L-alanine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-03-11 to 1983-03-31

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: No guideline available at that time

Deviations:

not applicable

Principles of method if other than guideline:

Intercomparison study on the determination of single administration toxicity in rats, Commission of the European Communities, Health and Safety Directorate, J. Assoc. Off. Anal. Chem. 62, 864-73, 1979

GLP compliance:

no

Remarks:

Study performed prior to implementation of GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-alanine

EC Number:

200-273-8

EC Name:

L-alanine

Cas Number:

56-41-7

Molecular formula:

C3H7NO2

IUPAC Name:

L-alanine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males 52 days, females 66 days
- Weight at study initiation: males 0.134 - 0.139 kg, females 0.127 - 0.133 kg
- Fasting period before study: 16 hours
- Housing: Makrolon cages type II
- Diet (e.g. ad libitum): standardised test animal diet ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days acclimatisation period before study begin

ENVIRONMENTAL CONDITIONS
According to method

IN-LIFE DATES: From: To: no data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Tragant

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 238 mg/ml
- Amount of vehicle (if gavage): 21.5 ml/kg
- Justification for choice of vehicle: solubilty, inherent vehicle
- Lot/batch no. (if required): not applicable
- Purity: ca. 100 %

MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg

Doses:

5110 mg/kg

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: no data available
- Necropsy of survivors performed: no data vailable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the observation period of 14 days.

Clinical signs:

other: No signs of toxicity were observed, neither at the male nor the female animals.

Gross pathology:

no data available

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LD50 value of L-alanine via the oral route represented by male and female rats was > 5110 mg/kg body weight.