EFSA Compendium of Botanicals

Draft - work in progress

Pueraria tuberosa (Willd.) DC.

Family:: Fabaceae
Approval state:: Approved
Number of articles retrieved:: 226
Number of processed references:: 11

Compositions

#1: saponins in tubers #2: alkaloids in tubers #3: Daidzein in tubers #4: Genistein in tubers #5: Puerarin in tubers #6: tannic acid in tubers #7: Puerarin in tubers #8: puerarin in roots #9: Puerarin in tubers #10: daidzein in tubers #11: genistein in tubers

Endpoint Studies

#1: Increased levels of sex hormones and secondary sexual organ weights in male rats #2: antifertility effect in male rats #3: Lethal dose (LD50) in rats #4: Mortality and hepatotoxicity in rats dosed with a methanol extract of the root #5: implantation failure in rats dosed with puerarin #6: Increased weights of adrenals and kidneys and some histological changes after dosing of butanol extract

Genotoxicity

Composition #1: Shilpashree, V. K., Dang, Raman., Das, Kuntal. Evaluation of phytochemical investigation and immunomodulatory activity of four different plant species of vidari by carbon clearance test on wister rats. annals of phytomedicine, 2015, vol. 4, no. 1, p. 94–98. .

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:

Saponins (RF-00004333-PAR)
Analytical method code:

Phytochemical screening (F604A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

saponins in tubers

Composition #2: Shilpashree, V. K., Dang, Raman., Das, Kuntal. Evaluation of phytochemical investigation and immunomodulatory activity of four different plant species of vidari by carbon clearance test on wister rats. annals of phytomedicine, 2015, vol. 4, no. 1, p. 94–98. .

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:

Alkaloids (RF-00004360-PAR)
Analytical method code:

Phytochemical screening (F604A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

alkaloids in tubers

Composition #3: Maji, A.K., Mahapatra, S., Banerjee, D. In-vivo immunomodulatory potential of standardized pueraria tuberosa extract and its isoflavonoids. international journal of pharmacy and pharmaceutical sciences, 2014, vol. 6, no. 1, p. 861–867. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

ethanol
Substance:

daidzein (RF-00000061-NTR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Analytical method - additional description:

RP-HPLC
Result unit:

Percent (G138A)
Result type:

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

1.70
Internal remarks:

Daidzein in tubers

Composition #4: Maji, A.K., Mahapatra, S., Banerjee, D. In-vivo immunomodulatory potential of standardized pueraria tuberosa extract and its isoflavonoids. international journal of pharmacy and pharmaceutical sciences, 2014, vol. 6, no. 1, p. 861–867. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

ethanol
Substance:

genistein (RF-00000297-NTR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Analytical method - additional description:

RP-HPLC
Result unit:

Percent (G138A)
Result type:

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

1.37
Internal remarks:

Genistein in tubers

Composition #5: Maji, A.K., Mahapatra, S., Banerjee, D. In-vivo immunomodulatory potential of standardized pueraria tuberosa extract and its isoflavonoids. international journal of pharmacy and pharmaceutical sciences, 2014, vol. 6, no. 1, p. 861–867. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

ethanol
Substance:

Puerarin (RF-00011022-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Analytical method - additional description:

RP-HPLC
Result unit:

Percent (G138A)
Result type:

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

8.31
Internal remarks:

Puerarin in tubers

Composition #6: Durgawale, T.P., Durgawale, P.P., Khanwelkar, C.C. Quantitative estimation of tannins by HPLC. der pharmacia lettre, 2016, vol. 8, no. 3, p. 123–126. .

Language:

English (en)
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

distilled water + chloroform
Substance:

tannic acid (RF-00004069-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

tannic acid in tubers

Composition #7: Maji, Amal K., Maity, Niladri., Banerji, Pratim., Banerjee, Debdulal. A validated RP-HPLC-UV method for quantitative determination of puerarin in Pueraria tuberosa DC tuber extract. . pharmaceutical methods, 2012, vol. 3, no. 2, p. 79–83. DOI: 10.4103/2229-4708.103879. [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:

ethanol
Substance:

Puerarin (RF-00011022-PAR)
Analytical method code:

HPLC-UV (F021A)
Analytical method - additional description:

RP-HPLC-UV
Result unit:

Percent (G138A)
Result type:

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

9.28
Internal remarks:

Puerarin in tubers

Composition #8: Mhaske, Harshad P., Vaidya, Vikas V., Kekare, Maharudra B., Champanerkar, Parikshit A., Parekh, Sagar A. Quantification of beta-Sitosterol and Puerarin from Pueraria tuberosa DC. by Using High Performance Thin Layer Chromatography . asian journal of chemistry, 2009, vol. 21, no. 5, p. 3449–3454. .

