Registration Dossier

Diss Factsheets

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

Reference
Name:
Unnamed
Type:
Constituent
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:
No symptoms were stated.
Body weight:
mean weights:
Males: after 7 d: 249 g , after 14 d: 288 g
Females: after 7 d: 214 g, after 14 d: 221 g
Gross pathology:
No findings were noticed.

Applicant's summary and conclusion