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Description of key information

Diethyl ketone caused signs of irritation in rabbits after dermal (without relevance for classification) and eye contact (with relevance for classification). It caused eye and respiratory irritation in humans.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Dermal irritation

In a dermal irritation study (BASF AG, 1969) two Vienna White rabbits were dermally exposed to undiluted diethyl ketone. The test site (intact dorsal skin) was covered with an occlusive dressing for 1, 5 , 15 minutes or 20 hours, respectively. Rabbits were observed for 7 -8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to OECD test guideline 404. The mean value of the scores for either erythema or edema formation at the 24 -, 48 - and 72 -hour reading calculated over all the animals tested was 1.83 and 0.67, respectively, for the 20 -h exposure period and 1.0 and 0.0, respectively, for the 15 min exposure period. These signs of irritation had resolved at the 6 -day reading. Scaling was noted in one animal at the end of the observation period (day 8). Based on these results it can be reliably estimated that a 4 -hour semi-occlusive dermal exposure according to OECD test guideline 404 would not lead to irritating effects triggering a classification of the test item as a skin irritant.

 

Eye irritation

In a primary eye irritation study (BASF AG, 1969), 50 µl of undiluted diethyl ketone was instilled into the conjunctival sac of one eye of 3 White Vienna rabbits. The eyes were not washed out after 24 hours. Animals were observed for 8 days. After 24 hour, slight erythema, slight edema as well as slight corneal opacity were observed. Next observation was made after 48 hours after application. No observation was performed after 72 hours. The mean value of the scores at the 24- and 48-hour reading for redness, chemosis, corneal opacity and irititis calculated overall the animals tested was 1.0, 0.5, 1.0 and 0.0, respectively. The observed changes were fully reversible in all animals within 48 h (chemosis), 7 days (redness), and 8 days (corneal opacity).

 

Human data on eye and respiratory irritation

Douglas and Coe (1987) reported that various concentrations of diethyl ketone were applied to the eyes of volunteers through tightly fitting goggles and, in separate experiments, to the lungs via a mouthpiece. Exposure to the eyes lasted for 15 seconds per concentration; lung exposure was achieved by the inhalation of 10 breaths of 1 L of gas at a given concentration. Eye response was detected subjectively, lung response (narrowing of the respiratory passages) was measured objectively by plethysmograph and the threshold concentrations for no-response were determined. The threshold for eye irritation was around 700 ppm (2470 mg/m³), whereas the threshold for respiratory irritation was around 400 ppm (1410 mg/m³) in human volunteers.


Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Based on the results obtained in the skin irritation study, the test substance does not meet the criteria for classification and labelling as skin irritant according to Directive 67/548/EEC and Regulation 1272/2008/EC. However, the substance is classified and labelled with R66 or EUH066 (repeated exposure may cause skin dryness or cracking) according to Directive 67/548/EEC or Regulation 1272/2008/EC.

Due to the mean score of 1 for corneal opactiy obtained in 2 of 3 animals in the eye irritation study, diethyl ketone is classified for eye irritation according to Regulation 1272/2008/EC as Cat.2, H319, causes serious eye irritation, but not according to Directive 67/548/EEC.

With regard to respiratory irritation, diethyl ketone is classified according to Directive 67/548/EEC as R37 (irritating to respiratory system) and according to Regulation 1272/2008/EC as STOT Single 3, H335 (may cause respiratory irritation).