thermomycolin

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Remarks:

Skin irritation in humans

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

6 - 17 Mar 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure was a human volunteer study according to Kligman and Wooding (1967). The study was performed before GLP or GCP was implemented but was performed according to state of t he art at that time.

Data source

Reference

Reference Type:

other: Synopsis

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Test procedure was according to Kligman AM and Wooding WM : A method for the measurement and evaluation of irritants of human skin, Journal of Investigative Dermatology, 1967; 49 : 78-94: The cumulative irritation to the skin was measured by a patch-test technique on intact skin of the volar forearms of 10 subjects. Under a square patch measuring 1 inch by 1 inch, 0.5 mL of the test substance was applied to the skin. The patches were secured in place by occlusive tape. Twenty-four hours after patch application, the test site was clinically evaluated and a new patch applied. The test was repeated for 10 days.

GLP compliance:

no

Remarks:

; before GLP or GCP but according to the same principles

Test material

Test material information

Constituent 1

Reference substance name:

Subtilisin

EC Number:

232-752-2

EC Name:

Subtilisin

Cas Number:

9014-01-1

Molecular formula:

Not applicable, please see remarks.

IUPAC Name:

Subtilisin

Method

Details on study design:

For the test 4 females and 6 males (age 18 - 45 years, white) The cumulative irritation to the skin was measured by a patch-test technique on intact skin of the volar forearms of 10 subjects. Under a square patch measuring 1 inch by 1 inch, 0.5 mL of a 1% solution in water of the test substance Subtilisin was applied to the skin (Concentration: 0.14% expressed as active enzyme protein). The patches were secured in place by occlusive tape. 24 h after each patch application, the test site was clinically evaluated and a new patch applied. The test was repeated for 10 days including daily readings.

Results and discussion

Results:

The mean primary skin irritation of 10 humans (Time points Days 1-10) was 0, as no human primary skin irritation was observed at all after application of subtilisin (1%, in water).

Applicant's summary and conclusion

Conclusions:

It is concluded that it is unlikely that the present test material (1% solution in water) would present a risk of primary skin irritation for humans under normal use conditions. Therefore it is regarded as not irritant (criteria used for interpretation of results: expert judgment)

Executive summary:

An in vivo human skin irritation test was conducted to assess the potential of the test substance, subtilisin, to cause cumulative skin irritation. The procedure of Kligman AM and Wooding WM: A method for the measurement and evaluation of irritants of human skin, Journal of Investigative Dermatology, 1967; 49 : 78-94, was followed. Under a square patch measuring 1 inch by 1 inch, 0.5 mL of the test substance was applied to the intact skinof the volar forearms of 10 subjects. The patches were secured in place by occlusive tape. Twenty-four hours after each patch application, the test site was clinically evaluated and a new patch applied. The test was repeated for 10 days with reading every day. The study was conducted before GLP or GCP was implemented but the state of the art of the time of the study was followed. The study concluded that it is unlikely that the present test material (1% subtilisin solution in water, 0.14% expressed as active enzyme protein) would present a risk of primary skin irritation for humans under normal use conditions.