IJT - CIR - February 2024 - 23S

Becker et al.
23S
Humulus lupulus (hops) harvesters, dermatitis has been attributed
to mechanical abrasion by the rough hairs on the
climbing stem. It has also been suggested that lupulin, the
yellow powdery secretion of the glandular hairs on the scales
of the strobiles, may be responsible for the irritation.
In a human maximization test of a product containing
Humulus Lupulus (Hops) Extract (.125%), the test product did
not demonstrate contact sensitization potential. An HRIPT of
Humulus Lupulus (Hops) Extract (10%; extracted with butylene
glycol) gave negative results. No reactions were observed
in an HRIPT that was conducted of a product mixture
that contains Humulus Lupulus (Hops) Extract (approximately
.18%). There were no signs ofirritation or sensitization
in an HRIPT of a product mixture that contained Humulus
Lupulus (Hops) Extract (approximately 5%).
In vitro assays showed that products and product mixtures
containing Humulus Lupulus (Hops) Extract up to .5% were
predicted to be either non-irritating or slight ocular irritants.
Humulus Lupulus (Hops) Extract was predicted to be a slight
ocular irritant in HET-CAM and cornea fibroblast assays and a
non-irritant in an EpiOcular assay. Another Humulus Lupulus
(Hops) Extract was predicted to be non-irritating in an HETCAM
assay and to SIRC fibroblastic cells.
In a 4-week use study of an eye cream that contained
Humulus Lupulus (Hops) Extract (.125%), the test material
did not demonstrate potential for eliciting ophthalmic
irritation.
In a survey offarmers, exposure to Humulus lupulus (hops)
was reported to cause the greatest number ofskin problems; 14
of 73 (19.2%) of the farmers reported work-related skin
symptoms, 11% of which were caused by Humulus lupulus
(hops). There were one, two, three, and four positive SPTs to
the following Humulus lupulus (hops) allergen preparations,
respectively: cone extract in glycerol, cone extract in saline,
leaf extract in glycerol, and leaf extract in saline.
In a study of occupational respiratory disease in Humulus
lupulus (hops) workers, using Workers' Compensation claims
filed by Humulus lupulus (hops) workers for respiratory
disease, the incidence rate 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 rate
for field vegetable crop workers. The authors concluded that
occupational exposure to Humulus lupulus (hops) dust is
associated with respiratory disease; respiratory disease rates
were higher in hop workers than in a comparison group of
agricultural workers.
In a study of occupational exposure of brewery workers to
organic dusts, including Humulus lupulus (hops), the potential
to affect respiratory function and immunological status was
examined. A large number ofbrewery workers complained of
acute symptoms that developed during the work shift. Lung
function tests were decreased compared to predicted levels.
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 oftotal IgE in 34 of97
(45.1%) brewery workers compared to controls, 1 of 76
(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 suggests that both smoking
and dust exposure in the brewery industry may be responsible
for the development of respiratory impairment and immunological
reactions.
There were case studies of subjects becoming sensitized to
Humulus lupulus (hops) plants or the constituent β-myrcene
while working with the plant on farms, laboratories, and in
breweries.
Discussion
The Panel examined the oral toxicity, genotoxicity, dermal and
ocular irritation, and sensitization studies ofHumulus lupulus
(hops)-derived ingredients, as well as studies on occupational
exposure. Essential oils, oleoresins, and natural extracts of
Humulus lupulus (hops) are GRAS for human consumption.
The Panel noted the presence ofβ-myrcene at up to 25.4%
in Humulus lupulus (hops) oil. This constituent is a potential
irritant, and there is an NTP study showing increased incidences
ofkidney tumors in male rats and liver tumors in male
mice after oral administration of 1.0 g/kg/day β-myrcene for
2 years. The increased incidence ofkidney tumors in this study
is likely attributable to a mechanism that is not relevant to
humans, and the increased incidence of liver tumors is attributable
to the high background incidence and susceptibility
to the development of liver tumors that is characteristic of the
mouse strain used in the study, and is also not predictive of
carcinogenicity in humans. Further, the daily dose of β-myrcene
administered orally to the rats and mice in the study
were much greater than the highest possible exposure to β-myrcene
that could occur from Humulus lupulus (hops)derived
ingredients in cosmetics. However, concerns about
β-myrcene, and possibly other constituents, cannot be addressed
fully by the Panel, because the available information is
not sufficient to characterize adequately the compositions of
Humulus lupulus (hops)-derived cosmetic ingredients. The
Panel emphasized the importance, generally, of adequately
characterizing the compositions of cosmetic ingredients derived
from plants, as manufactured and supplied to formulators
of cosmetic products.
There were possible estrogenic effects in persons who
worked with Humulus lupulus (hops) in the field. The studies
showed that the purported estrogenic effects were weak and
the degree of the exposure to the workers is far greater than
any exposure that could occur from the use of cosmetics that
contain these ingredients at the reported concentrations ofuse.
Because final product formulations may contain multiple
botanicals, each possibly containing similar constituents of
concern, formulators are advised to be aware of these
constituents and to avoid reaching levels that may be
hazardous to consumers. For example, in Humulus lupulus

