Registration Dossier
Registration Dossier
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EC number: 609-091-7 | CAS number: 35202-54-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- other: OECD Guidelines for the Testing of Chemicals: OECD 442E; In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation. Annex I: In Vitro Ski
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals: OECD 442E; In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation. Annex I: In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT), October 2017.
- Deviations:
- yes
- Remarks:
- Deviation to the OECD Guideline: • The cytotoxicity measurement and estimation of the CV75 value of the dose finding assay is performed by XTT test instead of flow cytometry. The technical proficiency of the h-CLAT with the OECD 442E guideline recommended
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- 3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-triene-7-carbonitrile
- EC Number:
- 609-091-7
- Cas Number:
- 35202-54-1
- Molecular formula:
- C11H11NO2
- IUPAC Name:
- 3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-triene-7-carbonitrile
Constituent 1
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Cell Viability (%)
- Value:
- 50.8
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Name: DNCB (2,4-dinitrochlorobenzene, CAS No.: 97-00-7) final concentration: 2 and 3 μg/mL, Purity ≥ 99%) Solvent: DMSO
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: Cell Viability (%)
- Value:
- 57.1
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Name: DNCB (2,4-dinitrochlorobenzene, CAS No.: 97-00-7) final concentration: 2 and 3 μg/mL, Purity ≥ 99%) Solvent: DMSO
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item CYANOBICYCLE with a log Pow of 1.22 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).
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