Registration Dossier
Registration Dossier
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EC number: 931-434-7 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available (analytical purity of test substance not specified).
Data source
Reference
- Reference Type:
- other: Study summary/letter
- Title:
- Unnamed
- Year:
- 1 959
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated human patch test with 50 volunteers, 72h induction, after 7 days 72h challenge.
- GLP compliance:
- no
Test material
- Reference substance name:
- Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids
- EC Number:
- 931-434-7
- Cas Number:
- 1338-39-2
- Molecular formula:
- C18H34O6
- IUPAC Name:
- Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids
- Reference substance name:
- 931-434-7
- EC Number:
- 931-434-7
- IUPAC Name:
- 931-434-7
- Details on test material:
- - Name of test material (as cited in study report): sorbitan monolaurate
- Analytical purity: not specified
- Lot/batch No.: 342, CEL #71287
Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50
- Controls:
- no data
- 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: one inch square patch of absorbent cotton twill sealed onto the skin with an elastic adhesive 2 inch square patch
- Vehicle / solvent: none
- Concentrations: undiluted
- Volume applied: no data
- other: 72 h induction, after 7 days 72 h of challenge in the same manner as used for induction procedure and on the same area of the skin
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test substance is not sensitising to human skin.
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