IJT - CIR - February 2024 - 19S

Becker et al.
19S
Table 13. In vitro Ocular Assays of Humulus Lupulus (Hops) Extract.
Concentration
(%)
Assay and Ingredient
(.06-.12)
(.06-.12)
HET-CAM. A product containing Humulus Lupulus
(Hops) Extract (.6% to 1.2%) tested at 10%
CFIO. A product containing Humulus Lupulus (Hops)
Extract (.6% to 1.2%) at 10%
Results
There were no signs of potential irritation in any form
of hyper-anemia, hemorrhage, or coagulation. The
IP-CAM score was .00 and the product was rated a
practically non-irritating under these conditions
The IOeq was 2.8 with a MCI of .0; the test substance
was rated at the lowest irritation level (IOeq = 0 to
15) as a slight ocular irritant
When combining the results of these two in vitro
HET-CAM/CFIO assays, the author concluded that
this cosmetic formulation containing Humulus
Lupulus (Hops) Extract (.6% to 1.2%) was a slight
ocular irritant
.5
Approximately
.18
EpiOcular. A product mixture containing Humulus
Lupulus (Hops) Extract at 5% in glycerin/water (50/
50) tested at 10%
HET-CAM. A product mixture containing Humulus
Lupulus (Hops) Extract (approximately .18% in
caprylic/capric triglyceride)
Approximately A product mixture that contains Humulus Lupulus
(Hops) Extract at 5%, 15%, 25%, and 50% in
paraffin oil was administered to SIRC fibroblastic
cells and evaluated for cytotoxicity by the use of
the Neutral Red Release method
.009, .027, .045,
and .09
Paraffin oil was the negative control and sodium
dodecyl sulfate (.01-.2%) was the positive control
CFIO - cornea fibroblast; ET50 - time until viability reaches 50%; HET-CAM - hen's egg test-chorion-allantoic membrane; IOeq - ocular irritation index; IPCAM
- primary irritancy index; MCI - mean cytotoxicity index.
Farmers (n = 73) who cultivated Humulus lupulus (hops)
plants and other crops from 18 randomly selected farms filled
out a questionnaire on their skin diseases and were administered
skin prick tests (SPT) for allergens ofHumulus lupulus
(hops) as well as grain dust, straw dust, hay dust, storage
mites, and antigens of microorganisms typical of farm environments.101
Only the results of the Humulus lupulus (hops)
are reported here. Fresh strobiles and leaves were cut into
small pieces, and extracted with glycerol and saline at 1:2 (w/
w) for 48 h at 4°C. The extracts were centrifuged and clear
supernatants were used in the testing. The subjects consisted
of42 males and 31 females, aged 16 to 84 (median 46) years,
with duration of employment resulting in exposure ranging
from 2 to 73 (median 31) years.
The questionnaire showed that Humulus lupulus (hops)
was reported to cause the greatest number ofskin problems; 14
farmers (19.2%) reported work-related skin symptoms, 2
(11%) of which were caused by Humulus lupulus (hops).
There were no reported skin problems associated with
working with Humulus lupulus (hops) by 65 subjects. The
reported skin symptoms of the subjects with skin problems
were mostly mild: four reported rashes on uncovered skin (the
description of which was sufficient to diagnose airborne
dermatitis), two subjects reported hand dermatitis, and two
reported pruritus without visible skin changes. One case of
airborne dermatitis to Humulus lupulus (hops) was severe
enough to be classified as debilitating.
Positive skin reactions to four Humulus lupulus (hops)
allergen preparations, i.e., cone extract in glycerol, cone
extract in saline, leaf extract in glycerol, and leaf extract in
saline, were found in one, two, three, and four of 65
subjects, respectively. In all, six subjects (8.2%) reacted to
at least one extract. Among the subjects reporting skin
problems related to Humulus lupulus (hops), SPTs gave
positive results in two subjects, and the tests were negative
in six subjects. The tests were also positive in four persons
whodid notreportany Humulus lupulus (hops)-related skin
problems. The predictive values for SPT of the extracts
(skin reaction to at least one of the preparations) were:
positive predictive value (PPV) = .33 and negative predictive
value (NPV) = .91.101
Inhalation. Washington State Workers' Compensation claims
filed by Humulus lupulus (hops) workers for respiratory
disease between 1995 and 2011 were systematically identified
and reviewed in a study ofoccupational respiratory disease in
Humulus lupulus (hops) workers.102 Incidences of respiratory
disease in Humulus lupulus (hops) workers were compared
Viability at 1, 4, and 24 h was 114%, 90%, and 79%. The
ET50 was > 1440 min. The test substance has
virtually no ocular irritation potential
Predicted that the test substance was practically nonirritating.
No further details were provided
Cytotoxicity was not observed at any concentration.
Predicted to be non-irritating
98
37
Reference
95,96
95,96
37

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