Consumer exposure to an oxidative hair dye. A [14C]- labelled Toluene-2,5-diamine mass balance study

Completed

Conditions: geen
not applicable

Registration Number: NL-OMON35782

Lead Sponsor: The Procter & Gamble Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

1. Apparently healthy as assessed by the TNO Health and lifestyle questionnaire, limited Physical examination and results of the pre-study laboratory tests
2. Age [>= 18 and <= 45] years at Day 01 of the study
3. Having given their written informed consent
4: Willing to comply with the study procedures
5: Hair length of at least 5 cm at inclusion and willing to refrain from hair cutting and hair dye use until day 01 of the study
6: Willing to have their coloured hair completely clipped (bald headed!)
7: Willing to refrain from blood donation during the whole study
8: Willing to use adequate measures to avoid pregnancy during the whole study (females only)
9: Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data
10: Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria

1. Participation in any clinical trial or medical treatment including administration of a radio labelled test substance up to 1 year before Day 01 of this study
2. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
3. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
4. Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine diseases, or dermatological diseases such as having dermatitis or particular skin diseases
5. A past history of having had a temporary henna tattoo applied or currently having a temporary henna tattoo
6. Prescribed medication (oral contraceptives and paracetamol excluded)
7. Bald headed or balding
8. Scars, cuts, wounds or dermal abnormalities on the scalp
9. Having a known allergy to hair colourants
10. Having a positive response to the allergy alert test to the test formulation (higher concentration), conducted 2 days in advance of Day 01 of the study
11. Positive pregnancy test (urine) (females)
12. Alcohol consumption more than 28 units/week (males) or 21 units /week (females) (1 unit of alcohol equals 10 grams of ethanol)
13. Recent blood donation (<1 month prior to the start of the study)
14. Not willing to give up blood donation during the study.
15. Pregnant or lactating or wishing to become pregnant in the period of the study
16. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
17. Not having a general practitioner
18. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study objective is to establish the systemic exposure of consumers<br /><br>to a toluene-2,5-diamine containing hair dye formulation under actual use<br /><br>conditions during a typical hair dyeing procedure.</p><br>

Secondary Outcome Measures