L-Glutamine, L-alanyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-01-23 to 1990-02-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

475-290-9

EC Name:

-

Cas Number:

39537-23-0

Molecular formula:

C8H15N3O4

IUPAC Name:

(2R)-2-[(2S)-2-aminopropanamido]-4-carbamoylbutanoic acid

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co.KG, Borchen, Germany
- Age at study initiation: 9 weeks (males); 10 weeks (females)
- Weight at study initiation: 155 - 202 g (males); 144 - 158 g (females)
- Fasting period before study: 16 h before treatment
- Housing: individually in Macrolon cages, type II
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 40 - 60 (for short periods down to 25%)
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 237 mg/mL
- Amount of vehicle: 21.5 mL/kg bw
- Lot/batch no.: E0844357

Doses:

5110 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continously observed for the first 4 - 6 h after administration; mortality: twice daily; weighing: on Day 1 prior to treatment and also 7 and 14 days after administration; clinical signs: continously for 4 - 6 h after treatment and once daily thereafter
- Necropsy of survivors performed: yes

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No alterations were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study no acute toxic effect occurred after oral administration of 5110 mg/kg bw test substance. LD50 > 5110 mg/kg bw.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.