3-ethoxy-4-hydroxybenzaldehyde

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Study is well described.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Objective of study:

metabolism

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-ethoxy-4-hydroxybenzaldehyde

EC Number:

204-464-7

EC Name:

3-ethoxy-4-hydroxybenzaldehyde

Cas Number:

121-32-4

Molecular formula:

C9H10O3

IUPAC Name:

3-ethoxy-4-hydroxybenzaldehyde

Details on test material:

no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, code Crl: CD(SD)BR VAF/Plus (Marget, Kent,  England)
- Age at study initiation: 7-8 weeks old (males), 9-10 weeks old (females)
- Weight at study initiation: 198-215 g
- Fasting period before study: 15 to 20 hours
- Housing: maximum 6 per cages during acclimatisation period. After  dosing, rats were housed in glass metabowls equipped with urine/faeces 
 separators.
- Individual metabolism cages: yes/no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before the start of the treatment.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 60% relative humidity
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h / 12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): dosing solutions were freshly prepared on the day of administration.

VEHICLE
- Justification for use and choice of vehicle (if other than water): frequently used as the dose  vehicle in metabolism studies of compounds with limited water solubility as it is well tolerated by rats, is water miscible, and has a high solvent capacity.

Doses / concentrations

Remarks:

Doses / Concentrations:
50, 100 and 200 mg/kg

No. of animals per sex per dose / concentration:

56 animals were used (28 males and 28 females) during the study.

Control animals:

not specified

Details on study design:

- Dose selection rationale: these dose levels were selected to model those used during a 2-week dietary administration toxicokinetic study.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

The test compound was therefore essentially completely absorbed

Details on excretion:

excretion was effectively complete at 5 days post-administration

Metabolite characterisation studies

Details on metabolites:

no data. However, ethylvanillin is rapidly metabolised

Any other information on results incl. tables

The test compound was therefore essentially completely absorbed and excretion was effectively complete at 5 days post-administration. Unchanged material was not detected in plasma by  radio HPLC,which demonstrated  that the test compound was subjected to rapid metabolism. Similary, no free ethylvanillin was detected  in urine, demonstrating its complete biotransformation prior to excretion.

 

Clinical signs/mortality:
No adverse reactions to treatment were observed in any of the rats dosed orally with ethyl 14C-vanillin at 50, 100 or 200 mg/kg.

Applicant's summary and conclusion

Conclusions:

The test compound was  absorbed and excretion was complete at 5 days post-administration (rat, male and female, oral).