Registration Dossier
Registration Dossier
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EC number: 205-858-1 | CAS number: 156-57-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01/02/2018-28/02/2018
- 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 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)
- Version / remarks:
- OECD, 2017
- GLP compliance:
- yes
Test material
- Reference substance name:
- Mercaptamine hydrochloride
- EC Number:
- 205-858-1
- EC Name:
- Mercaptamine hydrochloride
- Cas Number:
- 156-57-0
- Molecular formula:
- C2H7NS.ClH
- IUPAC Name:
- 2-aminoethanethiol hydrochloride
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- The test system used in this study is Reconstructed Human Cornea-like Epithelium (RhCE).
RhCE cell construct is a nonkeratinized epithelium composed of normal human keratinocytes in a three-dimensional structure. It mimics the corneal epithelium with progressively stratified but not cornified cells.
Test animals / tissue source
- Species:
- human
- Strain:
- other: KERATINOCYTES - 4F1188
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Sufficient amount of test item to cover the entire tissue surface.
- Duration of treatment / exposure:
- 5 hours and 58 minutes.
- Duration of post- treatment incubation (in vitro):
- 18 hours.
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: tissue viability
- Value:
- ca. 3.23
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test method and test conditions employed the tissues treated with test item cisteamine hydrochloride showed a relative percent viability < 60 % hence, it is concluded that the test item cisteamine hydrochloride was Irritant (I).
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