Registration Dossier
Registration Dossier
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EC number: 214-071-2 | CAS number: 1077-28-7
Eye irritation
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:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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. QA statement)
Test material
- Reference substance name:
- 5-(dithiolan-3-yl)valeric acid
- EC Number:
- 214-071-2
- EC Name:
- 5-(dithiolan-3-yl)valeric acid
- Cas Number:
- 1077-28-7
- Molecular formula:
- C8H14O2S2
- IUPAC Name:
- 5-(1,2-dithiolan-3-yl)pentanoic acid
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- 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
Constituent 1
impurity 1
impurity 2
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 validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- IVIS: 1.63
- Positive controls validity:
- valid
- Remarks:
- IVIS: 122.97
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 36.54
- Vehicle controls validity:
- not examined
- Remarks:
- Corrected opacity: 0
- Negative controls validity:
- valid
- Remarks:
- Corrected opacity: 101
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- Corrected OD490
- Value:
- ca. 0.002
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- 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. Further testing in another suitable method is to be done with tonnage band increase.
- 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.
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