Registration Dossier
Registration Dossier
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EC number: 205-137-1 | CAS number: 134-31-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2018
- 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:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Bis(8-hydroxyquinolinium) sulphate
- EC Number:
- 205-137-1
- EC Name:
- Bis(8-hydroxyquinolinium) sulphate
- Cas Number:
- 134-31-6
- Molecular formula:
- C9H7NO.1/2H2O4S
- IUPAC Name:
- bis(8-hydroxyquinolinium) sulphate
- Test material form:
- solid: particulate/powder
- Remarks:
- yellow powder
Constituent 1
In chemico test system
- Details on the study design:
- DPRA is a chemical method proposed to address the molecular initiating event of the skin sensitization AOP (adverse outcome pathway), i.e. protein reactivity, by quantifying the reactivity of the test chemical towards model synthetic peptides containing Lysine or Cysteine. After peptide-test chemical incubation the concentration of Cysteine- or Lysine-containing peptide is quantified by HPLC-UV and the percent peptide depletion is determined. On the base of obtained results, the substance is categorized in one of four reactivity classes for supporting the discrimination between skin sensitizers and non-sensitizers.
DPRA assay required the analysis of two independent analytical sequences (Cysteine and Lysine assay), that evaluate three independent preparations of Peptide/Test Chemical reactivity tests.
For each analytical sequence, fresh stock and working solutions of the test chemical as well as of peptides and reference controls have been prepared.
Results and discussion
- Positive control results:
- Co-elution of test chemical with Lysine-containing peptide was excluded since no peaks vere detected at the retention time of Lysine peak in Test Chemical co-elution control.
Co-elution of test chemical with Cysteine-containing peptide was exciuded since no peaks were detected at the retention time of Cysteine peck in Test Chemical co-elution control.
In vitro / in chemico
Resultsopen allclose all
- Parameter:
- other: cysteine peptide depletion
- Value:
- 39.88
- Vehicle controls validity:
- valid
- Remarks:
- phosphate buffer and water
- Positive controls validity:
- valid
- Remarks:
- cinnamic aldehyde
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- moderate
- Parameter:
- other: Lysine peptide depletion
- Value:
- 0.49
- Vehicle controls validity:
- valid
- Remarks:
- acetonitrile
- Positive controls validity:
- valid
- Remarks:
- Cinnamic Aldehyde
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- precipitation is observed
- Other effects / acceptance of results:
- On the base of Cysteine obtained results (mean Cysteine peptide depletion = 41,38 ± 1,5), the test substance should be considered a moderate sensitizer.
On the base of Lysine obtained results (Lysine peptide depletion = 0,57 ± 0,8), 8-hydroxyquinoline sulphate (batch 170330) test substance should be considered non sensitizer. However, considering that precipitation is observed immediateiy upon addition of the Test Chemical solution, the obtained negative results have to be considered uncertain and caution should be used in interpreting this data.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met: yes
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The substance can be considered a moderate sensitizer.
- Executive summary:
This substance was tested according to OECD TG 442C: due to measurable delpletion of cys-peptide, this substance is considered a moderate sensitiser.
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