Registration Dossier
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EC number: 271-272-8 | CAS number: 68527-63-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-05-31 to 2018-06-28
- 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:
- 2018
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:
- 2017-10-09
- Qualifier:
- according to guideline
- Guideline:
- other: 4.2.2 DB-ALM Protocol n° 190: SkinEthicTM HCE Eye Irritation Test Liquid (EITL)
- Version / remarks:
- 2017-06-07
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- EC Number:
- 271-272-8
- EC Name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- Cas Number:
- 68527-63-9
- Molecular formula:
- C22H42N2O.C4H10O4S
- IUPAC Name:
- 2-{2-[(8E)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol diethyl sulfate
- Test material form:
- liquid
- Details on test material:
- Test item formulations were found to be homogeneous and stable up to 24 hour in vehicle corn oil.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
R-127 / batch no. 180131
- Expiration date of the lot/batch:
2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Dry and dark at ambient temperature (10 – 30 °C)
- Stability under test conditions:
stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
Test animals / tissue source
- Species:
- human
- Strain:
- other: RhCE
- Details on test animals or tissues and environmental conditions:
- Test system: Reconstructed Human Corneal Epithelium, small, age day 5 (area: 0.5 cm2)
Source:
EPISKIN SNC
4, rue Alexander Fleming
69366 - Lyon Cedex 7
FRANCE
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
Application Substance Duration
Test substance 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item 30 ± 2 min
Negative contro 30 ± 2 µl 0.01M PBS pH = 7.4 30 ± 2 min
Positive control 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl methyl acetate 30 ± 2 min- Duration of treatment / exposure:
- Duration was 30 ± 2 min
- Duration of post- treatment incubation (in vitro):
- 37 ± 2 oC, 5 ± 1 % CO2, ≥ 90% humidity for 3 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- T1- (final), 30 min exposure
- Value:
- 26.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- T-2 (final) 30 min exposure
- Value:
- 19.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- Mean viablity both runs
- Value:
- 22.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is considered: No prediction can be made.
- Executive summary:
The substance Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) was examined for eye irrittaing and eye damaging properties in a study according to OECD 492.
The results do not allow a decision on C&L.
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