2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

other: human data

Adequacy of study:

supporting study

Study period:

2010-09-28 to 2010-10-01

Reliability:

other: not rated acc. to Klimisch

Rationale for reliability incl. deficiencies:

other: relevant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The primary skin irritation potential of the test material was investigated by conducting a 48-hour patch test.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol

EC Number:

607-858-0

Cas Number:

260781-16-6

Molecular formula:

C14H26O4

IUPAC Name:

1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

HYPOTHESIS TESTED: To determine by epidermal contact the primary irritation potential of the test material

STUDY PERIOD: 2010-09-28 to 2010-10-01

STUDY POPULATION
- Selection criteria:
Inclusion criteria
a) Male and female subjects, age 16 (with parental or guardian consent) and over
b) Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c) Prohibition of use of topical or systemic steroids and /or antihistamines for at least seven days prior to study initiation.
d) Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e) Considered reliable and capable of following directions.
Exclusion criteria:
a) Ill health
b) Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c) Females who are pregnant or nursing.
d) A history of adverse reactions to cosmetics or other personal care products.

- Total number of subjects participating in study: 53 subjects
- Sex/age: 37 females and 16 males; ranging in age from 16 to 74
- Total number of subjects at end of study: 51 subjects completed this study (subjects (1 male / 1 female) discontinued their participation for various reasons unrelated to the use of the test material)

Exposure assessment:

estimated

Details on exposure:

METHODOLGY.
The upper back between the scapulae served as the treatment area. Approximately 0.2 mL of the test material (1 % in DEP/EtOH 3:1), or an amount sufficient to cover the contact surface was applied to the 3/4" x 3.4" absorbent pad portion of a clear adhesive dressing. When secured to the appropriate treatment site, this dressing formed an occlusive patch.

The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value. The test site was reevaluated at seventy-two hours.

EXAMINATIONS
- Grading/Scoring system (Erythema and additional Dermal Sequelae):
0 = No visible skin reaction
0.5 = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Oedema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading
Erythema was scored numerically according to this key. if present, additional Dermal Sequelae were indicated by the appropriate letter code and a numerical value for severity.

Statistical methods:

No data

Results and discussion

Results:

Observations remained negative throughout the test interval.

Confounding factors:

No data

Strengths and weaknesses:

No data

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test material (1 % in DEP/EtOH 3:1) did not indicate a potential for dermal irritation.

Executive summary:

In this study the potential of the test material to induce primary irritation by epidermal contact was determined. Fifty-three subjects (16 males / 37 females) ranging in age from 16 to74 years were selected for this evaluation. Fifty-one subjects completed the study. The remaining subjects (1 male / 1 female) discontinued their participation for various reasons unrelated to the use if the test material.

The test item (1 % in DEP/EtOH 3:1) was evaluated by administration to the skin of the upper back between the scapulae. Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface was applied to an absorbent pad portion of an adhesive dressing. When secured to the appropriate treatment site, this dressing formed an occlusive patch.

The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. An evaluation key was used to evaluate the treatment site. The test site was reevaluated at seventy-two hours.

The results showed that the observations remained negative throughout the test interval.

In conclusion, under the conditions of this study, the test material (1 % in DEP/EtOH 3:1) did not indicate a potential for dermal irritation.