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:

Puerarin (RF-00011022-PAR)
Analytical method code:

Gelpermeation, High Performance Thin Layer Chromatography (HPTLC) (F017A)
Result unit:

Percent (G138A)
Result type:

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

2.45
Internal remarks:

puerarin in roots

Composition #9: Saha, Piyali., Saraswat, Ghungroo., Chakraborty, Pratip., Banerjee, Sayani., Pal, Bikas C., Kabir, Syed N. Puerarin, a selective oestrogen receptor modulator, disrupts pregnancy in rats at pre-implantation stage . reproduction, 2012, vol. 144, no. 5, p. 633–645. DOI: 10.1530/REP-11-0423. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

ethanol (tubers)
Substance:

Puerarin (RF-00011022-PAR)
Analytical method code:

Standard Chromatographic tests (paper- thin layer- and column chromatography) (F016A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Puerarin in tubers

Composition #10: Satpathy, Swaha., Patra, Arjun., Hussain, M. Delwar., Ahirwar, Bharti. Simultaneous estimation of genistein and daidzein in Pueraria tuberosa (Willd.) DC by validated high-performance thin-layer chromatography (HPTLC) densitometry method . journal of liquid chromatography & related technologies, 2017, vol. 40, no. 10, p. 499–505. DOI: 10.1080/10826076.2017.1329743. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

ethanol
Substance:

daidzein (RF-00000061-NTR)
Analytical method code:

Gelpermeation, High Performance Thin Layer Chromatography (HPTLC) (F017A)
Result unit:

Milligram/gram (G060A)
Result type:

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

68.7
Internal remarks:

daidzein in tubers

Composition #11: Satpathy, Swaha., Patra, Arjun., Hussain, M. Delwar., Ahirwar, Bharti. Simultaneous estimation of genistein and daidzein in Pueraria tuberosa (Willd.) DC by validated high-performance thin-layer chromatography (HPTLC) densitometry method . journal of liquid chromatography & related technologies, 2017, vol. 40, no. 10, p. 499–505. DOI: 10.1080/10826076.2017.1329743. [DOI link]

Language:

English (en)
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

ethanol
Substance:

genistein (RF-00000297-NTR)
Analytical method code:

Gelpermeation, High Performance Thin Layer Chromatography (HPTLC) (F017A)
Result unit:

Milligram/container (G059A)
Result type:

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

55.7
Internal remarks:

genistein in tubers

Endpoint study #1: Chauhan, Nagendra Singh., Sharma, Vikas., Thakur, Mayank., Christine Helena Frankland Sawaya, Alexandra., Dixit, V K. Pueraria tuberosa DC extract improves androgenesis and sexual behavior via FSH LH cascade. . thescientificworldjournal, 2013, vol. 2013, p. 780659. DOI: 10.1155/2013/780659. [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:

petroleum ether and ethanol
Type of toxicological test:

reproduction toxicity (CHD009TT)
Tested organism:

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

Wistar (CHD013ST)
Sex:

Male
Exposure duration:

28.0
Unit of exposure duration:

Day (G134A)
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

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

50
Critical effect:

REPRODUCTIVE (TOX05A)
Effect description:

The serum testestosterone, LH and FSH significantly increased in all the treated groups, dose-dependent increased relative weights of testes, prostate, seminal vesicles and epidydimis
Effect or parameter linked to the endpoint:

organ weights (CHD012BE)
Internal remarks:

Increased levels of sex hormones and secondary sexual organ weights in male rats

Endpoint study #2: Gupta, RS., Sharma, R., Sharma, A., Choudhary, R., Bhatnager, AK., Joshi, YC. Antifertility effects of Pueraria tuberosa root extract in male rats. pharmaceutical biology, 2004, vol. 42, no. 8, p. 603–609. DOI: 10.1080/13880200490902491. [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:

methanol
Type of toxicological test:

reproduction toxicity (CHD009TT)
Tested organism:

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

Wistar (CHD013ST)
Sex:

Male
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

60.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

20
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligrams per day (G209A)
Effect concentration:

100
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

Urogenital (TT006A)
Effect description:

