or transmitted in any form or by any means, electronic, print or by
other mechanical process, including photocopying, recording, or by any information storage and retrieval system
without permission in writing from the Managing Director of Shree Dhootapapeshwar Ltd.
[*/quote*]
Julian:
Wie Vollidioten für Giftmischer eine Studie in den Sand setzen.
Erstens: Der Test wird durchgeführt an Ratten. Ratten reagieren aber anders als Menschen!
"Oral acute toxicity study of test drug was carried at the limit dose of 2000 mg/kg orally in rats."
Zweitens: Der Bestandteil ist, SO WIRD BEHAUPTET ("is said to be mercury sulphide"), Quecksilber-Sulfid. Quecksilber-Sulfid eine Ungiftigkeit zu bescheinigen ist ein Verbrechen.
[*quote*]
Rasasindura is one among such mercurial preparations widely used by Ayurveda practitioners. Pharmaceutical processing of Rasasindura involves treating purified mercury with purified sulphur and juices of Aloe vera (Linn.) Burm. f. to form black sulphide of mercury, which is further treated with gradual, intermittent heat to transform into more stable form, i.e. cinnabar by Kupipakwa method [4]. Kupipakwa is a specialized heating system, i.e. gradual, intermittent heat by vertical electrical-muffle furnace. Rasasindura is said to be mercury sulphide, associated with several organic macro-molecules derived from processing with plant extracts [5]. Toxic effects of purified mercury were said to be neutralized in the presence of purified sulphur [6]. As per the classics, Rasasindura is administered with the adjuvant such as Guduchi ghana (solidified aqueous extract of Tinospora cordifolia Will.) [7]. Rasasindura has unique properties to pacify diseases such as diabetes, fistula, fever, lack of appetite, anaemia, oedema etc.; and it is considered equivalent to the elixir, which is known to overcome death [4,7]. Since reports of toxicity evaluation of this classical preparation (along with the adjuvant) was not available during extensive literature review, it was thought worthwhile to undertake the detailed toxicity assessment in albino rats.
[*/quote*]
http://www.ijpsonline.com/articles/toxicological-studies-of-rasasindura-an-ayurvedic-formulation-3370.html
[*quote*]
Scientific Publication of the Indian Pharmaceutical Association
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.
Research Paper
Toxicological Studies of Rasasindura, an Ayurvedic Formulation
R. A. Gokarn*, M. B. Nariya1, B. J. Patgiri2 and P. K. Prajapati2
Division of Ayurveda, Centre for Integrative Medicine and Research, Manipal University, Manipal-576 104, India
1Pharmacology Laboratory, All India Institute of Ayurveda, New Delhi-110076, India
2Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi-110076, India
*Corresponding Author:
R. A. Gokarn
Department of Rasashastra and Bhaishajya Kalpana
Mahatma Gandhi Ayurved College Hospital and RC, Salod (H), Wardha-442 001
E-mail: rohit_gn@yahoo.com
Date of Submission 16 February 2016
Date of Revision 01 February 2017
Date of Acceptance 02 June 2017
Indian J Pharm Sci 2017;79(4):633-640
This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms
DOI: 10.4172/pharmaceutical-sciences.1000272
Abstract
Rasasindura is a unique, Ayurvedic mercurial preparation widely used by practitioners.
Thi investigation is an attempt to perform acute and chronic oral toxicity evaluation of Rasasindura along with an adjuvant Guduchi Ghana (solidified aqueous extract of Tinospora cordifolia Will.) in rats. Oral acute toxicity study of test drug was carried at the limit dose of 2000 mg/kg orally in rats.
For chronic toxicity, Rasasindura with adjuvant was administered at therapeutic equivalent dose (45 mg/kg, orally), therapeutic equivalent dose×5 (225 mg/kg, orally), therapeutic equivalent dose×10 (450 mg/kg, orally) for 90 days and an additional recovery group of therapeutic equivalent dose×10 for 30-day observation after the treatment period. Acute toxicity result showed that drug did not produce any signs and symptoms of toxicity or mortality up to an oral dose of 2000 mg/kg in rats. Chronic toxicity results showed that Rasasindura, even at a level as high as therapeutic equivalent dose×10 level, had no significant effect whatsoever on the ponderal and hematological parameters. Although the drug produced mild to moderate adverse changes (in kidney, liver, intestine, and stomach) at therapeutic equivalent dose×10 dose level, equivalent of which are unlikely to be ever employed in a clinical trial. The observed changes were not seen at the lower dose levels as well as in the recovery study. Hence, it is suggested that the Rasasindura, along with the adjuvant prepared as per the customary method, is safe for consumption at the therapeutic dose level.
