Toxicology International (Formerly Indian Journal of Toxicology)

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Sub-chronic (90 day) oral toxicity study in rats with lutein diacetate


Affiliations
1 Department of Safety Assessment, Advinus Therapeutics Private Limited, Post. Box No. 5813, Plot Nos. 21&22, Peenya II Phase, Bangalore – 560 058, India
2 Industrial Organics, S.A.DEC.V Are Almazan No. 100 Topo Chico, Monterrey, N.L. 64260, Mexico
     

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The purpose of this study was to investigate the safety of Lutein diacetate (nutraceutical) by determining its potential toxicity following 90 days sub chronic administration in Sprague Dawley rats. The Lutein diacetate was administered orally by gavage as a suspension in corn oil at the graded doses of 2.1, 22.5 and 210 mg/kg b.wt./day for 90 consecutive days. Animals in the control recovery and high dose recovery groups were further observed for 28 days without any treatment. The changes observed were stained (light brown coloured) faeces at 210 mg/kg body weight/day dose during the 90 day treatment period and normal coloured faeces were observed during the recovery period. No treatment related effects were seen in any of the parameters monitored in rats given 2.1, 22.5 and 210 mg/kg body weight/day of Lutein diacetate. Results indicate that oral dose of Lutein diacetate is relatively safe in rats up to 210 mg/kg body weight/day.

Keywords

Lutein diacetate, 90 day exposure, NOAEL (No Observed Adverse Effect Level), Sprague Dawley rats, toxicity
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  • Sub-chronic (90 day) oral toxicity study in rats with lutein diacetate

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Authors

Santhosh Kumar D. P.
Department of Safety Assessment, Advinus Therapeutics Private Limited, Post. Box No. 5813, Plot Nos. 21&22, Peenya II Phase, Bangalore – 560 058, India
Ravikumar C.
Department of Safety Assessment, Advinus Therapeutics Private Limited, Post. Box No. 5813, Plot Nos. 21&22, Peenya II Phase, Bangalore – 560 058, India
Rajesh Eswarappa
Department of Safety Assessment, Advinus Therapeutics Private Limited, Post. Box No. 5813, Plot Nos. 21&22, Peenya II Phase, Bangalore – 560 058, India
Krishnappa H.
Department of Safety Assessment, Advinus Therapeutics Private Limited, Post. Box No. 5813, Plot Nos. 21&22, Peenya II Phase, Bangalore – 560 058, India
Rao K. S.
Department of Safety Assessment, Advinus Therapeutics Private Limited, Post. Box No. 5813, Plot Nos. 21&22, Peenya II Phase, Bangalore – 560 058, India
Jose Torres Quiroga
Industrial Organics, S.A.DEC.V Are Almazan No. 100 Topo Chico, Monterrey, N.L. 64260, Mexico
Raviyadava .
Industrial Organics, S.A.DEC.V Are Almazan No. 100 Topo Chico, Monterrey, N.L. 64260, Mexico

Abstract


The purpose of this study was to investigate the safety of Lutein diacetate (nutraceutical) by determining its potential toxicity following 90 days sub chronic administration in Sprague Dawley rats. The Lutein diacetate was administered orally by gavage as a suspension in corn oil at the graded doses of 2.1, 22.5 and 210 mg/kg b.wt./day for 90 consecutive days. Animals in the control recovery and high dose recovery groups were further observed for 28 days without any treatment. The changes observed were stained (light brown coloured) faeces at 210 mg/kg body weight/day dose during the 90 day treatment period and normal coloured faeces were observed during the recovery period. No treatment related effects were seen in any of the parameters monitored in rats given 2.1, 22.5 and 210 mg/kg body weight/day of Lutein diacetate. Results indicate that oral dose of Lutein diacetate is relatively safe in rats up to 210 mg/kg body weight/day.

Keywords


Lutein diacetate, 90 day exposure, NOAEL (No Observed Adverse Effect Level), Sprague Dawley rats, toxicity