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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Named in some reports as 2-propenenitrile, polymer with 1,2-ethanediamine
Dried material, described as viscous liquid, is used for some tests.
Specific details on test material used for the study:
Dried matrial with > 90% actives described as viscous liquid

In vitro test system

Details on study design:
Concentrations tested : 400, 200, 100, 50, 25, 12.5, 6.25, 3.125, 1.563, 0.781, 0.391, 0.195 mg/l expressed as water-free material using DMSO as a vehicle
Negative control : DMSO
Positive control : Cinnamic aldehyde
Three repetitions (runs) were performed. Each repetition consisted of 3 x 96-well plates for luminescence

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Parameter:
other: Viability %
Run / experiment:
1
Value:
> 71 - < 109
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Parameter:
other: Viability %
Run / experiment:
2
Value:
> 63 - < 107
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Parameter:
other: Viability %
Run / experiment:
3
Value:
> 74 - < 101
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Cell viability was not reduced below 50%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Classified as Negative using the KeratinoSens prediction model.