8-isopropyl-8-azabicyclo[3.2.1]octan-3-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

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:

8-isopropyl-8-azabicyclo[3.2.1]octan-3-one

EC Number:

222-315-4

EC Name:

8-isopropyl-8-azabicyclo[3.2.1]octan-3-one

Cas Number:

3423-28-7

Molecular formula:

C10H17NO

IUPAC Name:

8-isopropyl-8-azabicyclo[3.2.1]octan-3-one

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

200 mg/kg and 2000 mg/kg

No. of animals per sex per dose:

3

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item N-Isopropylnortropinon has acute toxic characteristics.
The LDso was determined to be between 300 and 500 mglkg bw.

Executive summary:

The acute toxic class method was performed with N-Isopropylnortropinon. It is the principle of the acute toxic 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. In the first step the test item N-Isopropylnortropinon was given in a dose of 200 mg/kg body weight to a group of 3 male rats (HsdBr1: WH Wistar) in a single exposure via oral gavage. In a second step the test item was given to a group of 3 female rats (HsdBr1:WH Wistar) in a single exposure via oral gavage. The dosage of 200 mg/kg bw caused neither compound-related mortality in the three male nor in the three female animals within 14 day p. appl.. A careful clinical examination was made once a day. At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes. No clinical signs of toxicity were observed throughout the observation period. Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection-no special gross pathological changes were found in animals of step 1 and step 2. According to the acute toxic class method regime, in a third step the test item N-Isopropylnortropinon was given to a further group of male animals in a dose of 2000 mg/kg bw. . The dosage of 2000 mg/kg bw caused peracute compound-related mortality in two male animals. Animal No. 1 was dead within 1 minute p.appl. and animal No. 2 was dead 10 minutes p. appl. Both animals showed tremor, convulsion, respiratory distress and prone position. No special gross pathological changes were found in the two males of step 3. Due to animal welfare reasons (severe signs of morbidity, resulting in peracute death), a third application of 2000 mg/kg bw was not performed and a dosage of 2000 mg/kg bw was stated to cause 100% compound-related mortality in this group. According to the acute toxic class method regime no further testing was required. According to the results obtained the LD50 was determined to be between 300 and 500 mg/kg bw.