Tetrahydro-2-methylfuran

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted according to an appropriate OECD guideline and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-2-methylfuran

EC Number:

202-507-4

EC Name:

Tetrahydro-2-methylfuran

Cas Number:

96-47-9

Molecular formula:

C5H10O

IUPAC Name:

2-methyltetrahydrofuran

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): tetrahydro-2-methylfuran

- Physical state: clear colourless liquid

- Storage condition of test material: room temperature in the dark under nitrogen

Test animals / tissue source

Species:

other: in vitro

Strain:

other: n/a

Details on test animals or tissues and environmental conditions:

Eyes were obtained as a by-product from freshly slaughtered animals. Cornea from each seleceted eye were removed leaving a 2 to 3 mm sclera to facilitate handling.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: positive control item: ethanol, negative control item: 0.9% w/v sodium chloride solution

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml of test item
- Concentration (if solution): undiluted

Duration of treatment / exposure:

10 minutes

Observation period (in vivo):

120 minutes, followed by final opacity/permeability readings

Number of animals or in vitro replicates:

3 corneas/group

Details on study design:

The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

Time point: 120 min

Value:

ca. 2.8

Negative controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

Time point: 120 minutes

Value:

63

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

Time point: 120 minutes

Value:

ca. 32.2

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

The corneas treated with the test item were cloudy post treatment and post incubation. The corneas treated with negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Tetrahydro-2-methylfuran was considered to be an ocular corrosive/severe irritant, as determined in an in vitro assay (BCOP) conducted in accordance with current OECD guideline and GLP.