Chestnut, C. sativa, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July - August 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

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

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

A clinical study on human volunteers show that the substance has no skin sensitization potential. See end-point 7.10.4

Reason / purpose for cross-reference:

data waiving: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2004

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.

GLP compliance:

no

Remarks:

study has been conducted in the spirit of the good Clinical Practice

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 : 309821
yellow liquid

Method

Type of population:

general

Ethical approval:

confirmed, but no further information available

Subjects:

Number of subjects empanelled: 56
- Number of subject satisfactorili completed the test procedure: 50
- Sex: 44 Females; 6 Males
- Age: 18-64 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: after each application, the patch is removed and the clinical examination is performed by the investigatior later in order to eliminate the pressure and the occlusion effects. The results of examination is negative if the skin loks normal. The following criteria are evaluated by the dermatologist according to a quotation from 0 to 3:
0 = absence : normal aspect
1 = slight (Erythema: Slight pinkish colour of all tested surface or visible on only part of this surface, Oedema: more palpable than visible, Dryness: subtile desquamation, frosted aspect, Vesicles: more palple than visible)
2 = Marked (Erythema: marked erythema covering all tested surface, Oedema: visible, Desquamation: visible, scally aspect, Vesicles:visible)
4 = Severe (Erythema: intense erythema covering all tested surface, Oedema: Cover more than all tested surface, Desquamation: important desquamation, cracking, Vesicles: vesicles covering more than all tested surface or blisters)

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):
0 = Negative, no reaction
? = Doubtful reaction
+ = Erythema and oedema
++ = Erythema, oedema and vesicles
+++ = severe reaction with blisters

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
4 volunteers suffered irritations during the induction phase, but the study continued without problem throught to the challenge phase
no volunteers demonstrated slight skin reations resulting irritation.

Applicant's summary and conclusion

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 56 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.

No reaction were observed during 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".