Keywords
Rasasindura, Guduchi ghana, Tinospora cordifolia, bhasma, toxicity
Ayurveda, the traditional system of Indian medicine, has enriched the historical background and is one of the great living traditions. Use of processed metals, minerals, and mercurial-processed herbs as a medicament has been an integral part of Ayurvedic practice. These metallic preparations have unique process of preparation, involving Shodhana (purification and/or detoxification) and Marana (incineration and/or calcination). Practitioners developed these methods to detoxify the raw material by chemical transformations and thus modify the properties of materials to enhance therapeutic potential [1,2]. Their extensive use of these medicaments since more than a millennium without any reports of any untoward events can be considered as a testimony to their safety; but no objective-verifiable data exists to support such claims. Pre-clinical studies of Ayurvedic drugs provide scientific basis for their traditional use and to prove that they are safe and efficacious [3].
Rasasindura is one among such mercurial preparations widely used by Ayurveda practitioners. Pharmaceutical processing of Rasasindura involves treating purified mercury with purified sulphur and juices of Aloe vera (Linn.) Burm. f. to form black sulphide of mercury, which is further treated with gradual, intermittent heat to transform into more stable form, i.e. cinnabar by Kupipakwa method [4]. Kupipakwa is a specialized heating system, i.e. gradual, intermittent heat by vertical electrical-muffle furnace. Rasasindura is said to be mercury sulphide, associated with several organic macro-molecules derived from processing with plant extracts [5]. Toxic effects of purified mercury were said to be neutralized in the presence of purified sulphur [6]. As per the classics, Rasasindura is administered with the adjuvant such as Guduchi ghana (solidified aqueous extract of Tinospora cordifolia Will.) [7]. Rasasindura has unique properties to pacify diseases such as diabetes, fistula, fever, lack of appetite, anaemia, oedema etc.; and it is considered equivalent to the elixir, which is known to overcome death [4,7]. Since reports of toxicity evaluation of this classical preparation (along with the adjuvant) was not available during extensive literature review, it was thought worthwhile to undertake the detailed toxicity assessment in albino rats.
Materials and Methods
Aloe vera and T. cordifolia were collected from the botanical garden of Gujarat Ayurved University, Jamnagar. The plant materials were authenticated and voucher specimens of each submitted to Pharmacognosy laboratory of Institute. Rasasindura and Guduchi ghana (solidified aqueous extract of T. cordifolia) were prepared in Department of Rasashastra and Bhaishajya Kalpana, Gujarat Ayurved University, Jamnagar; and SOPs were prepared and documented [4,8]. All chemicals used in the study were of analytical grade.
Experimental animals
Wistar albino rats of either sex weighing 200±20 g body weight were used for the study. The animals were maintained under ideal husbandry conditions in terms of standard conditions of temperature (23±2°), relative humidity (50 to 60%), and exposed to 12 h light-and-dark cycles. All animals were exposed to the same environmental conditions and were maintained on standard diet and drinking water ad libitum. The experimental protocol was approved by the Institutional Animal Ethical Committee (IAEC/10/2012/08, Ph.D.) as per the guideline of Committee for the Purpose of Control and Supervision on Experiments on Animals, India.
Dose selection
As per the classical guideline, the therapeutic dose of Rasasindura is 125 mg/d [9] and should be administered with the adjuvant as solidified aqueous extract of T. cordifolia (375 mg/d). Hence, total dose of drug with adjuvant is 500 mg/d. The suitable dose for rats was calculated by referring to table of Paget and Barnes [10] and was found to be 45 mg/kg rat (considered as therapeutic equivalent dose, TED). The test drug along with adjuvant was administered orally with the help of cannula, in the form of suspension in honey and distilled water solution.
Acute toxicity study
Young, healthy, nulliparous, and non-pregnant Wistar-strain albino, female rats were selected and acclimatized for seven days before the experiment. The Rasasindura along with adjuvant was orally administered at limit dose of 2000 mg/kg to overnight fasted female rats in sequential manner as per the OECD 425 guideline [11]. The rats were observed closely for behavioural changes, signs and symptoms of toxicity, and mortality continuously for the first six hours; and thereafter, periodically up to 14 d. The body weight of each rat was noted on the last day and the rats were sacrificed. The abdomen was opened through mid-line incision to record the autopsy changes, followed by dissecting the important organs for histopathological changes.
