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Toxicological information

Sensitisation data (human)

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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:
1959

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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.

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.