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Toxicological information

Sensitisation data (human)

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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

Reference
Name:
Unnamed
Type:
Constituent
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.