Registration Dossier

Administrative data

Description of key information

Acute administration by oral route, LD50= 16000 mg/kg b.w
Acute administration by dermal route, LD0 > 5000 mg/kg b.w

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute toxicity assessment by oral route:

Two studies are available for the assessment of acute administration by oral route. The Key study is well described and showing a clear dose/response relationship. The study performed in 1981 is conducted with an unknown method. No relevant signs of toxicity are reported. The substance shows mortality for concentrations above 4000 mg/kg.

The study performed in 1974 is conducted with an unknown method. The signs observed are: slight to moderate lethargy, piloerection, salivation, increase in respiratory rate, diarrhoea, diuresis and ataxia. No deaths occurred during the 14 day observation period up to 5000 mg/kg b.w

Acute toxicity assessment by dermal route:

One study is available for assessment by dermal route

The study performed in 1973 is conducted with an unknown method. The purity of substance is about 85%. No clinical symptoms were recorded and no death occurred during the 14 day observation period.

Justification for classification or non-classification

Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

No symptoms has been registered and no mortality has been observed for concentrations above 4000 mg/kg. The LD50 for oral administration is 4800 mg/kg b.w. For dermal exposure pathway the limit concentration has not be measured on pure substance, but on formulation, therefore the effect has been reported at concentration of the pure substance slightly under the related trigger value. Taking into account that no effects on skin has been reported at 1500 mg/kg for dermal exposure, it can be assumed that :

No classification for acute toxicity oral is warranted according to the CLP Regulation (EC n. 1272/2008)

No classification for acute toxicity dermal is warranted according to the CLP Regulation (EC n. 1272/2008)