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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: In compliance with GLP.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: OECD Principles of Good Labaratory Practice and the "Chernikaliengesetz" of the Federal Republic of Germany.
GLP compliance:
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
(S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
EC Number:
Cas Number:
Molecular formula:
C16-H26-N2 x C7-H11-N-O5
(S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
Details on test material:
- Name of test material (as cited in study report): AG-EE 623 Glutaminate
- Purity test date: dating from November 29, 1995
- Lot/batch No.: WB 02
- Expiration date of the lot/batch: guaranteed until November 30, 1996
- Other: location of study: Dr. Karl Thomae GmbH, 88397 Biberach

Test animals

other: albino rat Chbb:THOM (SPF)
Details on test animals or test system and environmental conditions:
- Source: Dr. Karl Thomae GmbH, 88397 Biberach
- Age at study initiation: 48-55 days
- Weight at study initiation: 128,1-224,2 g
- Fasting period before study: 1 day
- Housing: Collective housing in Noryl cages, type IV,
- Diet (e.g. ad libitum): ad libitum after 5h after administration, dry food
- Water (e.g. ad libitum): ad libitum

- Temperature (°C): 20 ± 3°C
- Humidity (%): 45%-75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 9/15 hours (7.00 a.m.-4.00 p.m.)

Administration / exposure

Route of administration:
oral: gavage
other: 0.5 % Hydroxyethylcellulose
Details on oral exposure:
- Concentration in vehicle: 250, 100 and 10 mg/ml
- Amount of vehicle (if gavage): 20 ml/kg
200, 2000, 5000 mg/kg
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The overall appearance and behavior of each animal were observed at least twice a day. Body weight of the animals was determined on the day of administration (day 1), as well as on days 2, 3, 5, 7 and 14 of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Results and discussion

Effect levels
Dose descriptor:
other: ALD50 (approximate lethal dose)
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
5000 mg/kg: 5/6 animals died until 6 hours after treatment.
2000 mg/kg: 5/6 animals died until 1.5 hours after treatment, one animal was found dead at day 3.
200 mg/kg: No animal died after treatment and through the end of the experiment.
Clinical signs:
other: 5000 mg/kg: Beginning 30 min after administration salivation, ataxia, mucous feces, lateral and abdominal position, tonoclonic convulsions and piloerection were seen in all the animals. Five of six animals died up to 6 hours after treatment. From day 2 un
Gross pathology:
5000 mg/kg:
The died animals showed hemorrhagic edema of the gastric mucosa. Two males and two females had additionally hyperemia of liver, spleen and kidneys. Reduced size of testes and epididymes size as well as perigastric organ adhesions and one node in the gastric area were observed in the surviving rat.
2000 mg/kg
Hemorrhagic gastric edema with hemorrhagic intestinal content as well as hyperemia of liver, spleen and kidneys were found in the initially died animals. The short time surviving animal had hyperemia of liver and lungs
200 mg/kg
No remarkable gross lesions.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Migrated information Criteria used for interpretation of results: EU
The oral administration of 5000 mg/kg and 2000 mg/kg led to severe toxic reactions followed by death of most animals of these groups. The
animals of the 200 mg/kg treated group showed slight toxic symptoms and survived the 14 days observation period.
Thus the ALD50 of the test item following oral administration in rats is higher than 200 mg/kg and lower than 2000 mg/kg.