Registration Dossier

Administrative data

Description of key information

The key study  is a read across from ATMP (CAS 6419-19-8) for acute oral toxicity reports an LD50 value of 2000mg/kg in rat (Safepharm Laboratories, 1995; rel 1). The key dermal study is a read across from the sodium salt (CAS 20592-85-2). It reports an LD50 value of >10 ml/kg (equivalent to >5740 mg active salt / kg bw) (Safepharm Labs, 1982; rel 1). 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
5 740 mg/kg bw

Additional information

The category hypothesis is that all the members are various ionised forms of the acid (CAS 6419 -19 -8). In dilute aqueous conditions of defined pH a salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. Hence some properties (measured or expressed in aqueous media) for a salt can be directly read-across (with suitable mass correction) to the parent acid and vice versa.

No studies were available for the inhalation endpoint and the data is waived in the presence of high reliability data available via the oral and dermal routes.

The most recent, high reliability studies were chosen as key information.

Justification for classification or non-classification

Based on the above information, no classification or labelling is required for the acute toxicity endpoints for the [nitrilootris(methylene)]trisphosphonic acid, ammonium salt in accordance with current EU guideline.