Registration Dossier
Registration Dossier
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EC number: 947-738-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
No sensitizing potential has been shown in the skin sensitization tests.
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
- Study period:
- July 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Non-GLP study, but performed according GLP rules, based on SOP.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442E
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Non-GLP study, but performed according GLP rules, based on SOP.
- Type of study:
- activation of dendritic cells
- Details on the study design:
- Selected concentrations: 35, 42, 50, 60, 72, 87, 104, 125 ug/mL
Mean CV75: 104 ug/mL
Treatment duration: 24 hrs
All concentrations used - per active ingredient (90%, conversion factor 1.1)
Cell system: THP-1 cells (ATCC TIB-202), passage number 12-16
Positive control: dinitrochlorobenzene (DNCB, CAS 97-00-7) in DMSO
Negative control: untreated control - Positive control results:
- RFI CD54 and RFI CD 86 for all concentrations and all runs (3) >200 and >150, respectively.
- Key result
- Run / experiment:
- other: all concentrations (8) / all runs (3)
- Parameter:
- other: RFI (CD86)
- Value:
- 150
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: all concentrations (8) / all runs (3)
- Parameter:
- other: RFI (CD54)
- Value:
- 200
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the h-CLAT assay there are no indications of skin sensitisation caused by the test substance.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June - July 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Non-GLP study, but performed according GLP rules, based on SOP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Non-GLP study, but performed according GLP rules, based on SOP.
- Type of study:
- activation of keratinocytes
- Details on the study design:
- Celles: HaCaT cells stably transfected (Givaudan), checked for mycoplasma, passage number 3 and 4.
Concentrations used: 0.2, 0.4, 0.8, 1.6, 3.1, 6.3, 12.5, 25.0, 50.0, 100.0, 200.0, 400.0 ug/mL
Duration of treatment: 48 hrs
All concentrations used - per active ingredient (90%, conversion factor 1.1)
Positive control: cinnamic aldehyde (CA, CAS 104-55-2, Sigma Aldrich) tested at 4, 8, 16, 32, 64 uM
Negative control: dimethylsulfoxide (DMSO, CAS 67-68-5, Sigma Aldrich) tested at 1% - Positive control results:
- Luciferase induction >1.5 in at least one of tested concentrations - yes (both repetitions)
EC 1.5 10.55 (rep. 1) and 12.34 (rep. 2) uM
Average induction at 64 uM: 5.96 (rep. 1) and 4.24 (rep. 2) - Key result
- Run / experiment:
- other: 1
- Parameter:
- other: I max
- Value:
- 1.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: I max
- Value:
- 1.11
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- High cytotoxicity at concentrations above 50 ug/mL.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of KeratinoSens assay showed no indication for skin sensitisation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No sensitizing potential has been shown in the skin sensitization tests.
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