Registration Dossier
Registration Dossier
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EC number: 214-275-1 | CAS number: 1119-34-2
Acute Toxicity: oral
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:
- 1 973
- 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 substance name:
- (+)-L-arginine hydrochloride
- EC Number:
- 214-275-1
- EC Name:
- (+)-L-arginine hydrochloride
- Cas Number:
- 1119-34-2
- Molecular formula:
- C6H14N4O2.ClH
- IUPAC Name:
- (2S)-2-amino-5-carbamimidamidopentanoic acid hydrochloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system 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.
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