Consumer exposure to oxidative hair dyes. A [14C]-PPD labelled mass balance study.

Completed

Conditions: nvt. dit is een veiligheidsonderzoek
systemic absorption

Registration Number: NL-OMON30980

Lead Sponsor: 'Oreal R&D, Worldwide Safety Evaluation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The individual concentration versus time courses of [14C]-radioactivity<br /><br>(recoveries) in all non-biological samples will be established and expressed as<br /><br>percentages relative to the applied dose. For biological (blood and urinary)<br /><br>samples, results will also be expressed as [14C]-PPDeq or as [14C]-PPDeq per<br /><br>unit of mass (g) or volume (mL). </p><br>

Secondary Outcome Measures