Registration Dossier
Registration Dossier
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EC number: 208-831-2 | CAS number: 542-85-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- 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:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Ethyl isothiocyanate
- EC Number:
- 208-831-2
- EC Name:
- Ethyl isothiocyanate
- Cas Number:
- 542-85-8
- Molecular formula:
- C3H5NS
- IUPAC Name:
- ethyl isothiocyanate
- Test material form:
- liquid
Constituent 1
In chemico test system
- Details on the study design:
- the test item and the positive conrol were prepared at 100 mM in acetonitrile, and were incubated in excess with the peptides at 1:10 and 1:50 ratio for cysteine and lysine peptides respectiveley.
each sample was tested 3 times from 3 independant solutions.
Results and discussion
- Positive control results:
- Depletion in lysine peptide : 56.23% (mean)
Depletion in cysteine peptide : 71.45% (mean)
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- mean
- Parameter:
- other: depletion in lysine peptide %
- Value:
- 41.79
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: depletion in cysteine peptide %
- Value:
- 95.41
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: use to support the identification of the sensitization potential
- Conclusions:
- The sensitivity of the test item is evaluated accodring to OECD 442C method. In the test conditions, the test substance shows mean depletion of 41.79% for lysine and 95.41% for cysteine, i;e; an overall average of 68.6% reflecting a high reactivity and thus a positive prediction of DPRA.
- Executive summary:
The sensitivity of the test item is evaluated accodring to OECD 442C method. In the test conditions, the test substance shows mean depletion of 41.79% for lysine and 95.41% for cysteine, i;e; an overall average of 68.6% reflecting a high reactivity and thus a positive prediction of DPRA.
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