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Registration Dossier
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EC number: 252-939-2 | CAS number: 36265-41-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018 -2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 25 Jun 2018
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test
- Version / remarks:
- Summary, 22 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals For use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model
- Version / remarks:
- 29 June 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate
- EC Number:
- 252-939-2
- EC Name:
- Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate
- Cas Number:
- 36265-41-5
- Molecular formula:
- C33H59NO4
- IUPAC Name:
- didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- The EpiOcular™ tissues are provided as kits (e.g. OCL-200-EIT; MatTek), consisting of the following components relevant for this study:
1x sealed 24-well plate containing 24 inserts with EpiOcular™ tissues on agarose
1x bottle EpiOcularTM assay medium
1x bottle Ca2+/Mg2+-free DPBS buffer
Test system
- Vehicle:
- water
- Controls:
- yes
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 108
- Negative controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The relative mean viability of the test item treated tissues was 108 %. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In the present study the eye irritating potential of Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate was analysed. Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcular, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 6 h exposure period and 18 h post-treatment period and compared to those of the concurrent negative controls.
The mixture of 50 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 50 mg test item per 1 mL Aqua dest. and 2 mL isopropanol showed colouring as compared to the solvent. Since the mean relative tissue viability of the test item treated tissues (TM) was above the 60% threshold value coloured tissue controls were performed for quantitative correction of results.
NSCliving [%] = [ODTVT/ODNC] * 100 = 0.7%
Difference of NSCliving of the two duplicate tissues must be < 20%, otherwise not accepted.
NSC1 [%] = [ODTVT1 / ODNC] * 100 = 0.7%
NSC2 [%] = [ODTVT2 / ODNC] * 100 = 0.7%
NSC1 – NSC2 = ± 0.0%
NSCliving was ≤ 60% (0.7%) relative to the negative control of living epidermis and could therefore be used for determination of the NSC-corrected mean relative tissue viability (NSCCV) according to the following formula:
NSCCV [%] = viabilityTM [%] – NSCliving [%] = 108.7% - 0.7% = 108.0%
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (108.0%, NSCliving-corrected).
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