1,4,7,10-Tetraazacyclododecane, 1,4,7,10-tetrakis(phenylmethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from Sept. to Oct. 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1997

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:

-

EC Number:

449-410-5

EC Name:

-

Cas Number:

18084-64-5

Molecular formula:

C36H44N4

IUPAC Name:

1,4,7,10-Tetrabenzyl-1,4,7,10-tetraazacyclododecane

Test animals

Species:

rat

Strain:

other: HAN: WIST (SPF)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Miglyol 812

Doses:

2000, 1644, 200, and 161.6 mg/kg
The doses of 1644 and 161.6 mg/kg were due to the determination of only 82 and 81% test substance in these formulations.

No. of animals per sex per dose:

in total 9 males and 3 females were used

Control animals:

no

Details on study design:

- water: demineralized, acidified water, pH 2-3, ad libitum

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 - < 500 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

3 male rats treated with 2000 mg/kg bw and 3 male rats treated with 1644 mg/kg bw died between days 4 and 6 after administration. As clinical signs ruffled fur, incerased defaecation and diarrhea became obvious on the day of application, followed by apathy, emaciation, and atactic gait seen in some of the rats.

No rat receiving 200 or 161.6 mg/kg bw died in the course of the study. As clinical signs ruffled fur and diarrhea became obvious on the day of application. Afterwards the animals were without clinical findings. Autopsy revealed no compound-related findings in these animals.

Applicant's summary and conclusion

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at the dose of 200 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. As clinical signs ruffled fur and diarrhea became obvious on the day of application. The dose of 2000 mg/kg bw was lethal to all animals between day 4 and 6 after adminstration.

According to OECD TG 423 (1996) the oral LD50 of the test substance is therefore > 300 to < 500 mg/kg body weight.