Registration Dossier
Registration Dossier
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EC number: 944-507-3 | CAS number: -
Skin irritation / corrosion
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:
- 2 006
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
- Reference substance name:
- Polysaccharids of kernel Avena sativa, Poaceae
- EC Number:
- 944-507-3
- IUPAC Name:
- Polysaccharids of kernel Avena sativa, Poaceae
- 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%
Constituent 1
additive 1
- 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.
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