Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-01-20 - 2017-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 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)
Deviations:
yes
Remarks:
Phenol red free RPMI 1640 medium instead of phenol red free EMEM
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk
Details on test material:
This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
The Assay uses isolated corneas obtained as a by-product from animals freshly slaughtered.

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Negative control: physiological saline 0.9 % NaCl
Positive control: Imidazole 20 % in physiological saline 0.9 % NaCl
Test item: 20 % suspended in physiological saline 0.9 % NaCl
Duration of treatment / exposure:
4 h
Number of animals or in vitro replicates:
3 corneas in each group

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Value:
ca. 36.57
Vehicle controls valid:
not examined
Negative controls valid:
yes
Remarks:
IVIS: 1.63
Positive controls valid:
yes
Remarks:
IVIS: 122.97
Irritation parameter:
cornea opacity score
Value:
ca. 36.54
Vehicle controls valid:
not examined
Remarks:
Corrected opacity: 0
Negative controls valid:
yes
Remarks:
Corrected opacity: 101
Positive controls valid:
yes
Irritation parameter:
fluorescein leakage
Remarks:
Corrected OD490
Value:
ca. 0.002
Negative controls valid:
yes
Positive controls valid:
yes
Remarks:
1.462

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No prediction can be made regarding the classification of the test substance Thioctic Acid to the evaluation criteria. Furhter testing in another suitable method is required.
Executive summary:

The eye irritancy potencial of Thioctic Acid was investigated in the bovine corneal opacity and permeability assay.

The test item was suspended with physiologicalsaline 0.9 % to give a 20 % concentration.

Mean in vitro irritation score: 36.57

Classification: No prediction can be made

The in vitro irritation score obtained with the positive control fell witin the two standard deviations of the current historical mean and therefore this assay is concidered to be valid.

The negative control responses should result in opacity and permeability values that are less the establisched upper limits for background bovine corneas treated with the respective negative control.