Registration Dossier
Registration Dossier
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EC number: 215-664-9 | CAS number: 1338-41-6
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: Limited data given (no data on test substance purity, only 5% test substance evaluated, coexamination of substances, patients of unspecified origin, no induction application).
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact sensitivity to emulsifiers
- Author:
- Hannuksela, M. et al.
- Year:
- 1 976
- Bibliographic source:
- Contact Dermatitis 2: 201-204
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Over 1200 patients with eczema were patch-tested with eight common emulsifiers, among these the test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan stearate
- EC Number:
- 215-664-9
- EC Name:
- Sorbitan stearate
- Cas Number:
- 1338-41-6
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- 1,4-anhydro-6-O-stearoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): Span 60
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 1206
- Sex: 505 men, 701 women - 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: chamber method (Pirilae 1975)
- Vehicle / solvent: petrolatum
- Concentrations: 5%
- Testing/scoring schedule: occlusion time of 24 hous, and the readings were made about 20 minutes after removal of the test substance, and after 2 and 4-5 days after the application of the test substance.
- Removal of test substance: yes
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: Irritant reactions were at their strongest on the first or second day, but disappeared or at least became markedly weaker within 4-5 days.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 5 (0.4%)
- Number of subjects with negative reactions: 1201
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: in 12% of the 1206 patients tested irritation of the skin was observed, no details were given for the test substance
Applicant's summary and conclusion
- Conclusions:
- In over 1200 patients with eczema that were patch-tested with eight common emulsifiers, among these the test substance, an allergic reaction to the test substance was observed in 5 volunteers (0.4%).
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