IJT - CIR - February 2024 - 24S

24S
International Journal of Toxicology 43(Supplement 1)
(hops)-derived ingredients, the Panel's concerns included
thepresenceof8-PN, β-myrcene, and quercetin in cosmetics,
which could result in estrogenic effects, dermal
irritation, and genotoxicity, respectively, as well as other
constituents of concern. The Panel noted that IFRA standards
to avoid adverse effect have been published for
several Humulus lupulus (hops) constituents (Table 11). At
the reported concentrations of use of these ingredients, the
constituents that may cause these effects will be present at
levels far below levels of concern, including for sensitization.
However, when formulating products with multiple
botanically-derived ingredients, manufacturers should
avoid reaching levels of plant constituents that may cause
sensitization or other adverse health effects.
There were instances of sensitization of persons who
worked with Humulus lupulus (hops) in the field and in
laboratories. The studies showed that the degree of the
exposure of these persons is far greater than any exposure
that could occur from the use ofcosmetics that contain these
ingredients at the reported concentrations of use. Additionally,
the plant has hairs and bristles that could abrade the
skin, thus increasing the chance of dermal penetration of
constituents that could cause sensitization. Such abrasion
would not occur with exposure to these cosmetic
ingredients.
The Panel is reassured by the HRIPT of 10% Humulus
Lupulus (Hops) Extract that sensitization should not be a
problem under the reported conditions and concentrations of
use in cosmetics because the highest reported concentration of
use was .2% Humulus Lupulus (Hops) Extract in hair products
and .13% in products that come in contact with the skin.
Overall, sensitization and constituent profile data show that
there should not be any issue with sensitization at the low
concentrations ofuse of these ingredients. The Panel cautions
that manufactures use cGMP to formulate products that are
non-sensitizing.
There is a substantial data profile on the constituents of
the Humulus Lupulus (Hops) Oil; many of these constituents,
including potential sensitizers, are similar to those in
the Humulus Lupulus (Hops) Extract. Therefore, the safety
data on one ingredient informs the other. Concern, however,
was expressed about alternative approaches to extraction
that might not produce material with the same safety profile
describedinthissafetyassessment. Thereare multiple
methods of extraction with multiple solvents (e.g., water/
propylene glycol, water/ethanol, water/butylene glycol, and
caprylic/capric triglyceride) presented for the ingredient
Humulus Lupulus (Hops) Extract and steam distillation for
Humulus Lupulus (Hops) Oil. The Panel's safety conclusion
is applicable only for Humulus Lupulus (Hops) Extract
and Humulus Lupulus (Hops) Oil that are prepared in a
manner that produces a similar chemical profile as that
described in this report, especially for the constituents of
concern. When prepared in a manner resulting in this
chemical profile, the Panel's conclusion is that these
ingredients do not have significant estrogenic activity,
genotoxicity, irritation, or sensitization potential. Ingredients
not prepared in a manner that produces a similar
chemical profile would be considered safe only if a similar
safety test profile was demonstrated.
The Panel expressed concern about pesticide residues,
heavy metals, and substances from plants of other species
(weeds) that may be present in botanical ingredients. Also,
multiple fungi and bacteria have been detected co-localized
with Humulus lupulus (hops) plants. To address these concerns,
the cosmetics industry should continue to use cGMPs to
limit impurities.
There were no constituents of concern associated with
phototoxicity and there were no indications ofphototoxicity in
the farmer workers exposed to high amounts ofHumulus lupus
(hops). Accordingly, phototoxicity assays were not deemed to
be required.
Also, the Panel noted the limited scope of the in vitro
genotoxicity assay in which an aqueous Humulus Lupulus
(Hops) Extract increased revertants 2-4 times that of controls.
The Panel concluded that these test results were not statistically
significant and that there was no significant risk of
genotoxicity.
The pulmonary disease associated with working with
Humulus lupus (hops) plants was reported to be caused by
constant inhalation exposure to the plant dust over extended
periods (e.g., years). This exposure is far greater than any
exposure would be associated with the use of cosmetic
products. In this context, the Panel discussed the issue of
incidental inhalation exposure from aerosol and pump hair
sprays. The limited data on occupational inhalation suggests
some potential for respiratory effects at large doses
over extended periods of time. Otherwise, there were no
inhalation toxicity data available. These ingredients are
reportedly used at concentrations up to .0002% in cosmetic
products that may be aerosolized and up to .00055% in
loose powder products that may become airborne. The
Panel noted that most droplets/particles would not be respirable
to any appreciable amount. Coupled with the small
actual exposure in the breathing zone and the concentrations
at which the ingredients are used, the available information
indicates that incidental inhalation would not be a
significant route of exposure that might lead to local respiratory
or systemic effects. The Panel considered other
data available to characterize the potential for Humulus
lupulus (hops)-derived ingredients to cause toxicity, genotoxicity,
irritation, and sensitization. They noted the lack
of systemic toxicity, genotoxicity, irritation, and sensitization
at relevant doses by Humulus lupulus (Hops)-derived
ingredients. They also noted that parts of the plants are
edible and extractives are GRAS as food additives. A detailed
discussion and summary of the Panel'sapproachto
evaluating incidental inhalation exposures to ingredients in
cosmetic products is available at https://www.cir-safety.
org/cir-findings.
https://www.cir-safety.org/cir-findings https://www.cir-safety.org/cir-findings

IJT - CIR - February 2024

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Contents
IJT - CIR - February 2024 - Cover1
IJT - CIR - February 2024 - Cover2
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IJT - CIR - February 2024 - Contents
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IJT - CIR - February 2024 - Cover3
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