Chronic toxicity study
The chronic toxicity study was carried out followed by standard guideline with modification as per experimental need [12,13]. Rats were randomized into six groups of six rats in each with three males and three females. Group (I) was kept as control group, received vehicle as honey solution in distilled water (5 ml/kg, orally). Group (II) to (IV) were administered with test drug Rasasindura along with adjuvant at TED (45 mg/kg, orally), TED×5 (225 mg/kg, orally), and TED×10 (450 mg/kg, orally), respectively. The suspensions of test drugs were administered orally once-a-day for 90 consecutive days in main study. Additional six animals were kept in satellite control group (V) and in the recovery TED×10 treated group (VI) for observation after the treatment period, for reversibility or persistence of any toxic effects. The duration of post-treatment period was fixed as 30 d (total of 120 d, including 90 d treatment period and 30 d recovery period). All the animals were dosed with constant dose volume of 5 ml/kg, orally.
The rats were observed daily, carefully for any overt and apparent signs and symptoms of toxicity. The bodyweight change of an individual rat was noted initially and thereafter weekly during the study period. At the end of experimental periods, blood was withdrawn by the retro-orbital puncture under light-ether anaesthesia using capillary tube for estimation of serum biochemical and haematological parameters. The body weight of each rat was noted on last day and rats were sacrificed. The abdomen was opened through mid-line incision to record the autopsy changes followed by dissecting out the important organs.
Haematological analysis was performed using an automatic haematological analyser (Swelab, Sweden). The parameters were total red blood cell (RBC), haemoglobin (Hb), packed cell volume (PCV), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), white blood cell (WBC), neutrophils percentage (%N), lymphocyte percentage (%L), eosinophil’s percentage, monocyte percentage, and platelet count (PC).
Serum bio-chemical parameters were carried out using fully automated biochemical random access analyser (BS-200, Lilac Medicare Pvt. Ltd., Mumbai). The parameters were blood glucose [14], urea [15], creatinine [16], total cholesterol [17], HDL-cholesterol [18], triglyceride [19], VLDL-cholesterol, LDL-cholesterol, total protein [20], albumin, globulin [21], alkaline phosphatase [22], SGOT [23], SGPT [24], uric acid [25], direct bilirubin [24], total bilirubin [26], and serum calcium [27].
Bone-marrow smear from the femur bone was prepared using standard procedure. All the important internal organs were carefully dissected namely brain, pituitary, liver, heart, thymus, spleen, kidney, lung, stomach, intestine, testis, prostate, seminal vesicle, uterus, ovary, adrenal gland, trachea, aorta, lymph node, and skin. After noting for any signs of gross lesion and ponderal changes of major organs, all were transferred to 10% phosphate buffered formalin solution for fixation and later on subjected to dehydrating, wax embedding, sectioning, and staining with haematoxylin and eosin (H and E) for histological evaluation by light microscopy. The slides were viewed under trinocular research Carl-Zeiss’s microscope at various magnifications to note down the changes in the microscopic features of the tissues.
Statistical analysis
The data is expressed as mean±standard error of mean for six rats per experimental group. One-way analysis of variance (ANOVA) was used to compare the mean values of quantitative variables among the groups, followed by Dunnet’s multiple t-test for unpaired data to determine significant difference between groups at P<0.05.
Results and Discussion
Acute toxicity study of test drug was carried out to record immediate adverse signs and symptoms of drug in female rats at dose levels that are several folds higher than the therapeutic equivalent dose. Administration of Rasasindura along with adjuvant did not affect any behavioural changes and other parameters observed during the acute toxicity test in female rats. No signs and symptoms of toxicity and mortality were observed up to oral dose of 2000 mg/kg of test drug in rats. Further, drug did not affect the cytoarchitecture of major organs like heart, kidney, liver, uterus, and ovary which suggest that LD50 value may be higher than 2000 mg/kg by oral route. As per UN classification, any substance, which has oral LD50 of more than 2000 mg/kg is considered as low hazard potential and categorized as UN 6.1 PG III [28]. Thus as per the above criterion Rasasindura along with adjuvant can be categorized as substances with low health hazard potential (Class 4 of GHS and UN 6.1 PG III).
