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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
(-)-Shikimic acid
IUPAC Name:
(-)-Shikimic acid
Details on test material:
Identification: (-)-Shikimic acid
CAS No.: 138-59-0
Roche No.: Ro0642565-000
Batch: 1329R037/ Lot. No. 0700791872
Purity: Min. 98.0% (dose calculation will not be adjusted to purity)
Expiry Date: 22 August 2014
Storage Conditions: At room temperature, protected from light*
Stability in Solvent: Not indicated by the Sponsor

Test system

Vehicle:
physiological saline
Amount / concentration applied:
Each 0.75 mL of a 20% (w/v) suspension of the test item in physiological saline were applied to three bovine corneas.
Duration of treatment / exposure:
The corneas were epxosed to the test item suspension for 240 minutes.
Details on study design:
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.

Results and discussion

In vivo

Irritant / corrosive response data:
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.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
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)).
Executive summary:

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.