4-methyl-4-phenylpentan-2-ol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Human repeat insult patch test performed under Good Clinical Practice (GCP).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Study type:

study with volunteers

Principles of method if other than guideline:

Standard clinical methodology

GLP compliance:

yes

Remarks:

Conducted to GCP

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-4-phenylpentan-2-ol

EC Number:

218-002-7

EC Name:

4-methyl-4-phenylpentan-2-ol

Cas Number:

2035-93-0

Molecular formula:

C12H18O

IUPAC Name:

4-methyl-4-phenylpentan-2-ol

Test material form:

other: Skin patch

Details on test material:

- Chemical name: 4-Methyl-4-phenylpentan-2-ol
- CAS number: 2035-93-0
- EC number: 218-002-7

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: Fifty-six (56)
- Sex: Male and female
- Age: 21-79 years of age
- Race: Not reported
- Demographic information: Not reported

Clinical history:

Inclusion criteria:
1. Male and female subjects age 16 and over
2. Absence of any visible skin disease which might be confused with a skin reaction from the test material
3. Prohbition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation
4. Completion of a Medical History form and the understanding and signing of an Informed Consent form
5. Considered reliable and capable of following directions
Exclusion criteria:
1. Ill health
2. Under adoctor's care or taking medication(s) which could influence the outcome of the study
3. Females who were pregnant or nursing
4. A history of adverse reactions to cosmetics or other personal care products

Controls:

There were no specific control individuals

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test) ; prick test; RAST; other immunological tests: Patch test

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: Occlusive
- Description of patch: 3/4" x 3/4" absorbent pad of an adhesive dressing manufactured by TruMed Technologies, Inc., Burnsville, MN, USA
- Vehicle / solvent: Not reported
- Concentrations: Not reported
- Volume applied: 0.2 mL of test material
- Testing/scoring schedule: The skin was assessed at each removal/replacement of the patch
- Removal of test substance: No washing of the skin following patch emoval was required


EXAMINATIONS
- Grading/Scoring system: 0=No visible skin reaction; +=Barely perceptible or spotty erythema; 1=Mild erythema covering most of the test site; 2=Moderate erythema, possible presence of mild edema; 3=Marked erythema, possible edema; 4=Severe erythema, possible edema, vesiculation, bullae and/or ulceration
- Statistical analysis: Not performed

Results and discussion

Results of examinations:

All observations remained negative throughout the test interval.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test material, Skin Lotion (AM1-0024), did not indicate a potential for dermal irritation or allergic contact sensitisation.

Executive summary:

The objective of this study was to determine by repetitive epidermal contact, the potential of AM1-0024 to induce primary or cumulative irritation and/or allergic contact sensitisation in a group of 56 subjects comprising males and females between the ages of 21 and 79 years. Following an induction phase consisting of 9 patches, each containing 0.2 mL AM1-0024 being applied to the same area of skin in the interscapular region, a similar challenge patch was applied, 24 hours following the final induction patch, to a new area of skin. The examination of the skin sites following removal of each patch after 24 hours in situ revealed no changes to the skin suggestive of an irritant response or allergic contact sensitisation.