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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Remarks:
L-arginine
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: No guideline available at that time
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, 864-873, 1979
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Arginine
EC Number:
200-811-1
EC Name:
Arginine
Cas Number:
74-79-3
Molecular formula:
C6H14N4O2
IUPAC Name:
arginine
Test material form:
not specified

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: males48 - 51 days, females 59 - 62 days
- Weight at study initiation: males 0.130 - 0.136 kg, females 0.130 - 0.147 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
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: solubility, 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 available

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-arginine via the oral route represented by male and female rats was > 5110 mg/kg body weight.