N-(5-chloro-2-isopropylbenzyl)cyclopropanamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-{[5-chloro-2-(propan-2-yl)phenyl]methyl}cyclopropanamine

EC Number:

941-682-8

Cas Number:

1476113-93-5

Molecular formula:

C13 H18 Cl N

IUPAC Name:

N-{[5-chloro-2-(propan-2-yl)phenyl]methyl}cyclopropanamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Doses:

2000 and 300 mg/kg bw

No. of animals per sex per dose:

3 females (2000 mg/kg bw)
6 females (300 mg/kg bw)

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 3/3 animals died at a dose level of 2000 mg/kg bw, no mortalities occurred at a dose level of 300 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

other: acute oral toxicity observed

Conclusions:

The test material caused mortality at the dose level of 2000 mg/kg bw (3/3). No animal died after single treatment with 300 mg/kg bw (0/6). Treatment with the test material at the dose level of 2000 mg/kg bw caused decreased activity (3/3), hunched back (3/3), tremors (intermittent) (3/3), tremors (continous) whole body (2/3), piloerection (2/3), red discharge from eyes (2/3) and and death (3/3).
Treatment with the test material at a dose level of 300 mg/kg bw caused decreased activity (1/6), hunched back (3/6), prone position (1/6), red discharge from eyes (1/6). There were no treatment related effects on body weight or body weight gain during the observation period on the surviving animals. In the rats, which died after treatment, diffuse, dark red discoloration could be observed in the non collapsed lungs.
There was no evidence of any gross findings in the rats, at a dose level of 300 mg/kg bw necropsied on the Day 14 of the study.
Thus, the acute oral LD50 value of the test material was found to be between 300 and 2000 mg/kg bw. Based on these results and according to EU classification criteria, the test material has to be classified.