Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
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)
GLP compliance:
yes
Type of study:
activation of keratinocytes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
EC Number:
294-347-7
EC Name:
Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
Cas Number:
91697-85-7
Molecular formula:
Not available
IUPAC Name:
Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
Test material form:
solid: bulk

In vitro test system

Details on the study design:
A valid KeratinoSensTMassay was performed according to OECD 442D and GLP. For the KeratinoSensTMassay 03590was dissolved in ethanolat 5 mg/mL. From this stock 11 spike solutions in ethanolwere prepared. The stock and spike solutions were diluted 400-fold in the assay resulting in test concentrations of 0.006 -13μg/mL(2-fold dilution series)in the first and second experiment and resulting in test concentrations of 0.15 -13μg/mL (1.5-fold dilution series) in the third experiment. The highest test concentration was considered to be the limit of solubility. Noprecipitate was observed at any dose level tested

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
other: Experiment 1
Parameter:
other: maximum luciferase activity induction
Value:
1.38
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: maximum luciferase activity induction
Value:
1.76
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Key result
Run / experiment:
other: 3
Parameter:
other: maximum luciferase activity induction
Value:
1.55
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion