EFSA Compendium of Botanicals

Draft - work in progress

Arnica montana L.

Family:: Asteraceae
Approval state:: Approved
Number of articles retrieved:: 1374
Number of processed references:: 5

Compositions

#1: sesquiterpene lactones: helenalin and derivatives #2: sequiterpene lactones, helenanolides, flowers, HPLC #3: helenanolides esters and derivatives in flowers #4: guaianolides, pseudoguaianolides and related esters in flowers #5: dihydrohelenaline esters, flowers, RPLC-ESI-MS-MS #6: helenaline esters, flowers, RPLC-ESI-MS-MS #7: Pyrrolizidine alkaloids, flowering head, GC-MS #8: tussilagine, flowering head, GC-MS #9: isotussilagine, flowering head, GC-MS

Endpoint Studies

#1: LD50 in hamster at 85mg/kg linked to helenin - decrease in glutathione levels #2: LD50 in mouse at 150 mg/kg linked to helenin - decrease in glutathione levels

Genotoxicity

Composition #1: Willuhn, G. Arnica Flowers: Pharmacology, Toxicolgy, and Analysis of the Sesquiterpene Lactones - Their Main Active Substances. acs symposium series, 1998, vol. 691, p. 118–132. .

Language:

English (en)
Plant part:

Flowering top (as part-nature) (A166H)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Substance:

helenalin (RF-00003416-PAR)
Additional substance description:

sesquiterpene lactones: helenalin and derivatives
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

sesquiterpene lactones: helenalin and derivatives

Composition #2: [Anonymous]. Final report on the safety assessment of Arnica montana extract and Arnica montana. . international journal of toxicology, 2001, vol. 20 Suppl 2, p. 1–11. .

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Substance:

Sesquiterpene lactones (RF-00004319-PAR)
Additional substance description:

Helenanolides
Analytical method code:

HPLC with standard detection methods (F019A)
Analytical method - additional description:

TLC
Result unit:

Percent (G138A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

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

0.3-0.9
Internal remarks:

sequiterpene lactones, helenanolides, flowers, HPLC

Composition #3: Kos, O., Lindenmeyer, MT., Tubaro, A., Sosa, S., Merfort, I. New sesquiterpene lactones from arnica tincture prepared from fresh flowerheads of Arnica montana . planta medica, 2005, vol. 71, no. 11, p. 1044–1052. DOI: 10.1055/s-2005-871284. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

EToH/H2O 70/30
Substance:

Sesquiterpene lactones (RF-00004319-PAR)
Additional substance description:

helenanolides esters and derivatives
Analytical method code:

Nuclear Magnetic Resonance (NMR) (F061A)
Analytical method - additional description:

GC (FID), GC/MS, NMR
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

helenanolides esters and derivatives in flowers

Composition #4: Kos, O., Lindenmeyer, MT., Tubaro, A., Sosa, S., Merfort, I. New sesquiterpene lactones from arnica tincture prepared from fresh flowerheads of Arnica montana . planta medica, 2005, vol. 71, no. 11, p. 1044–1052. DOI: 10.1055/s-2005-871284. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

EToH/H2O 70/30
Substance:

guaianolides (RF-00010821-PAR)
Additional substance description:

pseudoguaianolides, esters
Analytical method code:

Gaschromatography (GC) (F037A)
Analytical method - additional description:

GLC-MS, NMR
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

guaianolides, pseudoguaianolides and related esters in flowers

Composition #5: Perry, Nigel B., Burgess, Elaine J., Rodriguez Guitian, Manuel A., Romero Franco, Rosa., Lopez Mosquera, Elvira., Smallfield, Bruce M., Joyce, Nigel I., Littlejohn, Roger P. Sesquiterpene Lactones in Arnica montana: Helenalin and Dihydrohelenalin Chemotypes in Spain . planta medica, 2009, vol. 75, no. 6, p. 660–666. DOI: 10.1055/s-0029-1185362. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

unknown
Substance:

Sesquiterpene lactones (RF-00004319-PAR)
Additional substance description:

dihydrohelenalin esters
Analytical method code:

HPLC with standard detection methods (F019A)
Analytical method - additional description:

LC-ESI-MS-MS
Result unit:

Milligram/gram (G060A)
Result expression:

