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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-253-4 | CAS number: 1419212-73-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06-10-2012 to 09-10-2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed according to the guideline and under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- other: EU B40bis (EC440/2008)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole
- EC Number:
- 800-253-4
- Cas Number:
- 1419212-73-9
- IUPAC Name:
- 2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from"
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark
Constituent 1
Test system
- Details on study design:
- The EpiSKIN assay uses reconstructed human epidermis to assess skin corrosion. For the viability test enzymatic conversion of MTT to formazan is used.
In a pre-test direct interaction of the test substance with the detection chemical MTT is assessed. As the substance showed interference additional controls were added (water killed EPISKIN tissues).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 94.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 74.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 min
- Value:
- 84.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test substance interfered with the reduction of MTT to blue formazan salt. Direct reduction compared to negative controls was 6.1 to 29.1% (validity criterion < 30%).
Any other information on results incl. tables
Exposure time |
Mean corrected OD540 |
Correction applied |
Relative mean viability |
|
Negative control: |
240 min |
0.772 |
|
100 % |
Positive controls: |
240 min |
0.029 |
|
3.8% |
Test substance |
3 min 60 min 240 min |
0.727* 0.577* 0.655* |
0.046# 0.197# 0.225# |
94.2% 74.7% 84.8% |
* TODTT = [ODTV – (ODkt - ODku)]
# correction value: ODkt - ODku
ODTV : chemical treated viable tissues
TODTT : true MTT metabolic conversion for treated tissue.
ODku : untreated killed tissues
ODkt: chemical treated killed tissues
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is non-corrosivein the EPISKIN reconstructed human epidermal model.
- Executive summary:
In the EpiSKIN test, tissues of reconstructed human skin were treated with 50 uL of the test substance in duplicate during 3, 60 and 240 minutes. After treatment tissues were rinsed and incubated with MTT for 3 hours (at room temeprature). Thereafter tissues were allowed to dry, epidermis and collagen were separated, suspended (after vortexing) in isopropanol and kept overnight (all procedures in dark). Optical density of homogene solutions of MTT treated tissues was measured at 540 nm. As the test substance was shown to interfere with the MTT reduction, additional controls were included (non-viable tissue). Viability was expressed as the corrected percentage MTT conversion versus negative control. The true viability was 74.7 -94.2% for the different exposure times, which is indicative for non-corrosive substances.
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.
