nvt. dit is een veiligheidsonderzoek systemic absorption
Conditions
Interventions
A single typical hair dye procedure per subject will be performed by a
professional hairdresser. Four hairdressers will be involved in the study.
Sponsors
L'Oreal R&D, Worldwide Safety Evaluation
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 3:A pregnancy test (dipstick in urine) 4:Having given their written informed consent 5: Willing to have their coloured hair completely clipped (bald headed!) 6:Willing to use adequate measures to avoid pregnancy during the whole study (females only) 7:Willing to refrain from hair cutting (2-3 months) and to let grow their hair to about a 5 cm length on Day01
Exclusion criteria
Exclusion criteria: 1: 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 2: Positive pregnancy test (urine) (females) 3: Prescribed medication (except oral contraceptives and paracetamol) 4: Having a known allergy to PPD 5: Having a positive response to the retroauricular sensitisation test to PPD, conducted 2 days in advance of Day 01 of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The individual concentration versus time courses 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, 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