Registration Dossier
Registration Dossier
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EC number: 256-350-1 | CAS number: 48076-38-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Expert Statement
- Type of information:
- other: Expert Statement
- Adequacy of study:
- supporting study
- Study period:
- 2013-02-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The combination of the individual test methods into the test battery evaluation is performed as described in the following publication:
-Bauch C Knolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R., 2012. Putting the parts together: combining in vitro methods to test for skin sensitizing potentials. Regul Toxicol Pharmacol. 63: 489-504. - GLP compliance:
- yes
- Remarks:
- Expert Statement (All studies were conducted in accordance with GLP.)
- Type of study:
- other: Expert Statement
Test material
- Reference substance name:
- 2-Propenoic acid, C16-18-alkyl esters
- EC Number:
- 292-060-1
- EC Name:
- 2-Propenoic acid, C16-18-alkyl esters
- Cas Number:
- 90530-21-5
- IUPAC Name:
- 2-Propenoic acid, C16-18-alkyl esters
Constituent 1
In vivo test system
Test animals
- Details on test animals and environmental conditions:
- The data used for the evaluation of the in vitro sensitization potential of the test item were generated in separate in vitro sensitization studies:
- Direct Peptide Reacitivity Assay (DPRA)
- Keratinocyyte Activation Assay- LuSens
- Dendritic Cell Line Acitivation Assay Myeloid U937 Skin Sensitization Test (MUSST)
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: DPRA
- Parameter:
- other: peptide depletion [%]
- Value:
- 12.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Run / experiment:
- other: LuSens
- Parameter:
- other: luciferase activity induction
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Run / experiment:
- other: MUSST
- Parameter:
- other: CD86 expression induction
- Value:
- 1.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
for deteils see "Overall remarks, attachments"
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the results and applying the evaluation criteria the test substance is predicted to be a skin sensitizer.
- Executive summary:
A combination of several in vitro methods addressing key steps of the adverse outcome pathway (AOP) for skin sensitization as defined by OECD, has been conducted to assess the skin sensitizing potential of the test substance,
- protein reactivity (DPRA),
- activation of keratinocytes (LuSens), and
- activation of dendritic cells (MUSST).
In this report, the results of the individual studies are summarized and evaluated to predict the presence or absence of skin sensitizing potential of the test substance.
The combination of test methods and the evaluation of their results has been evaluated and published by Bauch et al., 2012. Based on the performance standards of the OECD test guideline No. 429 (Local Lymph Node Assay, LLNA, OECD 2010), the evaluation based on the DPRA, LuSens and MUSST methods yields an overall accuracy of 95 % compared to results in humans (for comparison: for the same data set the LLNA yielded an overall accuracy of 86 %). A skin sensitizing (quantitative) potency assessment using the reported results was not validated at the time of writing this report.
Based on the results and applying the evaluation criteria the test substance is predicted to be a skin sensitizer.
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