[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

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:

1966

Report date:

1966

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.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene

EC Number:

267-510-5

EC Name:

[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene

Cas Number:

67874-81-1

Molecular formula:

C16H28O

IUPAC Name:

[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 37 out of 45 completed the program
- Sex: 19 males and 18 females
- Age: 16 participants 16-20 years, 5 participants 21-30 years, 8 participants 31-40 years, 7 participants 41-50 years, 1 participants 51-60 years

Controls:

yes, solvent control

Route of administration:

dermal

Details on study design:

The test patch was a one-inch square of Webril (absorbent non-woven cotton fabric) affixed to the center of a 1 x 3-inch strip of adhesive elastic bandage material. The test bandings were specially prepared by Duke Laboratories, Inc. Immediately before application to each subject 0.5mL of sample (5%) was added to the Webril swatch and the bandage was then placed on the subjects upper arm. Six to nine different samples were tested simultaneously on each group of subjects, and the order in which they were applied was rotated from one subject to the next. The subject removed the bandages 24 hours after application. Early in the test program a large number of subjects was similarly tested with 95% ethanol on similar test patches, and a smaller number was tested with similar samples and with alcohol applied under closed patches. The results of these experiments, which are the subject of a separate report demonstrated that closed patch exposures caused frequent strong reactions, even to alcohol alone, and that alcohol on the semi-open test patch adopted caused essentially no irritation. The basic schedule for the large number of tests in the program of which this is a part comprised a series of nine 24-hour exposures on a Monday-Wednesday-Friday sequence for three successive weeks, the reaction to each exposure being scored at the session following and the reaction to the ninth application on Monday of the fourth week. The test patch was applied to the same site each time, unless reaction to sample or tape adhesive rendered this inadvisable, in which case the test patch was either omitted or applied to a fresh site. On Monday of the sixth week challenge patch was applied to a site not previously exposed, and removed after 24 hours. Reactions to challenge were scored on Wednesday and Friday of this week.

Results and discussion

Results of examinations:

Under the conditions of the test the compound caused very little primary irritation. None of the 37 subjects was sensitized by the sample.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test the substance was not sensitising.

Executive summary:

A HRIPT was performed with 5% test substance. 37 subject were dermally exposed. The basic schedule for the large number of tests in the program of which this is a part comprised a series of nine 24-hour exposures on a Monday-Wednesday-Friday sequence for three successive weeks, the reaction to each exposure being scored at the session following and the reaction to the ninth application on Monday of the fourth week. The test patch was applied to the same site each time, unless reaction to sample or tape adhesive rendered this inadvisable, in which case the test patch was either omitted or applied to a fresh site. On Monday of the sixth week challenge patch was applied to a site not previously exposed, and removed after 24 hours. Reactions to challenge were scored on Wednesday and Friday of this week. Under the conditions of the test the compound caused very little primary irritation. None of the 37 subjects was sensitized by the sample. Under the conditions of the test the substance was not sensitising.