Isopropyl acetate

Endpoint summary

Description of key information

The weight of evidence from available animal studies indicate that isopropyl acetate is not or at worst minimally irritating to skin and slightly irritating to the eye.

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)

Additional information

There are no reliable skin irritation studies available with isopropyl acetate. There are such studies available with closely related substances. A 4 -hour occlusive treatment of 6 rabbits with 0.5 mL of the the substance n-butyl acetate, which is structurally similar to isopropyl acetate, in a study similar to OECD TG 404 did not induce any erythema nor edema, therefore the test item does not reveal any irritating potential under the conditions tested. The dermal irritation of n-propyl acetate was examined. Barely perceptible irritation was noted following application of 0.01 ml test material. A study to examine ethyl acetate as a permeation enhancer solvent for transdermal drug delivery reported mild to moderate irritation to rabbit skin following application of a transdermal drug delivery device containing the drug levonorgestrel and neat ethyl acetate. Control devices containing only water were also found to be mildly irritating. Some residual irritancy may have been caused by adhesive remaining on the skin following test cell removal or the semi-permeable membrane used in the device. Whilst the solvent was not in direct contact with the skin (separated by the 50um membrane), the duration of exposure was significantly longer than required for a guideline study. This study is deemed sufficiently reliable to characterise ethyl acetate as not significantly irritating to the skin. The results from these two studies can be interpolated to confidently predict that isopropyl acetate would behave similarly and would not be a skin irritant. This prediction is supported from studies that cannot be assessed as reliable but that nevertheless provide consistent evidence that isopropyl acetate is not an irritant to the skin, a characteristic consistent with this homologous series of acetate esters.

 

There are no reliable eye irritation studies available for the substance isopropyl acetate. However, reliable data is available for the two acetate esters either side of this substance in the homologous series. Both ethyl acetate and n-butyl acetate produce moderate eye irritation that fully resolves within 2 weeks of exposure. The trend seems to be for more noticeably acute effects with ethyl acetate than butyl acetate but that the effects seen with the latter are a little more persistent. The primary irritation index is 15 for ethyl acetate and 7.5 for n-butyl acetate. It is reasonable to conclude that the value for isopropyl acetate will fall somewhere between these two values.

Justification for classification or non-classification

Based on the weight of available evidence in animal studies, no classification is recommended for skin irritation

There are no reliable eye irritation studies available for the substance isopropyl acetate. However, reliable data is available for the two acetate esters either side of this substance in the homologous series. On the basis of this data, neither ethyl acetate nor n-butyl acetate warrant classification as an eye irritant. It is reasonable to conclude that isopropyl acetate should not be classified for eye irritation either.

The results from a number of older studies cannot be taken into account for classification purposes as they used doses far in excess of that recommended in current guideline methods.