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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 604-144-0 | CAS number: 139525-77-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 604-144-0
- EC Number:
- 604-144-0
- Cas Number:
- 139525-77-2
- Molecular formula:
- C13H15NO.HCl
- IUPAC Name:
- 604-144-0
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Constituent 1
- Specific details on test material used for the study:
- Batch : 18113833Purity : 100,7%Expiry date : 1 septembre 2018Storage conditions : room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- negative control : 50 µLpositive control : 50 µLTest item : 25 mg
- Duration of treatment / exposure:
- 3 mn and 60 mn
- Duration of post-treatment incubation (if applicable):
- 60 mn
- Number of replicates:
- 2 per dose/ control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 mn
- Value:
- ca. 70.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 mn
- Value:
- ca. 13.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean OD562 for the negative control treated tissues was 1.720 for the 3-Minute exposure period and 1.541 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.The relative mean tissue viability for the positive control treated tissues was 6.1% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test item was considered to be corrosive to the skin.EU CLP Regulation (EC) No 1272/2008 and UN GHS Hazard statement H314 “Causes severe skin burns and eye damage” Category 1B or 1C.UN Packing Group II or III “Substance Presenting Minor or Medium Danger”.
- Executive summary:
The Mephtamin-HCL, on the basis of EPIDERM Skin Corrosion Test, is considered to be corrosive to the skin (Category 1)
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.
