N,N'-(2-chloro-1,4-phenylene)bis(3-oxobutaneamide)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-11-30 to 1999-12-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted: February 24, 1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-010-4

EC Name:

-

Cas Number:

53641-10-4

Molecular formula:

C14H15ClN2O4

IUPAC Name:

N-[3-chloro-4-(3-oxobutanamido)phenyl]-3-oxobutanamide

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

HSD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstraße 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 weeks
- Weight at study initiation: males: 206 - 214 g, females: 184 - 194 g
- Randomization: Randomization schemes 98.0708 and 98.0949
- Housing: Groups of five animals in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
- Animal identification: fur marking with KMnO4 and cage numbering

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized water

Details on oral exposure:

The animals received the compound as a 20% suspension in deionized water, the administration volume being 10 ml/kg body weight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Dose range finding study:
500, 1000, 2000 mg/kg bw each one male and one female
Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight on test days 1 (pre-administration), 8 and 15. Clinical signs: Each animal was examined for changes in appearance and behaviour twice every day , on weekends and on public holidays once per day.
At the end of the observation period the animals were sacrificed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: hypoactivity, irregular respiration, squatting posture, uncoordinated and stilted gait.

Gross pathology:

The animals killed at the end of the observation period
showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU-REACh

Conclusions:

No deaths occurred during the whole study. Based on the results obtained in this study the LD50 of the test item is greater than 2000 mg/kg bw for male and female rats.

Executive summary:

No deaths occurred during the whole study. The development of body weight was not impaired. The following clinical signs were observed after the administration of the test substance: hypoactivity, irregular respiration, squatting posture, uncoordinated and stilted gait. At day two of the study all clinical signs were reversible. At the end of the observation period the animals showed no macroscopically visible changes.