Consumer exposure to an actual, dark-shaded oxidative hair dye. A [14C]-PPD labelled mass balance study*.

Completed

• Conditions: nvt. diit is een veiligheidsonderzoek; systemic exposure (absorption)

• Registration Number: NL-OMON32506
• Lead Sponsor: TNO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

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 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Establishing a Mass Balance</p><br>