Safety Evaluation of Methoxyflavones Mixture (Ⅰ) from <i>Kempferia parviflora</i>; 28-day Repeated Dose Oral Toxicity Test and Mouse Micronucleus Test

A battery of toxicological studies was conducted in accordance with international guidelines to investigate the genotoxicity and repeated-dose oral toxicity in rats of synthetic curcumin (VEAMIN 99, >99% purity). There was no evidence of mutagenicity in a bacterial reverse mutation test, whereas an in vitro mammalian chromosomal aberration test was positive for induction of chromosomal aberrations which is in line with results reported for natural curcumin. There was no evidence of genotoxicity in an in vivo mammalian micronucleus test. Synthetic curcumin did not cause mortality or toxic effects in a 90-day repeated-dose oral toxicity study at daily doses of 250, 500, or 1000 mg/kg body weight (bw)/day (administered by gavage in a split dose). The no observed adverse effect level (NOAEL) determined from the 90-day study was 1000 mg/kg bw/day for both male and female Wistar rats.

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The added value of the 90-day repeated dose oral toxicity test for industrial chemicals with a low (sub)acute toxicity profile in a high quality dataset

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2014.04.008 ◽

2014 ◽

Vol 69 (3) ◽

pp. 320-332 ◽

Cited By ~ 7

Author(s):

Katy Taylor ◽

David J. Andrew ◽

Laura Rego

Keyword(s):

Acute Toxicity ◽

Toxicity Test ◽

Added Value ◽

Repeated Dose ◽

Toxicity Profile ◽

Industrial Chemicals ◽

Oral Toxicity ◽

High Quality ◽

Dose Oral

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A 4-week Repeated dose Oral Toxicity Study of Mecasin in Sprague-Dawley Rats to Determine the Appropriate Doses for a 13-week, Repeated Toxicity Test

Journal of Pharmacopuncture ◽

10.3831/kpi.2015.18.037 ◽

2015 ◽

Vol 18 (4) ◽

pp. 45-50 ◽

Cited By ~ 2

Author(s):

Sungchul Kim ◽

Eunhye Cha ◽

Jongchul Lee ◽

Seongjin Lee ◽

Manyong Park ◽

...

Keyword(s):

Toxicity Test ◽

Toxicity Study ◽

Repeated Dose ◽

Sprague Dawley ◽

Oral Toxicity ◽

Sprague Dawley Rats ◽

Dose Oral

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A Toxicological Assessment of Creatyl-l-Leucine

International Journal of Toxicology ◽

10.1177/1091581817751142 ◽

2018 ◽

Vol 37 (2) ◽

pp. 171-187 ◽

Cited By ~ 4

Author(s):

Robin A. Reddeman ◽

Róbert Glávits ◽

John R. Endres ◽

Timothy S. Murbach ◽

Gábor Hirka ◽

...

Keyword(s):

Micronucleus Test ◽

Female Rats ◽

Repeated Dose ◽

Oral Toxicity ◽

Synthetic Compound ◽

Male And Female Rats ◽

Toxicological Studies ◽

Dose Oral

A battery of toxicological studies was conducted to investigate the genotoxicity and repeated-dose oral toxicity of creatyl-l-leucine, a synthetic compound, in rats in accordance with internationally accepted guidelines. There was no evidence of mutagenicity in a bacterial reverse mutation test and in an in vitro mammalian chromosomal aberration test. There was no genotoxic activity observed in an in vivo mammalian micronucleus test at concentrations up to the limit dose of 2,000 mg/kg bw/d. Creatyl-l-leucine did not cause mortality or toxic effects in Hsd.Han Wistar rats in a 90-day repeated-dose oral (gavage) toxicity study at doses of 1,250, 2,500, and 5,000 mg/kg bw/d. The no observed adverse effect level from the 90-day study was determined to be 5,000 mg/kg bw/d, the highest dose tested, for both male and female rats.

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