Lupine, L. albus, ext.

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Data on human volunteers are available

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 February - 19 March 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Human Repeat Insult Patch Test using generally-accepted methods, performed according to Good Clinical Practice

Remarks:

No certificate of Analysis was available for the test item

Reason / purpose for cross-reference:

data waiving: supporting information

Type of sensitisation studied:

skin

Study type:

study with volunteers

Qualifier:

no guideline followed

Principles of method if other than guideline:

Repeated Insult Patch Test was performed to determine the irritation and/or sensitization potential of the tested product after repeated topical application under occlusive patch test conditions to the skin of human subjects with all type of skin.

GLP compliance:

no

Remarks:

Good clinical practice

Type of population:

general

Ethical approval:

confirmed, but no further information available

Subjects:

- Number of subjects empanelled: 113
- Number of subject satisfactorili completed the test procedure: 112 (one subject was discontinued during the test procedure after the 9 th application due to protocol exclusion)
- Sex: 85 Females; 28 Males
- Age: 18-70 years
- The subjects chosen were dependable and able to read and understand instructions. The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article or determination of potential effects of the test article.

Clinical history:

None

Controls:

Patch containing no product was applied to serve as a non-treated control.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Total occlusive
- Application area: The back: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Haye's chamber occlusive patch
- Vehicle / solvent: No data
- Concentrations: pure
- Volume applied: 25 µL
- Testing schedule:
Induction phase: A sufficient amount of the tested product to cover the surface of the patch was placed into a Haye's chamber occlusive patch and applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line. This procedure was performed by the investigator and repeated every Monday, Wednesday and Friday until 9 applications.
Frequency: Induction phase: 3 times a week during 48 h; Challenge phase: once during 48 h
Duration: Induction phase: 3 weeks; Rest phase: 2 weeks; Challenge phase: 1 week
Challenge phase: After a rest period of 2 weeks (no applications of the test article), the Challenge patch was applied to a previously unpatched (virgin) and patched (inductor) test site.
- Removal of test substance: Application site was scored 30 minutes, 24 and 48 h after removal.

EXAMINATIONS
- Grading/Scoring system:
Induction phase: Dermal responses for the Induction phase of the study were scored according to the following scale:
- = No evidence of any effect
1 = Mild (Pink, uniform erythema covering most of the contact site)
2 = Moderate (Pink-red erythema uniform in the entire contact site)
3 - Marked (Bright red erythema with/ without petechiae or papules)
4 = Severe (Deep red erythema with/ without vesiculation or weeping)

Challenge phase: Dermal responses for the Challenge phase of the study were scored according to the following criteria of I.C.D.R.G. (the International Contact Dermatitis Research Group):
- = Negative
+? = Doubtful reaction a (Slight erythema)*
+ = Weak (non-vesicular) reaction**
++ = Strong (oedematous or vesicular) reaction
+++ = Extreme (bullous or ulcerative)***
NT = Not tested
IR = Irritant reaction of different types

* ?+ is a questionable faint or macular (non-palpable) erythema and is not interpreted as proven allergic reaction
** + is a palpable erythema, suggestive of a slight oedematous reaction
*** From coalescing vesicles

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 112; There were no responses to any subject during the induction phase and tge challenge phase.

None

Conclusions:

Under the conditions employed in this study, the test item did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis. The test item can be considered as "hypoallergenic".

Executive summary:

A panel of 113 men and women human volunteers participated in a repeat insult patch test in which a test item applied as such, to the back of the subjects under occlusive patches. 112 subjects completed the study. During the induction phase 9 patches were applied, separated by a 48 h interval. The patches were removed 48 h after application. Following 2 weeks rest period, a challenge patch was applied and the sites scored 30 minutes, 48 and 72 h after application.

No reaction were observed during the induction and the challenge phase.

Under the conditions employed in this study, the test item did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis. The test item can be considered as "hypoallergenic".