Registration Dossier

Administrative data

Description of key information

No studies are available for didenac and information is based on read across to a similar substance, dienone. Based on read across to dienone, the oral discriminating dose for didenac is considered to be 500 mg/kg bw in male and female rats. The dermal LD50 is >2000 mg/kg in male and female rats. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
500 mg/kg bw

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
Dose descriptor:
LD50
Value:
mg/kg bw

Additional information

 

Read-across justification summary is attached to this endpoint summary.

Based on read across to dienone, the oral discriminating dose for didenac is considered to be 500 mg/kg bw in male and female rats. The dermal LD50 is >2000 mg/kg in male and female rats.


Justification for selection of acute toxicity – oral endpoint
Only acute oral toxicity value. Discriminating dose for didenac, by read-across to dienone, is 500 mg/kg bw.

Justification for selection of acute toxicity – dermal endpoint
Only acute dermal toxicity value. LD50 for didenac, by read-across to dienone, is >2,000 mg/kg bw.

Justification for classification or non-classification

Based on read across to dienone and according to the Directive 67/548 EEC, didenac is classified: Xn, R22 - Harmful if swallowed and as Acute Oral Category 4 according to Regulation (EC) 1272/2008 (CLP).