Rape oil, polymer with tung oil

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

eperimental start/end date: 27/03/2018 - 29/03/2018

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:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Source strain:

not specified

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Test chemicals were administered neat by topical application onto the construct.
16μL (32μL/cm2)

Duration of treatment / exposure:

42 minutes at room temperature.

Duration of post-treatment incubation (if applicable):

incubated at 37°C for 42 additional hours.

Number of replicates:

6

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

89

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

					Mean OD	SD	Mean OD
1	BLANK	0.033	0.033	0.033	0.033	0.0%	0.033
2		0.034	0.033	0.033	0.033				Cell viability [%]
1	NEGATIVE CONTROL	1.223	1.218	1.23	1.224	1.8%	1.214	ODNC=ODNC raw- ODblank	100.0%
2		1.229	1.23	1.217	1.225			1.181
3		1.187	1.199	1.194	1.193
1	POSITIVE CONTROL	0.051	0.051	0.052	0.051	0.2%	0.049		1.4%
2		0.049	0.049	0.049	0.049			0.016
3		0.048	0.047	0.047	0.047
1	18P0447-1PL	1.121	1.129	1.103	1.117	3.0%	1.084		89.0%
2		1.085	1.072	1.069	1.075			1.051
3		1.062	1.06	1.054	1.059

According to the classification of the official method and under the conditions of the assay, the product: “PhytoVie® Defense (INCI: Brassica Campestris/Aleurites Fordi Oil Copolymer)” is no irritant.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Substance is shown to be not irritating under the conditions of the study.