Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No data on followed guidelines, no data on test substance. This study can be used as supportive data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: clinical case study
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Polyglycerin
IUPAC Name:
Polyglycerin
Details on test material:
- Name of test material (as cited in study report): Polyglycerin
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50
- Sex: males and females
- Age: 17-78
- Race: unspecified
- Demographic information: no data
- Other: know diseases: allergy (10 patients), acne (2 patients), diabetes (1 patient), Pollin (2 patients)
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)


ADMINISTRATION
- Type of application: occlusive
- Description of patch: commercial test plaster
- Vehicle / solvent: none
- Concentrations: undiluted
- Volume applied: no data
- Testing/scoring schedule: degree of skin irritation was examined
- Removal of test substance: after 24 hours the plaster was removed

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: The plaster was removed after 24 hours and the test area was assessed. Further assessments were carried out after 48 and 72 hours.

RESULT OF CASE REPORT:
- Number of subjects with negative reactions: all
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
The epidermal test was used to assess primary skin irritation caused by Polyglycerin-3 in 50 volunteers. Test substance was applied to the clinically intact skin. The patch was removed after 24 hours and the test area was evaluated. Evaluations were repeated after 48 and 72 hours.
No positive or doubtful results were recorded after 48 and 72 hours. The test did not provide any indication for a primary skin irritation or for the triggering of already existing allergy to Polyglycerin-3.

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