Registration Dossier
Registration Dossier
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EC number: 608-174-5 | CAS number: 28183-82-6
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 2-Propenenitrile, polymer with 1,2-ethanediamine
- EC Number:
- 608-174-5
- Cas Number:
- 28183-82-6
- IUPAC Name:
- 2-Propenenitrile, polymer with 1,2-ethanediamine
- Test material form:
- liquid: viscous
- Details on test material:
- Named in some reports as 2-propenenitrile, polymer with 1,2-ethanediamine
Dried material, described as viscous liquid, is used for some tests.
Constituent 1
- Specific details on test material used for the study:
- Dried matrial with > 90% actives described as viscous liquid
In vitro test system
- 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
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- 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%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classified as Negative using the KeratinoSens prediction model.
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