Statistically significant reduced weight of testes and secondary reproductive organs, reduces sperm motility and antifertility effect
Effect or parameter linked to the endpoint:

reproduction (CHD014BE)
Internal remarks:

antifertility effect in male rats

Endpoint study #3: Santosh, Nagwani., Mohan, Kumar., Royana, Singh., Yamini, Tripathi B. Hepatotoxicity of tubers of Indian Kudzu (Pueraria tuberosa) in rats. food and chemical toxicology, 2010, vol. 48, no. 4, p. 1066–1071. DOI: 10.1016/j.fct.2010.01.026. [DOI link]

Study relevance:

Human health
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

methanol
Type of toxicological test:

acute toxicity (CHD016TT)
Limit test:

Yes
Tested organism:

Rat (as animal) (A0CNV)
Sex:

Male/Female
Exposure duration:

24.0
Unit of exposure duration:

Hour (G099A)
Number of organisms dosed:

8
Control groups used:

no
Endpoint measured:

Lethal dose rate in 50% of experimental organisms (CHD029EP)
Concentration unit:

Milligrams per kilogram body weight (G225A)
Effect concentration:

2275
Critical effect:

Other toxicities (TOX19A)
Target tissue:

glandular: Thyroid (TT033A)
Effect description:

The animals receiving single dose of PTME showed low intake of food and water. The physical activity was significantly reduced and the response was dose dependent resulting in death on higher doses. The calculated LD50 was 227.5 mg/100 g B.W. in rats.
Effect or parameter linked to the endpoint:

mortality (CHD010BE)
Internal remarks:

Lethal dose (LD50) in rats

Endpoint study #4: Santosh, Nagwani., Mohan, Kumar., Royana, Singh., Yamini, Tripathi B. Hepatotoxicity of tubers of Indian Kudzu (Pueraria tuberosa) in rats. food and chemical toxicology, 2010, vol. 48, no. 4, p. 1066–1071. DOI: 10.1016/j.fct.2010.01.026. [DOI link]

Study relevance:

Human health
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

methanol
Type of toxicological test:

short-term toxicity (CHD017TT)
Limit test:

Yes
Tested organism:

Rat (as animal) (A0CNV)
Sex:

Male/Female
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Exposure duration:

30.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

6
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligram/100 gram (G057A)
Effect concentration:

50
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

All animals died when dosed with 50 and 100 mg/kg bw. Significantly increased hepatic enzymes in blood and dose-dependent histopathological changes in the liver
Effect or parameter linked to the endpoint:

body weight (CHD005BE)
Internal remarks:

Mortality and hepatotoxicity in rats dosed with a methanol extract of the root

Endpoint study #5: Saha, Piyali., Saraswat, Ghungroo., Chakraborty, Pratip., Banerjee, Sayani., Pal, Bikas C., Kabir, Syed N. Puerarin, a selective oestrogen receptor modulator, disrupts pregnancy in rats at pre-implantation stage . reproduction, 2012, vol. 144, no. 5, p. 633–645. DOI: 10.1530/REP-11-0423. [DOI link]

Study relevance:

Human health
Substance:

Puerarin (RF-00011022-PAR)
Plant part:

Roots and other underground parts used as staple food (as part-nature) (A0F5F)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

methanol
Type of toxicological test:

reproduction toxicity (CHD009TT)
Limit test:

Yes
Tested organism:

Rat (as animal) (A0CNV)
Sex:

Female
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Exposure duration:

2.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

6
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Lowest observable effect concentration (CHD027EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

> 300
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

urogenital: Uterus (TT052A)
Effect description:

Puerarin at >300 mg/kg per day for 4 days post-coitus resulted in complete implantation failure. It impacts the uterine expression of oestrogen receptor and P4 receptor
Effect or parameter linked to the endpoint:

reproduction (CHD014BE)
Internal remarks:

implantation failure in rats dosed with puerarin

Endpoint study #6: Shukla, S. Toxicological studies of Pueraria tuberosa, a potent antifertility plant. international journal of pharmacognosy, 1995, vol. 33, no. 4, p. 324–329. .

Study relevance:

Human health
Plant part:

Unspecified (A07XD)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

butanol extract
Type of toxicological test:

short-term toxicity (CHD017TT)
Tested organism:

Rat (as animal) (A0CNV)
Sex:

Female
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Exposure duration:

24.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

6
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

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

150
Critical effect:

SYSTEMIC (TOX01A)
Target tissue:

urogenital: Kidneys (TT046A)
Effect description:

Increased weights of adrenals after 12, 18 and 24 days of dosing and histological changes, Kidney weight increased after 24 days
Effect or parameter linked to the endpoint:

histopathology non neoplastic (CHD025BE)
Internal remarks:

Increased weights of adrenals and kidneys and some histological changes after dosing of butanol extract