There were no behavioural changes observed in Rasasindura treated groups during the course of chronic toxicity study. No symptoms of toxicity and mortality was observed in treated groups at TED×10, TED×5, and TED dose levels in the main study and TED×10 in the recovery study. Normal body weight gain was observed in control rats during main study (90 d) as well as recovery study (120 d). An increase in body weight was found in Rasasindura treated groups at all dose levels. Changes in body weight are an important factor to monitor the health of an animal. Loss of body weight is usually the first sign indicating the onset of an adverse effect. The dose, at which body weight loss is by 10% or more, is considered to be a toxic dose, irrespective of whether or not it is accompanied by any other changes [29]. The percentage change in body weight pattern in test drug treated groups did not differ significantly from the changes observed in the control groups, which suggest the absence of serious toxic effect of Rasasindura during chronic administration in rats.
Out of the nine organs for which relative weights were recorded (Table 1), Rasasindura treated group showed significant decrease in relative weight of liver in TED treated group in comparison to the normal control, whereas in other dose levels the changes were non-significant. A significant increase was observed in relative weight of testis at TED, uterus weight at TED×5, and kidney and testis at TED×10 dose levels; however, the changes were almost reversed in the drug treated recovery group at TED×10 dose level. Normally, decrease in the weight of an organ is indicative of loss of tissue mass in that organ, exception being the secretory organs in which the decrease in weight sometimes is seen along with the increased activity. In this case, the increase in the weight of reproductive organs may be indicative of stimulation of hormone secretion. In the present study, there were no remarkable changes observed in the relative weight of the organs at higher doses of test drugs. Hence, it may be, understood that the drugs do not tend to produce any serious toxic effect on the relative weight of the important internal organs in chronic toxicity studies.
Relative weight Control group Drug treated groups R Control group Recovery TED x 10
TED TED×5 TED×10
Liver (g/100 g) 3.57±0.17 3.12±0.10* 3.27±0.06 3.26±0.09 2.72±0.07 2.99±0.11
Heart (mg/100 g) 280.41±8.88 266.04±5.36 289.12±9.69 281.65±6.78 240.44±8.42 269.80±12.81
Kidney (mg/100 g) 720.10±26.28 675.17±19.26 766.08±30.88 804.74±25.63* 691.42±18.42 714.44±10.76
Spleen (mg/100 g) 194.50±9.32 173.56±8.14 206.28±18.26 189.69±10.14 158.85±7.44 179.45±8.87
Thymus (mg/100 g) 172.54±6.73 165.65±5.21 167.91±7.71 158.91±7.60 145.56±10.91 146.15±12.89
Testis (g/100 g) 648.26±28.37 818.50±41.74* 684.25±123.10 868.99±45.83 792.01±61.68 661.95±39.86
Prostate (mg/100 g) 146.97±21.19 128.77±11.70 129.53±9.04 180.36±7.43 145.07±24.68 167.09±16.38
S. vesicle (mg/100 g) 504.08±95.14 504.55±55.60 481.70±32.76 527.32±47.38 421.09±62.60 477.01±58.91
Uterus (mg/100 g) 230.03±17.72 215.88±28.98 323.70±26.45* 222.81±21.52 197.89±8.69 178.48±9.04
The results are expressed as mean±SEM, where n=6. SEM: Standard error of mean. *P<0.05, compared with control group
Table 1: Effect of test drugs on relative weight of organs of rats recorded during chronic toxicity study.
Analysis of the effects of Rasasindura on haematological parameters (Table 2) revealed Non-significant increase in WBC count at each of the dose level studied in the main study; however, contrary effect was observed in the recovery phase in the drug treated group in comparison to the control group. However all the values were within the normal range [30]. The test drug at all dose level did not affect the RBC related parameters. This clearly indicates that the test drug did not affect the cellular and non-cellular elements of the blood to significant extent. Further, with the discontinuation of the drug, most of the values were similar to that observed in the recovery control group, which suggests that the drug is devoid of any serious haematological toxicity, even at higher dose on repeated administration.
