Linseed oil, oxidized

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18-jan-2010 to 22-jan-2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 431: In Vitro Skin Corrosion: Human Skin Model Test

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Version / remarks:

BIS

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Linseed oil, oxidized

EC Number:

272-038-8

EC Name:

Linseed oil, oxidized

Cas Number:

68649-95-6

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).

IUPAC Name:

Oxidation products of seed oil obtained from Linum usitatissimum, Linaceae (linseed)

Details on test material:

- Name of test material (as cited in study report): Blown linseed oil
- Substance type: Hazy yellow to brown liquid
- Physical state: Liquid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl of the undiluted test substance

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl water

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8N

Duration of treatment / exposure:

- 3 minutes and 1 hour exposure times

Details on study design:

TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 3 minutes and 1 hour

SCORING SYSTEM:
- Percentage viability

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

percentage of control

Run / experiment:

3 minutes

Value:

97

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

102

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

based on Annex I of 1272/2008/EC (CLP)

Conclusions:

The positive and negative controls were within the historical control data.

Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Blown linseed oil compared to the negative control tissues was 97% and 102%, respectively. Because the mean relative tissue viability for Blown linseed oil was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Blown linseed oil is considered to be not corrosive.

Finally, it is concluded that this test is valid and that Blown linseed oil is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.