Administrative data
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According to: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and II) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (July, 2013)
Attached justification
Cross-reference
Data source
Materials and methods
Test guideline
#1 - Test guideline
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Test material
Test animals / tissue source
Test system
Each 0.75 mL of a 20% (w/v) suspension of the test item in physiological saline were applied to three bovine corneas.
The corneas were epxosed to the test item suspension for 240 minutes.
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Each three bovine corneas were exposed to each 0.75 mL of a 20% (w/v) suspension of the test item in physiological saline, the negative control (physiological saline), or the positive control (10% (w/v) Benzalkonium chloride in physiological saline) for 240 minutes. After treatment the test item suspension and the controls were rinsed off the corneas and the corneas' opacity was determined. In a second step the permeability of the corneas was determined photometrically after 90 minutes treatment with fluorescein solution.
Model and software
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Any other information on materials and methods incl. tables
Results and discussion
In vitro / ex vivo / in chemico
Results
#1 - Results
mean value
Relative to the negative control, the test item (-)-Shikimic acid caused a distinct increase of the corneal opacity, whereas permeability effects did not occur. The calculated mean IVIS was 119.99 (threshold for serious eye damage: IVIS = 55). According to OECD 437 the test item is classified as serious eye damaging.
In vivo
Results
Additional information about applicability domain and reliability of (Q)SAR predictions
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Similar substances with experimental data
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Any other information on results incl. tables
Overall remarks, attachments
Attachments
Applicant's summary and conclusion
In conclusion, according to the current study and under the experimental conditions reported, (-)-Shikimic acid is serious eye damaging (CLP/EPA/GHS (Cat 1) (GHS)).
This in vitro study was performed to assess the corneal damage potential of(-)-Shikimic acid by means of the BCOP assay using fresh bovine corneas.
After a first opacity measurement of the fresh bovine corneas (t0), the 20% (w/v) suspension in saline of the test item (-)-Shikimic acid, the positive, and the negative controls were applied to corneas and incubated for 240 minutes at 32 ± 1 °C. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas and opacity was measured again (t240).
After the opacity measurements permeability of the corneas was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative control (saline) neither an increase of opacity nor permeability of the corneas could be observed (mean IVIS = 1.16).
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity on the corneas (mean IVIS = 184.01) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test item (-)-Shikimic acid caused a distinct increase of the corneal opacity, whereas permeability effects did not occur. The calculated mean IVIS was 119.99 (threshold for serious eye damage: IVIS = 55). According to OECD 437 the test item is classified as serious eye damaging.