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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 295-171-3 | CAS number: 91845-01-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.06.2018 - 16.11.2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
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 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- Adopted February, 2015
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- The objective of this study was to evaluate the ability of 03590 to activate the antioxidant/electrophile responsive element (ARE)-dependent pathway in the KeratinoSens assay.
Test material
- Reference substance name:
- Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine
- EC Number:
- 295-171-3
- EC Name:
- Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine
- Cas Number:
- 91845-01-1
- Molecular formula:
- C24H48NO4, C25H51N2O3
- IUPAC Name:
- 2-(dimethylamino)ethyl hexadecanoate; 2-(dimethylamino)ethyl octadecanoate; N-[3-(dimethylamino)propyl]hexadecanamide; N-[3-(dimethylamino)propyl]octadecanamide
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Details on the study design:
- The design of this study is based on the following study guideline:
OECD Guideline TG 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method (adopted February, 2015).
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Maximum Luciferase Activity Induction
- Value:
- 1.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: 2
- Parameter:
- other: Maximum Luciferase Activity Induction
- Value:
- 1.76
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: Maximum Luciferase Activity Induction
- Value:
- 1.55
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
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.
