1H-Dibenz[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

2,4-diazatetracyclo[12.4.0.0²,⁶.0⁷,¹²]octadeca-1(18),3,7,9,11,14,16-heptaen-3-amine

EC Number:

616-785-3

Cas Number:

80012-43-7

Molecular formula:

C16 H15 N3

IUPAC Name:

2,4-diazatetracyclo[12.4.0.0²,⁶.0⁷,¹²]octadeca-1(18),3,7,9,11,14,16-heptaen-3-amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

200mg/kg and 2000mg/kg

No. of animals per sex per dose:

3 male and 3 female for the dose of 200 mg/kg and 3 male for the dose of 2000mg/kg

Control animals:

no

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

The acute toxic class method was perfonned with WAL 801 BS (synonymous to WAL 801 Stufe 617). It is the principle of the acute toxie class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item to enable its classification.

The starting dose (step 1) was 200 mg/kg body weight. The oral application of the test item at a dose of 200 mg/kg BW caused no compound-related mortalities in three male and three female animals within 14 days p. appl..

No clinical signs of toxicity were observed throughout the observation period.

Throughout the l4-days observation period no weight loss was recorded (table 1). The weight gain was within the expected range. Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.

No other macroscopic necropsy findings were recorded.

Since no compound-related mortality was found further testing was required. According to OECD guideline 423 the next step (step 2) was perfonned at the next higher dose level of 2000 mg/kg BW.

The oral application of the test item to a group of three male animals at a dose of 2000 mg/kg BW caused compound related mortalities in all 3 animals within 4 hours p. appl..

Since compound-related mortality of all animals was observed at step 2 (2000 mg/kg BW) no further testing was required. According to the results obtained the LD50 was determined to be between 300 and 500 mg/kg BW.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item WAL 801 BS has acute toxic characteristics.
Thc LD50 was determined to be between 300 and 500 mg/kg BW.