Registration Dossier

Diss Factsheets

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:
2006
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

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:
Osilift is the commercilized product
Appearance: light clear yellow liquid
Storage conditions: 20°C in a dark place

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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