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Toxicological information

Skin sensitisation

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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:
2017
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

Constituent 1
Chemical structure
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

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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