Verification of the metabolic pathways and identification of suitable biomarkers of exposure following oral and dermal exposure for each of the selected pesticides in humans.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
aandoeningen zijn geen onderdeel van deze studie. Doel is namelijk het bepalen van humane biomarkers in urine en haar.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentration of parent compound(s) and/or its metabolite(s) in urine and hair
after oral and dermal exposure, including relative metabolite conversion
factors and recovery percentages. In addition, the excretion patterns of
parents/metabolites in urine over the first 48 hours after administration will
be determined.
Secondary outcome
Not applicable
Background summary
Pesticides are applied in the vicinity of homes and it is unknown what the
residents* exposure is. The exposure will be measured by urinary biomonitoring
in the *Onderzoek Bestrijdingsmiddelen en Omwonenden* study. To interpret the
urinary biomonitoring data, information on human metabolism of the substances
is needed. Difficulties may arise when using animal data and therefore a
controlled human volunteer study is the best way to interpret biomonitoring
data. Benefits of using human volunteers for studying the metabolism at low
doses far outweigh the minimal risks involved.
Study objective
Verification of the metabolic pathways and identification of suitable
biomarkers of exposure following oral and dermal exposure for each of the
selected pesticides in humans.
Study design
Cross-over human volunteer study
Intervention
Each volunteer will be exposed orally and dermally to one of the selected
compounds.
Study burden and risks
The maximum quantity of exposure per session will not exceed the acceptable
daily intake (ADI) for that pesticide. ADI values established by the EFSA are
deemed to be safe for daily exposure over a lifetime. Adverse effects and
health risk are therefore not expected. Participants have to visit the research
laboratory two times. One session will be dedicated to oral administration and
the other session involves dermal administration. After administration,
participants have to collect urine over the following 48 hours. The first 8
hours following administration will be spent in an office workplace at the
research institute. Participants will also be asked to complete a questionnaire
about their personal characteristics, life style and pesticide use. To get a
detailed overview of the food intake, volunteers will be asked to complete a 48
h diary.
Geert Grooteplein 10
Nijmegen 6526 GA
NL
Geert Grooteplein 10
Nijmegen 6526 GA
NL
Listed location countries
Age
Inclusion criteria
- Good general health i.e. no use of prescribed medication (except oral contraceptives);
- Age between 18 and 65 years;
- BMI between 20 and 25;
- Alcohol consumption less than two standard glasses a day;
- Caucasian (to minimize genetic differences);
Exclusion criteria
- Pregnancy or willing to become pregnant during the study;
- Skin disorders, e.g. atopic eczema, psoriasis, or other chronic skin diseases that causes hyperkeratosis;
- Skin abnormalities on the non-dominant forearm, e.g. scars and injuries;
- Smoking;
- Direct contact or working with pesticides;
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 | NL56428.091.16 |