Registration Dossier
Registration Dossier
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EC number: 947-738-8 | CAS number: -
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Phosphoric acid, mixed esters with alcohols, C7-9-iso-, C8-rich and alcohols, C11-14-iso-, C13-rich, ethoxylated, potassium salt
- EC Number:
- 947-738-8
- Molecular formula:
- Molecular formulas of exemplary components: C33H68KO10P C49H100KO16P C24H49K2O10P C24H50KO10P C16H34KO4P C8H17K2O4P C8H18KO4P
- IUPAC Name:
- Phosphoric acid, mixed esters with alcohols, C7-9-iso-, C8-rich and alcohols, C11-14-iso-, C13-rich, ethoxylated, potassium salt
- Test material form:
- liquid
Constituent 1
In vitro test system
- 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
Results and discussion
- Positive control results:
- RFI CD54 and RFI CD 86 for all concentrations and all runs (3) >200 and >150, respectively.
In vitro / in chemico
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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