Reaction mass of 1-(2,6,6-trimethylcyclohex-2-en-1-yl)hepta-1,6-dien-3-one and 1-(2,6,6-trimethylcyclohex-1-en-1-yl)hepta-1,6-dien-3-one

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 1964

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:

1964

Report date:

1964

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize, (Appraisal of the safety of chemicals in Foods, Drugs, and Cosmetics, published in 1959 by the association of food and drugs officials of the united states, P. 52)

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Reaction mass of 1-(2,6,6-trimethylcyclohex-2-en-1-yl)hepta-1,6-dien-3-one and 1-(2,6,6-trimethylcyclohex-1-en-1-yl)hepta-1,6-dien-3-one

EC Number:

904-551-6

Molecular formula:

C16H24O

IUPAC Name:

Reaction mass of 1-(2,6,6-trimethylcyclohex-2-en-1-yl)hepta-1,6-dien-3-one and 1-(2,6,6-trimethylcyclohex-1-en-1-yl)hepta-1,6-dien-3-one

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 47 subjects started the program of which 40 subjects completed the program.
- Sex: 12 males and 28 females
- Age: 6 (16-20 years), 8 (21-30 years), 11 (31-40 years), 7 (41-50 years) 7 (51-60 years), 1 (60 years).

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test

ADMINISTRATION
- Type of application: Early in the test program a large number of subjects was similary 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, demonstrated that closed patch exposure caused frequent strong reactions, even to alcohol alone, and that alcohol on the semi-open test patch adopted caused essentially no irritation.
- Description of patch: The test patch was a one-inch square of Webril (absorbent woven cotton facric) affixed to the centre of a 1 X 3 - inch strip of adhesive elastic bandage material. The test bandages were specially prepared by Duke Laboratories, Inc.
- Vehicle / solvent: ethanol
- Concentrations: 6.25%
- Volume applied: 0.5 mL
- Testing/scoring schedule: Six to nine different samples were 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 subjects removed the bandages 24 hours after application. the basic schedule for the large number of tests in the program of which this is a part compried 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 a challenge patch was applied to a site not previously exposed, and removed after 24 hours. Reactions to the challenge were scored on Wednesday and Friday of this week. Minor departures from this scedule were occasionally necessitated and were recorded.

EXAMINATIONS
- Grading/Scoring system: 0: No evidence of irritation, 1: slight erythema, 2: marked erythema, 3: erythema and papules, E: erythema and edema, 4: Very strong edema and/or papules, 5: vesicular eruption, 6: grade E or stronger reaction extending well beyond area of contact.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
None of the 40 subjects tested was sensitized by the sample.

OTHER RESULTS:
Subjects 11, 17, 43, and 58 were tested with closed patches for the first three applications, with the regular semi-open patches thereafter. Subject 17 exhibited strongly edematous reactions to the adhesive tape of the bandage after the fifth application and was therefore excused from further participation.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test 6.25% test substance was not sensitising.

Executive summary:

A HRIPT test was performed with 6.25% test substance in ethanol. 40 volunteers finished the study and were exposed to 1 mL solution mainly under semi-occlusive conditions. The subjects removed the bandages 24 hours after application. The basic schedule for the large number of tests in the program of which this is a part compried 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 a challenge patch was applied to a site not previously exposed, and removed after 24 hours. Reactions to the challenge were scored on Wednesday and Friday of this week. Minor departures from this schedule were occasionally necessitated and were recorded. None of the 40 subjects tested was sensitized by the sample. Under the conditions of the test 6.25% test substance was not sensitising.