Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July and August 2005
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 Repeat Insult Patch Test
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:
2005
Report date:
2005

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: Method of Marzulli-Maibach
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:
yes

Test material

Constituent 1
Reference substance name:
Rye, ext.
EC Number:
290-271-3
EC Name:
Rye, ext.
Cas Number:
90106-48-2
IUPAC Name:
Oligosaccharides and polysaccharides of glucose from Rye
Test material form:
liquid
Details on test material:
BATCH: 5.180.1
Liquid limpid
Color: yellow
Storage Condition: Room temperature

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects empanelled: 54
- Number of subject satisfactorili completed the test procedure: 53 (one subject was discontinued during the test procedure after the 1st application due to violation of the protocol)
- Sex: 41 Females; 13 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:
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
- 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 and discussion

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: 54; There were no response to any subject during the induction phase and tge challenge phase.

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:

Under the conditions of a reêated insult (occlusive) patch test procedure conducted in a panel of 54 subjects, the product was "Dermatologist-tested" and did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.

The test item can be considered as "hypoallergenic".