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

Specific investigations: other studies

Administrative data

Endpoint:

hepatotoxicity

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles.

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

Principles of method if other than guideline:

Three rabbits were administered by gavage with 0.2 ml/kg bw (200 mg/kg bw)* of test substance as 2 % aqueous emulsion in glutradialdehyde and liver function tests were performed at 8 and 14 days post dosing to test hepatotoxicity. Three control animals treated with aqua dest were used as control. *Calculation was based on density of the test substance (1 g/ml).

GLP compliance:

no

Type of method:

in vivo

Endpoint addressed:

acute toxicity: oral

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:

other:

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.62-3.07 kg

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion in glutardialdehyde

Details on exposure:

VEHICLE
- Concentration in vehicle (%): 2
- Amount of vehicle (if gavage): 10 ml/kg bw

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

single

Frequency of treatment:

once

Post exposure period:

14 days

Doses / concentrations

Remarks:

Doses / Concentrations:
200 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and body weight: clinical signs daily
- Necropsy of survivors performed: yes

Examinations

Examinations:

Liver function tests namely BST (bromosulphthaleine ) retention and SGPT (serum glutamate-pyruvate transaminase) level.

Results and discussion

Details on results:

Mortality: 1/3 animals died.
Clinical signs: Decrease in food consumption was observed in 1 animal which later died.
Body weight: Decrease in body weight gain was observed.
Gross pathology: Necropsy in deceased animals revealed acute dilatation of the heart and signs of liver injury. No alterations were observed in the sacrificed animals.
Liver function test: In survivors, SGPT level and Bromosulphthalein (BST) retention were within normal limits at 8 d and 14 d after dosing.

Applicant's summary and conclusion

Executive summary:

This study is well documented which meets basic scientific principles and is reliable with restrictions. Three rabbits along with 3 controls were treated with 200 mg/kg bw of test substance to test hepatotoxicity. Decrease in food consumption was observed in 1 animal which later died. Necropsy in deceased animal revealed acute dilatation of the heart and signs of liver injury. No alterations were observed in the sacrificed animals. In survivors, SGPT level and Bromosulphthalein (BST) retention were within normal limits at 8 d and 14 d after dosing.