Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-207-3 | CAS number: 6168-72-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- DL-2-aminopropan-1-ol
- EC Number:
- 228-207-3
- EC Name:
- DL-2-aminopropan-1-ol
- Cas Number:
- 6168-72-5
- Molecular formula:
- C3H9NO
- IUPAC Name:
- 2-aminopropan-1-ol
1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ Skin Model (MatTek Corporation, MA, USA)
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- neat (undiluted)
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- The test article, the negative control (sterile, deionized water), and the positive control (8N KOH) were tested by treating four EpiDerm™ tissues per test article/control. Two tissues were used to assess viability after the 3-minute exposure, and two were used to assess viability after the 60-minute exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute exposure
- Value:
- 26.69
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-minute exposure
- Value:
- 9.84
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Corrosive
- Other effects / acceptance of results:
- The test article was observed to reduce MTT directly in the absence of viable cells. A killed control experiment was performed concurrently in the definitive assay. Additional calculations were performed to account for the direct MTT reduction.
The test article was determined not to have probable photometric MTT interference. Therefore, colorant controls were not performed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Results warrant 1B/1C sub-category. As a worst-case, 1B is concluded.
- Executive summary:
In the Episkin model, the test article was classified as corrosive with sub-category 1B/1C. Classification in catgeory 1B was concluded as a worst-case.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
