Registration Dossier
Registration Dossier
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EC number: 675-808-5 | CAS number: 18611-43-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Remarks:
- Direct peptide reactivity Asay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.8-15.9.2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins)
- Version / remarks:
- June 2021
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- 1,1,3,3-tetrachloroprop-1-ene
- EC Number:
- 675-808-5
- Cas Number:
- 18611-43-3
- Molecular formula:
- C3H2Cl4
- IUPAC Name:
- 1,1,3,3-tetrachloroprop-1-ene
- Test material form:
- liquid
- Details on test material:
- concentration 99,87%
Constituent 1
In chemico test system
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- Details on the study design:
- Cysteine peptide
Name: Cysteine peptide
Batch: 111016HS-MHeW0321
Storage: at -20°C or below
Purity: 90.1 %
Molecular weight: 750.88 g/mol
Sequence: Ac-RFAACAA-OH
Expiry date: September 10, 2021 - Vehicle / solvent:
- acetonitrile
- Positive control:
- cinnamic aldehyde
Results and discussion
- Positive control results:
- positive control, from
absorbance at 220 nm measuring the peak area of the appropriate peaks and calculating the
concentration of the peptide using the linear calibration curves derived from the calibration
standards
the mean percent peptide depletion value of the three replicates for the positive control
cinnamaldehyde should be between 60.8% and 100% for the cysteine peptide and between
40.2% and 69.0% for the lysine peptide and the maximum standard deviation (SD) for the
positive control replicates should be < 14.9% for the percent cysteine depletion and
< 11.6% for the percent lysine depletion
In vitro / in chemico
Results
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean cystein depletion
- Value:
- 67 %
- At concentration:
- 0.49 mM
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on these results and the cysteine 1:10 / lysine 1:50 prediction model, the test item
“1133-Tetrachloropropene” was concluded to be positive and to show high reactivity
towards the synthetic peptides thus is a potential skin sensitizer under the
experimental conditions of the in chemico Direct Peptide Reactivity Assay (DPRA)
method. - Executive summary:
Based on these results and the cysteine 1:10 / lysine 1:50 prediction model, the test item
“1133-Tetrachloropropene” was concluded to be positive and to show high reactivity
towards the synthetic peptides thus is a potential skin sensitizer under the
experimental conditions of the in chemico Direct Peptide Reactivity Assay (DPRA)
method.
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