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Description of key information

An acute oral LD50 value of > 5110mg/kg bw from a reliable study was derived. No mortality occurred during the observation period of 14
days. No signs of toxicity were observed either at the male nor the female animals.
The acute dermal study and the acute inhalation study were waived based on the very low systemic toxicity as well as on the physico-chemical and toxikokinetic properties.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 110 mg/kg bw
Quality of whole database:
Comparable to guideline study with acceptable restrictions (Klimisch Code 2)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No acute toxic effects were observed for the oral route up to the maximum dose of 5110 mg/kg body weight. The LD50 value of L-alanine via the oral route represented by male and female rats was > 5110 mg/kg body weight. These results show that the toxicity of L-alanine via the oral route is extremely low.

No acute toxic effects were observed for the oral route for single or repeated oral doses of 50 g L-alanine per subject in three human studies (Genuth 1973; Koeslag et al 1985a and 1985b).

Citations:

Genuth S.M. Effects of oral alanine administration in fasting obese subjects. Metabolism. 1973 Jul; 22(7): 927-37;

Koeslag, J.H., Levinrad, L.I., Klaff, L.J., 1985a. Pancreatic polypeptide response to exercise: effect of alanine and glucose ingestion in carbohydrate-starved athletes. S. Afr. Med. J. 67, 884–887;

Koeslag, J.H., Levinrad, L.I., Lochner, J.D., Sive, A.A., 1985b. Postexercise ketosis in post-prandil exercise: effects of glucose and alanine ingestion in humans. J. Physiol. 358, 395–403.


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for classification or non-classification

Based on the data available no classification for acute toxicity (oral toxicity, dermal toxicity, inhalation toxicity) is required.