Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
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.
Inhalation is not a relevant route based upon the vapour pressure and particle size (granulometry) of L-arginine.
There is sufficient weight of evidence for the absence of acute toxicity via the inhalative route. The 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 particuliar dangerous property is available, further testing on vertebrate animals for this property shall be omitted..."

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion