EFSA Compendium of Botanicals

Draft - work in progress

Vitex agnus-castus L. // Vitex pseudonegundo (Hausskn.) Hand.-Mazz.

Family:: Lamiaceae
Approval state:: Approved
Number of articles retrieved:: 941
Number of processed references:: 8

Compositions

Endpoint Studies

#1: Reproductive effects in humans (post-marketing surveillance or clinical trials - Review, no specific data) #2: Allergic and skin effects in humans (post-marketing surveillance or clinical trials - Review, no specific data) #3: GI effects and weight gain in humans (post-marketing surveillance or clinical trials - Review, no specific data) #4: Neurologic effects in humans (post-marketing surveillance or clinical trials - Review, no specific data) #5: Cardiovascular effects in humans (post-marketing surveillance or clinical trials - Review, no specific data) #6: Hepatitis in humans (post-marketing surveillance or clinical trials - Review, no specific data)

Genotoxicity

Composition #1: Aynehchi, Y., Sormaghi, M. H. Salehi., Amin, G. H., Soltani, A., Qumehr, N. Survey of Iranian plants for saponins, alkaloids, flavonoids and tannins. II. international journal of crude drug research, 1982, vol. 20, no. 1, p. 61–70. .

Language:

English (en)
Plant part:

Live plants (as part-nature) (A0BA0)
Extraction/Preparation method:

Solvent extraction (A0BZR)
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 whole plant

Composition #2: Aynehchi, Y., Sormaghi, M. H. Salehi., Amin, G. H., Soltani, A., Qumehr, N. Survey of Iranian plants for saponins, alkaloids, flavonoids and tannins. II. international journal of crude drug research, 1982, vol. 20, no. 1, p. 61–70. .

Language:

English (en)
Plant part:

Live plants (as part-nature) (A0BA0)
Extraction/Preparation method:

Solvent extraction (A0BZR)
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 whole plant

Composition #3: Novak, J., Draxler, L., Gohler, I., Franz, CM. Essential oil composition of Vitex agnus-castus - comparison of accessions and different plant organs . flavour and fragrance journal, 2005, vol. 20, no. 2, p. 186–192. DOI: 10.1002/ffj.1404. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

microdistillation
Substance:

Diterpenes Diterpenes (RF-00004378-PAR)
Additional substance description:

"Dehydroabietane"
Analytical method code:

GC-FID (F040A)
Analytical method - additional description:

Also: GC-MS
Result unit:

Percent (G138A)
Result type:

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

<=1.2
Internal remarks:

Dehydroabietane (a diterpene) in fruits

Composition #4: Novak, J., Draxler, L., Gohler, I., Franz, CM. Essential oil composition of Vitex agnus-castus - comparison of accessions and different plant organs . flavour and fragrance journal, 2005, vol. 20, no. 2, p. 186–192. DOI: 10.1002/ffj.1404. [DOI link]

Language:

English (en)
Plant part:

Aerial part of plants (as part-nature) (A166F)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

fruits extracted via microdistillation, leaves extracted with modified Clevenger water distillation
Substance:

(-)-globulol (RF-00003756-PAR)
Additional substance description:

"Ledol"
Analytical method code:

GC-FID (F040A)
Analytical method - additional description:

Also: GC-MS
Result unit:

Percent (G138A)
Result type:

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

<=1.8
Internal remarks:

Ledol (globulol) in leaves and fruits

Composition #5: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

rotundifuran
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

67
Internal remarks:

Rotundifuran (a labdane diterpene) in fruits

Composition #6: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

8-epi-manoyl oxide
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

6
Internal remarks:

8-epi-manoyl oxide (a labdane diterpene) in fruits

Composition #7: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

vitetrifolin D, a labdane diterpene
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

14
Internal remarks:

Vitetrifolin D (a labdane diterpene) in fruits

Composition #8: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

4-Hydroxybenzoic acid (RF-00008325-PAR)
Additional substance description:

"p-hydroxybenzoic acid glucose ester" (derivative of 4-hydroxybenzoic acid)
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

15
Internal remarks:

p-hydroxybenzoic acid glucose ester in fruits

Composition #9: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

vitexilactone
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

25
Internal remarks:

Vitexilactone (a labdane diterpene) in fruits

Composition #10: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

4-Hydroxybenzoic acid (RF-00008325-PAR)
Additional substance description:

"p-hydroxybenzoic acid"
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

125
Internal remarks:

p-hydroxybenzoic acid in fruits

Composition #11: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

"Vitexlactam C", a labdane diterpene
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

