IJT - CIR - February 2024 - 20S

20S
International Journal of Toxicology 43(Supplement 1)
with rates in field vegetable crop farm workers. A total of 57
cases of respiratory disease associated with Humulus lupulus
(hops) dust inhalation were reported. The attending
health care practitioner diagnosed 61% of these cases as
having work-related asthma. Chronic obstructive pulmonary
disease was diagnosed in 7% of these cases; the remaining
cases were diagnosed as allergic respiratory
disorders (e.g., allergic rhinitis [18%] or asthma-associated
symptoms [e.g., dyspnea; 14%]). All cases were associated
with Humulus lupulus (hops) harvesting, secondary hops
processing, or indirect exposure. The incidence of respiratory
disease in Humulus lupulus (hops) workers was 15
cases per 10,000 full-time workers, which was 30 times
greater than the incidence for field vegetable crop workers.
A strong temporal association between Humulus lupulus
(hops) dust exposure and respiratory symptoms and a clear
association between an increase in Humulus lupulus (hops)
dust concentrations and the clinical onset ofsymptoms were
apparent in 3 cases. The authors concluded that occupational
exposure to Humulus lupulus (hops) dust is associated
with respiratory disease; respiratory disease rates were
higher in Humulus lupulus (hops) workers than in a comparison
group of agricultural workers.
In a study of occupational exposure of brewery workers
to organic dusts such as Humulus lupulus (hops), barley,
and brewery yeast, the potential to affect respiratory
function and immunological status was examined.103 Male
subjects (n = 97) employed in a brewery plant had a mean
age of 40 years, and the mean duration of employment was
16 years. The control group consisted ofunexposed workers
(n = 76). Respiratory symptoms were recorded. Lung
function was measured by recording maximum expiratory
flow-volume (MEFV) curves. Immunological testing was
performed on all brewery workers and 37 of the control
volunteers using SPTs with Humulus lupulus (hops), barley,
and yeast antigens as well as other non-occupational allergens,
and by determining total serum IgE levels. There
was a higher prevalence of most of the chronic respiratory
symptoms in brewery workers compared to controls. Occupational
asthma was recorded in only 2 (2.1%) of the
brewery workers; smoking was reported to be the major
factor (that was examined in this study) responsible for the
high prevalence of chronic respiratory symptoms in
workers, not exposure to dust of the brewing ingredients,
including Humulus lupulus (hops). A large number of
brewery workers complained of acute symptoms that developed
during the work shift. Lung function test scores
were decreased compared to predicted levels. Multivariate
analysis of these respiratory function parameters suggested
the importance of workplace exposure in explaining lung
function abnormalities. There was a greater instance of
positive SPTs in brewery workers for Humulus lupulus
(hops) than in controls (15% vs 3%). There were increased
serum levels of total IgE in 34 out of 97 (45.1%) brewery
workers compared to controls, 1 out of76 (2.7%). However,
workers with positive SPTs had a prevalence of chronic
respiratory symptoms and lung function changes similar to
those of workers with negative SPTs. The authors concluded
that the data suggest that both smoking and dust
exposure in the brewery industry may be responsible for the
development of respiratory impairment and immunological
reactions.
Case Reports
Case reports ofirritation and sensitization to Humulus lupulus
(hops) or the constituent β-myrcene while working with the
plant on farms, laboratories, and in breweries are recited in
Table 14.11,54,104-106
Summary
This is a safety assessment of Humulus Lupulus (Hops)
Extract and Humulus Lupulus (Hops) Oil as used in cosmetics.
Both ofthese ingredients are derived from the strobile
of the Humulus lupulus plant, commonly called hops. The
reported functions of Humulus Lupulus (Hops) Extract in
cosmetics include antimicrobial agent, hair conditioning
agent, and skin-conditioning agent - miscellaneous; Humulus
Lupulus (Hops) Oil is reported to function as a fragrance
ingredient.
Previously, the wINCI listed four other names for Humulus
Lupulus (Hops) Extract. Data submitted under those deleted
names have been assigned to Humulus Lupulus (Hops) Extract
and the deleted names are now technical names for
Humulus Lupulus (Hops) Extract.
Humulus lupulus (hops) strobile is an ingredient in food
(most commonly in beer) and most of the other parts of this
plant (shoots, leaves, flowers, seeds, rhizomes, and essential
oils) are edible. The FDA determined that essential oils,
oleoresins (solvent-free), and natural extractives (including
distillates) ofHumulus lupulus L. (hops) are GRAS for human
consumption.
Humulus lupulus (hops) plants are reported to contain
several constituents of concern, including 8-PN, β-myrcene,
and quercetin; these constituents could result in estrogenic
activity, dermal irritation, and genotoxicity, respectively, if
concentrations were high enough. Geraniol, limonene, linalool,
and sesquiterpene lactones are potential dermal sensitizers.
Humulus Lupulus (Hops) Oil is reported to contain
sesquiterpene lactones.
The butylene glycol extract of Humulus Lupulus (Hops)
Extract is reported to contain no detectable β-myrcene. A
product mixture that contains approximately .18% Humulus
Lupulus (Hops) Extract is reported to have a theoretical
content of β-myrcene of .0022% based on the content of the
starting materials; it is noted that the method of manufacture
does not favor β-myrcene retention.
The Humulus lupulus (hops)-derived ingredients were
reported to the VCRP database and surveyed by the Council in

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