Registration Dossier
Registration Dossier
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EC number: 948-544-6 | CAS number: 2141947-89-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Remarks:
- Direct Peptide Reactivity Assay (DPRA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Mar 2018 to 05 Apr 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Guideline 442C. In Chemico Skin
Sensitization: Direct Peptide Reactivity Assay (DPRA) (4 February 2015) - Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Direct Peptide Reactivity Assay (DPRA)
Test material
- Reference substance name:
- 4-[3-formyl-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]benzonitrile
- EC Number:
- 948-544-6
- Cas Number:
- 2141947-89-7
- Molecular formula:
- C20H20BNO4
- IUPAC Name:
- 4-[3-formyl-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]benzonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Purity 99.73%
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: Cysteine Reactivity Assay
- Parameter:
- other: mean Percent SPCC Depletion for the test item
- Value:
- 66.5
- Run / experiment:
- other: Lysine Reactivity Assay
- Parameter:
- other: mean Percent SPCL Depletion for the Test Item
- Value:
- 4.2
- Run / experiment:
- other: Cysteine 1:10 / Lysine 1:50 prediction model
- Parameter:
- other: DPRA prediction and reactivity classification
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- In conclusion, this DPRA test is valid. PF-06961030 was positive in the DPRA and was classified in the “moderate reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model
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