Registration Dossier

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 vivo

Resultsopen allclose all
Irritation parameter:
other: in vitro irritancy score
Basis:
other: test item
Time point:
other: 120 minutes
Score:
63
Reversibility:
other: n/a
Irritation parameter:
other: in vitro irritancy score
Basis:
other: negative control
Time point:
other: 120 min
Score:
2.8
Reversibility:
other: n/a
Irritation parameter:
other: in vitro irritancy score
Basis:
other: positive control
Time point:
other: 120 min
Score:
32.2
Reversibility:
other: n/a
Irritant / corrosive response data:
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.