EFSA Compendium of Botanicals

Draft - work in progress

Hop (as plant) // Humulus lupulus L.

Family:: Cannabaceae
Approval state:: Approved
Number of articles retrieved:: 5785
Number of processed references:: 3

Compositions

Endpoint Studies

#1: the two different hops extracts have teratogenic effects on mouse sperm and reduce the level of serum testosterone, dehydrotestosterone and estradiol at the same time #2: subchronic toxicity: NOAEL 3.484 mg/kg b.w. for males and 4.022 for females

Genotoxicity

#1: chromosomal aberration - clastogenic potential

Composition #1: Frackowiak, Anna., Kozlecki, Tomasz., Skibinski, Przemyslaw., Gawel, Wieslaw., Zaczynska, Ewa., Czarny, Anna., Piekarska, Katarzyna., Gancarz, Roman. Solubility, inhibition of crystallization and microscopic analysis of calcium oxalate crystals in the presence of fractions from Humulus lupulus L.. journal of crystal growth, 2010, vol. 312, no. 23, p. 3525–3532. DOI: 10.1016/j.jcrysgro.2010.09.040. [DOI link]

Language:

English (en)
Plant part:

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

Solvent extraction (A0BZR)
Additional extraction description:

sodium hydroxide
Substance:

Calcium oxalate (RF-00003960-PAR)
Analytical method code:

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

GC/MS
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

calcium oxalate

Endpoint study #1: Shao, Yue., Li, Lei., Chong, Li-ming., Xu, Li., Gui, Bo., Liu, Xiang-yun., Zhou, Li., Sun, Zu-yue. Reproductive toxicity of hops extracts to male mice. shengzhi yu biyun, 2014, vol. 34, no. 5, p. 354–359. .

Study relevance:

Human health
Plant part:

Cone (as part-nature) (A166G)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

hops extracts
Type of toxicological test:

reproduction toxicity (CHD009TT)
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Male
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

20.0
Unit of exposure duration:

Day (G134A)
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

0.05-5
Critical effect:

TERATOGENIC (TOX06A)
Target tissue:

Urogenital (TT006A)
Effect description:

the two different hops extracts have teratogenic effects on mouse sperm and reduce the level of serum testosterone, dehydrotestosterone and estradiol at the same time
Effect or parameter linked to the endpoint:

reproduction (CHD014BE)
Internal remarks:

the two different hops extracts have teratogenic effects on mouse sperm and reduce the level of serum testosterone, dehydrotestosterone and estradiol at the same time

Endpoint study #2: Suzuki, Shigeo., Morimoto-Kobayashi, Yumie., Takahashi, Chika., Taniguchi, Yoshimasa., Katayama, Mikio. Genetic, acute and subchronic toxicity studies of matured hop extract produced by extraction from heat-treated hops. journal of toxicological sciences, 2018, vol. 43, no. 7-9, p. 473–484. DOI: 10.2131/jts.43.473. [DOI link]

Study relevance:

Human health
Plant part:

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

Drying (dehydration) (A07KG)
Type of toxicological test:

subchronic (CHD013TT)
Limit test:

Not applicable
Tested organism:

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

spleen cells (CHD107ST)
Sex:

Male/Female
Route of exposure:

ORAL: FEED (OECD2230PL)
Exposure duration:

90.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

20
Control groups used:

yes, plain diet
Endpoint measured:

No observed adverse effect level (CHD010EP)
Concentration unit:

Percent (G138A)
Effect concentration:

5
Critical effect:

SYSTEMIC (TOX01A)
Target tissue:

glandular: Thyroid (TT033A)
Effect description:

increase potasium and protein in urine, neutrophiles in blood, decreased PT, LDH, increased weight of thyroid glands, hearth and salivary glands
Effect or parameter linked to the endpoint:

organ weights (CHD012BE)
Internal remarks:

subchronic toxicity: NOAEL 3.484 mg/kg b.w. for males and 4.022 for females

Genotox #1: Suzuki, Shigeo., Morimoto-Kobayashi, Yumie., Takahashi, Chika., Taniguchi, Yoshimasa., Katayama, Mikio. Genetic, acute and subchronic toxicity studies of matured hop extract produced by extraction from heat-treated hops. journal of toxicological sciences, 2018, vol. 43, no. 7-9, p. 473–484. DOI: 10.2131/jts.43.473. [DOI link]

Study category:

Genotoxicity
Type of toxicological test:

chromosome aberration assay (CHD047TT)
Method type:

in vitro
Guideline used:

No guideline followed
Tested organism:

Other (A07XE)
Exogenous metabolic activation applied:

with and without
Control groups used:

yes, concurrent vehicle
Endpoint measured:

chromosome aberration
Is genotoxic:

Positive
Remarks on genotox study:

positive at dose level 3,33 microgram per mL with metabolic activation
Internal remarks:

chromosomal aberration - clastogenic potential
Internal ID:

WOS:000449247400007