Linseed oil, oxidized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18-feb-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

Qualifier:

according to guideline

Guideline:

other: OECD guideline 437 (Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants )

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): 750 µl per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 10% (w/v) Benzalkonium Chloride

Duration of treatment / exposure:

- Exposure: 10 minutes
- Post incubation period: 120 minutes

Details on study design:

TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
- A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

10 minutes

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The individual in vitro irritancy scores for the negative controls was 0 for all three corneas. The individual positive control in vitro irritancy scores ranged from 119 to 162 for Benzalkonium Chloride

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

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

Conclusions:

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 136 and was within the historical positive control data range.

Blown linseed oil did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0 after 240 minutes of treatment.

Finally, it is concluded that this test is valid and that Blown linseed oil is not irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.