EFSA Compendium of Botanicals

Draft - work in progress

Cloves (as plant) // Caryophyllus aromaticus L. // Eugenia caryophyllata Thunb. // Syzygium aromaticum (L.) Merr. & L.M.Perry

Family:: Myrtaceae
Approval state:: Approved
Number of articles retrieved:: 4177
Number of processed references:: 5

Compositions

#1: Eugenol in essential oil from flower #2: biflorin and isobiflorin in flower buds #3: eugenol in buds

Endpoint Studies

#1: Hepatotoxicity after intake of essential oil in a 15 month-old boy

Genotoxicity

#1: Essential oil showed mutagenic effect with S9 #2: Mutagenic effect in E. coli CC104mutMmutY strain

Composition #1: Shoeibi, Sh., Rahimifard, N., Pirouz, B., Yalfani, R., Pakzad, S.R., Mirab Samiee, S., Pirali Hamedani, M. Mutagenicity of four natural flavors: Clove, cinnamon, thyme and Zataria multiflora Boiss.. journal of medicinal plants, 2009, vol. 8, no. SUPPL. 5, p. 89–96. .

Language:

English (en)
Plant part:

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

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

hydrodistillation
Substance:

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

GC-MS (F046A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

Eugenol in essential oil from flower

Composition #2: Lee, Hwi-Ho., Shin, Ji-Sun., Lee, Woo-Seok., Ryu, Byeol., Jang, Dae Sik., Lee, Kyung-Tae. Biflorin, Isolated from the Flower Buds of Syzygium aromaticum L., Suppresses LPS-Induced Inflammatory Mediators via STAT1 Inactivation in Macrophages and Protects Mice from Endotoxin Shock . journal of natural products, 2016, vol. 79, no. 4, p. 711–720. DOI: 10.1021/acs.jnatprod.5b00609. [DOI link]

Language:

English (en)
Plant part:

Bud (as part-nature) (A066Z)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

70% ethanol at 60oC
Substance:

biflorin (RF-00011324-PAR)
Additional substance description:

biflorin and isobiflorin
Analytical method code:

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

LC-MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

biflorin and isobiflorin in flower buds

Composition #3: Vijayasteltar, Liju., Nair, Gopakumar Gopinathan., Maliakel, Balu., Kuttan, Ramadasan., Krishnakumar, I. M. Safety assessment of a standardized polyphenolic extract of clove buds: Subchronic toxicity and mutagenicity studies . toxicology reports, 2016, vol. 3, p. 439–449. DOI: 10.1016/j.toxrep.2016.04.001. [DOI link]

Language:

English (en)
Plant part:

Bud (as part-nature) (A066Z)
Extraction/Preparation method:

Essential oil (as part-nature) (A166Q)
Substance:

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

Unspecified (F598A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

eugenol in buds

Endpoint study #1: Janes, SEJ., Price, CSG., Thomas, D. Essential oil poisoning: N-acetylcysteine for eugenol-induced hepatic failure and analysis of a national database . european journal of pediatrics, 2005, vol. 164, no. 8, p. 520–522. DOI: 10.1007/s00431-005-1692-1. [DOI link]

Study relevance:

Human health
Plant part:

Unspecified (A07XD)
Preparation/Extraction method:

Essential oil (as part-nature) (A166Q)
Additional plant/substance description:

Commercial essential oil
Type of toxicological test:

case report (CHD060TT)
Limit test:

Not applicable
Tested organism:

Human (as organism) (A056J)
Sex:

Male
Route of exposure:

OTHER (OECD0PL)
Unit of exposure duration:

single (food/feed) (G203A)
Number of organisms dosed:

1
Control groups used:

no
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Millilitre (G156A)
Effect concentration:

10 - 20
Critical effect:

HEPATOTOXICITY (TOX02A)
Target tissue:

digestive: Liver (TT023A)
Effect description:

a boy developed fulminant hepatic failure after ingesting 10 ml of clove oil.
Effect or parameter linked to the endpoint:

histopathology non neoplastic (CHD025BE)
Internal remarks:

Hepatotoxicity after intake of essential oil in a 15 month-old boy

Genotox #1: Shoeibi, Sh., Rahimifard, N., Pirouz, B., Yalfani, R., Pakzad, S.R., Mirab Samiee, S., Pirali Hamedani, M. Mutagenicity of four natural flavors: Clove, cinnamon, thyme and Zataria multiflora Boiss.. journal of medicinal plants, 2009, vol. 8, no. SUPPL. 5, p. 89–96. .

Study category:

Mutagenicity
Type of toxicological test:

bacterial gene mutation assay (CHD027TT)
Method type:

in vitro
Tested organism:

Salmonella typhimurium (as organism) (A0CPZ)
Strain of test organism:

TA 100 (CHD024ST)
Exogenous metabolic activation applied:

with and without
Route of exposure:

OTHER (OECD0PL)
Endpoint measured:

gene mutation
Is genotoxic:

Positive
Remarks on genotox study:

Positive response at 500 µg/ml in the Ames Salmonella reversion assay with S9
Internal remarks:

Essential oil showed mutagenic effect with S9
Internal ID:

eid=2-s2.0-69249188407

Genotox #2: dos Santos, Patricia Estevam., Monte Egito, Lucila Carmem., Batistuzzo de Medeiros, Silvia Regina., Agnez-Lima, Lucymara Fassarella. Genotoxicity induced by Eugenia caryophyllata infusion. journal of toxicology and environmental health-part a-current issues, 2008, vol. 71, no. 7, p. 439–444. DOI: 10.1080/15287390701839232. [DOI link]

Study category:

Mutagenicity
Type of toxicological test:

bacterial forward mutation assay (CHD026TT)
Method type:

in vitro
Tested organism:

Escherichia coli (as organism) (A0CQA)
Sex:

No data
Exogenous metabolic activation applied:

no data
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes, concurrent no treatment
Endpoint measured:

gene mutation
Is genotoxic:

Positive
Remarks on genotox study:

An increase in mutagenesis and high cytotoxicity was observed with the CC104mutMmutY strain from 6 mg/ml treatment
Internal remarks:

Mutagenic effect in E. coli CC104mutMmutY strain
Internal ID:

WOS:000253643600004