Registration Dossier

Administrative data

Description of key information

SKIN IRRITATION:
in vivo: 5 studies reporting 'not irritating'
in vitro: 6 studies reporting results consistent with 'low irritancy potential'
EYE IRRITATION
in vivo: 2 studies reporting 'not irritating'
in vitro: 2 studies reporting results consistent with 'low irritancy potential'. (One of these is not available for review.)

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 adverse effect observed (not irritating)

Additional information

Skin irritation

A number of skin irritation studies are available for 2 -butoxyethyl acetate (2BA). Most of them are poorly reported and do not follow the experimental conditions recommended in the European guidelines but they all consistently indicate that 2BA is not irritant or slightly irritant. Three studies were reported to be carried out in accordance with the guidelines, although individual results are not presented for two and one only reports full data for a single animal. All of these studies reported little or no irritancy. There are also a number of in vitro studies reported where 2BA was used alongside a number of other substances in projects to develop alternative in vitro tests to avoid the use of animal studies. These also consistently report results consistent with a low potential for skin irritancy. A weight of evidence approach is used to conclude a low potential for skin irritancy.

Eye irritation

Three in vivo animal studies are available. All have some shortcomings but all consistently show that 2BA is only a slight and transient eye irritant substance. 2BA has also been tested in two in vitro alternative tests and these two both show a low potential for eye irritancy. Overall, the weight of evidence, alongside the general observation that esters of simple alcohols are not generally eye irritants, leads to the conclusion that this substance has a low potential for eye irritation.

Respiratory irritation

No data available. No indication that respiratory irritation is likely to be a property of this substance.

Justification for classification or non-classification

Skin irritancy: The authoris of both studies carried out to current guidelines concluded that the substance is not a skin irritant according to the European classification criteria. The data presented along with other available information support this conclusion. No classification is therefore warranted for skin irritation.

Eye irritancy: The weight of evidence available indicates a low potential for irritancy to the eye. There is no data that indicates levels of irritation that approach that required to trigger classification as an eye irritant.