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EC number: 941-809-7
CAS number: -
For each exposure condition, three corneas were visually inspected and
showed no abnormalities. Three corneas were treated with 0.9 % sodium
chloride as solvent/vehicle control. The IVIS of 0.9 % sodium chloride
was -0.2 ± 0.4 (-0.6 to 0.2) with a mean opacity value
of -0.2 ± 0.4 (-0.6 to 0.2) and a mean permeability
value of 0.001 ± 0.001 (0.001 to 0.002).
Three corneas were selected for treatment with the positive control 100
% N,N-dimethylformamide. Treatment resulted in a mean IVIS of 100.5 ±
9.9. The corrected mean value of the opacity was 81.9 ± 6.0,
ranging from 76.4 to 88.3. The corrected mean value of the permeability
was 1.240 ± 0.340, ranging from 0.890 to 1.570. Before
starting the permeability test, the dye solution sodium fluorescein was
checked for its quality. The dye solution is valid for use, if a
dilution of the stock solution containing 10 µg/mL gave the
correct concentration on the calibration curve (acceptable range OD490:
1.75 ± 0.2). The average concentration of 2
measurements calculated by the spectrophotometer was 1.7797 µg/mL
(OD 1.7692 and OD 1.7902) and thus valid for use. This means that the
test conditions were optimal to determine the irritating potential of
Three corneas were selected for treatment with the test item. Treatment
resulted in a mean IVIS of 32.3 ± 5.8 after 10 minutes
treatment, ranging from 28.2 to 38.9. The net value of the opacity score
ranged from 2.6 to 4.4, the mean value was 3.8 ± 1.0.
The mean corrected permeability value of the corneas was 1.900 ± 0.372,
ranging from 1.583 to 2.310.
In an ex vivo eye irritation guideline study (bovine corneal
opacity and permeability assay) according to OECD 437 under GLP
conditions, 0.75 mL of a 10 % solution of “Sophorolipids: fermentation
products of glucose and fatty acids, C18-unsatd., esters with glycerol
with yeast Candida Bombicola, partially hydrolysed” in physiological
saline was applied on corneas for 10 min at 32 °C. The test was
performed in triplicates.
Physiological saline was used as negative control, N,N-dimethylformamide
as positive control. Both controls confirmed the validity of the study.
In this study, the mean in vitro irritation score was 32.3 ± 5.8.
According to the guideline, no prediction can be made using this value.
For precautionary measures, “Sophorolipids: fermentation products of
glucose and fatty acids, C18-unsatd., esters with glycerol with yeast
Candida Bombicola, partially hydrolysed” is classified voluntarily as irritating
to eyes (GHS Category 2).
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