Benzenemethanamine, .alpha.-(2-methylpropyl)-2-(1-piperidinyl)-, (.alpha.S)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.10.1998 - 04.02.1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according the OECD Principles of Good Labaratory Practice and the"Chemikaliengesetz" of the F ederal Republic of Germany. No guideline was followed. However, the test is very well described and is considered reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Principles of method if other than guideline:

OECD Principles of Good Labaratory Practice
OECD Environment Monograph No. 73
"Chemikaliengesetz" of the F ederal Republic of Germany.

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

AGEE 623 (S)-AMINE

IUPAC Name:

AGEE 623 (S)-AMINE

Test material form:

other: fluid

Details on test material:

- Lot/batch No.: WB501
- Expiration date of the lot/batch: August 31, 2000

Test animals

Species:

rat

Strain:

other: Chbb:THOM

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 49 days
- Weight at study initiation: 132-200 g
-

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: An extended acute-toxic-class (ATC) method was used: Initially 2000 mg/kg were given to
1 male and 1 female. After the dose was not tolerated, a further group was treated with 200 mg/kg.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg male/female: 2 ml/kg
200 mg/kg group: 0.2 ml/kg

Doses:

2000 mg/kg
200 mg/kg

No. of animals per sex per dose:

2000 mg/kg: 1 male, 1 female
200 mg/kg: 3 male, 3 female

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: ALD

Effect level:

> 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg: Both animals died withing approx. 4.5 hours.
200 mg/kg: No animal died after administration and through the end of the experiment.

Clinical signs:

other: 2000 mg/kg: Ataxia, breathing difficulties, tonic-clonic cramps, found dead approx. 4.5 hours after administration 200 mg/kg: Salivation, abdominal pain reactions during the administration day. No toxic symptoms from day 2 until end of observation

Gross pathology:

No gross lessions were seen during necropsy.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the German "Chemikaliengesetz" (Chemical Act) the toxicity of the test substance is to be classified: "injurious to health" (R22)