IJT - CIR - February 2024

Table of Contents for the Digital Edition of IJT - CIR - February 2024

Contents
IJT - CIR - February 2024 - Cover1
IJT - CIR - February 2024 - Cover2
IJT - CIR - February 2024 - 1S
IJT - CIR - February 2024 - 2S
IJT - CIR - February 2024 - Contents
IJT - CIR - February 2024 - 4S
IJT - CIR - February 2024 - 5S
IJT - CIR - February 2024 - 6S
IJT - CIR - February 2024 - 7S
IJT - CIR - February 2024 - 8S
IJT - CIR - February 2024 - 9S
IJT - CIR - February 2024 - 10S
IJT - CIR - February 2024 - 11S
IJT - CIR - February 2024 - 12S
IJT - CIR - February 2024 - 13S
IJT - CIR - February 2024 - 14S
IJT - CIR - February 2024 - 15S
IJT - CIR - February 2024 - 16S
IJT - CIR - February 2024 - 17S
IJT - CIR - February 2024 - 18S
IJT - CIR - February 2024 - 19S
IJT - CIR - February 2024 - 20S
IJT - CIR - February 2024 - 21S
IJT - CIR - February 2024 - 22S
IJT - CIR - February 2024 - 23S
IJT - CIR - February 2024 - 24S
IJT - CIR - February 2024 - 25S
IJT - CIR - February 2024 - 26S
IJT - CIR - February 2024 - 27S
IJT - CIR - February 2024 - 28S
IJT - CIR - February 2024 - 29S
IJT - CIR - February 2024 - 30S
IJT - CIR - February 2024 - 31S
IJT - CIR - February 2024 - 32S
IJT - CIR - February 2024 - 33S
IJT - CIR - February 2024 - 34S
IJT - CIR - February 2024 - 35S
IJT - CIR - February 2024 - 36S
IJT - CIR - February 2024 - 37S
IJT - CIR - February 2024 - 38S
IJT - CIR - February 2024 - 39S
IJT - CIR - February 2024 - 40S
IJT - CIR - February 2024 - 41S
IJT - CIR - February 2024 - 42S
IJT - CIR - February 2024 - 43S
IJT - CIR - February 2024 - 44S
IJT - CIR - February 2024 - 45S
IJT - CIR - February 2024 - 46S
IJT - CIR - February 2024 - 47S
IJT - CIR - February 2024 - 48S
IJT - CIR - February 2024 - 49S
IJT - CIR - February 2024 - 50S
IJT - CIR - February 2024 - 51S
IJT - CIR - February 2024 - 52S
IJT - CIR - February 2024 - 53S
IJT - CIR - February 2024 - 54S
IJT - CIR - February 2024 - 55S
IJT - CIR - February 2024 - 56S
IJT - CIR - February 2024 - 57S
IJT - CIR - February 2024 - 58S
IJT - CIR - February 2024 - 59S
IJT - CIR - February 2024 - 60S
IJT - CIR - February 2024 - 61S
IJT - CIR - February 2024 - 62S
IJT - CIR - February 2024 - 63S
IJT - CIR - February 2024 - 64S
IJT - CIR - February 2024 - 65S
IJT - CIR - February 2024 - 66S
IJT - CIR - February 2024 - 67S
IJT - CIR - February 2024 - 68S
IJT - CIR - February 2024 - 69S
IJT - CIR - February 2024 - 70S
IJT - CIR - February 2024 - 71S
IJT - CIR - February 2024 - 72S
IJT - CIR - February 2024 - 73S
IJT - CIR - February 2024 - 74S
IJT - CIR - February 2024 - 75S
IJT - CIR - February 2024 - 76S
IJT - CIR - February 2024 - 77S
IJT - CIR - February 2024 - 78S
IJT - CIR - February 2024 - 79S
IJT - CIR - February 2024 - 80S
IJT - CIR - February 2024 - 81S
IJT - CIR - February 2024 - 82S
IJT - CIR - February 2024 - 83S
IJT - CIR - February 2024 - 84S
IJT - CIR - February 2024 - 85S
IJT - CIR - February 2024 - 86S
IJT - CIR - February 2024 - 87S
IJT - CIR - February 2024 - 88S
IJT - CIR - February 2024 - 89S
IJT - CIR - February 2024 - 90S
IJT - CIR - February 2024 - 91S
IJT - CIR - February 2024 - 92S
IJT - CIR - February 2024 - 93S
IJT - CIR - February 2024 - 94S
IJT - CIR - February 2024 - 95S
IJT - CIR - February 2024 - 96S
IJT - CIR - February 2024 - 97S
IJT - CIR - February 2024 - 98S
IJT - CIR - February 2024 - 99S
IJT - CIR - February 2024 - 100S
IJT - CIR - February 2024 - 101S
IJT - CIR - February 2024 - 102S
IJT - CIR - February 2024 - 103S
IJT - CIR - February 2024 - 104S
IJT - CIR - February 2024 - 105S
IJT - CIR - February 2024 - 106S
IJT - CIR - February 2024 - 107S
IJT - CIR - February 2024 - 108S
IJT - CIR - February 2024 - 109S
IJT - CIR - February 2024 - 110S
IJT - CIR - February 2024 - 111S
IJT - CIR - February 2024 - 112S
IJT - CIR - February 2024 - 113S
IJT - CIR - February 2024 - 114S
IJT - CIR - February 2024 - 115S
IJT - CIR - February 2024 - 116S
IJT - CIR - February 2024 - 117S
IJT - CIR - February 2024 - 118S
IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
https://www.nxtbookmedia.com