3,4-dihydro-2-methoxy-2H-pyran

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo test already available

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions due to only 7 d observation period (all signs were not reversible).

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Reference 3

Reference Type:

secondary source

Title:

3,4-Dihydro-2-methoxy-2H-pyran (CAS No. 4454-05-1)

Author:

OECD

Year:

2003

Bibliographic source:

cited in OECD SIDS 3,4-Dihydro-2-methoxy-2H-pyran for SIAM 16, 27-30 May 2003, Paris, France.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

only 7 d observation period (all signs were not reversible)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dihydro-2-methoxy-2H-pyran

EC Number:

224-698-3

EC Name:

3,4-dihydro-2-methoxy-2H-pyran

Cas Number:

4454-05-1

Molecular formula:

C6H10O2

IUPAC Name:

2-methoxy-3,4-dihydro-2H-pyran

Details on test material:

- Name of test material (as cited in study report): Methoxydihydropyran
- Physical state: clear colourless liquid
- Analytical purity: ca. 96%
- Impurities (identity and concentrations): 4% dimer acrolein, traces of acrolein and methylvinylether
- Lot/batch No.: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3-4 Kg
- Housing: single
- Diet (e.g. ad libitum): standard pellet feed
- Water: ad libitum
- Acclimation period: >3 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml undiluted

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

7 d (at 1h, 24h, 48h, 72h and 7 d)

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

1.1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-42 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48-42 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-42 h

Score:

2.4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Other effects:

Clinical signs: Violent defensive movements, screams and shutting of eyes were observed 24 h - 4d after application. Cornea and conjunctiva were covered with whitish ulcerous like mass.

Any other information on results incl. tables

Animal	Reading	Opacity	Iritis	Redness	Chemosis
1	24 h	0	0	1	2
2	24 h	1	0	1	2
3	24 h	1	0	1	2
4	24 h	1	0	1	2
5	24 h	1	0	1	2
6	24 h	1	0	1	2
1	48 h	1	0	1	2
2	48 h	1	0	1	4
3	48 h	1	0	1	2
4	48 h	2	0	1	3
5	48 h	1	0	1	3
6	48 h	1	0	1	3
1	72 h	1	0	1	2
2	72 h	1	0	1	2
3	72 h	1	0	1	2
4	72 h	2	0	1	3
5	72 h	1	0	1	3
6	72 h	2	0	1	3
mean 1	24 - 72 h	0.67	0.00	1.00	2.00
mean 2	24 - 72 h	1.00	0.00	1.00	2.67
mean 3	24 - 72 h	1.00	0.00	1.00	2.00
mean 4	24 - 72 h	1.67	0.00	1.00	2.67
mean 5	24 - 72 h	1.00	0.00	1.00	2.67
mean 6	24 - 72 h	1.33	0.00	1.00	2.67
Total mean	24 - 72 h	1.11	0.00	1.00	2.44

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information

Executive summary:

This study is comparable to the guideline study with acceptable restrictions due to only 7 d observation period (all signs were not reversible during this time). 0.1 mL of the unchanged test substance was instilled to the eye of six rabbits and left unwashed. The scores for cornea, iris, conjunctivae and chemosis were 1.1, 0, 1.0 and 2.4, respectively (mean of the 24, 48 and 72 h readings).

Conclusion: According to the test results, Methoxydihydropyran is moderatly irritating to the eye.