(E)-3-methyl-5-cyclopentadecen-1-one

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 1995-03-06 to 1995-04-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Occlusive repeated insult patch study in humans

GLP compliance:

yes

Remarks:

Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

(5E)-3-Methyl-5-cyclopentadecen-1-one

Cas Number:

101151-17-1

Molecular formula:

C16 H28 O

IUPAC Name:

(5E)-3-Methyl-5-cyclopentadecen-1-one

Constituent 2

Reference substance name:

(5Z)-3-Methyl-5-cyclopentadecen-1-one

Cas Number:

21944-94-5

Molecular formula:

C16 H28 O

IUPAC Name:

(5Z)-3-Methyl-5-cyclopentadecen-1-one

Constituent 3

Reference substance name:

(4E)-3-Methyl-4-cyclopentadecen-1-one

Cas Number:

62221-84-5

Molecular formula:

C16 H28 O

IUPAC Name:

(4E)-3-Methyl-4-cyclopentadecen-1-one

Test material form:

liquid

Details on test material:

- Physical state: clear colourless liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 102 subjects completed the study (118 were enrolled)
- Sex: males and female
- Age: 18-74 years
- Race: white + 2 hispanic
- Demographic information: no data

Clinical history:

Inclusion criteria:
- individuals free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results.
- individuals with uniformly-coloured skin on the lower thoracic area of the back which would have allowed a discernible erythema

Exclusion criteria:
- individuals with any visible skin disease at the evaluation site which, in the opinion if the investigative personnel, would have interfered with the study results
- individuals receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results
- individuals who were being treated for asthma
- individuals with psoriasis and/or active atopic dermatitis/eczema
- females who were pregnant, planning a pregnancy or nursing a child
- individuals with a known sensitivity to cosmetics fragrances, skin care products or topical drugs as related to products being evaluated.

Controls:

none

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Description of patch: non-porous, plastic film adhesive bandage with a 2 cm x 2 cm Webril pad affixed with hypo-allergenic tape (Micropore) as needed.
- Vehicle / solvent: diethyl phtalate
- Concentrations: 10 % (diluted sample, as received)
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase: 9 consecutive applications, 48-hour intervals (72-hour if weekend)
Rest period: 14 days
Challenge phase: during the 6th week of the study
Rechallenge: if required, whenever there was evidence of possible sensitisation, 1 or 2 weeks after challenge
- Removal of patches: approximately 24 hours after each application
- Other: patches applied to the infrascapular area of the back, either to the right or left of the midline

EXAMINATIONS
During induction sites were evaluated at 48-hour intervals (72-hour if weekend). After challenge, evaluations were done after 48 and 72 hours.
- Grading/Scoring system:
- = No reaction
? = Minimal or doubtful response, slightly different from surrounding normal skin
+ = Definite erythema. No oedema
+* = Definite erythema. Minimal or doubtful oedema.
++ = Definite erythema. Definite oedema.
+++ = Definite erythema. Definite oedema and vesiculation.
- Statistical analysis: none

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 102
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:

Under the condition of the study, the test material is not a skin sensitiser at 10% in diethyl phtalate. The NESIL /NOAEL is determined to be 4.5 g/cm2.

Executive summary:

A panel of 102 male and female human volunteers participated in a repeat insult patch test in which a 10% solution of test material in Diethyl phthalate applied to the back of the subjects under occlusive patches. During the induction phase nine patch were applied, separated by a 48-hour interval. The patches were removed 24 hours after application. Following a 14-day rest period, a challenge patch was applied and the sites scored 48 and 72 hours after application.

Under the conditions employed in this study, there was no evidence of sensitisation to the test material at 10%.

A No Expected Sensitisation Induction level (NESIL) or NOAEL can be derived from this study as follows:

Single 0.2 ml 10% ST06C95 induction dose (relative density = 0.927) <=> 0.018 g

Area of exposure: 2 cm x 2 cm = 4 cm²

NESIL or NOAEL = applied dose / area of exposure = 0.018 / 4 = 0.0045 g/cm²= 4500 µg/cm²

The NESIL / NOAEL is determined to be 4500 µg/cm².