1,3-dioxepane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

- The test performance was similar to OECD guideline, however with few deviations (Observation period of 6 days, 0.05 ml test substance applied isntead of 0.1 ml, no rinsing, no reading at time point 4 h) that did not affect the validity of the results for assessment. - The study is scientifically acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

, observation period of 6 days, 0.05 ml test substance applied instead of 0.1 ml, no rinsing, no reading at time point 4h.

GLP compliance:

no

Remarks:

; GLP was not compulsory at the time the study was conducted

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dioxepane

EC Number:

208-015-6

EC Name:

1,3-dioxepane

Cas Number:

505-65-7

Molecular formula:

C5H10O2

IUPAC Name:

1,3-dioxepane

Details on test material:

Butandiolformal (1,3-Dioxacycloheptane)
Purity 99.99%
Physical state: liquid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

- Age at study initiation: no data
- Weight at study initiation:
Animal 1: 2.10 kg
Animal 2: 2.37 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye was treated with physiological saline and served for control

Amount / concentration applied:

0.05 ml test substance in the right eye;
0.05 ml physiological saline in ther left eye for control.

Duration of treatment / exposure:

Following application, the eyes were not washed. Examination and scoring were performed at the following time points: 10 min, 1, 3, 24, 48, 72 hours, and 6 days.

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

2

Details on study design:

Eye irritation was tested using an internal method (BASF test). 0.05 ml of the test substance were applied to the conjunctival sac of one eye of each of 2 animals. The adjacent eye which was treated with physiological saline served as control. The effects of the test substance were scored at the following time intervals: 10 min, 1h, 3h, 24h, 48h, 72h, and 6 days. At the end of the observation period, the eyes were fluorescein-stained for detection of corneal damages.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48-72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-48-72h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48-72h

Score:

1.66

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-48-72h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-48-72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

ANIMAL 1:
- After 10 minutes: slight redness of the conjunctivae, slight chemosis, slight corneal opacity;
- After 1 hour: distinct redness of the conjunctivae, distinct chemosis, slight corneal opacity;
- After 24 hours: distinct redness of the conjunctivae, slight chemosis, milky corneal opacity; mucosal bleeding and milky secretion;
- After 48 hours: slight redness of the conjunctivae, slight chemosis, slight corneal opacity; suppurative secretion;
- After 72 hours: slight redness of the conjunctivae, slight chemosis, slight corneal opacity; suppurative secretion, mucosal bleeding; scar on the upper eyelid;
- After 6 days: no more findings, fluorescein-staining revealed no corneal lesions.
ANIMAL 2:
- After 10 minutes: slight redness of the conjunctivae, slight chemosis, slight corneal opacity;
- After 1 hour: distinct redness of the conjunctivae, distinct chemosis, slight corneal opacity;
- After 24 hours: distinct redness of the conjunctivae, slight chemosis, slightly milky to milky corneal opacity; mucosal bleeding;
- After 48 hours: distinct redness of the conjunctivae, slight chemosis, slight corneal opacity; mucosal bleeding;
- After 72 hours: slight redness of the conjunctivae, no more chemosis, slight corneal opacity; mucosal bleeding;
- After 6 days: no more findings, fluorescein-staining revealed no corneal lesions.