1-Piperazineacetamide, N-(4-aminophenyl)-N,4-dimethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 February - 27 February 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 423) and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

CDBB 0213 BS

IUPAC Name:

CDBB 0213 BS

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): CDBB 0213 BS
- Physical state: light pink powder
- Analytical purity: 100.0 % HPLC
- Purity test date: 19. december 2001
- Lot/batch No.: PKLSCH00630A
- Expiration date of the lot/batch: 5 december 2002

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: male: 184-189 g, female: 143-148 g
- Housing: 3 animals in Noryl cages, type IV
- Diet (e.g. ad libitum): Kliba No. 3878, Provimi Kliba AG, Kaiseraugst, Switzerland ad libitum
- Water (e.g. ad libitum): Municipal drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 45-75%
- Air changes (per hr): maximum 12x/h
- Photoperiod (hrs dark / hrs light): 12/12 hours; 6.00 a.m.-6.00 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous hydroxyethylcellulose

Doses:

2000 mg/kg of the test substance

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least twice a day. The animals were observed for a period of 14 days post treatment. Body weight of the animals was determined on the day of administration (day 1), as well as on days 2, 8 and 15 of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, clinical signs

Statistics:

none performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Clinical signs observed were sedation, chewing and piloerection on Day 1 only.

Gross pathology:

At necropsy of the animals, no gross pathologic findings were observed.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. CLP

Conclusions:

In an acute oral toxicity test, an approximate lethal dose of the test substance in rats was determined to be > 2000 mg/kg.