Hematological Parameters Control group Drug treated groups R control group Recovery TED×10
TED TED×5 TED×10
RBC (106/ml) 7.55±0.08 7.69±0.17 7.41±0.10 7.86±0.22 8.67±0.26 8.74±0.26
Hemoglobin (g/dl) 13.85±0.34 13.95±0.21 13.60±0.16 14.00±0.21 15.38±0.24 15.38±0.33
PCV% 42.18±0.58 42.48±0.95 41.40±0.43 44.41±1.01 48.76±1.22 49.60±1.30
MCV (fl) 55.86±0.41 55.25±0.47 55.84±0.48 56.54±0.75 56.32±1.18 56.75±0.80
MCH (pg/red cell) 18.35±0.32 18.15±0.24 18.35±0.27 17.84±0.37 17.38±0.53 17.63±0.38
MCHC (g/dl) 32.81±0.49 32.87±0.25 32.84±0.24 31.58±0.33 30.84±0.42 31.03±0.34
WBC (103/ml) 6816.66±630.03 8114.28±1217.61 8114.28±1068.91 7585.71±570.47 7020.00±575.67 6233.33±276.48
Neutrophil% 24.50±4.32 28.42±5.47 19.57±2.32 17.14±1.79 23.00±4.93 23.66±2.10
Lymphocyte % 71.66±4.27 66.57±5.81 76.85±2.13 79.42±2.04 75.80±5.06 72.00±2.51
Eosinophil% 2.33±0.21 2.71±0.28 2.00±0.21 2.00±0.21 2.60±0.24 2.33±0.21
Monocyte% 1.50±0.22 2.28±0.28 1.57±0.20 1.42±0.20 2.60±0.24 2.00±0.36
PLT (103/ml) 1152.83±54.10 1267.57±47.57 1154.00±62.82 1267.85±51.82 1115.80±45.11 1057.50±83.48
The results are expressed as mean±SEM, where n=6. SEM: Standard error of mean
Table 2: Effect of test drugs on hematological parameters in rats recorded during chronic toxicity study.
The effects of Rasasindura on serum bio-chemical parameters are presented in Table 3. Out of eighteen parameters studied, significant decrease was observed in blood glucose level at TED and TED×5 treated groups, while significant increase in creatinine level at TED dose level and triglyceride level at TED×5 dose level in comparison to the control group in main study. However, similar significant changes were not observed in higher dose of Rasasindura. After discontinuation of test drug in the recovery group, the observed changes in glucose level, creatinine, and triglyceride were almost same as seen in the recovery control group. Cholesterol level and HDL-cholesterol level in rats were unaffected by the test drug at all dose level in comparison to the control group; hence, it can be inferred that the observed changes do not cause any serious toxic effect (Table 4).
Biochemical Parameters Control group Drug treated groups R control group Recovery TED×10
TED TED×5 TED×10
Glucose (mg/dl) 92.83±8.63 68.57±2.61* 70.85±4.11* 107.28±3.63 117.50±4.86 111.66±3.34
Urea (mg/dl) 69.83±4.88 81.00±2.43 64.00±4.35 69.14±8.74 88.60±5.00 65.16±3.15
Creatinine (mg/dl) 0.58±0.03 0.70±0.03* 0.62±0.03 0.55±0.02 0.56±0.02 0.60±0.02
Total protein (g/dl) 7.08±0.17 6.94±0.19 6.95±0.24 7.12±0.10 6.90±0.24 7.05±0.10
Albumin (g/dl) 3.58±0.16 3.61±0.15 3.67±0.23 3.72±0.08 3.36±0.14 3.35±0.08
Globulin (g/dl) 3.50±0.17 3.12±0.10 3.28±0.17 3.40±0.09 3.33±0.15 3.70±0.17
ALP (IU/L) 233.25±45.02 149.00±11.82 143.33±23.78 263.42±37.67 261.40±37.64 281.33±51.96
SGOT (IU/L) 138.16±7.85 153.28±9.11 142.85±8.42 148.85±9.83 124.50±8.65 143.83±5.17
SGPT (IU/L) 67.00±7.82 53.28±1.37 58.28±5.16 62.00±6.92 57.00±2.70 57.00±4.20
Uric acid (mg/dl) 0.70±0.13 0.81±0.09 0.84±0.09 0.72±0.06 0.95±0.16 1.05±0.09
D. Bilirubin (mg/dl) 0.13±0.03 0.11±0.01 0.10±0.00 0.12±0.02 0.13±0.03 0.13±0.02
T. Bilirubin (mg/dl) 0.45±0.05 0.48±0.07 0.41±0.04 0.48±0.06 0.45±0.07 0.48±0.08
Calcium (mg/dl) 9.58±0.30 8.98±0.17 9.81±0.25 9.22±0.22 9.35±0.22 9.48±0.09
The results are expressed as mean±SEM, where n=6. SEM: Standard error of mean. *P<0.05 compared with control group; @P<0.05 compared with recovery control group
Table 3: Effect of test drugs on biochemical parameters in rats recorded during chronic toxicity study.
