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International Journal of Toxicology 43(Supplement 1)
Table 14. (continued)
Presentation
A 43-year-old female subject who worked in a laboratory that
investigated Humulus lupulus (hops), presented with
conjunctivitis, rhinitis, bronchitis, and dermatitis of the face.
Data, Tests, and Results
She had no history of asthma or hay fever or previous
dermatitis or inflammation of the mucous membranes. In
her workplace, the dried plant strobiles were pulverized in a
mill, some of which became airborne; she had no exposure
to Humulus lupulus (hops) pollen. The results of a patch test
of the Humulus lupulus (hops) dust was ++ and an
intradermal test of .1 mL aqueous Humulus lupulus (hops)
extract was +++. She was able to drink beer with no
symptoms.
A 28-year-old male subject who was a chemist for a brewery
presented with sneezing, itching, hives, closed feeling in his
throat, wheezing, shortness of breath, abdominal bloating,
watering eyes, and irregular heartbeat.
His job required exposure to Humulus lupulus (hops) plants in
the field and laboratory. In laboratory, he crushed and
rubbed strobiles in his hands and inhaled for aroma.
Laboratory also used pure β-myrcene, which is a volatile oil.
He had never had hay fever or asthma, but had a former
allergy (watering eyes) to Siamese cats. As a child, milk
ingestion would produce hives. Walnuts induced a burning
feeling in his throat and stomach. Patch tests with crushed,
dried Humulus lupulus (hops) flowers (two varieties) were
negative. A patch test of β-myrcene was positive after 4 h
and strongly positive after 48 h. Strongly positive reactions
were observed in scratch and intradermal tests to most
pollens, house dust, pyrethrum, orris root, and grain dust;
moderate reactions were observed to some molds and
horse dander. Tests were negative for other molds and
other animals. Drinking a beer did not produce symptoms
unless he had been exposed to β-myrcene.
2015(and updated in 2016) under the revised INCI names, and
that is how they are reported herein.
According to VCRP data received in 2017, Humulus
Lupulus (Hops) Extract was reported to be used in 375 formulations,
including 317 leave-on formulations and 54 rinseoffformulations.
The results ofthe concentration ofuse survey
conducted by the Council in 2015 (and updated in 2016)
indicate that the highest reported maximum concentration of
use of Humulus Lupulus (Hops) Extract is up to .2% in hair
conditioners.
Humulus Lupulus (Hops) Oil is not in use according to the
VCRP and the industry survey.
Rats fed a low-fat diet, a high-fat diet, or high-fat diet
supplemented with 1% xanthohumol-rich extract ofHumulus
lupulus (hops) extracts for 41 days and male mice fed a normal
diet, a high-fat diet, or high-fat diets supplemented with 2% or
5% of various Humulus lupulus (hops) extracts for 20 weeks
had no mortalities or adverse effects reported for any group.
The additions of any of the Humulus lupulus (hops) extracts
reduced the effects of the high-fat diet on weight gain. The
weights of livers and mesenteric and epididymal adipose
tissues of mice fed the supplemented high-fat diets were
similar to those of the controls, as were the plasma glucose
levels at the end of the test period.
An aqueous Humulus Lupulus (Hops) Extract (10 to
400 mg/µL in ethanol) was weakly mutagenic (an increase in
induced revertants 2 to 4 times the controls) to S. typhimurium
with and without metabolic activation. In another assay, a
Humulus Lupulus (Hops) Extract was not mutagenic to S.
typhimurium and E. coli at up to 10,000 µg/plate, with or
without metabolic activation. A product mixture containing
5% Humulus Lupulus (Hops) Extract at 10% (.05% hops in
deionized water) was not mutagenic to S. typhimurium with or
without metabolic activation.
Historically, there is circumstantial evidence of potential
estrogenic activity connected to Humulus lupulus (hops)
exposure, including menstrual disturbances reported to be
common among female Humulus lupulus (hops) harvesters. 8PN
has been shown to be the source of the estrogenic activity
ofHumulus lupulus (hops) plants. It mimics the action of17βestradiol,
albeit with a lesser (10- to 20,000-fold) potency.
In a 2-week cumulative irritation test of a product containing
Humulus Lupulus (Hops) Extract (.125%), the test
product did not demonstrate a significant irritation potential in
human skin. In a human patch test of a product containing
Humulus Lupulus (Hops) Extract at .06 to .12%, the irritation
index was .04 (out of 5) and the test article was rated a nonirritant.
No adverse reactions were observed in a patch test ofa
product mixture that contains Humulus Lupulus (Hops) Extract
(approximately .18%).
The causative agents of Humulus lupulus (hops) plantinduced
contact skin reactions have not been established. In
Reference
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