Cyclopentanol, 2-pentyl-, (1R,2S)-rel-

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From October 12, 2009 to November 20, 2009

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2009

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:

no

Remarks:

Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

cis-2- Pentylcyclopentanol

Cas Number:

157357-30-7

Molecular formula:

C10H20O

IUPAC Name:

cis-2- Pentylcyclopentanol

Test material form:

other: liquid

Details on test material:

- Test material: ST 11 C 09 @ 10% in 75% DEP / 25% ethanol
- Physical state: clear colourless liquid
- Storage conditions: ambient

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 112 subject enrolled, 101 completed
- Sex: 32 males, 80 females
- Age: 21-68 years
- Race: Asian: 24, Black: 9, Caucasian: 62, Hispanic

Clinical history:

Inclusion criteria:
- were males or females, 18 years of age or older, in general good health,
- were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results
- were of any skin type or race providing the skin pigmentation would allow discernment of erythema.
- had completed a medical screening procedure
- had read, understood and signed an informed consent agreement.

Exclusion criteria:
- had any visible skin disease at the study site which, in the opinion if the investigative personnel, would have interfered with the evaluation
- were receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results
- had psoriasis and/or active atopic dermatitis/eczema
- were females who were pregnant, planning a pregnancy or nursing a child
- had 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: Material was evaluated under an occlusive model plastic chamber patch (25 mm Hilltop Chamber) lined with a non-woven cotton pad. The patch was secured with hypoallergenic tape (Micropore), as needed.
- Vehicle / solvent: diethyl phtalate / ethanol
- Concentrations: 75% DEP / 25% ethanol
- Volume applied: 0.3 mL
- Testing/scoring schedule:
Induction phase: Patches were applied on Monday, Wednesday and Friday for 3 consecutive weeks.
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

Subjects who missed the ninth evaluation (N9G) but have had 9 patch applications and 8 evaluations were considered to have completed the induction phase.
Following a negative induction, a 48/72-hour sequence of “-/+”, “?/+” or “+/+” resulted in an additional reading being performed at the 96-hour interval.


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: 101
- 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, the test material is not a skin sensitizer at 10% in 75% DEDP / 25% EtOH.

Executive summary:

A panel of 101 male and female human volunteers completed a repeat insult patch test in which a 10% solution of test material in 75% Diethyl phthalate / 25% Ethanol 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.

None of the subjects exhibited skin irritation reactions or positive reactions.

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