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Diss Factsheets

Toxicological information

Sensitisation data (human)

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Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Test guideline
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:
informed consent given by human subjects

Test material

Constituent 1
Reference substance name:
2 % Pat Hyd-C-50777/f
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


Type of population:
not specified
Ethical approval:
confirmed and informed consent free of coercion received
- 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.
No data
Route of administration:
Details on study design:
- The Readi-Bandage (Parke Davis) was used occlusively.
- Approximately 0.2 mL was applied to each patch.

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

- 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.

- 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.

- 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.

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

- 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

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