Arginine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
No acute toxic effects were observed for the oral route up to the maximum dose of 5110 mg/kg body weight. This result shows that the toxicity of L-arginine via the oral route is extremely low.
The absence of acute toxic effects even at application of increased value doses indicates a low systemic toxicity of L-arginine.
No data on acute dermal toxicity for L-arginine is available. Due to its very low systemic toxicity and the fact that L-arginine (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.
As there is sufficient weight of evidence for the absence of acute toxicity via the dermal route this study is not conducted in accordance with Annex XI no. 1.2. REACH and for reasons of animal welfare: "Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available, further testing on vertebrate animals for this property shall be omitted..."