Registration Dossier

Administrative data

Description of key information

Skin irritation potential: not irritating.  Supported by results from a secondary source.  Result for a read across substance: not irritating.
Eye irritation potential: not irritating. Result for a read across substance: not irritating.

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 IRRITATION

In an old in vivo skin irritation study, 2 -(2 -butoxyethoxy)ethyl acetate produced only very slight irritation in some of the exposed rabbits which was fully reversed within 72 hours. The study did not meet the full requirements of current OECD guideline but the methodology and results are reported in some detail and the method followed forms the basis for current testing methods.  Whilst exact matching of the results against classification criteria was not possible, they strongly suggested that the response did not meet the threshold for classification as a skin irritant.  This information is supported by unverifiable data from a secondary source which reports that the substance is slightly irritating to skin. The lack of skin irritation potential is supported by date from a very similar substance 2-butoxyethyl acetate.  In an in vivo skin irritation study in which basic details are available, 2 -butoxyethyl acetate (EGBEA) produced only very slight irritation in some of the exposed rabbits which was fully reversed within 72 hours. The response did not meet the threshold for classification as a skin irritant. Use of read across to a similar substance can be justified to meet the data information requirements when data is not available for the substance itself.

EYE IRRITANCY

In an old study that followed the basic principles of the later OECD guideline study, the eye irritation potential of 2 -(2 -butoxyethoxy)ethyl acetate in pure form was tested in the rabbit. Results were expressed in terms of the amount of material required to cause a particular level of irritation. The study did not report on all end points normally used to determine eye irritancy classification against EU criteria and did not use the Draize scoring system. This makes an interpretation difficult. However, a number of other substances were tested in the study and a number of these that gave similar results are not classified as irritant, including some that are listed on Annex 1 of the Dangerous Substances Directive 67/548. This supports a conclusion that the substance does not have significant eye irritation potential.

In an in vivo eye irritation study in which basic details are available, 2 -butoxyethyl acetate produced only very slight irritation in a few of the exposed rabbits, manifest as mild conjunctival redness, which was fully reversed within 48 hours. The response did not meet the threshold for classification as an eye irritant. Due to the structural similarity and similar disposition of functional groups within the molecule, the result from this study can be considered predictive of the eye irritancy potential of the substance 2 -(2 -butoxyethoxy)ethyl acetate.

RESPIRATORY IRRITANCY

No data available. There are no indicators that suggest any potential for respiratory irritancy.

JUSTIFICATION FOR USE OF DATA FROM EGBEA.

In this case use of the data from EGBEA can be justified to assess the potential for local irritant effects, which primarily result from local hydrolysis of the substance to form acetic acid. The use of data from EGBEA can be considered part of a weight of evidence approach to fulfil the data requirements for this end point. A more detailed justification for read across for irritation is contained in a report attached to chapter 13 of this IUCLID dossier.

Justification for classification or non-classification

The weight of evidence suggests that 2 -(2 -butoxyethoxy)ethyl acetate is of low skin irritating potential and does not meet the criteria for classification as a skin irritant.

The weight of evidence suggests that 2 -(2 -butoxyethoxy)ethyl acetate is of low eye irritating potential and does not meet the criteria for classification as a eye irritant.