Serum Lipid profile Control group Drug treated groups R control group Recovery TED x 10
TED TED x 5 TED x 10
Total cholesterol (mg/dl) 34.33±3.45 38.42±1.81 37.28±3.92 30.71±2.01 37.50±3.59 28.16±1.86@
HDL-cholesterol (mg/dl) 33.16±3.15 37.14±4.50 37.85±5.70 27.85±2.08 31.66±3.41 25.16±1.60
Triglyceride (mg/dl) 61.33±3.67 76.14±6.55 78.42±6.07* 70.28±6.80 70.16±5.29 73.83±8.56
VLDL-cholesterol (mg/dl) 12.26±0.73 15.22±1.31 15.68±1.21 14.05±1.36 14.03±1.05 14.76±1.71
LDL-cholesterol (mg/dl) 11.10±1.68 13.32±3.86 14.40±3.30 11.20±0.80 7.43±1.90 11.76±2.26
The results are expressed as mean ± SEM, where n=6. SEM: Standard error of mean. *P<0.05 compared with control group; @P<0.05 compared with recovery control group
Table 4: Effect of test drugs on serum lipid profile in rats recorded during chronic toxicity study.
Significant decrease in blood urea was observed in recovery TED×10 treated rats in comparison to the recovery control group however same was not observed in main study. Test drugs did not influence the level of serum transaminases, urea, and creatinine to a significant extent in main study; which suggests that the test drug may not affected the liver and kidney function in the treated rats. The observed values of above bio-chemical parameters are within the normal range [30].
The histopathological studies of twenty organs showed that Rasasindura along with adjuvant at highest dose level exhibited mild to moderate changes in kidney, liver, intestine, stomach, and lung in comparison to the control group. Rasasindura produced mild pigment deposition, fatty changes in epithelium, and oedematous changes in kidney tubule, whereas recovery group showed normal cytoarchitecture (Figure 1). Rasasindura TED×10 and TED×5 treated groups exhibited pigment deposition, mild necrosis, and fatty changes in the liver in comparison the control group, while the recovery group showed almost normal cytoarchitecture (Figure 2). Test drug at highest-dose level exhibited mild to moderate loss of villi and cell infiltration in intestine (Figure 3) and displayed mild to moderate sub-mucosal inflammation in the stomach (Figure 4). Mild effusion was seen in cytoarchitecture of lung of one of the rat at higher dose of TED×10 dose level in comparison to the control group; whereas, in other dose levels the changes were almost normal (Figure 5). Bone marrow smear and the other organs exhibited normal cytoarchitecture in the Rasasindura-preparation treated groups, both in the main study as well as in the recovery study, in comparison to the control groups.
IJPS-Histopathology-kidney
Figure 1: Histopathology of kidney tissues (x400 magnification)
(A) Normal cytoarchitecture (control group), (B) edema and fatty changes (TED×5), (C) oedema, pigment deposition and fatty changes (TED×10), (D) almost normal cytoarchitecture (recovery TED×10)
IJPS-Normal-cytoarchitecture
Figure 2: Histopathology of liver tissues (x400 magnification)
(A) Normal cytoarchitecture (control group), (B) pigment deposition, mild necrosis and fatty changes (TED×5), (C) pigment deposition, mild necrosis and fatty changes (TED×10), (D) fatty changes (recovery TED×10)
IJPS-mild-moderate-loss
Figure 3: Histopathology of intestine tissues (x200 magnification)
(A) Normal cytoarchitecture (control group), (B) almost normal cytoarchitecture (TED×5), (C) mild to moderate loss of villi and cell infiltration (TED×10), (D) almost normal cytoarchitecture (recovery TED×10)
IJPS-almost-normal-cytoarchitecture
Figure 4: Histopathology of stomach tissues (x100 magnification)
(A) Normal cytoarchitecture (control group), (B) normal cytoarchitecture (TED×5), (C) mild to moderate sub-mucosal inflammation (TED×10), (D) almost normal cytoarchitecture (recovery TED×10)
IJPS-almost-normal-cytoarchitecture
Figure 5: Histopathology of lung tissues (x100 magnification) (A) Normal cytoarchitecture (control group), (B) normal cytoarchitecture (TED×5), (C) mild effusion (TED×10), (D) almost normal cytoarchitecture (recovery TED×10)
The observed histopathological changes were not seen at therapeutic dose level and not in the recovery study. The result of bio-chemical parameters reveal that the drugs do not seem to produce any drastic changes in the liver and kidney function parameters in rats; which suggests that the organ damage as mentioned above in chronic toxicity is of mild intensity at higher dose level, however drug is relatively safe at therapeutic dose level. In previous 28-d toxicity study also demonstrated that Rasasindura (50-100 mg/kg) in Wistar-albino rats did not have any adverse effect on kidney [31]. Further, feeding on Rasasindura supplemented food did not elicit any evidence of heavy metal toxicity in larvae or flies, since there was neither any evidence of lethality, nor of any developmental defects in the emerging flies [32].
