2-(1-(3',3'-dimethyl-1'-cyclohexyl)ethoxy)-2-methyl propyl propanoate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 2001-03-05 to 2001-05-24

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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 Practices

Test material

Test material information

Constituent 1

Reference substance name:

2-{(1RS)-1-[(1SR)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Molecular formula:

C17 H32 O3

IUPAC Name:

2-{(1RS)-1-[(1SR)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Constituent 2

Reference substance name:

2-{(1RS)-1-[(1RS)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Molecular formula:

C17 H32 O3

IUPAC Name:

2-{(1RS)-1-[(1RS)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Constituent 3

Reference substance name:

2-METHYL-2-{[(1RS,2RS)-2,6,6-TRIMETHYLCYCLOHEPTYL]OXY}PROPYL PROPIONATE

Molecular formula:

C17H32O3

IUPAC Name:

2-METHYL-2-{[(1RS,2RS)-2,6,6-TRIMETHYLCYCLOHEPTYL]OXY}PROPYL PROPIONATE

Test material form:

liquid

Details on test material:

- Physical state: clear colourless liquid
- Storage condition of test material: ambient

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 108 subjects completed the study (113 were enrolled)
- Sex: males (21.2 %) and female (78.8 %)
- Age: 18.6 to 70.6
- Race: Asian (1.8 %), Black (0.9 %), Caucasian (86.7 %), Hispanic (9.7 %), Other (0.9 %)
- Demographic information: none

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 of any skin type or race providing the skin pigmentation would allow discernment of erythema.

Exclusion criteria:
- individuals with any visible skin disease at the study site which, in the opinion if the investigative personnel, would have interfered with the evaluation
- individuals receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results
- 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: 20 %
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase: 9 consecutive applications, 48-hour intervals (72-hour if weekend)
Rest period: 10-15 days
Challenge phase: during the 6th week of the study
- 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. 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: 108
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:

Under the condition of the study, ST 04 C 91 is not a skin sensitiser at 20% in diethyl phtalate. The NESIL /NOAEL is determined to be 2.3 µg/cm².

Executive summary:

A panel of 108 male and female human volunteers participated in a repeat insult patch test in which a 20% solution of ST 04 C 91 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 ST 04 C 91 at 20%.

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

Single 0.2 mL 20% test material induction dose (relative density = 0.938) <=>0.00938 mg

Area of exposure: 2 cm x 2 cm = 4 cm²

NESIL or NOAEL = applied dose / area of exposure = 0.00938 / 4 = 0.0023 mg/cm²= 2.3 µg/cm²

The NESIL / NOAEL is determined to be 2.3 µg/cm².