N-benzyl-4-methoxy-α-methylphenethylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 4 May to 20 May 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-benzyl-4-methoxy-α-methylphenethylamine

EC Number:

256-155-1

EC Name:

N-benzyl-4-methoxy-α-methylphenethylamine

Cas Number:

43229-65-8

Molecular formula:

C17H21NO

IUPAC Name:

N-benzyl-1-(4-methoxyphenyl)propan-2-amine

Details on test material:

- Name of test material (as cited in study report): TH 1165 II
- Physical state: yellow liquid
- Analytical purity: 98.2 % (area)
- Purity test date:
- Lot/batch No.: 61
- Expiration date of the lot/batch: 8 april 2000 (allocated by NOTOX, 1 year after receipt of the test substance)
- Storage condition of test material: at room temperature in the dark
- Stability under storage conditions: not indicated

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland G,mbH, Sulzfeld, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: body weight did not exceed 20% of the sex mean
- Housing: polycarbonate cages, 3 animals per cage
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance
- Diet (e.g. ad libitum): Carfil Quality BVBA, Oud-Turnhout, Belgium ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before start of the treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Photoperiod (hrs dark / hrs light): 12 hrs each

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Initially, TH 1165 II was administered by oral gavage to 3 females Wistar rats at 2000 mg/kg bw. In a stepwise procedure additional groups of animals were dosed at 200 (females) and 200 (males) mg/kg bw. All animals were subjected to daily observations and weekly determination of body weight. macroscopic examination was performed on the day of death or after terminal sacrifice (day 15)

Doses:

one dose per animal at 2000 mg/kg b.w.
one dose per animal at 200 mg/kg b.w.

No. of animals per sex per dose:

3 female at 2000 mg/kg b. w.
3 female and 3 male at 200 mg/kg bw

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 day (pre-administration); 8 and 15 and at death (if found dead after day 1).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The incidence of mortality was as follow, presented in chronological order of treatment:
Dose level: Mortality: Sex:
2000 mg/kg 3/3 females
200 mg/kg 0/3 females
200 mg/kg 0/3 males

Clinical signs:

no clinical signs were noted.

Body weight:

The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain

Gross pathology:

no autopsy findings were noted.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 value of TH 1165 II in Wistar rats was established 200-2000 mg/kg bw.