Benzenemethanamine, .alpha.-ethyl-

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:

other: Guideline study conducted unter GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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

Test material

Test material information

Constituent 1

Reference substance name:

1-phenylpropan-1-amine

EC Number:

608-356-4

Cas Number:

2941-20-0

Molecular formula:

C9 H13 N

IUPAC Name:

1-phenylpropan-1-amine

Test material form:

other: solution in olive oil DAB 10

Details on test material:

Name of test substance: 1-Phenylpropylamin
Substance number: 97/98
Batch number: K 67/ 11.2.97/ Fr. 5
CAS number: 2941-20-0
Degree of purity/content: 99.7 g/100 g (GC)
Date of manufacturing: 11-Feb-1997
Physical state/appearance: Liquid, colourless
Storage conditions: Room temperature, exclusion of oxygen (store
under nitrogen)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

200, 500, and 2000 mg/kg bw

No. of animals per sex per dose:

200 mg/kg bw: 3 male animals
500 mg/kg bw: 3 male animals
2000 mg/kg bw: 3 male and female animals

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 500 mg/kg bw

Mortality:

200 mg/kg bw: no mortality after 14 days
500 mg/kg bw: 3/3 found dead
2000 mg/kg bw: 3/3 found dead

Gross pathology:

animals that died: glandular stomach: severe hyperemia; small intestine: hyperemia of the mucosa

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose of (R)-1-Phenylpropylamin after oral application was found to be greater than
200 mg/kg and less or equal to 500 mg/kg body weight.

Executive summary:

To two groups each of three fasted animals (males) a single oral dose of the test material preparation in olive oil DAB 10 at dose levels of 500 and 2000 mg/kg body weight was given. Another group of six fasted animals (3 males and 3 females) was treated in the same way with a dose of 200 mg/kg body weight. Signs of toxicity noted in the 2000 and 500 mg/kg dose group comprised poor general state, dyspnoea, apathy, ataxia and paresis. Twitching, saltatory spasm and flexion spasm were additionally observed in rats of the 2000 mg/kg dose group. Symptoms observed in the 200 mg/kg dose group comprised impaired or poor general state, dyspnoea, apathy and staggering. The surviving animals appeared normal within 5 hours after application. The expected body weight gain was observed in the course of the study. All animals of the 500 and 2000 mg/kg dose group died within 1 hour after application. No mortality occurred in the 200 mg/kg dose group.

Necropsy findings of the animals that died comprised severe hyperemia in the glandular stomach and hyperemia of the mucosa in the small intestine (2000 mg/kg). No abnormalities were noted at necropsy of animals sacrificed at the end of the study and of the animals of the 500 mg/kg dose group that died. Under the conditions of this study the median lethal dose of (R)-1-Phenylpropylamin after oral application was found to be greater than 200 mg/kg and less or equal to 500 mg/kg body weight.