Lupine, L. albus, ext.

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:

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

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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

Remarks:

Clinical study

Test material

Test material information

Constituent 1

Reference substance name:

Lupine, L. albus, ext.

EC Number:

282-001-8

EC Name:

Lupine, L. albus, ext.

Cas Number:

84082-55-3

IUPAC Name:

Enzymatic hydrolysis products of Lupinus Albus, Fabaceae, seed

Test material form:

liquid

Details on test material:

BATCH: 10 005 1
Liquid limpid
Color: Amber
Storage Condition: Room temperature
Expiry date: 05/07/2011

Method

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 and discussion

Results:

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

Any other information on results incl. tables

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	-

Applicant's summary and conclusion

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.