Registration Dossier
Registration Dossier
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EC number: 608-174-5 | CAS number: 28183-82-6
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- KeratinoSens method
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- In-vitro test
- Specific details on test material used for the study:
- Dried matrial with > 90% actives described as viscous liquid
- Details on the study design:
- Concentrations tested : 400, 200, 100, 50, 25, 12.5, 6.25, 3.125, 1.563, 0.781, 0.391, 0.195 mg/l expressed as water-free material using DMSO as a vehicle
Negative control : DMSO
Positive control : Cinnamic aldehyde
Three repetitions (runs) were performed. Each repetition consisted of 3 x 96-well plates for luminescence - Run / experiment:
- other: 1
- Parameter:
- other: Viability %
- Value:
- 71
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Run / experiment:
- other: 2
- Parameter:
- other: Viability %
- Value:
- 63
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Run / experiment:
- other: 3
- Parameter:
- other: Viability %
- Value:
- 74
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Cell viability was not reduced below 50%
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classified as Negative using the KeratinoSens prediction model.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Performed to GLP using guidelines current in 2018
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Principles of method if other than guideline:
- Useof cysteine and lysine
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- In vitro test
- Specific details on test material used for the study:
- Dried matrial used
Purity 92.5%
Molecular weight used for calculations 113 g/mol
Appearance, Greenish-yellow liquid - Details on the study design:
- The underlying rationale of the assay is that if a chemical is capable of reacting with proteins then it has the potential to act as a sensitizer. The endpoint measured in the assay is the percentage depletion over time of two synthetic peptides (containing respectively a cysteine and a lysine amino acid) from the peptide mixtures following an approximate 24 hour (22-26 hours) incubation with the test item. The percentage of peptide depletion is calculated by High Performance Liquid Chromatography using ultra-violet detection.
- Run / experiment:
- other: 1
- Parameter:
- other: Peptide depletion %
- Remarks:
- Cysteine
- Value:
- 1.95
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Run / experiment:
- other: 2
- Parameter:
- other: Peptide depletion
- Remarks:
- Lysine
- Value:
- -0.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- No other adverse effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Solutions were analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. The mean result of 0.974% depletion places M153 in the reactivity class of minimal and therefore it is predicted by DPRA to be a non-skin sensitiser.
Referenceopen allclose all
Solutions were analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. The mean result of 0.974% depletion places M153 in the reactivity class of minimal and therefore it is predicted by DPRA to be a non-skin sensitiser.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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