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

Jump To References Section

Authors

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

Keywords:

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

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.

Downloads

Download data is not yet available.

Published

2018-04-05

How to Cite

D. P., S. K., C., R., Eswarappa, R., H., K., K. S., R., Quiroga, J. T., & ., R. (2018). Sub-chronic (90 day) oral toxicity study in rats with lutein diacetate. Toxicology International, 16(1), 55–62. Retrieved from http://informaticsjournals.com/index.php/toxi/article/view/20846

Issue

Section

Original Research
Received 2018-04-05
Accepted 2018-04-05
Published 2018-04-05

 

References

Duncan, JL, Aleman, TS, Gardner, LM, Castro, ED, Marks, DA, Emmons, JM, Bieber, ML, Steinberg, JD, Bennet, J, Stone, EM, Macdonald, IM, Cideciyan, AV, Maguire, MG and Jacobson, SG (2002). Macular pigment and lutein supplementation in choroideremia, Exp. Eye Res., 74:371-381.

Kruger, CL, Murphy, M, DeFreitas, Z, Pfannkuch, F and Heimbach, J (2002). An innovative approach to the determination of safety for a dietary ingredient derived from a new source: case study using a crystalline lutein product. Food and Chem. Toxicol., 40: 1535-49.

OECD Guideline (1998). No. 408 for Testing of Chemicals, "Repeated Dose 90-day Oral Toxicity Study in Rodents” adopted on September 21, 1998.

Olmedilla, B, Granado, F, Blanco, I and Vaquero, M (2003). Lutein, but Not α-Tocopherol, supplementation improves visual function in patients with age related cataracts; a 2 year double blind, placebo-controlled pilot study. Nutrition, 19: 21-24.

Richer, S, Stiles, W, Statkute, L, Pulido, J, Frankowski, J, Rudy, D, Pei, K, Tsipursky and M, Nyland, J (2004).

Double-masked, placeb- controlled, randomized trial of lutein and antioxidant supplementation in the intervention of age-related macular degeneration: the Veterans LAST study (Lutein Antioxidant Supplementation Trial), Optometry, 75: 216-30.

Samimi, DB (2005). Carotenoids: Nature's cure to macular degeneration?. Nutrition Bytes, 10.

Scheffe, H (1953). A method for judging all contrasts in the analysis of variance, Biometrika, 40: 87-110.

Snedecor, GW and Cochran, WG (1987). Statistical Method, Seventh ed. The lowa State University press. Ames. Lowa, USA.

Spainhour, CB (2001). OTC Drugs and Nutraceuticals in Regulating Toxicology. Gad, SC (Ed.), p 192-204, Taylor and Francis, London and New York.

WHO (2000). General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine, WHO, Geneva.