Heptan-2-one

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation 

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with OECD and EU commission guidelines. Test animals had 0.5 ml aliquots of stock test article applied to shorn patches of skin and covered with an occlusive dressing for 4 hours. After treatment , the test article was washed away and the animals were observed for 72 hours. A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced well-defined erythema and slight oedema. Other signs of skin irritation noted were light brown discolouration of the epidermis, loss of skin flexibility and/or elasticity, crust formation and slight desquamation. The test item produced a primary irritation index of 3.7 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.

Eye Irritation

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following: OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002) and Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008 A single application of the test item to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. One treated eye appeared normal at the 48-Hour observation and two treated eyes appeared normal at the 72-Hour observation. The test item produced a maximum group mean score of 12.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

 

Respiratory Tract Irritation

 

The potential for methyl n-amyl ketone to cause respiratory tract irritation was evaluated based on the results of an acute LC50 study in which rats were exposed to 3.88-23.9 mg/mL of the test material for up to six hours. Based on the type and duration of clinical signs observed during and following exposure, methyl n-amyl ketone is not considered to be a respiratory tract irritant.

 

 

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the regulation criteria for EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, MAK is not classified for skin irritation. While the study report calls this substance out as a moderate skin irritant, no mean irritation value rose above a score of 2.0 at any time point in the study. 

Based on the regulation criteria for EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, MAK is not classified for eye irritation. There was no score in the study that was above the threshold level for classification under CLP.

Methyl n-amyl ketone is not classified for Respiratory Tract Irritation according to Annex I of Directive 67/548/EEC. Based on the clinical signs observed in an LC50 study in which rats were exposed to 3.88-23.9 mg/mL of the test material for up to 6 hours, methyl n-amyl ketone is not classified for Specific Target Organ Toxicity – Single Exposure Category 3 for respiratory tract irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).