N,N'-ethylenebis[N-acetylacetamide]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is in accordance to common test guidelines and GLP and therefore rated as reliable without restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-ethylenebis[N-acetylacetamide]

EC Number:

234-123-8

EC Name:

N,N'-ethylenebis[N-acetylacetamide]

Cas Number:

10543-57-4

Molecular formula:

C10H16N2O4

IUPAC Name:

N,N'-ethylenebis[N-acetylacetamide]

Details on test material:

- Name of test material (as cited in study report): TAED

- Physical state: yellowish powder
- Analytical purity: > 99 %

- Lot/batch No.: production of December 18, 1984
- Storage condition of test material: darkness at approximately 5°C in a refrigerator

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 - Age at study initiation: 6-10 wks - Weight at study initiation: males 218+/- 4 g, females 212 +/-15 g - Fasting period before study: 16 hrs - Housing: fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals - Diet (e.g. ad libitum): ad libidum - Water (e.g. ad libitum): ad libidum - Acclimation period: at least 7 days ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 +/- 3 - Humidity (%): 50 +/-20 - Air changes (per hr): - Photoperiod (hrs dark / hrs light): 12/12 IN-LIFE DATES: From: 07-may-1985 To: 21-may-1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: starch mucilage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 8 ml/kg
- Justification for choice of vehicle: formulation of a stable and homogenous suspension of the test item in the vehicle
- Lot/batch no. (if required):
- Purity:


MAXIMUM DOSE VOLUME APPLIED: 8 ml/kg


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

The acute oral toxicity of TAED was tested only at a dose level of 2000 mg/kg body weight.

No. of animals per sex per dose:

5 male and 5 female animals

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation twice a day, on weekends and public holidays only twice/ weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occured during the whole study.

Clinical signs:

The following clinical signs were observed in males and females after administration of 2000 mg/kg body weight: hypoactivity, squatting posture, sunken flanks, ataxic gait, narrowed palpebral fissures and irregular respiration. Additionally, increased salivation and twitching was noted in each one female animal. On day two of the study all clinical signs were disappeared.

Body weight:

Development of body weight was not impaired.

Other findings:

- Other observations:
The Animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Summary

Acute oral toxicity testing of TAED in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals.

No deaths occurred after administration of 2000 mg/ kg body weight. After substance administration male and female animals showed hypoactivity, squatting posture, sunken flanks, ataxic gait, narrowed palpebral fissures and irregular respiration. Additionally, increased salivation and twitching was noted in each one female animal. On day two of the study all clinical signs had disappeared.

Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.