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Description of key information

LD50 rat oral route > 2000 mg/kg bw

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
Quality of whole database:
WoE based on studies conducted according to internationally accepted testing guidelines.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

LD50 rat oral route for the substance is higher than 2000 mg/kg bw (conclusion derived by WoE approach based on the results of the preliminary dose range finding and main test OECD TG 422 and considering the low reactivity of the substance).

According to the Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 testing by the dermal route does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). LD50 rat oral route for the substance is higher than 2000 mg/kg bw (conclusion derived by WoE approach) and no classification is required for acute oral toxicity. No dermal acute toxicity is expected and no new test is considered necessary because there is no exposure upon use. Classification as skin sensitiser requires higher protection for the workers.

Testing by inhalation route is not appropriate for this substance because the exposure of human via inhalation is unlikely.

Justification for classification or non-classification

LD50 rat oral route > 2000 mg/kg/bw and no classification regarding acute oral toxicity is required for the substance according to the CLP Regulation (EC n.1272/2008).

There is no concern regarding dermal route based on in vitro skin irritation study and inhalation exposure is unlikely due to the low vapour pressure of the substance. Classification as skin sensitiser requires higher protection for the workers. 

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