Registration Dossier

Administrative data

Description of key information

Several GLP-studies according to or equivalent to OECD guidelines 404 and 405 are available for diisobutyl ketone.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin: Several studies in rabbits conducted under GLP and according to OECD guideline 404 showed no or very slight irritation not meeting the criteria for classification as skin irritant. Some older non-GLP studies conducted with guinea pigs showed skin irritation effects. However, the details provided in those study reports are insufficient for proper evaluation of the data and no details on the purity of the test material is given.

Eye: two studies of acceptable quality (Klimisch 2) - conducted in rabbits - showed very slight irritation not meeting the criteria for classification.

Respiratory: in a human volunteer study (see section 7.10.5) using diisobutyl ketone vapor concentrations of 50 and 100 ppm. The higher concentration caused slight irritation of the eyes and nose initially, but the sensation decreased during the exposure. In a sensory irritation study in mice, DIBK caused a significant decrease in respiratory rate following head only vapor exposure for 15 mins

at concentrations of 184 to 351 ppm, suggesting some sensory irritation of the respiratory tract.


Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin irritation: according to EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) and GHS/CLP the mean values for erythema and edema scores were less than 2 for all animals tested. According to annex VI and I of these directives diisobutyl ketone is not classified as skin irritant.

Eye irritation: according to the annex VI of the council directive 67/548 EEC (amended by directive 83/467 EEC) the average scores over all animals cornea opacity, iris lesions, conjunctivae and chemosis were 0 at all, respectively at 24, 48 and 72 hours. According to EU criteria no classification for eye irritancy is required.

Respiratory: diisobutyl ketone is classified as respiratory irritant R37 according to annex VI of the council directive 67/548 EEC (amended by directive 83/467 EEC) and H335 according to GHS/CLP.