Registration Dossier

Administrative data

Description of key information

A GLP-study according to OECD guideline 401 and several non-GLP studies equivalent or similar to OECD guidelines 401 and 403 are available for diisobutyl ketone (DIBK).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 233 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
14 500 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The oral LD50 values for DIBK in experiments in rats ranges from 3200 to 6899 mg/kg and greater than 3200 mg/kg in mice. The dermal LD50 values ranged from greater than 2000 to greater than 16100 mg/kg in rats, 4556 to 10868 mg/kg in rabbits and greater than 16 mg/kg in guinea pigs. As the rat is the relevant species for classification and labeling criteria, the LD50 value from the rat study is being taken as the key value. The inhalation LC50 value for DIBK in rats and guinea pigs was greater than 11500 mg/m3 after 4 hours of exposure.

Justification for classification or non-classification

LD50 values for oral and dermal route are greater than 2000 mg/kg/bw and LC50 values are greater than 20 mg/l. According to the EU criteria for classification and labeling, diisobutyl ketone is not classified for acute toxicity for any route of exposure.