Reaction Mass of 1,4-dimethyl-7-(prop-1-en-2-yl)-1,2,3,4,5,6,7,8-octahydroazulene and 3,8-dimethyl-5-(prop-1-en-2-yl)-1,2,3,3a,4,5,6,7-octahydroazulene and 4,8a,9,9-tetramethyldecahydro-1,6-methanonaphthalen-1-ol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

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:

Test material was repeatedly applied to human subjects in order to assess the potential for contact irritation and/or allergic sensitisation.

GLP compliance:

no

Remarks:

informed consent given by human subjects

Test material

Test material information

Constituent 1

Reference substance name:

2 % Pat Hyd-C-50777/f

IUPAC Name:

2 % Pat Hyd-C-50777/f

Details on test material:

- Name of test material (as cited in study report): 2 % Pat Hyd-C-50777/f
- Physical state: clear liquid
- Date received: 1983-02-8

Method

Type of population:

not specified

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

PANEL SELECTION
- 58 subjects (14 male and 44 female) were placed on test (see Table I)
- Subjects ranged in age from 18 to 58.
- 13 subjects were aged 18 to 30.
- 13 subjects were aged 31 to 45.
- 11 subjects were aged 46 to 65.

Clinical history:

- Each subject was assigned a permanent identification number.
- Each subject completed a history form.
- No subject was used if he or she exhibited any dermatological or other medical or physiological condition, which would preclude topical application of the test material.
- No known pregnant or nursing women were used on the panel.
- At least six weeks had elapsed since a subject was last patched in a repeated insult patch test.

Controls:

No data

Route of administration:

dermal

Details on study design:

PATCH PREPARATION
- The Readi-Bandage (Parke Davis) was used occlusively.
- Approximately 0.2 mL was applied to each patch.

PATCH SITES
- All patch sites were thoroughly cleansed with 70 % isopropyl alcohol prior to each patching.

INDUCTION PHASE
- The left upper back area was used as the patch site for induction.
- Each patch site was recorded on an anatomical diagram of each subject’s individual data sheet.

CHALLENGE PHASE
- The right upper back area was used as a virgin patch site for the challenge.
- Each patch site was recorded on an anatomical diagram of each subject’s individual data sheet.

INDUCTION SCHEDULE
- A series of nine induction patches were applied for a period of three weeks (Monday, Wednesday and Friday).
- If a missed patching was unable to be made up during the same week, the subject was re-patched at the end of the induction phase on the tenth visit (see Addendum I, attached).
- Additional absences caused the subject to be dropped from panel.
- Any absences and re-patchings were noted by date on each individual data sheet (see Addendum II, attached).
- Subjects were instructed that each patch must remain in place, and the area was to be kept dry for 24 hours, at which time the patch was to be removed.
- A 24 hour rest period, during which no test material was applied, followed the removal of the Monday and Wednesday patch applications.
- a 48 hour rest period followed removal of the Friday patch application.
- The test area was observed when the subject returned and the reaction was scored and recorded using the (modified) scoring scale of the International Contact Dermatitis Research Group System.
- The identical site was then re-patched until nine induction patchings were completed.

REST PERIOD
- A rest period of approximately two weeks followed the application of the last induction patch.
- No test material was applied during the rest period.

CHALLENGE PHASE
- The original patch site was observed and the subject queried as to whether any reaction was experienced during the rest period.
- The challenge patch was applied to a virgin site.
- Subjects were instructed to keep the patches dry.
- Each subject reported 24 hours later for patch removal.
- The original patch site was observed and the challenge site was scored.
- Each subject reported at 48 and 72 hours post-patching for additional observation, scoring or reactions and recording of results.

Results and discussion

Results of examinations:

- Individual results are presented in Tables I and II (attached).
- A total of 51 subjects (14 male and 37 female) completed the test.
- Reasons for discontinuence are shown in Addendum II (attached).
- The original patch sites exhibited no reactions during rest or at the challenge.
- No reactions were observed during the induction phase nor at the challenge phase.

Applicant's summary and conclusion

Conclusions:

Application of the test material caused no reactions during the induction phase or the challenge phase.