11
Internal remarks:

Vitexlactam C (a labdane diterpene) in fruits

Composition #12: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

"Vitexlactam A"
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

40
Internal remarks:

Vitexlactam A (a labdane diterpene) in fruits

Composition #13: Li, Shenghong., Qiu, Shengxiang., Yao, Ping., Sun, Handong., Fong, Harry H. S., Zhang, Hongjie. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction . evidence-based complementary and alternative medicine, 2013 . DOI: 10.1155/2013/432829. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

n-hexane and methanol (4077 g of dried fruits)
Substance:

labdane diterpenes (RF-00004392-PAR)
Additional substance description:

"Vitexlactam B"
Analytical method code:

GC-MS (F046A)
Result unit:

Milligram (G155A)
Result type:

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

4
Internal remarks:

Vitexlactam B (a labdane diterpene) in fruits

Composition #14: Duymus, H. G., Ciftci, G. Akalin., Yildirim, S. Ulusoylar., Demirci, B., Kirimer, N. The cytotoxic activity of Vitex agnus castus L. essential oils and their biochemical mechanisms . industrial crops and products, 2014, vol. 55, p. 33–42. DOI: 10.1016/j.indcrop.2014.01.041. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

myrcene (RF-00003503-PAR)
Analytical method code:

GC-FID (F040A)
Analytical method - additional description:

Also: GC-MS
Result unit:

Percent (G138A)
Result type:

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

2.7
Internal remarks:

Myrcene in essential oil of fruits

Composition #15: Duymus, H. G., Ciftci, G. Akalin., Yildirim, S. Ulusoylar., Demirci, B., Kirimer, N. The cytotoxic activity of Vitex agnus castus L. essential oils and their biochemical mechanisms . industrial crops and products, 2014, vol. 55, p. 33–42. DOI: 10.1016/j.indcrop.2014.01.041. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

1,8-cineole (RF-00003470-PAR)
Analytical method code:

GC-FID (F040A)
Analytical method - additional description:

Also: GC-MS
Result unit:

Percent (G138A)
Result type:

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

18.2
Internal remarks:

1,8-cineole in essential oil of fruits

Composition #16: Khalilzadeh, Emad., Saiah, Gholamreza Vafaei., Hasannejad, Hamideh., Ghaderi, Adel., Ghaderi, Shahla., Hamidian, Gholamreza., Mahmoudi, Razzagh., Eshgi, Davoud., Zangisheh, Mahsa. Antinociceptive effects, acute toxicity and chemical composition of Vitex agnus-castus essential oil . avicenna journal of phytomedicine, 2015, vol. 5, no. 3, p. 218–230. .

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

myrcene (RF-00003503-PAR)
Additional substance description:

"beta-myrcene"
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.49
Internal remarks:

beta-Myrcene in essential oil of leaves

Composition #17: Khalilzadeh, Emad., Saiah, Gholamreza Vafaei., Hasannejad, Hamideh., Ghaderi, Adel., Ghaderi, Shahla., Hamidian, Gholamreza., Mahmoudi, Razzagh., Eshgi, Davoud., Zangisheh, Mahsa. Antinociceptive effects, acute toxicity and chemical composition of Vitex agnus-castus essential oil . avicenna journal of phytomedicine, 2015, vol. 5, no. 3, p. 218–230. .

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

beta-Eudesmol (RF-00010708-PAR)
Additional substance description:

a eudesmane sesquiterpene (group of concern)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.42
Internal remarks:

Beta-Eudesmol in essential oil of leaves

Composition #18: Khalilzadeh, Emad., Saiah, Gholamreza Vafaei., Hasannejad, Hamideh., Ghaderi, Adel., Ghaderi, Shahla., Hamidian, Gholamreza., Mahmoudi, Razzagh., Eshgi, Davoud., Zangisheh, Mahsa. Antinociceptive effects, acute toxicity and chemical composition of Vitex agnus-castus essential oil . avicenna journal of phytomedicine, 2015, vol. 5, no. 3, p. 218–230. .

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

beta-selinene (RF-00011306-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.44
Internal remarks:

Beta-Selinene in essential oil of leaves

Composition #19: Khalilzadeh, Emad., Saiah, Gholamreza Vafaei., Hasannejad, Hamideh., Ghaderi, Adel., Ghaderi, Shahla., Hamidian, Gholamreza., Mahmoudi, Razzagh., Eshgi, Davoud., Zangisheh, Mahsa. Antinociceptive effects, acute toxicity and chemical composition of Vitex agnus-castus essential oil . avicenna journal of phytomedicine, 2015, vol. 5, no. 3, p. 218–230. .

