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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Effect of Selected Amino Acids on Toxicity in Rats
Author:
Breglia, R., Ward, C., Jarowski, C.
Year:
1973
Bibliographic source:
Journal of Pharmaceutical Sciences, 62(1), 49-55

Materials and methods

Principles of method if other than guideline:
Scientific examination
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Test type:
other: Scientific examination
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 125 - 150 g
- Weight at study initiation: ca. 2 months
- Fasting period before study: 1day
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 6 ml
- Concentration in vehicle: 140 mg/kg, 2310 mg/kg
- Justification for choice of vehicle: Destilled water has no impact on its own

MAXIMUM DOSE VOLUME APPLIED: 6 ml
Doses:
140 mg/kg, 2310 mg/kg
No. of animals per sex per dose:
5 per dose
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 400 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
LD50 of L-argine-HCl was determined to be 12400 mg/kg b.w. in a scientific study with rats.