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Administrative data

Description of key information

LD50 of L-argine-HCl was determined to be 12400 mg/kg b.w. in a scientific study with rats. L-arginine-HCl is practically non-toxic. The studies for acute dermal toxicity and toxicity via the inhalation route were waived due to the results from oral toxictiy studies.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
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
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

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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 400 mg/kg bw
Based on:
test mat.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
12 400 mg/kg bw
Quality of whole database:
Klimisch code 2: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

LD50 of L-arginine-HCl was determined to be 12400 mg/kg b.w. in a scientific study with rats. This is in line with a study with L-arginine in which no toxicity occured up to the maximum test dose which was just 5110 mg/kg.

Above result shows that the toxicity of L-arginine-HCl via the oral route is extremely low. Inhalation is not a relevant route based upon the vapour pressure and particle size (granulometry) of L-arginine-HCl. There is sufficient weight of evidence for the absence of acute toxicity via the inhalative route.

The absence of acute toxic effects even at application of increased value doses indicates a low systemic toxicity of L-arginine-HCl.

No data on acute dermal toxicity for L-arginine-HCl or L-arginine is available. Due to its very low systemic toxicity and the fact that L-arginine-HCl (with high water solubility and a log P value well below 0) may be too hydrophilic to cross the lipid rich environment of the stratum corneum it is highly improbable that an acute dermal toxicity study would result in any toxicity.

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.