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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited documentation (analytical purity of test substance not specified).

Data source

Reference
Reference Type:
other: Study summary/letter
Title:
Unnamed
Year:
1959

Materials and methods

Endpoint addressed:
skin irritation / corrosion
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

Ethical approval:
not specified
Details on study design:
50 subjects were dermally exposed to the undiluted test substance with an occlusive patch initially for 72 h (one inch square patch of absorbent cotton twill sealed onto the skin with an elastic adhesive 2 inch square patch). After 7 days, the test substance was applied in the same manner as used for induction procedure and on the same area of the skin.

Results and discussion

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test, the test substance was not irritating.