3-methyl-5-phenylpentanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Study was initiated on 1975-03-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed in human volunteers, however the study was lacking information on certain areas of demographics, and also the study was limited by the test concentration. The level of reporting in the methods and results lacked some detail.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The irritation and sensitising properties of the test substance were evaluated in 47 male and female panelists (39 panelists completed the study) in a repeated insult patch test. Nine applications of the test substance at a 5 % concentration in Alcohol SDA 39C.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-5-phenylpentanol

EC Number:

259-461-3

EC Name:

3-methyl-5-phenylpentanol

Cas Number:

55066-48-3

Molecular formula:

C12H18O

IUPAC Name:

3-methyl-5-phenylpentan-1-ol

Test material form:

not specified

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 47 enrolled, 39 completed the study
- Sex: male and female
- Age: 16 to 60+ years

16-20 yr 21-30 yr 31-40 yr 41-50 yr 51-60 yr >60 yr Unknown* Total
Female 5 1 4 5 2 5 1 23
Male 4 1 4 3 1 3 16

8 panelists were dropped from the study for excessive absences (panelists 4, 11, 15, 20, 22, 30, 31 and 41)
- Demographic information: All panelists were recruited from the St Petersburg, Florida area.

Clinical history:

The allergies, dermatitides and concomitant medication for all panelists was recorded. The panelists which reported any of allergies, dermatitides or concomitant medication are listed below.

Panelist Allergies Dermatitides Concomitant medication
1 None None Iron
3 None None Diuril
4 None None Dilantin, Cyclospasmol
5 None None Diutensen
7 Punk, mango tree None None
8 None None Rx - nerves
11 None None Aspirin, thyroid
21 Aspirin None None
27 Bee stings None None
28 Asthma None Ser-Ap-Es, aspirin
37 Hay fever None None
42 Bees, wasps None None

Information for the female panelist, No. 35 was not available.

Controls:

Vehicle control (99.75 % with 0.25 % distilled water)

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 1 x 1 inch Webril swatch affixed to the centre of a 1 x 2-inch elastic bandage.
- Vehicle / solvent: Alcohol SDA 39C
- Concentrations: 5 %
- Volume applied: 0.5 mL
- Testing/scoring schedule: Please refer to table 1 under the field "Any other information on materials and methods incl. tables".
- Removal of test substance: The panelists were told to removed the patch 24 hours after the application

EXAMINATIONS
- Grading/Scoring system:
Reactions to the test material were scored to the following scale:
0 – No evidence of irritation
1 – Slight erythema
2 – Marked erythema
3 – Erythema and papules
4 – Edema; erythema may or may not be present
5 – Erythema, edema and papules
6 – Vesicular eruption
7 – Strong reaction spreading beyond test site
Min – Reaction meets minimal requirements for the grade assigned

Effects on superficial layers of skin were recorded as follows
A – Slight glazed appearance
B – Marked glazing
C – Glazing with peeling and cracking
F – Glazing with fissures
G – Film of dried serous exudates covering all or portions of the patch site
H – Small petechial erosions and/or scabs

Results and discussion

Results of examinations:

RESULTS WITH TEST SUBSTANCE
Primary irritation:
Little or none: 39/39
Moderate: 0/39
Marked: 0/39

Sensitisation:
Not sensitised: 39/39
Possibly sensitised: 0/39
Probably sensitised: 0/39

RESULTS WITH CONTROL
Primary irritation:
Little or none: 39/39
Moderate: 0/39
Marked: 0/39

Sensitisation:
Not sensitised: 39/39
Possibly sensitised: 0/39
Probably sensitised: 0/39

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, the test substance was found not to be sensitising in humans when tested at a 5% concentration using a human repeat insult patch test. In addition, no irritation was noted during the course of the study.

Executive summary:

The skin sensitisation potential and irritation of the test substance was assessed in a human repeat insult patch test. The test substance was applied for a total of nine applications as a 5% formulation to male and female volunteers and assessed for reactions. Under the conditions of the study, the test substance was found not to be sensitising in humans when tested at a 5% concentration using a human repeat insult patch test. In addition, no irritation was noted during the course of the study.