The results reiterates the fact that Bhasmas, despite their trace heavy metal content, are safe when appropriately manufactured and consumed as per directed instructions [33]. Toxic effects of mercury were said to be neutralized in the presence of sulphur [6].
In Ayurvedic system of medicine, Anupana (called vehicle, as a medium of administration) improves acceptability and palatability and helps in absorption of the main drug; additionally, it may also act as early antidote [32]. Guduchi used as adjuvant in current study is having antioxidant property acts as hepatoprotective drug and has potential against aflatoxins and heavy metal toxicity [34,35].
From the present study, it is concluded that Rasasindura along with adjuvant is not toxic on acute administration at a maximum oral dose level of 2000 mg/kg in female rats. However, on chronic administration of test drug for 90 d produced mild to moderate adverse changes in the kidney, liver, intestine, and stomach of rats at TED×10 dose level, equivalent of which are not likely to be ever employed in clinical conditions, conversely Rasasindura at TED dose has no toxic potential. Rasasindura prepared as per customary method and administered with appropriate adjuvant is safe to consume at therapeutic dose level.
Acknowledgments
The authors wish to thank the staff of Pharmacology laboratory and R. S and B. K Department, Institute of Postgraduate Teaching and Research in Ayurveda for their support.
Financial assistance
None.
Conflict of interests
None declared.
References
Krishnamachary B, Rajendran N, Pemiah B, Krishnaswamy S, Krishnan UM, Sethuraman S, et al. Scientific validation of different purification steps involved in the preparation of an Indian Ayurvedic medicine, Lauha Bhasma. J Ethnopharmacol 2012;142:98-104.
Kohli KR. Ayurvedic medicines and heavy metals issue. Ayurveda Herit 2005;1:5-6.
http://apps.who.int/medicinedocs/en/d/Jh2946e/.
Gokarn RA, Patgiri B. An approach towards pharmaceutical standardization of Shadguna rasasindura. J Res Edu Indian Med 2013;19:97-102.
Patil S, Chaudhary AK. Quantitative estimation of Guduchi Ghana obtained from different amount of water used for kwath. Int J Pharma Arch 2013;2:160-4.
Kumar A, Nair AGC, Reddy AVR, Garg AN. Availability of essential elements in bhasmas: analysis of Ayurvedic metallic preparations by INAA. J Radioanal Nucl Chem 2006;270:173-80.
Shastry K. Sadananda Sharma’s Rasa Tarangini. 11th ed. New Delhi: Motilal Banarasidas; 2004. p. 140-1.
Dhundi SN, Yadav P, Patgiri BJ, Prajapati PK. Pharmaceutical standardization of Guduchi Ghana (solidified aqueous extract of Tinospora cordifolia Moerrs.). Int Res J Pharm 2011;2:102-4.
http://naturalingredient.org/wp/wp-content/uploads/API-Vol-7.pdf.
Paget GE, Barnes JM. Toxicity tests. In: Laurance DR, Bacharach AL, editors. Evaluation of drug activities: pharmacometrics. New York: Academic Press; 1964. p. 205-10.
https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/oecd/oecd_gl425-508.pdf.
https://www.oecd.org/chemicalsafety/testing/Revision-OECD-TG408-repeated-dose-90-day-oral-toxicity-study-in-rodents.pdf.
http://ayush.gov.in/sites/default/files/File779%20%20%204.pdf.
Pennock CA, Murphy D, Sellers J, Longdon KJ. A comparison auto analyzer method for the estimation of glucose in blood. Clin Chim Acta 1973;48:193-201.
Talke H, Schubert GE. Enzymatic urea determination in the blood and serum in Warburg optical test. Klin Wochenschr 1965;42:174-5.
