Linseed oil, polymd.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02-February-2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

in accordance with GLP

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

1

Reference substance name:

3-[(8-{5-hexyl-6-[(2Z)-oct-2-en-1-yl]-2-(8-{2-[(7Z,10Z,13Z)-octadeca-7,10,13-trienoyloxy]-3-[(9Z,12Z)-octadeca-9,12-dienoyloxy]propoxy}-8-oxooctyl)cyclohex-3-en-1-yl}octanoyl)oxy]-2-[(7E,10E,13Z)-octadeca-7,10,13-trienoyloxy]propyl (9Z,12Z,15Z)-octadeca-9,12,15-trienoate

EC Number:

614-114-9

Cas Number:

67746-08-1

Molecular formula:

Not applicable for UVCB

IUPAC Name:

3-[(8-{5-hexyl-6-[(2Z)-oct-2-en-1-yl]-2-(8-{2-[(7Z,10Z,13Z)-octadeca-7,10,13-trienoyloxy]-3-[(9Z,12Z)-octadeca-9,12-dienoyloxy]propoxy}-8-oxooctyl)cyclohex-3-en-1-yl}octanoyl)oxy]-2-[(7E,10E,13Z)-octadeca-7,10,13-trienoyloxy]propyl (9Z,12Z,15Z)-octadeca-9,12,15-trienoate

Details on test material:

- Name of test material (as cited in study report): Standolized linseed oil
- Substance type: Hazy yellow/brown viscous liquid
- Physical state: liquid
- Analytical purity: treated as 100% pure
- Lot/batch No.: 09.317.013
- Expiration date of the lot/batch: 21 December 2010
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark
- Other: -

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

unchanged (no vehicle)

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:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- 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

Remarks:

mean

Run / experiment:

10 min

Value:

1.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Standolized linseed oil did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.5 after 10 minutes of treatment.

Finally, it is concluded that this test is valid and that Standolized linseed oil is a non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.