Registration Dossier

Administrative data

Description of key information

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:
no study available

Additional information

Skin: A 4 -hour application of 0.5g of the substance (moistened with corn oil) to occluded rabbit skin resulted in no erythema, edema or other reaction on any of 6 animals. All dosed sited remained unaffected throughout the 7 day observation period.

Eye: Instillation of 50 mg of sample (equivalent of 0.1 ml) into rabbit eyes resulted in no corneal injury in any of 6 animals. Iritis was apparent in 3 animals and minor conjunctival irritation developed in 6 rabbits. Substantial ocular discharge was evident in 3 animals. After 24 hours, all rabbit eyes exhibited a normal appearance.

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.