Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 15,2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
Identity : D-Penthenyltriacetate
Batch No: 049903
Purity >95%
Stability in Solvent : Not relevant
Stirage: At room temperature
Expiration Date: February 18, 2011

Test animals / tissue source

Species:
cattle
Details on test animals or tissues and environmental conditions:
Test System: Freshly isolated bovine cornea

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
0.16
Negative controls validity:
valid
Positive controls validity:
not valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This in vitro study was performed to assess the corneal irritation and damage potential of D­ Panthenyltriacetate by means of the BCOP assay using fresh bovine corneae.
After a first opacity measurement of the fresh bovine corneae (to), the neat test item D­ Panthenyltriacetate, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 2 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t10) . Further, the corneae were incubated for another 120 minutes at 32 ± 2 °C in complete medium, and opacity was measured a third time (t130).
After the opacity measurements permeability of the corneae was determined while application of 1 ml of a fluorescein solution for 90 minutes at 32 ± 2 °C in a horizontal position. The liquid coming out was measured spectrophotometrically.

With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed.

The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as severe eye irritant.

The test item D-Panthenyltriacetate did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 0.16 and therefore, the test item was classified as non eye irritant.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item D-Panthenyltriacetate is not considered to be an eye irritant.