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

Eugenol (RF-00003807-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.71
Internal remarks:

Eugenol in essential oil of leaves

Composition #20: Neves, Roberta C. S., Da Camara, Claudio A. G. Chemical composition and acaricidal activity of the essential oils from Vitex agnus-castus L. (Verbenaceae) and selected monoterpenes . anais da academia brasileira de ciencias, 2016, vol. 88, no. 3, p. 1221–1233. DOI: 10.1590/0001-3765201620140050. [DOI link]

Language:

English (en)
Plant part:

Aerial part of plants (as part-nature) (A166F)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation of leaves and flowers separately
Substance:

(-)-globulol (RF-00003756-PAR)
Additional substance description:

also: "ledol"
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.2-2.1
Internal remarks:

Globulol/Ledol in essential oil of leaves and flowers

Composition #21: Neves, Roberta C. S., Da Camara, Claudio A. G. Chemical composition and acaricidal activity of the essential oils from Vitex agnus-castus L. (Verbenaceae) and selected monoterpenes . anais da academia brasileira de ciencias, 2016, vol. 88, no. 3, p. 1221–1233. DOI: 10.1590/0001-3765201620140050. [DOI link]

Language:

English (en)
Plant part:

Fruit unspecified (as part-nature) (A067D)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

Dillapiole (RF-00004277-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.0
Internal remarks:

Dill apiole in essential oil of fruits

Composition #22: Neves, Roberta C. S., Da Camara, Claudio A. G. Chemical composition and acaricidal activity of the essential oils from Vitex agnus-castus L. (Verbenaceae) and selected monoterpenes . anais da academia brasileira de ciencias, 2016, vol. 88, no. 3, p. 1221–1233. DOI: 10.1590/0001-3765201620140050. [DOI link]

Language:

English (en)
Plant part:

Flower (as part-nature) (A067B)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

1,8-cineole (RF-00003470-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.5
Internal remarks:

1,8-cineole in essential oil of flowers

Composition #23: Borzoui, Ehsan., Naseri, Bahram., Abedi, Zahra., Karimi-Pormehr, Mohammad Sadegh. Lethal and Sublethal Effects of Essential Oils From Artemisia khorassanica and Vitex pseudo-negundo Against Plodia interpunctella (Lepidoptera: Pyralidae) . environmental entomology, 2016, vol. 45, no. 5, p. 1220–1226. DOI: 10.1093/ee/nvw100. [DOI link]

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

myrcene (RF-00003503-PAR)
Additional substance description:

"beta-myrcene"
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

1.63
Internal remarks:

beta-Myrcene in essential oil of leaves

Composition #24: Borzoui, Ehsan., Naseri, Bahram., Abedi, Zahra., Karimi-Pormehr, Mohammad Sadegh. Lethal and Sublethal Effects of Essential Oils From Artemisia khorassanica and Vitex pseudo-negundo Against Plodia interpunctella (Lepidoptera: Pyralidae) . environmental entomology, 2016, vol. 45, no. 5, p. 1220–1226. DOI: 10.1093/ee/nvw100. [DOI link]

Language:

English (en)
Plant part:

Leaves (as part-nature) (A0EKT)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Additional extraction description:

Hydrodistillation
Substance:

1,8-cineole (RF-00003470-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

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

19.46
Internal remarks:

1,8-cineole in essential oil of leaves

Endpoint study #1: Di Lorenzo, Chiara., Ceschi, Alessandro., Kupferschmidt, Hugo., Luede, Saskia., Nascimento, Elizabeth De Souza., Dos Santos, Ariana., Colombo, Francesca., Frigerio, Gianfranco., Norby, Karin., Plumb, Jenny., Finglas, Paul., Restani, Patrizia. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality . british journal of clinical pharmacology, 2015, vol. 79, no. 4, p. 578–592. DOI: 10.1111/bcp.12519. [DOI link]

Study relevance:

Human health
Plant part:

Fruit unspecified (as part-nature) (A067D)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol
Type of toxicological test:

other (CHD008TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

yes
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

urogenital: Uterus (TT052A)
Effect description:

Inter-menstrual bleeding or disorders
Effect or parameter linked to the endpoint:

not reported (CHD030BE)
Internal remarks:

Reproductive effects in humans (post-marketing surveillance or clinical trials - Review, no specific data)

Endpoint study #2: Di Lorenzo, Chiara., Ceschi, Alessandro., Kupferschmidt, Hugo., Luede, Saskia., Nascimento, Elizabeth De Souza., Dos Santos, Ariana., Colombo, Francesca., Frigerio, Gianfranco., Norby, Karin., Plumb, Jenny., Finglas, Paul., Restani, Patrizia. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality . british journal of clinical pharmacology, 2015, vol. 79, no. 4, p. 578–592. DOI: 10.1111/bcp.12519. [DOI link]

Study relevance:

