Registration Dossier
Registration Dossier
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EC number: 294-347-7 | CAS number: 91697-85-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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)
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
- EC Number:
- 294-347-7
- EC Name:
- Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
- Cas Number:
- 91697-85-7
- Molecular formula:
- Not available
- IUPAC Name:
- Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Details on the study design:
- A valid KeratinoSensTMassay was performed according to OECD 442D and GLP. For the KeratinoSensTMassay 03590was dissolved in ethanolat 5 mg/mL. From this stock 11 spike solutions in ethanolwere prepared. The stock and spike solutions were diluted 400-fold in the assay resulting in test concentrations of 0.006 -13μg/mL(2-fold dilution series)in the first and second experiment and resulting in test concentrations of 0.15 -13μg/mL (1.5-fold dilution series) in the third experiment. The highest test concentration was considered to be the limit of solubility. Noprecipitate was observed at any dose level tested
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Experiment 1
- Parameter:
- other: maximum luciferase activity induction
- Value:
- 1.38
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- 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.
