Registration Dossier
Registration Dossier
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EC number: 208-060-1 | CAS number: 506-93-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
No toxicokinetical studies are available for guanidine nitrate. Assessment is based on available acute toxicity data and physicochemical properties and is developed with the aid of ECHA guidance on information requirements and chemical safety assessment chapter R7c.
Guanidine nitrate is good water soluble and has a log P value of -1.7, therefore absorption has to be expected. After oral exposure signs of systemic toxicity including death were observed in acute toxicity studies, thus absorption of guanidine nitrate has occurred. As a consequence it is likely the substance will also be absorbed if it is inhaled. This assumption is supported by read-across data from an acute toxicity study by inhalation route, were systemic effects were observed. As data from a dermal acute toxicity study show no systemic effects at the limit dose of 2000 mg/kg bw/d, guanidine nitrate is expected to be not favourable for dermal absorption. As outlined in R7c the stratum corneum provides its greatest barrier function against hydrophilic compounds. If water solubility is above 10,000 mg/L and the log P value below 0 the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for guanidine nitrate is considered to be low, due to the water solubility of 256,000 mg/L and the log P value of -1.7.
In the acute oral toxicity study clear signs of the central nervous/neuromuscular system were observed, which indicate that the substance has been distributed to the CNS. The excretion route is expected to be via the urine, because guanidine nitrate dissociates in body fluids into the corresponding ions, is highly water soluble and has a low molecular weight of 122 g/mol.
Guanidine hydrochloride is used as pharmaceutical. According to prescribing information guanidine is indicated for the reduction of symptoms of muscle weakness and easy fatigability associated with the myasthenic syndrome of Eaton-Lambert. The clinical pharmacology is described as follows: “Guanidine apparently acts by enhancing the release of acetylcholine following a nerve impulse. It also appears to slow the rates of depolarization and repolarization of muscle cell membranes.”
Nitrate is the principal nitrogen source for plants, taken up from soil as essential nutrient. Thus, nitrate is a natural ingredient of vegetables, fruits and cereals. From standard textbooks on pharmacology and physiology nitrate is known to be absorbed from the gastro-intestinal tract and excreted in the urine.
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