Registration Dossier
Registration Dossier
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EC number: 948-946-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of bis(2-ethylhexyl) adipate and cyclohexyl 2-ethylhexyl adipate and dicyclohexyl adipate
- EC Number:
- 948-946-1
- Molecular formula:
- C20H36O4, C18H30O4, C22H42O4
- IUPAC Name:
- Reaction mass of bis(2-ethylhexyl) adipate and cyclohexyl 2-ethylhexyl adipate and dicyclohexyl adipate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 30869
- Expiration date of the lot/batch: 2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- EpiOcular OCL-200 kit from MatTek In Vitro Life Sciences, Bratislave, Slovakia
Reconstructed cornea: three-dimensional non-keratinized tissue construct composed of normal human-derived epidermal keratinocytes
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- other: MTT reduction control
- Amount / concentration applied:
- 50µl
- Duration of treatment / exposure:
- 30min
- Duration of post- treatment incubation (in vitro):
- 2h
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: tissue viability
- Value:
- 103
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Test substance |
|
tissue 1 |
tissue 2 |
mean |
inter-tissue variability [%] |
NC |
mean OD570 |
2.205 |
2.233 |
2.219 |
|
viability [% of NC] |
99.4 |
100.6 |
100.0 |
1.2 |
|
18/0104-1 |
mean OD570 |
2.308 |
2.242 |
2.275 |
|
viability [% of NC] |
104.0 |
101.0 |
102.5 |
3.0 |
|
PC |
mean OD570 |
0.810 |
0.671 |
0.741 |
|
viability [% of NC] |
36.5 |
30.2 |
33.4 |
6.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that Reaction mass of Hexanedioic acid, 1-cyclohexyl 6-(2-ethylhexyl) ester, Hexanedioic acid, 1,6-dicyclohexyl ester and Hexanedioic acid, 1,6-bis(2-ethylhexyl) ester does not show an eye irritation potential in the EpiOcular™ in vitro eye irritation test under the test conditions chosen.
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