Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
clinical study, patch test in human
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Assay on 10 volunteers the irritant potential of the studied product after its unique application, maintained for 48 hours in contact with skin under an occlusive patch
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Polysaccharids of kernel Avena sativa, Poaceae
EC Number:
944-507-3
IUPAC Name:
Polysaccharids of kernel Avena sativa, Poaceae
additive 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
oxidane
Test material form:
liquid
Details on test material:
Glycosense A is the code name of the manufactured product Osilift
Appearance: light clear yellow liquid
Storage conditions: 20°C in a dark place
Batch number : 6 210 1
Concentration tested: 25%
Specific details on test material used for the study:
The test was performed on Glycosense A at 25%

In vitro test system

Vehicle:
water

Test animals

Species:
other: human (woman)
Strain:
not specified

Test system

Number of animals:
10 volunteers, women
Details on study design:
Haye's-Chambers occlusive patch

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: erythema, oedema, papules, vesicles, blisters
Time point:
48 h
Score:
ca. 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The product Glycosense A 25% can be considered as non irritant after an application of 48 consecutive hours on 10 volunteers.