Dry matter (B002A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

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

10.9-18.2
Internal remarks:

dihydrohelenaline esters, flowers, RPLC-ESI-MS-MS

Composition #6: Perry, Nigel B., Burgess, Elaine J., Rodriguez Guitian, Manuel A., Romero Franco, Rosa., Lopez Mosquera, Elvira., Smallfield, Bruce M., Joyce, Nigel I., Littlejohn, Roger P. Sesquiterpene Lactones in Arnica montana: Helenalin and Dihydrohelenalin Chemotypes in Spain . planta medica, 2009, vol. 75, no. 6, p. 660–666. DOI: 10.1055/s-0029-1185362. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

unknown
Substance:

helenalin (RF-00003416-PAR)
Additional substance description:

helenalin esters
Substance used for equivalence:

helenalin (RF-00003416-PAR)
Analytical method code:

HPLC with standard detection methods (F019A)
Analytical method - additional description:

LC-ESI-MS-MS
Result unit:

Milligram/gram (G060A)
Result expression:

Dry matter (B002A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

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

5.2-10.3
Internal remarks:

helenaline esters, flowers, RPLC-ESI-MS-MS

Composition #7: PASSREITER, CM., WILLUHN, G., RODER, E. TUSSILAGINE AND ISOTUSSILAGINE - 2 PYRROLIZIDINE ALKALOIDS IN THE GENUS ARNICA . planta medica, 1992, vol. 58, no. 6, p. 556–557. DOI: 10.1055/s-2006-961549. [DOI link]

Language:

English (en)
Plant part:

Flowering top (as part-nature) (A166H)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

methanol
Substance:

Pyrrolizidine alkaloids (RF-00000230-TOX)
Analytical method code:

GC-MS (F046A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Pyrrolizidine alkaloids, flowering head, GC-MS

Composition #8: PASSREITER, CM., WILLUHN, G., RODER, E. TUSSILAGINE AND ISOTUSSILAGINE - 2 PYRROLIZIDINE ALKALOIDS IN THE GENUS ARNICA . planta medica, 1992, vol. 58, no. 6, p. 556–557. DOI: 10.1055/s-2006-961549. [DOI link]

Language:

English (en)
Plant part:

Flowering top (as part-nature) (A166H)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

methanol
Substance:

Tussilagine (RF-00000307-TOX)
Analytical method code:

GC-MS (F046A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

tussilagine, flowering head, GC-MS

Composition #9: PASSREITER, CM., WILLUHN, G., RODER, E. TUSSILAGINE AND ISOTUSSILAGINE - 2 PYRROLIZIDINE ALKALOIDS IN THE GENUS ARNICA . planta medica, 1992, vol. 58, no. 6, p. 556–557. DOI: 10.1055/s-2006-961549. [DOI link]

Language:

English (en)
Plant part:

Flowering top (as part-nature) (A166H)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

methanol
Substance:

isotussilagine (RF-00003454-PAR)
Analytical method code:

GC-MS (F046A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

isotussilagine, flowering head, GC-MS

Endpoint study #1: Willuhn, G. Arnica Flowers: Pharmacology, Toxicolgy, and Analysis of the Sesquiterpene Lactones - Their Main Active Substances. acs symposium series, 1998, vol. 691, p. 118–132. .

Study relevance:

Human health
Substance:

helenalin (RF-00003416-PAR)
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

alcohol and water extracts
Type of toxicological test:

acute toxicity (CHD016TT)
Tested organism:

Hamster (as animal) (A0CNX)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

no data
Endpoint measured:

Concentration producing lethality in 50% of experimental organisms (CHD023EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

85
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

decrease of hepatic glutathionine levels
Effect or parameter linked to the endpoint:

not reported (CHD030BE)
Internal remarks:

LD50 in hamster at 85mg/kg linked to helenin - decrease in glutathione levels

Endpoint study #2: Willuhn, G. Arnica Flowers: Pharmacology, Toxicolgy, and Analysis of the Sesquiterpene Lactones - Their Main Active Substances. acs symposium series, 1998, vol. 691, p. 118–132. .

Study relevance:

Human health
Substance:

helenalin (RF-00003416-PAR)
Plant part:

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

Solvent extraction (A0BZR)
Additional plant/substance description:

water and alcohol
Type of toxicological test:

acute toxicity (CHD016TT)
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

No data
Route of exposure:

ORAL: UNSPECIFIED (OECD2234PL)
Control groups used:

no data
Endpoint measured:

Concentration producing lethality in 50% of experimental organisms (CHD023EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

150
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

decrease of hepatic glutathionine levels
Effect or parameter linked to the endpoint:

not reported (CHD030BE)
Internal remarks:

LD50 in mouse at 150 mg/kg linked to helenin - decrease in glutathione levels