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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Remarks:
Keratin
Type of information:
experimental study
Adequacy of study:
key study
Study period:
48 hour exposure
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study performed 2017 to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Version / remarks:
KeratinoSensTM cell line (test system)
GLP compliance:
yes (incl. QA statement)
Type of study:
activation of keratinocytes
Justification for non-LLNA method:
In-vitro alternative

Test material

Constituent 1
Chemical structure
Reference substance name:
1-Propanaminium, 3,3',3''-[phosphinylidynetris(oxy)]tris[N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-, N,N',N''-tri-C6-18 acyl derivs. trichlorides
EC Number:
280-518-3
EC Name:
1-Propanaminium, 3,3',3''-[phosphinylidynetris(oxy)]tris[N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-, N,N',N''-tri-C6-18 acyl derivs. trichlorides
Cas Number:
83682-78-4
IUPAC Name:
1-Propanaminium, 3,3',3''-[phosphinylidynetris(oxy)]tris[N-(3-aminopropyl)-2-hydroxy-N,Ndimethyl-, N,N',N''-tri-C6-18 acyl derivs, trichlorides
Specific details on test material used for the study:
46560D15

In vitro test system

Details on the study design:
The KeratinoSensTM cell line (test system) is an immortalized adherent cell line derived from HaCaT human keratinocytes, stably transfected with a selectable plasmid containing the luciferase gene under the transcriptional control of the Anti-oxidant Response Element (ARE) from a gene that is known to be up-regulated by contact sensitisers. The luciferase signal reflects the activation by sensitisers of endogenous Nrf2 dependent genes, and the dependence of the luciferase signal in the recombinant cell line on Nrf2 has been demonstrated. This allows quantitative measurement (by luminescence detection) of luciferase gene induction, using well established light producing luciferase substrates, as an indicator of the activity of the Nrf2 transcription factor in cells

Results and discussion

Positive control results:
Valid results with Effect > EC1.5 limit for positive response. At the highest concentration of positive control the response was 15 fold induction

In vitro / in chemico

Results
Key result
Run / experiment:
other: Test materials
Parameter:
other: Luciferase activity
Value:
1.263
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Response in range 0.91 - 1.26, with highest response at 25mg/l of material tested (ca 10 mg/l actives)
At 50 mg/l there was significant cytotoxicty and 100% complete cytotoxicty (20 and 40mg/l actives)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The luciferase inihibition was below the limits considered to cause a positive response for sensitisation with a score of < 1.5.
The test was run up to the limit of cytotoxicty and is considered valid
The positive control gave a high response of 15.
Executive summary:

The substance is not considered to be sensitising on the basis of this study.

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