Registration Dossier
Registration Dossier
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EC number: 944-507-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- alternative method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex VI of French Official Journal n°302 of 30/12/1999
- Deviations:
- not specified
- Principles of method if other than guideline:
- Determination of the cytotoxicity after contact of the test element (5 dilutions) with a monolayer of cells marked by a vital dye (Neutral Red) by calculation of the percentage of cell death and the IC50 or concentration of test element that inhibited of 50 % the survival and cell growth
- GLP compliance:
- no
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:
- Osilift is the commercilized product
Appearance: light clear yellow liquid
Storage conditions: 20°C in a dark place
Constituent 1
additive 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SIRC (ATCC -CCL60)
- Remarks:
- Cornea fibroblasts
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- cellular mortality CI50
- Run / experiment:
- One on one
- Value:
- > 50 - <= 100
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The irritant potential of the product Osilift towards rabbit cornea fibroblasts was determined at the concentrations of 5 to 50%. The IC50 of Osilift is higher than 50%. The per cent mortality observed at the dilution of 50% is to 48%. The cytotoxicity of Osilift is thus slight.
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