Registration Dossier
Registration Dossier
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EC number: 227-572-6 | CAS number: 5892-47-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, number 442c “In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)” (adopted: February 04, 2015)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Details on the study design:
- Preparation of test item solution: the test item was dissolved in acetonitrile and a stock solution of 100 mM was prepared, whereby the purity of the registration substance in the test item was taken in account.
Incubation of test item with peptide solution: The test item solution were incubated with the cystein and lysine peptide solutions in glass vials using defined ratios of test item to peptide (10 cyctein peptide, 60 lysine peptide). The reaction solutions were lefr in the dark at 25 ± 2 hours before running the HPLC analysis. Reference controls, co-elution controls as well as the cynnamic aldehyde as positive control were set up in parallel. - Positive control results:
- The mean percent peptide depletion value of the three replicates for the positive control (cinnamic aldehyde) was between 60.8% and 100% for the cysteine peptide.
The mean percent peptide depletion value of the three replicates for the positive control (cinnamic aldehyde) was between 40.2% and 69.0% for the lysine peptide. - Key result
- Parameter:
- other: percentage cyctein peptide depletion
- Remarks:
- mean of three replicates
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Parameter:
- other: percentage lysine peptide depletion
- Remarks:
- mean of three replicates
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: The obtained results in this study alone cannot be used for the classification
- Conclusions:
- The skin sensitization property of the registration substance was investigated using the Direct Pepride Reactivity Assay (DPRA) according to the Guideline 442c. A negative result was obtained. No significant binding affinity to the cysteine or lysine of the peptide was found, indicating no acitivation of one of the key events in the adverse outcome pathway.
- Executive summary:
The skin sensitization property of the registration substance was investigated using the Direct Pepride Reactivity Assay (DPRA) according to the Guideline 442c. A negative result was obtained. No significant binding affinity to the cysteine or lysine of the peptide was found, indicating no acitivation of one of the key events in the adverse outcome pathway.
Reference
Results of the Cysteine Peptide Depletion |
||||||
Sample |
Peak Area at 220 nm |
Peptide Concentration [mM] |
Peptide Depletion [%] |
Mean Peptide Depletion [%] |
SD of Peptide Depletion [%] |
CV of Peptide Depletion [%] |
Positive Control |
1320.4471 |
0.1577 |
70.95 |
71.10 |
0.18 |
0.25 |
1315.4908 |
0.1571 |
71.06 |
||||
1304.7782 |
0.1559 |
71.29 |
||||
Test Item |
4599.0210 |
0.5435 |
0.00 |
0.00 |
0.00 |
- |
4764.8755 |
0.5631 |
0.00 |
||||
4555.8262 |
0.5385 |
0.00 |
||||
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|
|
|
|
|
|
Results of the Lysine Peptide Depletion |
||||||
Sample |
Peak Area at 220 nm |
Peptide Concentration [mM] |
Peptide Depletion [%] |
Mean Peptide Depletion [%] |
SD of Peptide Depletion [%] |
CV of Peptide Depletion [%] |
Positive Control |
1660.4912 |
0.2034 |
59.71 |
60.33 |
0.55 |
0.92 |
1627.6788 |
0.1994 |
60.51 |
||||
1616.5613 |
0.1980 |
60.78 |
||||
Test Item |
4253.7705 |
0.5204 |
0.00 |
0.00 |
0.00 |
- |
4218.3535 |
0.5161 |
0.00 |
||||
4216.4116 |
0.5158 |
0.00 |
||||
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|
|
|
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The skin sensitization property of the registration substance was investigated using the Direct Pepride Reactivity Assay (DPRA) according to the Guideline 442c. A negative result was obtained, supporting no classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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