Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

May 01, 1996 - June 17, 1996

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Not a validated method for determining skin irritation or skin sensitisation, but provides reliable supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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:

Repeated Insult patch test: A 9-day repeated occlusive application for 24 hours, after which a rest period of approximately 2 weeks, a challenge patch was applied to fresh sites and were scored 24 and 72-hours after application.

GLP compliance:

no

Remarks:

but conducted in accordance with Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane

EC Number:

916-737-4

Molecular formula:

Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane

IUPAC Name:

Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 5% Sample D in DMP
- Description: Transparent liquid
- Received on April 24, 1996

Method

Type of population:

general

Ethical approval:

other: informed consent was obtained

Subjects:

- Number of subjects exposed: 55 (53 completed the study)
- Sex: 2 males and 53 females
- Age: 20 to 63 years
- Other: the subjects did not exhibit any physical or dermatological condition that would have precluded application of the test substance.

Clinical history:

No data.

Controls:

No.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: repeated insult patch test

ADMINISTRATION
- Type of application: occlusive
- Induction phase:
Approximately 0.2 mL test substance was placed onto a Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects were instructed to remove the patch 24-hours after application. 24-hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated every Monday, Wednesday and Friday until 9 applications of the test substance had been made.
- Challenge phase:
After a rest period of approximately 2 weeks, the challenge patch was applied to a previously unpatched (virgin) test site. The site was scored 24 and 72-hours after application.

EXAMINATIONS
Skin responses for both the induction and challenge phases of the study were scored according to the following 6-point scale:
0 = No evidence of any effect
+ = Barely-Perceptible (minimal, faint, uniform or spotty erythema)
1 = Mild (pink, uniform erythema covering most of the contact site)
2 = Moderate (pink-red erythema uniform in the entire contact site)
3 = Marked (bright-red erythema with/wthout petechiae or papules)
4 = Severe (deep-red erythema with/without vesiculation or weeping)

All other observed dermal sequelae are appropriately recorded and described as mild, moderate or severe.

Results and discussion

Results of examinations:

No skin responses were observed during the induction phase.
A transient, barely-preceptible non-specific patch test response was observed on one test panelist during the challenge phase of the study. This non-specific response was not considered to be irritant or allergic in nature.
Two subjects discontinued for personal reasons.

Applicant's summary and conclusion

Conclusions:

Under the conditions of a repeated insult (occlusive) patch test procedure, the test substance 5% Sample D in DMP did not induce irritation nor show any evidence of induced allergic contact dermatitis in human subjects.