se PA. mh 1838
Environmentat Protection Posticides and Toxic Substances as 1
Agency Washington DC 20460 ae

2-Ethyl-1,3-Hexanediol

( Gr VL ‘va “ek mpeWine)

- Pesticide Registration
Standard

CHAPTER II: REGULATORY POSITION AND RATIONALE

lL. Introduction

2. Description of Chemical

3. Regulatory Position

4. Regulatory Rationale

5. Criteria for Registration under the Standard
7. Tolerance Reassessment

4. Regulatory Rationale

Limited data are available to support the registration of
2-ethyl-1,3-hexanediol, with the exception of a primary dermal irritation
study and efficacy data. All other acute and chronic toxicology studies

and product chemistry studies are either not available or not usable by
current standards. There are no environmental fate or ecological effects data.

Despite the lack of data, the Agency has concluded that it should continue the
registration for this chemical for the following reasons:

A. No valid, adverse effects data of regulatory concern have been uncovered
in the review of the studies which have been received. Therefore,
the benefits demonstrated by the sale of this product outweigh the
known risks, when label directions are followed.

Incidents of 2-ethyl~1,3-hexanediol ingestion, as well as eye and other
means of exposure have been reported. However, no indication of any
resulting problems has been given. (EPA 1980, MRID #GS00200019).

In accordance with FIFRA, the Agency's policy is r net to cancel routinely

the registration of products for which it lacks data or to withhold
registration merely for the lack of data. (See Sections 3(c)(2) (BY and
3(c)(7) of PIFRA.) "Rathér, publication of the Standard provides a
mechanism for identifying data needs, and registration under the Standard
allows for upgrading of labels during the period in which the required
data are being generated. When these data are received, they will be
reviewed by the Agency, and the registrability of the chemical will be

reassessed.