Lupine, L. albus, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 - 28 January 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Human single patch test using generally-accepted methods performed according to Good Clinical Practice

Remarks:

Lack of data concerning the test item, absence of analysis certificate

Reason / purpose for cross-reference:

data waiving: supporting information

Type of study / information:

Acute skin tolerance on volunteers

Endpoint addressed:

skin irritation / corrosion

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

Remarks:

Clinical study

Ethical approval:

confirmed, but no further information available

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 should be included in the study

Exposure assessment:

measured

Details on exposure:

Single application of 0.02 mL of the studied test item, on the external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).

Results:

11 volunteers have been included. The average irritation index is 0

Table 7.10.3/1: Skin irritation – reactions :

Inclusion number	Initials	In-situ reaction of product	Individual scores of product	In-situ reaction on test-site
1	VA-MA	-	0.0	-
2	CH-AL	-	0.0	-
3	HO-SA	-	0.0	-
4	CH-IU	-	0.0	-
5	TI-MA	-	0.0	-
6	TI-AN	-	0.0	-
7	SM-MI	-	0.0	-
8	CO-DA	-	0.0	-
9	MO-CO	-	0.0	-
10	MO-CO	-	0.0	-
11	MO-FA	-	0.0	-

Conclusions:

The test item can be considered as non-irritant after an application with the help of an occlusive patch for 48 h on 11 volunteers.

Executive summary:

In a single patch test, 11 volunteers (men and women) from 19 to 41 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 external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).

11 volunteers have been included and were analyzed. The average irritation index is 0.

 

Under the conditions employed in this study, test item was considered as non-irritant.