(+)-L-arginine hydrochloride

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:

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

Test material information

Constituent 1

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

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.