Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate

EC Number:

201-899-4

EC Name:

Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate

Cas Number:

89-33-8

Molecular formula:

C12H12N2O3

IUPAC Name:

ethyl 5-oxo-1-phenyl-4,5-dihydro-1H-pyrazole-3-carboxylate

Details on test material:

purity: 99.7 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht strain: Hoe: WISKf(SPF71)
- Age at study initiation: males: about 7 weeks; females: about 8 weeks.
- Weight at study initiation: males: 197 - 201 gr; femals: 180 - 195 gr
- Fasting period before study: 16 hours
- Housing:in completely air conditioned rooms in macrolone cages in groups of 5 animals
- Diet: Rattendiät Altromin 1324, (Altromin-GmbH, Lage/Lippe), ad libitum (e.g. ad libitum):
- Water: tap water out of plastic bottles ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% starch

Details on oral exposure:

dose: 2000 mg/kg bw
concentration in vehicle: 20% (w/v)
application volume: 10 ml/kg bw

Doses:

2000 mg(kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Doses: 500, 1000 and 2000 mg/kg bw
1 male and 1 female per dose
no letality, no impact on the developmnent of the body weight

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: squatting posture, hollow flanks,decreased spontaeous activity,bristling coat, irregular respirate, uncoordinated gait.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Since LD50>2000 mg/kg bw the substance is not subject for classification for acute oral toxicity.

Executive summary:

The substance was tested for acute oral toxicity accordng to OECD guideline 401. 5 male and 5 female Wistar-rats got a single dose of 2000 mg/kg bw by gavage. After the application no mortality occured. Only at the day of application the animals showed unspecific symptoms such as impact on the respiration and the movement. But these symptoms were reversible on the next day The development of the body weight was also normal. The LD50 for acute oral toxicity is therefore greater than 2000 mg/kg bw.