Registration Dossier
Registration Dossier
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EC number: 261-605-5 | CAS number: 59113-36-9
Sensitisation data (human)
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 the test substance. This study can be used as supportive data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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
- Reference substance name:
- Diglycerin
- IUPAC Name:
- Diglycerin
- Details on test material:
- - Name of test material (as cited in study report): Diglycerin, highly concentrated
- Substance type: no data
- Analytical purity: 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
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50
- Sex: males and females
- Age: 13-76
- Race: unspecified
- Demographic information: no data
- Other: know diseases: healthy 38, 7 allergic, 5 acne - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: not reported
- Description of patch: commercial test plaster
- Vehicle / solvent: none
- Concentrations: 50 % in water
- Volume applied: no data
- Testing/scoring schedule: degree of skin irritation was examined 24, 48 and 72 hours after application
- Removal of test substance: after 24 hours the plaster was removed
- test area: underarm or back
Results and discussion
- Results of examinations:
-
RESULT OF CASE REPORT:
- Number of subjects with negative reactions: all but one
- Number of subjects with irritating reactions: one showed weak or uncertain erythema at 24 hours only
Applicant's summary and conclusion
- Conclusions:
- The epidermal test was used to assess primary skin irritation caused by Diglycerin 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. After 24 hours only one uncertain reaction occurred which cannot be interpreted as a sign of intolerance of the test substance to the skin.
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