Slot C. Plasma creatinine determination: a new and specific Jaffe reaction method. Scand J Clin Lab Invest 1965;17:381-7.
Roeschlau P, Bernt E, Gruber WA. Enzymatic determination of total cholesterol in serum. J Clin Chem Clin Biochem 1974;12:226.
Dominiczak M, McNamara J, Nauk M, Wiebe D, Warnick G. Measurement of high-density-lipoprotein cholesterol. In: Rifai N, Warnick GR, Dominiczak MH, editors. Handbook of lipoprotein testing. 2nd ed. Washington DC: AACC Press; 2000. p. 819.
Fossati P, Prencipe L. Serum triglycerides determined colorimetrically with an enzyme that produces hydrogen peroxide. Clin Chem 1982; 28:2077-80.
Tietz NW. Text book of Clinical Chemistry. Philadelphia (PA): WB Saunders; 1986. p. 579.
Doumas BT, Arends RL, Pinto PC. In standard methods of clinical chemistry, vol. VII. Chicago: Academic Press; 1972. p. 175-89.
Wilkinson JH, Boutwell JH, Winsten S. Evaluation of a new system for kinetic measurement of serum alkaline phosphatase. Clin Chem 1969;15:487-95.
Tietz NW. Clinical guide to laboratory tests. 3rd ed. Philadelphia (PA): WB Saunders; 1995. p. 76.
Burtis CA, Ashwood ER. Tietz textbook of Clinical Chemistry. 3rd ed. Philadelphia (PA): WB Saunders; 1999. p. 652, 1136.
Kabasakalian P, Kalliney S, Wescott A. Determination of uric acid in serum, with use of uricase and tribromophenol-aminoantipyrine chromogen. Clin Chem 1973;19:522.
Pearlman PC, Lee RT. Detection and measurement of total bilirubin in serum with use of surfactants as solubilizing agents. Clin Chem 1974;20:447.
Biggs HG, Moorehead WR. 2-Amino-2-methyl-1-propanol as the alkalizing agent in an improved continuous-flow cresolphthalein complexone procedure for calcium in serum. Clin Chem 1974;20:1458-60.
https://www.unece.org/trans/danger/publi/unrec/12_e.html.
Timbrell JA. Principles of biochemical toxicology. London: Taylor and Francis Limited; 1982. p. 446.
Gad SC. The rat: pathology. In: Gad SC, Chengellis CP editors. Animal Models in Toxicology. Boca Raton: CRC press; 2007. p. 147-217.
Anita K, Sharma A, Venkateshwaralu U, Gotecha VK. Toxicological evaluation of Rasasindoor in albino rats. Int Ayur Med J 2013;1:1-6.
Dwivedi V, Anandan EM, Mony RS, Muraleedharan TS, Valiathan MS, Mutsuddi M, et al. In vivo effects of traditional ayurvedic formulations in Drosophila melanogaster model relate with therapeutic applications. PLoS ONE 2012;7:e37113.
Sathya T, Murthy B, Vardhini N. Genotoxicity evaluation of certain bhasmas using micronucleus and Comet assays. Int J Alt Med 2009;7:1.
Sharma V, Gupta R, Sharma S. Preventive effects of Tinospora cordifolia extract against aflatoxin-B1 induced oxidative stress in swiss albino mice. Asian J Pharma Clin Res 2011;4:49-55.
Sharma V, Pandey D. Beneficial Effects of Tinospora cordifolia on blood profile in male mice exposed to lead. Toxicol Int 2010;17:8-11.
About the Journal
The Indian Journal of Pharmacy was started in 1939 as "a quarterly journal devoted to the Science and practice of Pharmacy in all its branches". The Chief editor and the main guiding force behind the 'Journal' was Prof. M.L. Schroff, Head of the Department of Pharmaceutics. Benaras Hindu University, Benaras.
more
Impact Factor® for 2016 is 0.66
Abstracting and Indexing Information
Web of Science Science Citation Index Expanded DOAJ EMBASE CNKI EBSCO IndMed Index Copernicus Scimago SCOPUS
Subscribe to our Newsletter
All our latest content delivered to your inbox
Home About Us Editors Current Issue Archives Instructions Sitemap Advertising Feedback Copyright and Disclaimer
Copyright © 2019 ijpsonline.com. All Rights Reserved.
[*/quote*]
Navigation
[0] Message Index
Go to full version