Registration Dossier

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

Constituent 1
Chemical structure
Reference substance name:
L-alanine
EC Number:
200-273-8
EC Name:
L-alanine
Cas Number:
56-41-7
Molecular formula:
C3H7NO2
IUPAC Name:
(2S)-2-aminopropanoic acid

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:
No signs of toxicity were observed, neither at the male nor the female animals.
Body weight:
no data available
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.