Tetrahydro-3-methylfuran

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to guideline method, but predates GLP. Purity of test compound not provided and observation period terminated after 14 days instead of 21. Results are sufficient in detail for evaluation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Purity of test substance not reported and observation terminated at 14 days instead of 21 and only two animals were tested.

GLP compliance:

not specified

Remarks:

study predates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-3-methylfuran

EC Number:

236-537-4

EC Name:

Tetrahydro-3-methylfuran

Cas Number:

13423-15-9

Molecular formula:

C5H10O

IUPAC Name:

tetrahydro-3-methylfuran

Details on test material:

Furan, 3-methyl tetrahydro-
100% active ingredient, stabilized with 0.025 wt. % Ionol®

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Single application, one eye wased after 20 seconds while other eye was unwashed.

Observation period (in vivo):

Observations made at one and four hours and at 1,2,7,and 14 days

Number of animals or in vitro replicates:

2

Details on study design:

A dose of 0.1 ml of terahydro-3-methylfuran was instilled into the right conjunctival sac of each of two albino rabbits. After 20 second, one exposed eye was washed with tap water for one minute while the other was not washed. Observation of the cornea, iris, and conjuctiva were made with a hand slit lamp at the appropriate times, 5% fluorescein stain and biomicroscope were used for these examinations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of animals 1and 2 (individually), unwashed eye

Time point:

other: 24-72 hours

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of animals 1 and 2 (individually), unwashed eye

Time point:

other: 24-72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of animals 1 and 2 (individually), unwashed eye

Time point:

other: 24-72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of animals 1 and 2 (individually), unwashed eye

Time point:

other: 24-72 hours

Score:

2.67

Max. score:

4

Reversibility:

not specified

Any other information on results incl. tables

Dose	Treatment of Eyes	Ocular Effects
		Cornea	Iris	Conjunctiva
0.1 ml of Product*	Not washed	Moderate but deep injury at 1-3 days; mild injury with superficial vascularization at 7 days; small areas of haziness under magnification at 14 days.	Minimal congestion 1-4 hours; moderate iritis 1-3 days.	Mild redness 1 hour - 3 days, minimal at 7 days; severe to moderate swelling 1-4 hours, mild 1-3 days, minimal at 7 days; copious discharge 1 hour - 3 days, minimal at 7 days**.
0.1 ml of Product*	Washed (after 20 seconds of exposure)	Moderate but deep injury 1-3 days; small area of haziness under magnification 7-14 days.	Minimal to mild congestion 1-4 hours: moderate iritis 1-2 days: mild iritis at 3 days.	Mild redness 1 hour - 3 days; moderate swelling 1-4 hours, mild 1-2 days, minimal at 3 days; copious discharge 1 hour - 2 days, mild at 3 days***.
* 3-methyl-tetrahydrofuran, stabilized with 0.025 wt. % Ionol®  **Fibrin in discharge 1-3 days. *** Fibrin in discharge 1-2 days.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

3 -Methyltetrahydrofuran produced moderate but penetrating corneal damage, moderate iritis and conjuctivitis in both rabbit eyes that were not promptly washed after dosing and in a rabbit eye that was washed 20 seconds after contact. Both corneas still had mild damage at 14 days.

Executive summary:

Tetrahydro-3-methylfuran (3meTHF) should be regarded as capable of causing irreversible effects on the eye based on in vivo administration of 0.1 ml of 3meTHF into the right conjunctival sac of each of two albino rabbits. After 20 seconds, one exposed eye was washed with tap water for one minute while the other was not washed. Observation of the cornea, iris, and conjuctiva were made with a hand slit lamp at the appropriate times, 5% fluorescein stain and biomicroscope were used for these examinations. 3meTHF produced moderate but penetrating corneal damage, and moderate iritis and conjuctivitis in both rabbit eyes that were not promptly washed after dosing and in a rabbit eye that was washed 20 seconds after contact. Both corneas still had mild damage at 14 days.