Rape oil, polymer with tung oil

Skin sensitisation

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

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)

Deviations:

not specified

GLP compliance:

yes

Type of study:

activation of keratinocytes

Test material

Test material information

Constituent 1

Reference substance name:

Rape oil, polymer with tung oil

EC Number:

606-051-0

Cas Number:

185323-46-0

IUPAC Name:

Rape oil, polymer with tung oil

In vitro test system

Details on the study design:

KeratinoSens cells were plated on 96-well tissue culture treated black walled clear bottom polystyrene plates, 125µL per well. The cells were left for 24 h to adhere and the media was replaced with a low serum medium prior to dosing with the test compound at a range of 12 concentrations (see Assay Summary for details). Each compound is dosed on two separate plates, one to determine luminsence (Keap1-Nrf2-ARE pathway) and a second to determine cytotoxicity (MTT cell viability assay). Following an incubation period of 48 h, the cells were either lysed and assessed for the luciferase reporter gene expression using a luminescent assay (Luciferase Assay Kit, Promega) and the BioTek luminometer or loaded with MTT [yellow; 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide]. After 4 hour incubation the resulting formazan from the MTT cell viability assay was solubilised in a 10% SDS solution. The plates were then scanned at 570nm using a SunriseTM microplate absorbance reader (TECAN).

Results and discussion

In vitro / in chemico

Results

Key result

Run / experiment:

mean

Parameter:

other: Calc. EC1.5 (%)

Value:

0.015

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

	Test Compound Response
Compound Id	Calc.EC1.5(%)				Flag	Sensitizing
	Exp. 1	Exp. 2	Exp. 3	Mean±SD		Potential
PhytoVie® Defense	0.0149	>0.02	>0.02	0.0149	1/3		No (-)

Calc. EC1.5 : Effective concentration at 1.5 fold increase.

Flag : The number of experiments showing a sensitizing potential out of the total number of experiments. Yes (+) Compound shows sensitizing potential.

No (-) : Compound does not show sensitizing potential.

No (-) * : Compound shows borderline senstizing potential.

Assay Summary
Incubation time:	48h
Concentrations (%):	0.00001, 0.00002, 0.00004, 0.00008, 0.00016, 0.000315,  0.00063,
	0.00125, 0.0025, 0.005, 0.01, 0.02
Replicates per concentration:	3
Cell model:	KeratinoSens
Vehicle:	DMSO
MW:	999.99
KeratinoSens vehicle SD:	10% (passed), 16% (passed), 10% (passed)
Certified on:	2018-04-17

Data Summary

	Calc.IC30(%)	MR (%)	MR(%)
Cell viability (MTT) 1	>0.02	NR	NR
Cell viability (MTT) 2	>0.02	NR	NR
Cell viability (MTT) 3	>0.02	NR	NR

	Sensitizing Potential		Calc.EC1.5(%)	MR(Imax)	MR(%)
KeratinoSens 1		Yes (+)	0.0149	1.58	0.02
KeratinoSens 2		No (-)	>0.02	NR	NR
KeratinoSens 3		No (-)	>0.02	1.41	0.02

Calc. EC1.5 : Effective concentration at 1.5 fold increase.

Calc. IC30 : Inhibitory concentration at 30% loss of cell viability. MR (Imax ) Maximum fold response of KeratinoSens.

MR    (%)    : Maximum     %     response. 

MR (%) : Maximum fold response concentration.

Yes (+) : Compound shows sensitizing potential.

No (-) : Compound does not show sensitizing potential.

No (-) * : Compound shows borderline senstizing potential. NR No response observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Compound does not show sensitizing potential.