Registration Dossier
Registration Dossier
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EC number: 205-858-1 | CAS number: 156-57-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2018 - March 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Source strain:
- other: 09-KERA-007 + 09-KERA-010
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 20 mg/tissue
- Duration of treatment / exposure:
- 3, 60 , 240 min
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 80.46
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no corrosive
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since, the tissue viability is 80.46 % after the 240-minute exposure, the test item Cysteamine Hydrochloride is predicted to be non-corrosive under the experimental conditions described .
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