IJT - CIR - February 2024 - 6S

6S
International Journal of Toxicology 43(Supplement 1)
Table 1. Current and Revised INCI Names, Definitions, and Functions of the Humulus lupulus (Hops)-Derived Ingredients in This Safety
Assessment.1,4
Ingredient
Humulus Lupulus (Hops)
Extract
8016-25-9
8060-28-4
Definition
Humulus Lupulus (Hops) Extract is the extract
obtained from the inflorescence (hops cone) of
Humulus lupulus.
In 2017, the definition of Humulus Lupulus (Hops)
Extract was changed from " the extract of the whole
plant, Humulus lupulus. "
Humulus Lupulus (Hops)
Cone Extract (deleted
monograph)
Humulus Lupulus (Hops)
Flower Extract (deleted
monograph)
Humulus Lupulus (Hops)
Stem Extract (deleted
monograph)
Humulus Lupulus (Hops)
Strobile (deleted
monograph)
8007-04-3
In 2017, the INCI name Humulus Lupulus (Hops)
Cone Extract was revised and the name will be
retained in the monograph as a technical name of
Humulus Lupulus (Hops) Extract.
In 2017, the INCI name Humulus Lupulus (Hops)
Flower Extract was revised and the name will be
retained in the monograph as a technical name
Humulus Lupulus (Hops) Extract.
In 2017, the INCI name Humulus Lupulus (Hops)
Stem Extract was revised and the name will be
retained in the monograph as a technical name
Humulus Lupulus (Hops) Extract.
In 2017, the INCI name Humulus Lupulus (Hops)
Strobile was revised and the name will be retained
in the monograph as a technical name Humulus
Lupulus (Hops) Extract.
Humulus Lupulus (Hops) Oil Humulus Lupulus (Hops) Oil is the volatile oil
obtained from the inflorescence (hops cone) of
Humulus lupulus.
Humulus Lupulus (Hops)
Cone Oil (deleted
monograph)
8007-04-3
In 2017, the INCI name Humulus Lupulus (Hops)
Cone Oil was revised and the name will be retained
in the monograph as a technical name Humulus
Lupulus (Hops) Oil
lupulus " . Data have been submitted under the revised names;
with the exception of the cosmetic use data, these data are
presented under the corrected names, Humulus Lupulus
(Hops) Extract and Humulus Lupulus (Hops) Oil.
The terms " inflorescence, "" cone, " and " strobile " refer,
synonymously, to the structures formed by the female
Humulus lupulus (hops) plant after the flowers have
bloomed, whether or not they have been fertilized. Thus, for
example, " cone oil " is thesameas " strobile oil. Both " cone "
and " strobile " are usedinthe literature. Also, " hops " is used
commonly for the plant name as well as for the harvested
strobiles; in the literature, it is not always clear ifauthors are
referring to the whole plant or just the strobiles. In this
report, it is assumed that the authors are referring solely to
the strobiles, unless otherwise indicated.
Most of the parts of Humulus lupulus (hops) (i.e., shoots,
leaves, flowers, seeds, rhizomes, and essential oils) are edible; the
strobile is the most commonlyconsumed infood (mostly in
beer).5,6 The U.S. Food and Drug Administration (FDA) has
determined that essential oils, oleoresins (solvent-free), and
natural extractives (including distillates) of Humulus lupulus
Antimicrobial agent; antiperspirant agent; hair
conditioning agent
Skin-conditioning agent - miscellaneous
Skin protectant
None reported
Fragrance ingredient
Fragrance ingredient
Functions
Antimicrobial agent; fragrance ingredient; hair
conditioning agent; skin-conditioning agent -
miscellaneous; skin protectant; skin-conditioning
agent - miscellaneous
(hops) are generally recognized as safe (GRAS) for human
consumption. [21CFR182.20] Consumption of these Humulus
lupulus (hops)-derived foods would result in much larger systemic
exposures than what is expected from use ofingredients in
cosmetic products, even if there was 100% dermal absorption.
Thus, the systemic toxicity potential ofHumulus lupulus (hops)derived
ingredients is not the focus of this safety assessment
(although such information may be included). The primary focus
of this safety assessment is the review of safety based on local
effects (e.g., topical exposures).
Botanical cosmetic ingredients, such as Humulus lupulus
(hops)-derived ingredients, may contain hundreds of constituents,
some of which have the potential to cause toxic
effects. For example, sesquiterpene lactones, which are
present in the Humulus lupulus (hops) plant, may cause
Type IV allergic reactions (cell-mediated, delayed-type
hypersensitivity) and other toxicity when present in sufficient
amounts. Another example, β-myrcene, is reported to
be a dermal irritant and a possible carcinogen (including in a
National Toxicology Program (NTP) report).7-11 In this
safety assessment, the Panel is reviewing information available

IJT - CIR - February 2024

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