Registration Dossier
Registration Dossier
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EC number: 214-882-1 | CAS number: 1205-30-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- 4-chloro-5-sulphamoylbenzoic acid
- EC Number:
- 214-882-1
- EC Name:
- 4-chloro-5-sulphamoylbenzoic acid
- Cas Number:
- 1205-30-7
- Molecular formula:
- C7H6O4NClS
- IUPAC Name:
- 4-chloro-3-sulfamoylbenzoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
In chemico test system
- Details on the study design:
- Solutions of ÁCIDO SULFAMOIL were successfully analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Cysteine
- Parameter:
- other: Mean peptide depletion by Acido Sulfamoil (%)
- Remarks:
- The DPRA prediction and the reactivity of Acido Sulfamoil based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
- Value:
- 1.18
- Key result
- Run / experiment:
- other: Lysine
- Parameter:
- other: Mean peptide depletion by Acido Sulfamoil(%)
- Remarks:
- The DPRA prediction and the reactivity of Acido Sulfamoil based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
- Value:
- 1.41
Applicant's summary and conclusion
- Interpretation of results:
- other: not to be a potential skin sensitizer.
- Conclusions:
- Solutions of ÁCIDO SULFAMOIL were successfully analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. The mean peptide depletion in the presence of the test item was 1.30% placing ÁCIDO SULFAMOIL in the reactivity class of “minimal” and hence it is predicted by DPRA not to be a potential skin sensitizer.
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