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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, 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 with acceptable restrictions (occlusive dressing)

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive dressing

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.

GLP compliance:

no

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 liquid
- Analytical purity: 99.5%
- Impurities (identity and concentrations): 0.5 % water

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach-Waldheim
- Weight at study initiation: 3.5 Kg
- Diet (e.g. ad libitum): Rabbit food Ssniff, INTERMAST, Soest
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): undiluted, no further data

Duration of treatment / exposure:

20 hour(s)

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 cmx2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing: no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

2

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: desquamation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: substance residues at the application site

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

Moderate erythema was seen at 24-72 hr (2/2 animals) and desquamation at 6 and 8 d (1/2 animals).

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal	Reading	Erythema	Edema	Comment
1	24 h	2	0	brownish substance residues at the applicate site
2	24 h	2	0	reddish substance residues at the applicate site
1	48 h	2	0	brownish substance residues at the applicate site
2	48 h	2	0	reddish-yellow substance residues at the applicate site
1	72 h	2	0	brownish substance residues at the applicate site
2	72 h	2	0	reddish-yellow substance residues at the applicate site
1	6 d	0	0	desquamation
2	6 d	1	0	reddish-yellow substance residues at the applicate site
1	8 d	0	0	desquamation
2	8 d	0	0	no effects, substance residues at the applicate site
mean 1	24 - 72 h	2.00	0.00
mean 2	24 - 72 h	2.00	0.00
mean	24 - 72 h	2.00	0.00

Applicant's summary and conclusion

Executive summary:

This study is comparable to guideline with acceptable restrictions (occlusive dressing). Unchanged liquid test substance was applied on the clipped skin of two rabbits under semiocclusive conditions for 20h. After 20 h the application site was not washed. Moderate erythema was seen at 24-72 hr in both animals and desquamation at 6 and 8 days in 1 animal. No animals showed necrosis or ulceration.

Conclusion: Based to the test results, Methoxydihydropyran is irritating to the skin