Registration Dossier
Registration Dossier
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EC number: 944-507-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- HRIPT test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09/2006 to 10/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: HRIPT (Marzulli and Maibach)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- other: iterative oclusive patch test (Marzulli-Maibach method)
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 vivo test system
Test animals
- Species:
- other: human
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 57
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- These kind of results affirm that the risk of inducing sensitization throught skin contact with the product Glycosense A (25%) are minimal. The product Glycosense A (25%) can be considered as hypoallergenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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