This pilot study will be conducted prior to initiating a large study to determine the potential dermal and inhalation exposure during pour liquid activities. This study is being conducted to test materials and methods for measuring potential dermal…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet van toepassing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is container volume/shape. The out come of the
study is inhalation and dermal exposure data
Secondary outcome
not appropriate
Background summary
The Antimicrobial Exposure Assessment Task Force II (AEATF II) was formed to
generate generic exposure data on a broad range of use pattern and application
methods as well as post application exposures to support registration and
re-registration by its member companies of such uses for most antimicrobial
ingredients. The data will be representative of subject activities and methods
used in the handling of antimicrobial products. The data generated from these
studies will be used in assessing potential exposure to subjects and users and
will be used in developing risk assessment.
Study objective
This pilot study will be conducted prior to initiating a large study to
determine the potential dermal and inhalation exposure during pour liquid
activities. This study is being conducted to test materials and methods for
measuring potential dermal and inhalation exposures associated with pouring
activities with a liquid antimicrobial pesticide product. Information obtained
in this pilot study will be used to design and conduct a more robust main study
of workers engaged in pouring liquid antimicrobial pesticide products.
Performance of sample matrices and collection methods, matrix specific
analytical methods, determination of the magnitude of residues likely to be
observed in various matrices, and duration of pour periods or number of
containers to be emptied required to get detectable quantities are among the
specific objectives for this study.
Study design
The primary purpose of this study is to monitor exposure of subjects who pour
liquid antimicrobial pesticide products. The monitored study subjects will pour
product repeatedly from a container into a receiving vessel.
The number of subjects monitored will be two. Potential dermal and inhalation
exposure of each individual study participant will be measured during separate
pouring activities for time duration or product volume that exaggerates the
typical time spent pouring antimicrobial products. This increase in task
duration will be necessary in order to achieve measurable quantities on the
sampling matrices. The test material, i.e., an end-use formulation containing
didecyl dimethyl ammonium chloride (DDAC), CAS No. 7173-51-5, will be poured in
this study. The Registation sheet (Wetttelijk Gebruiksvoorschrif) for the
commercially available product to be used in this study will be documented in
the study file.
Container size (1L and 20 L) in combination with receiving containers will be
the major variable tested in this pilot. The liquid will be poured from the
test container into different sized shallow receiving containers starting with
empty containers. During the process of pouring the receiving container will
gradually be filled. This was chosen as a worst case for splash back during the
pouring activities.
Since these factors cannot be controlled in real world application, height of
pour and rate of pour, or other pertinent physical stature indices will be
recorded as measures of use. Ambient temperature, humidity and estimated flow
will be recorded during the pouring activities, and the air exchange rate of
the experimental room will be determined during the experimental day prior or
following the experiments.
Potential dermal exposure to the test substance will be measured externally
using whole body inner (cotton long underwear) and outer dosimeters, hand
washes, and face/neck wipes. The monitored subject will wear one layer of
clothing (normal outer work garments which will be provided, plus shoes and
socks) over inner whole body cotton dosimeters. The outer work garments will
be WPS (Worker Protection Standards) compliant and consist of long pants and
long-sleeved shirts. These garments will be provided by the AEATF II. The
subject will not wear any Personal Protection Equipment (PPE) since it not
recommended and specified by the product label, however safety goggles will be
provided. Potential inhalation exposure for each subject will be measured by
means of a personal air sampling pump set at 2L/minute attached to an IOM
inhalable sampler head provided with a 25 mm GF filter. In addition the study
subject will be supplied with another pump attached to an OSHA Versatile
Sampler (OVS) tube with a glass fiber (GF) filter and XAD2 sorbent material.
Study burden and risks
Light physical strenght is needed to handling the bottles/ containers, however
the test subjects can dtermine their work rate. The study subjects will wear 2
lihgt weights air sampling pumps, that will be attached their a belt.
The duration of skin exposure will be reduced by the washing procedure of hands
and wipe procedure of forehead and neck immediately following the end of the
handling. It is reasonable to assume that there will not be health effects due
to handling the containers or due to exposure.
1300 Wilson Blvd
Arlington VA 22209
Verenigde Staten
1300 Wilson Blvd
Arlington VA 22209
Verenigde Staten
Listed location countries
Age
Inclusion criteria
Eligible based on medical history (P6895/01 F02)
Exclusion criteria
dermal diseases including scars, wounds and abnormalities, conjunctivitis, known history of respiratory disease, known history of allergic reaction to ammonium compunds(P6895/01 F02 and section 4.5.2 )
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL11523.041.06 |