Sorbitan stearate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1992-09-28 until 1992-10-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (analytical purity of test substance not specified, only 30% test substance evaluated, repeated application).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

Six emulsifiers were tested for their irritancy potential in a test panel of 25 healthy volunteer subjects in a repeat insult patch test.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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): sorbitan stearate

Method

Ethical approval:

confirmed, but no further information available

Details on study design:

The test substance was applied in a test panel of 25 normal healthy volunteer subjects (24 women, 1 men). The mean age was 44, ranging from 23 to 65. The study design was that of a repeat insult patch test consisting of six applications over a 15 day period under occlusive conditions. All subjects had been given a medical examination including blood pressure reading, pulse rate determination, medical history and full examination of the skin before joining the test panel and each subjects medical history was updated and recorded immediately prior to participation in the study. The nature of the study was explained to the subjects and they were informed that they were able to withdraw the study at any stage without obligation and without being required to state a reason. No subject had taken part in a study involving the test site during the previous 20 weeks and had not taken part in any study involving any other part of the back during the previous 8 weeks. Each subject received approximately 0.1 g of the respective six test materials (formulated in 30 % w/w in olive oil), among these the test substance, on the designated test sites on the back under occlusive conditions using 12 mm aluminium Finn chambers on Scanpor tape. Re-applications were made to the same test sites. At each assessment time the sites were graded using an arbitrary 8 scale, as follows: 0 = no reaction, 1 = slight, patchy erythema, 2 = moderate uniform erythema, 3 = strong erythema, 4 = strong erythema, spreading outside site of application, 5 = strong erythema, spreading outside site of application with either swelling or vesiculation, 6 = severe reaction with erosion. Re-applications were not made to any site which showed a reaction at any time that was graded as 2 (moderate erythema) or more.

Results and discussion

Results:

All subjects attended on all occasions and were considered to have completed the study. There were no grade 1 or grade 2 or higher reactions recorded during the 15 day application period. Therefore, the test substance was considered as non-irritant und the conditions of the test.

Applicant's summary and conclusion

Conclusions:

Repeated application of the test substance to human skin induced no irritating effects.