Registration Dossier
Registration Dossier
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EC number: 206-746-5 | CAS number: 372-18-9
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:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: cysteine (Cys-) and lysine (Lys-) containing peptides.
Test material
- Reference substance name:
- 1,3-difluorobenzene
- EC Number:
- 206-746-5
- EC Name:
- 1,3-difluorobenzene
- Cas Number:
- 372-18-9
- Molecular formula:
- C6H4F2
- IUPAC Name:
- 1,3-difluorobenzene
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Parameter:
- other: Mean peptide depletion [%]
- Value:
- 3.31
Any other information on results incl. tables
Several experiments were performed, one of them was invalid. The peptide depletion values after incubation of valid experiments are shown in Table 3-a:
Table3-a Results
|
Cys-peptide |
Lys-Peptide |
Mean peptide |
First experiment |
6.46 |
0.16 |
3.31 |
Verification |
3.11 |
0.01 |
1.56 |
The DPRA prediction is “negative” with minimal reactivity according to the Cysteine 1:10/Lysine 1:50 prediction model.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- negative
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