Benzenepropanoic acid, .beta.,4-dimethoxy-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in accordance with GLP; Low purity of the test substance (71.2 %)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl 3-methoxy-3-(4-methoxyphenyl)propanoate

EC Number:

614-925-8

Cas Number:

69098-08-4

Molecular formula:

C12 H16 O4

IUPAC Name:

methyl 3-methoxy-3-(4-methoxyphenyl)propanoate

Details on test material:

- Name of test material (as cited in study report): 3-(4-Methoxyphenyl)-3-methoxypropionsaueremethylester, technical grade
- Batch No.: Ansatz 165
- Purity: 71.2 %.
- Date of manufacturing: 22 Apr 1993
- Physical state: The test substance was described as solid brown. After heating at about 30° C it became liquid brown.
- Stability: the stability of the test substance over the study period was proven by reanalysis. The stability of the test substance in olive oil DAB 10 over a
time period of 4 hours was confirmed by analysis.
- Storage condition of test material: REFRIGERATOR, EXCLUSION OF LIGHT AND AIR (UNDER NITROGEN), EXCLUSION OF MOISTURE

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: males 177 g, females 183 g
- Fasting period before study: 16 hours
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

VEHICLE
- Concentration in vehicle: 40%
- Justification for choice of vehicle: THE TEST SUBSTANCE IS INSOLUBLE IN WATER

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, once each workday
- Necropsy of survivors performed: yes (gross pathology)
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

other: No symptoms were stated.

Gross pathology:

No findings were noticed.