Benzenemethanamine, 2-chloro-N,N-dimethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[(2-chlorophenyl)methyl]dimethylamine

EC Number:

688-329-1

Cas Number:

10175-31-2

Molecular formula:

C9H12ClN

IUPAC Name:

[(2-chlorophenyl)methyl]dimethylamine

Test material form:

liquid

Specific details on test material used for the study:

- Stability under test conditions: no information available
- Solubility and stability of the test substance in the solvent/vehicle: no information available

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Test item was freshly formulated at a concentration of 200 and 30 mg/mL in the vehicle, in the Central Dispensary Unit of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was stirred with a magnetic stirrer up to finishing the treatment.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Age at study initiation: 11 weeks
- Weight at study initiation: approx. 205 - 230g
- Housing: Type II polypropylene/polycarbonate cages; 9 animals, 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

A single oral gavage administration (10 mL/kg bw) was followed by a fourteen-day observation period. Before treatment the animals were fasted. The food, but not water, was withheld during an overnight period. Animals were weighed just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment.

Doses:

The starting dose level was 2000 mg/kg bw. Due to mortality, Groups 2 and 3 received a dose level of 300 mg/kg bw, respectively.

No. of animals per sex per dose:

9 animals, 3 animals/group

Control animals:

no

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item caused mortality at a dose level of 2000 mg/kg bw (3/3) and 300 mg/kg bw (1/6).

Clinical signs:

other: Clinical signs were observed in animals treated at 300 mg/kg bw with test item. These included decreased activity (3/6), hunched back (6/6), tremors (intermitten) whole body (2/6) and death (1/6).

Gross pathology:

White liquid material found in the digestive content of the stomach in 4/4 found dead rats, was considered to be test item-related. Dilation with gas of the small intestines noted in these found dead animals as test item effect cannot be ascertained, it cannot be excluded under the conditions of this study. In one of female dosed at 300 mg/kg bw, diffuse red discoloration of the stomach mucosa was also recorded at necropsy.
Non collapsed and red discoloured lungs observed in all found dead rats were regarded as agonal changes rather than test item administration effects.
There was no evidence of the macroscopic observations in surviving animals dosed at 300 mg/kg bw and terminated on Day 14.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

The single-dose oral toxicity of the test material, dissolved in PEG 400, was performed according OECD TG 423 with female Wistar rats. The test material caused mortality at a dose level of 2000 mg/kg bw (3/3) and 300 mg/kg bw (1/6). Clinical signs were observed in animals treated at 300 mg/kg bw with the test material. These included decreased activity (3/6), hunched back (6/6), tremors (intermitten) whole body (2/6) and death (1/6). Body weight and body weight gain showed no indication of a treatment-related effect. There was no evidence of the macroscopic observations in surviving animals dosed at 300 mg/kg bw and terminated on Day 14. Under the conditions of this study, the acute oral LD50 value of the test material was found to be between 300 and 2000 mg/kg bw.