EFSA Compendium of Botanicals

Draft - work in progress

Globularia alypum L.

Family:: Plantaginaceae
Approval state:: Approved
Number of articles retrieved:: 210
Number of processed references:: 6

Compositions

#1: salicylic acid in full plant #2: Alkaloids in aerial parts #3: a lignan glycoside, "syringaresinol 4’-O-b-d-glucopyranoside" in leaves #4: Syringin in leaves #5: Tannins in both methanol and aqueous extracts of leaves

Endpoint Studies

#1: Various effects eg. Histopathological changes in lung with thinned alveolar walls, reduced growth and laxative effect. #2: Developmental effect (reduced number of foetuses) and increased number of implantations after dosing of pregnant rats for the first 6 days of pregnancy #3: Fewer viable foetuses and increased number of resorptions in female rats dosed for 30 days (some of the period prior to gestation)

Genotoxicity

Composition #1: Ben Hassine, Bechir., Bui, A., Mighri, Z. Study of Tunisian medicinal plants. Identification of phenolic acids of Globularia alypum L. by two-dimensional thin-layer chromatography and HPLC. journal de la societe chimique de tunisie, 1982, vol. 7, p. 3–10. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Substance:

Salicylic acid (RF-00000241-VET)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

salicylic acid in full plant

Composition #2: Viladomat, F., Codina, C., Llabres, J. M., Bastida, J. Alkaloid screening of plants of Catalonia (Spain). III. international journal of crude drug research, 1986, vol. 24, no. 3, p. 123–30. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

unspecified
Substance:

Alkaloids (RF-00004360-PAR)
Additional substance description:

tertiary and quaternary alkaloids
Analytical method code:

Standard Chromatographic tests (paper- thin layer- and column chromatography) (F016A)
Analytical method - additional description:

Also: alkaloid precipitating reactions and titration
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Alkaloids in aerial parts

Composition #3: Kirmizibekmez, Hasan., Bassarello, Carla., Piacente, Sonia., Calis, Ihsan. Phenylethyl glycosides from Globularia alypum growing in Turkey. helvetica chimica acta, 2008, vol. 91, no. 8, p. 1525–1532. DOI: 10.1002/hlca.200890166. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

methanol
Substance:

lignans (RF-00004361-PAR)
Additional substance description:

a lignan glycoside, "syringaresinol 4’- O-b-d-glucopyranoside"
Analytical method code:

Standard Chromatographic tests (paper- thin layer- and column chromatography) (F016A)
Analytical method - additional description:

Also: NMR, MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

a lignan glycoside, "syringaresinol 4’-O-b-d-glucopyranoside" in leaves

Composition #4: Kirmizibekmez, Hasan., Bassarello, Carla., Piacente, Sonia., Calis, Ihsan. Phenylethyl glycosides from Globularia alypum growing in Turkey. helvetica chimica acta, 2008, vol. 91, no. 8, p. 1525–1532. DOI: 10.1002/hlca.200890166. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

methanol
Substance:

Eleutheroside B (RF-00011069-PAR)
Additional substance description:

syringin
Analytical method code:

Standard Chromatographic tests (paper- thin layer- and column chromatography) (F016A)
Analytical method - additional description:

Also: NMR, MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Syringin in leaves

Composition #5: Harzallah, Hanene Jrah., Neffati, Aicha., Skandrani, Ines., Maaloul, Eya., Chekir-Ghedira, Leila., Mahjoub, Touhami. Antioxidant and antigenotoxic activities of Globularia alypum leaves extracts . journal of medicinal plants research, 2010, vol. 4, no. 19, p. 2048–2053. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

both methanol extract and aqueous extract
Substance:

Tannins (RF-00004337-PAR)
Analytical method code:

Phytochemical screening (F604A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Tannins in both methanol and aqueous extracts of leaves

Endpoint study #1: Fehri, Badreddine., Aiache, Jean-Marc., Ahmed, Kk Mueen. Active spermatogenesis induced by a reiterated administration of Globularia alypum L. aqueous leaf extract. . pharmacognosy research, 2012, vol. 4, no. 3, p. 138–47. DOI: 10.4103/0974-8490.99073. [DOI link]

Study relevance:

Human health
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

water
Type of toxicological test:

short-term toxicity (CHD017TT)
Tested organism:

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

Wistar (CHD013ST)
Sex:

Male/Female
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

30.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

10
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

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

300
Critical effect:

SYSTEMIC (TOX01A)
Target tissue:

respiratory: Lung (TT041A)
Effect description:

Reduced growth and laxative effect. A pronounced thinning of pulmonary arteriolar wall affecting female (both doses) and male rats. Also pulmonary hypertension, respiratory distress syndrome, and lymphoid hyperplasia;
Effect or parameter linked to the endpoint:

histopathology non neoplastic (CHD025BE)
Internal remarks:

Various effects eg. Histopathological changes in lung with thinned alveolar walls, reduced growth and laxative effect.

Endpoint study #2: Elbetieha, A., Oran, SA., Alkofahi, A., Darmani, H., Raies, AM. Fetotoxic potentials of Globularia arabica and Globularia alypum (Globulariaceae) in rats . journal of ethnopharmacology, 2000, vol. 72, no. 1-2, p. 215–219. DOI: 10.1016/S0378-8741(00)00246-4. [DOI link]

Study relevance:

Human health
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

95% ethanol
Type of toxicological test:

reproduction toxicity (CHD009TT)
Limit test:

No data
Tested organism:

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

Sprague-Dawley (CHD012ST)
Sex:

Female
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

6.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

9
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

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

800
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

urogenital: Uterus (TT052A)
Effect description:

Decrease in number of viable fetuses and increase in percentage of resorptions compared to total number of implantations
Effect or parameter linked to the endpoint:

development (CHD006BE)
Internal remarks:

Developmental effect (reduced number of foetuses) and increased number of implantations after dosing of pregnant rats for the first 6 days of pregnancy

Endpoint study #3: Elbetieha, A., Oran, SA., Alkofahi, A., Darmani, H., Raies, AM. Fetotoxic potentials of Globularia arabica and Globularia alypum (Globulariaceae) in rats . journal of ethnopharmacology, 2000, vol. 72, no. 1-2, p. 215–219. DOI: 10.1016/S0378-8741(00)00246-4. [DOI link]

Study relevance:

Human health
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

95% ethanol
Type of toxicological test:

reproduction toxicity (CHD009TT)
Limit test:

No data
Tested organism:

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

Sprague-Dawley (CHD012ST)
Sex:

Female
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

30.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

10
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

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

800
Critical effect:

REPRODUCTIVE (TOX05A)
Target tissue:

urogenital: Uterus (TT052A)
Effect description:

Decrease in number of viable fetuses and increase in percentage of resorptions compared to the total number of implantation sites sites
Effect or parameter linked to the endpoint:

development (CHD006BE)
Internal remarks:

Fewer viable foetuses and increased number of resorptions in female rats dosed for 30 days (some of the period prior to gestation)