3-Furancarboxaldehyde, tetrahydro-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-12-15 until 1998-01-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

oxolane-3-carbaldehyde

EC Number:

629-664-5

Cas Number:

79710-86-4

Molecular formula:

C5 H8 O2

IUPAC Name:

oxolane-3-carbaldehyde

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Hra:(NZW)SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc. (Denver, PA)
- Age at study initiation: young adult (at least three month old)
- Weight at study initiation: at least 200g grams at the start of the study
- Housing: singly, in suspended, stainless-steel mesh cages. Cages and racks were washed once a week.
- Diet: Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum
- Water: municipal drinking water, regularly assayed
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-21°C
- Humidity: 41-55 %
- Photoperiod: 12 hours of artificial light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied 0.1 mL of test item as such was pplaced into conjunctival sac of one eye (right)

Duration of treatment / exposure:

First animal: The treated eye of one animal was immediately washed after instillation.
Second animal: The treated eye of one animal was not washed after instillation.

Observation period (in vivo):

Observation: immediately after instillation of the test substance and at 1, 24, 48, 72 and 96 hours and at 7, 14 and 21 days after instillation of the test substance.

Number of animals or in vitro replicates:

2

Details on study design:

TREATMENT
The right eyes of two animals were treated. The left eyes were not treated.

REMOVAL OF TEST SUBSTANCE
- Washing:The treated eye of one animal was washed with runing water
- The treated eye of the second animal was not wahsed after exposure
- Time after start of exposure: Immediately after instillation

SCORING SYSTEM: OECD system as specified in OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #1

Remarks:

(not irrigated)

Time point:

other: 24 - 48 -72 h

Score:

1.67

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #2

Remarks:

(irrigated)

Time point:

other: 24-48-72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #1

Remarks:

(not irrigated)

Time point:

other: 24 - 48 -72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #2

Remarks:

(irrigated)

Time point:

other: 24 - 48 -72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #1

Remarks:

(not irrigated)

Time point:

other: 24 - 48 -72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 6

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #2

Remarks:

(irrigated)

Time point:

other: 24 - 48 -72 h

Score:

2.67

Max. score:

3

Reversibility:

not reversible

Results 7

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #1

Remarks:

(not irrigated)

Time point:

other: 24 - 48 -72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 8

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #2

Remarks:

(irrigated)

Time point:

other: 24 - 48 -72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Any other information on results incl. tables

Animal	Irrigated	Corneal Opacity, Iris Effects, Redness, Chemosis
		1 h	24 h	48h	72h	96h	Day 7	Day 14	Day 21
1	No	0,0,2,3	1^a,1,3,3	2^a,1,3,3	2^a,1,3,3	3^a,x,3,3	3^a,x,3,3	3^a,X,2,2	2^a,0,2,1
2	Yes	0,0,1,3	1^a,1,2,3	1^a,1,3,3	2^a,1,3,3	1^a,1,3,3	0,0,3,1	0,0,2,0	0,0,1,0

 

X) Due to opacity, iris details were obscured.

a) Greater than three-quarters up to the whole area of the cornea was involved

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU