DL-α-methylbenzylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-12-05 to 2012-01-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(17 December 2001)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(30 May 2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(December 2002)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

DL-α-methylbenzylamine

EC Number:

210-545-8

EC Name:

DL-α-methylbenzylamine

Cas Number:

618-36-0

Molecular formula:

C8H11N

IUPAC Name:

1-phenylethan-1-amine

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 10 weeks
- Weight at study initiation: Mean weight 180.3-209.3 g
- Fasting period before study: 16 hours before administration
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30–70
- Air changes (per hr): Central fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 15 g /100 mL (300 mg/kg bw )
- Justification for choice of vehicle: Solution in olive oil Ph.Eur.

MAXIMUM DOSE VOLUME APPLIED
An administration volume of 2 mL/kg bw of suitable test item preparation was used to facilitate application.

Doses:

2000 mg/kg bw (undiluted)
300 mg/kg bw ( 15 g/100 mL) (2 administrations)

No. of animals per sex per dose:

3 animals/dose
2 replicates

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observation: At least once daily; Weighing: Day 0, 7, 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Pathology, mortality

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals of the 2000 mg/kg bw test group died immediately after administration. No mortality occurred in both 300 mg/kg bw test groups.

Clinical signs:

other: Because all animals of the 2000 mg/kg bw test group died immediately after administration no clinical signs could be determined. In the first and second test group 300 mg/kg bw following obseravtions were made: · Impaired general state in 5 out of 6

Gross pathology:

The macroscopic pathological findings in the animals of the 2000 mg/kg bw test group revealed red discoloration in all lobes of the lung, dark discoloration of the liver and extensive bleeding in the glandular stomach.
Additionally one of these animals showed edema in all lobes of the lung. There were no macroscopic pathological findings in the animals of both 300 mg/kg bw test groups sacrificed at the end of the observation period.