Human health
Plant part:

Fruit unspecified (as part-nature) (A067D)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol
Type of toxicological test:

other (CHD008TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

yes
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

IMMUNOTOXICITY (TOX09A)
Target tissue:

Skin/subcutis (TT056A)
Effect description:

Acneform facial inflammation and allergic reactions including: pruritis, erythema and GI symptoms
Effect or parameter linked to the endpoint:

not reported (CHD030BE)
Internal remarks:

Allergic and skin effects in humans (post-marketing surveillance or clinical trials - Review, no specific data)

Endpoint study #3: Di Lorenzo, Chiara., Ceschi, Alessandro., Kupferschmidt, Hugo., Luede, Saskia., Nascimento, Elizabeth De Souza., Dos Santos, Ariana., Colombo, Francesca., Frigerio, Gianfranco., Norby, Karin., Plumb, Jenny., Finglas, Paul., Restani, Patrizia. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality . british journal of clinical pharmacology, 2015, vol. 79, no. 4, p. 578–592. DOI: 10.1111/bcp.12519. [DOI link]

Study relevance:

Human health
Plant part:

Fruit unspecified (as part-nature) (A067D)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol
Type of toxicological test:

other (CHD008TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

yes
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

Digestive (TOX18A)
Target tissue:

Digestive (TT002A)
Effect description:

Gastrointestinal disorders with diarrhea, persistent gastroenteritis, nausea and weight gain
Effect or parameter linked to the endpoint:

body weight (CHD005BE)
Internal remarks:

GI effects and weight gain in humans (post-marketing surveillance or clinical trials - Review, no specific data)

Endpoint study #4: Di Lorenzo, Chiara., Ceschi, Alessandro., Kupferschmidt, Hugo., Luede, Saskia., Nascimento, Elizabeth De Souza., Dos Santos, Ariana., Colombo, Francesca., Frigerio, Gianfranco., Norby, Karin., Plumb, Jenny., Finglas, Paul., Restani, Patrizia. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality . british journal of clinical pharmacology, 2015, vol. 79, no. 4, p. 578–592. DOI: 10.1111/bcp.12519. [DOI link]

Study relevance:

Human health
Plant part:

Fruit unspecified (as part-nature) (A067D)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol
Type of toxicological test:

other (CHD008TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

yes
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

NEUROTOXICITY (TOX04A)
Target tissue:

Neurologic (TT004A)
Effect description:

Headaches and dizziness
Effect or parameter linked to the endpoint:

neurology (CHD027BE)
Internal remarks:

Neurologic effects in humans (post-marketing surveillance or clinical trials - Review, no specific data)

Endpoint study #5: Di Lorenzo, Chiara., Ceschi, Alessandro., Kupferschmidt, Hugo., Luede, Saskia., Nascimento, Elizabeth De Souza., Dos Santos, Ariana., Colombo, Francesca., Frigerio, Gianfranco., Norby, Karin., Plumb, Jenny., Finglas, Paul., Restani, Patrizia. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality . british journal of clinical pharmacology, 2015, vol. 79, no. 4, p. 578–592. DOI: 10.1111/bcp.12519. [DOI link]

Study relevance:

Human health
Plant part:

Fruit unspecified (as part-nature) (A067D)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol
Type of toxicological test:

other (CHD008TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

yes
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

PULMONARY AND CARDIAC (TOX08A)
Target tissue:

cardiovascular / haematological: Heart (TT011A)
Effect description:

Arteriospasm
Effect or parameter linked to the endpoint:

not reported (CHD030BE)
Internal remarks:

Cardiovascular effects in humans (post-marketing surveillance or clinical trials - Review, no specific data)

Endpoint study #6: Di Lorenzo, Chiara., Ceschi, Alessandro., Kupferschmidt, Hugo., Luede, Saskia., Nascimento, Elizabeth De Souza., Dos Santos, Ariana., Colombo, Francesca., Frigerio, Gianfranco., Norby, Karin., Plumb, Jenny., Finglas, Paul., Restani, Patrizia. Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality . british journal of clinical pharmacology, 2015, vol. 79, no. 4, p. 578–592. DOI: 10.1111/bcp.12519. [DOI link]

Study relevance:

Human health
Plant part:

Fruit unspecified (as part-nature) (A067D)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

ethanol
Type of toxicological test:

other (CHD008TT)
Tested organism:

Human (as organism) (A056J)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

yes
Endpoint measured:

Dose not reported (CHD066EP)
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

Hepatitis
Effect or parameter linked to the endpoint:

not reported (CHD030BE)
Internal remarks:

Hepatitis in humans (post-marketing surveillance or clinical trials - Review, no specific data)