EFSA Compendium of Botanicals

Draft - work in progress

Sophora flavescens Aiton

Family:: Fabaceae
Approval state:: Approved
Number of articles retrieved:: 2614
Number of processed references:: 2

Compositions

#1: oxymatrine #2: quinolizidine alkaloids (isomatrine) #3: matrine #4: oxymatrine #5: matrine

Endpoint Studies

Genotoxicity

#1: Positive in Chinese hamster lung fibroblast cells with S9 mix

Composition #1: Wang Lei., Wu Xing-De., He Juan., Li Gen-Tao., Peng Li-Yan., Li Yan., Song Liu-Dong., Zhao Qin-Shi. A New Quinolizidine Alkaloid from Sophora flavescens. chemistry of natural compounds, 2014, vol. 50, no. 5, p. 876–879. DOI: 10.1007/s10600-014-1104-8. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts (as part-nature) (A067M)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Methanol
Substance:

Oxymatrine (RF-00010939-PAR)
Analytical method code:

Colorimetry, Spectroscopy (Spectrometry) and Photometry (F008A)
Analytical method - additional description:

UV, IR, NMR, HPLC, MPLC, HR-ESI-MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

oxymatrine

Composition #2: Wang Lei., Wu Xing-De., He Juan., Li Gen-Tao., Peng Li-Yan., Li Yan., Song Liu-Dong., Zhao Qin-Shi. A New Quinolizidine Alkaloid from Sophora flavescens. chemistry of natural compounds, 2014, vol. 50, no. 5, p. 876–879. DOI: 10.1007/s10600-014-1104-8. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts (as part-nature) (A067M)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Methanol
Substance:

Quinolizidine alkaloids (RF-00004327-PAR)
Additional substance description:

isomatrine
Analytical method code:

Colorimetry, Spectroscopy (Spectrometry) and Photometry (F008A)
Analytical method - additional description:

UV, IR, NMR, HPLC, MPLC, HR-ESI-MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

quinolizidine alkaloids (isomatrine)

Composition #3: Wang Lei., Wu Xing-De., He Juan., Li Gen-Tao., Peng Li-Yan., Li Yan., Song Liu-Dong., Zhao Qin-Shi. A New Quinolizidine Alkaloid from Sophora flavescens. chemistry of natural compounds, 2014, vol. 50, no. 5, p. 876–879. DOI: 10.1007/s10600-014-1104-8. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts (as part-nature) (A067M)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Methanol
Substance:

Matrine (RF-00003483-PAR)
Analytical method code:

Colorimetry, Spectroscopy (Spectrometry) and Photometry (F008A)
Analytical method - additional description:

UV, IR, NMR, HPLC, MPLC, HR-ESI-MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

matrine

Composition #4: Che, Jeong-Hwan., Yun, Jun-Won., Kim, Yun-Soon., Kim, Seung-Hyun., You, Ji-Ran., Jang, Ja-June., Kim, Hee Chan., Kim, Hyeon Hoe., Kang, Byeong-Cheol. Genotoxicity and subchronic toxicity of Sophorae radix in rats: Hepatotoxic and genotoxic potential . regulatory toxicology and pharmacology, 2015, vol. 71, no. 3, p. 379–387. DOI: 10.1016/j.yrtph.2015.01.012. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts (as part-nature) (A067M)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

water
Substance:

Oxymatrine (RF-00010939-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Result unit:

Milligram/gram (G060A)
Result type:

Numerical Value (VAL)
Value (concentration, content):

42.7
Internal remarks:

oxymatrine

Composition #5: Che, Jeong-Hwan., Yun, Jun-Won., Kim, Yun-Soon., Kim, Seung-Hyun., You, Ji-Ran., Jang, Ja-June., Kim, Hee Chan., Kim, Hyeon Hoe., Kang, Byeong-Cheol. Genotoxicity and subchronic toxicity of Sophorae radix in rats: Hepatotoxic and genotoxic potential . regulatory toxicology and pharmacology, 2015, vol. 71, no. 3, p. 379–387. DOI: 10.1016/j.yrtph.2015.01.012. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts (as part-nature) (A067M)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

water
Substance:

Matrine (RF-00003483-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Result unit:

Milligram/gram (G060A)
Result type:

Numerical Value (VAL)
Value (concentration, content):

18.2
Internal remarks:

matrine

Endpoint study #1: Che, Jeong-Hwan., Yun, Jun-Won., Kim, Yun-Soon., Kim, Seung-Hyun., You, Ji-Ran., Jang, Ja-June., Kim, Hee Chan., Kim, Hyeon Hoe., Kang, Byeong-Cheol. Genotoxicity and subchronic toxicity of Sophorae radix in rats: Hepatotoxic and genotoxic potential . regulatory toxicology and pharmacology, 2015, vol. 71, no. 3, p. 379–387. DOI: 10.1016/j.yrtph.2015.01.012. [DOI link]

Study relevance:

Human health
Plant part:

Roots and other underground parts (as part-nature) (A067M)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

water
Type of toxicological test:

subchronic (CHD013TT)
Guideline used:

According to
Guideline:

OECD GUIDELINE 408 (REPEATED DOSE 90-DAY ORAL TOXICITY IN RODENTS) (OECD1256PL)
Tested organism:

Rat (as animal) (A0CNV)
Strain of test organism:

Fischer344 (CHD009ST)
Sex:

Male/Female
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

90.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

10
Control groups used:

yes
Endpoint measured:

No observed adverse effect daily dose (CHD005EP)
Concentration unit:

Milligrams per kilogram body weight per day (G211A)
Effect concentration:

10
Critical effect:

SYSTEMIC (TOX01A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

Body weight reduction, anemia and liver injury
Effect or parameter linked to the endpoint:

no adverse effect observed (CHD018BE)
Internal remarks:

A dose-related change in body weight, a significant increase in liver weight along with increases in serum alkaline phosphatase and alanine transaminase. A small but statistically significant reduction in levels of red blood cells, hemoglobin, and hematocrit in the treated rats suggest the possibility of anemia, accompanied by liver injury.

Genotox #1: Che, Jeong-Hwan., Yun, Jun-Won., Kim, Yun-Soon., Kim, Seung-Hyun., You, Ji-Ran., Jang, Ja-June., Kim, Hee Chan., Kim, Hyeon Hoe., Kang, Byeong-Cheol. Genotoxicity and subchronic toxicity of Sophorae radix in rats: Hepatotoxic and genotoxic potential . regulatory toxicology and pharmacology, 2015, vol. 71, no. 3, p. 379–387. DOI: 10.1016/j.yrtph.2015.01.012. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

chromosome aberration assay (CHD047TT)
Method type:

in vitro
Guideline:

OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test) (OECD1289PL)
Tested organism:

Hamster (as animal) (A0CNX)
Strain of test organism:

lung fibroblasts (V79) (CHD032ST)
Exogenous metabolic activation applied:

with
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes
Endpoint measured:

chromosome aberration
Is genotoxic:

Positive
Remarks on genotox study:

positive with S9 mix
Internal remarks:

Positive in Chinese hamster lung fibroblast cells with S9 mix
Internal ID:

WOS:000352823800004