Chestnut, C. sativa, ext.

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Remarks:

other data Human single patch test using generally accepted methods

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

Human single patch test using generally-accepted methods

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Adequate data from a clinical study on volunteers show the substance is not irritation for the skin. See end-point 7.10.5

Reason / purpose for cross-reference:

data waiving: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Type of study / information:

Acute skin tolerance on volunteers

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Skin irritation potential of the test item was studied in volunteers using 48 hour single patch test and skin reactions were evaluated.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chestnut, C. sativa, ext.

EC Number:

283-619-0

EC Name:

Chestnut, C. sativa, ext.

Cas Number:

84695-99-8

IUPAC Name:

Chestnut, C. sativa, ext.

Test material form:

liquid

Details on test material:

Batch : 30591
yellow liquid

Method

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

Volunteers of the demale or male sex from 18 to 65 years of age, with a normal skin , without any dermatological lesion on the experimental area shoul be included in the study

Exposure assessment:

measured

Details on exposure:

Single application of 0.02 mL of the studied test item, on the outer forearm and the back, a control patch without product was simultaneous applied, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).
Exactey 48h after, patches were removed and the areas rinsed with distilled water. After 30 mins, the dermatologist examination was conducted in daylight.

Results and discussion

Results:

21 volunteers were included in the study : 19 women and 2 men. Mean age : 34 years. After 48 hours of application, two skin reaction were observed on the treated site and none on the control site. The mean irritation index was 0.07. The test item was considered as non-irritant.

Applicant's summary and conclusion

Conclusions:

21 volunteers were included in the study : 19 women and 2 men. Mean age : 34 years. After 48 hours of application, two skin reaction were observed on the treated site and none on the control site. The mean irritation index was 0.07. The test item was considered as non-irritant.

Executive summary:

In a single patch test, 21 volunteers (men and women) from 19 to 56 years of age, with a normal skin, without any dermatological lesion on the experimental area, have been included in the study. Single application of 0.02 mL of the test item, on the outer forearm and the back, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).

After 48 hours of application, two skin reaction were observed on the treated site and none on the control site. The mean irritation index was 0.07. The test item was considered as non-irritant under the conditions employed in the study.