Registration Dossier

Administrative data

Description of key information

DDNSA and DNNSA were administered by gavage to 5 rats/sex at 2000 and 2500 mg/kg bw, respectively. For DDNSA, no mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. The LD50 is > 2000 mg/kg bw (PSL 2001). For DDNSA one female died and bloating of the stomach was observed. The LD50 was > 2500 mg/kg bw (PSL, 1978)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Two studies are available on structural analogues. Both show very low acute oral toxicity and are used in a weight of evidence approach

Justification for selection of acute toxicity – inhalation endpoint
The inhalation route is considered not relevant in view of the high viscosity and low vapour pressure of the test substance. The uses identified are not expected to lead to aerosol formation with droplets in the inhalable range.

Justification for classification or non-classification

Based on the LD50 values derived, no classification according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC). Given the high viscosity and the fact that the test substance is not a pure hydrocarbon, classification for aspiration hazards is not required. No specific target organ toxicity was observed in any of the acute studies and thus STOT single exposure classification is not required.