nvt. diit is een veiligheidsonderzoek systemic exposure (absorption)
Conditions
Interventions
Intervention: A single typical hair dye procedure per subject will be performed
by a professional hairdresser. Four professional hairdressers will be involved
in the study.
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1:Female/Male; Age 18-45 years; 2:Healthy as assessed by health questionnaire, physical examination, clinical chemistry a pregnancy test in urine will be done. 3:Prescribed medication (oral contraceptives and paracetamol excluded) 4:Having given their written informed consent 5:Willing to have their coloured hair completely clipped (bald headed!) 6:Willing to refrain from blood donation during the whole study 7:Willing to use adequate measures to avoid pregnancy during the whole study (females only) 8:Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data 9: Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned 10: Willing to refrain from hair cutting to let grow their hair to about a 5 cm length on day 01 of the study
Exclusion criteria
Exclusion criteria: 1:Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 2:Participation in any clinical trial or medical treatment including administration of a radiolabelled test substance up to 1 year before Day 01 of this study 3: Positive pregnancy test (urine) (females) or lactating 4: Prescribed medication (except oral contraceptives and paracetamol) 5: Alcohol consumption more than 28 units/week (males) or 21 units/week (females); 1 unit of alcohol equals 10 grams of ethanol 6:Having a known allergy to PPD 7: Having a positive response to the retro-auricular sensitisation test to PPD, conducted 2 days in advance of Day 01 of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The individual concentration of [14C]-radioactivity (recoveries) in all non-biological samples will be established and expressed as percentages relative to the applied dose. For biological (blood and urinary) samples, the individual concentration versus time courses of [14C]-radioactivity will be established and expressed as percentages relative to the applied dose; results will also be expressed as [14C]-PPDeq or as [14C]-PPDeq per unit of mass (g) or volume (mL). | — |
Secondary
| Measure | Time frame |
|---|---|
| Establishing a Mass Balance | — |
Countries
Netherlands
Outcome results
None listed