Acetamide, 2-chloro-N-methyl-N-(4-nitrophenyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 January - 26 February 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and in accordance with an OECD guideline (see below).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

CDBE 0055 XX

IUPAC Name:

CDBE 0055 XX

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): CDBE 0055 XX
- Physical state: solid
- Analytical purity: 99.05%
- Purity test date: 19 December 2001
- Lot/batch No.: PKLHUC00799
- Expiration date of the lot/batch: 21 Nov 2002

Test animals

Species:

rat

Strain:

other: CrlGlxBrlHan: WI(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: m: 189 - 234g, f: 140-153g
- Housing: housed in groups of 3 animals in Noryl cages, type IV.
- Acclimatisation period: at least 7 days
- Diet (e.g. ad libitum):pellets ad libitum
- Water (e.g. ad libitum): tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): max 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous hydroxyethyl cellulose 0.5%

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
no data were available. Therefore 2000 mg/kg bw were chosen as the starting dose for the study.

Doses:

2000 mg/kg
200 mg/kg

No. of animals per sex per dose:

3 males /3 femals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
twice a day on working days, on non-working days only once. body weights were checked on days 1, 2, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food & water consumption

Statistics:

Statistics were performed using validated SAS based statistic programs.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: ALD, approximate lethal dose

Effect level:

>= 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg goup: all females and one male died within 24 hrs after dosing. one male was found dead on study day 4. one male survived to the end of the observation period.
200 mg/kg group: no mortality was observed.

Clinical signs:

other: 2000 mg/kg goup: after administration, diarrhea, cyanosis, slight sedation, shallow respiration, piloerection and emanciation were present. 200 mg/kg group: no clinical signs were observed.

Gross pathology:

2000 mg/kg goup: at necropsy, dilated stomach, dark red coloured stomach and small intestine mucosa were found.
200 mg/kg group: no gross pathological findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the results of the study, the ALD for CDBE 0055 XX in rats following single oral administration is between 200 - 2000 mg/kg bw.