UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

 

February 21, 2007

MEMORANDUM:

Subject: 	DIETARY EXPOSURE ASSESSMENT OF OCTHILINONE USE OF INDIRECT
FOOD CONTACT SURFACES

From:	A. Najm Shamim, PhD., Chemist

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

To:	Talia Lindheimer, Risk Assessor for Octhilinone RED

	Risk Assessment and Science Support Branch

	Antimicrobials Division (7510P)

				And

	Diane Isbell, CRM for Octhilinone RED

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Thru:	Mark Hartman, Chief

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

DP Barcode: 		

Chemical Name:      2-n-Octyl-4-isothiazolin-3-one (Octhilinone or OIT)	

		

PC Code:		099901 

CAS Registry No.     26530-20-1

Dietary Exposure and Risk Assessment:

AD’s label reviews have shown that Octhilinone has the following use
patterns/use sites. Some of which may require  indirect food contact
dietary exposure assessments.: Adhesives ; fillers, wood coatings ,
chaulking, sealants, wall paper, leather and hide, textiles, cooling
towers, fabrics, polymer compounds. Most of the uses listed do not fall
in the category of food use, except for the use in adhesives. Following
labels lists the adhesive use of Octhilinone:

				Table 1

Product Name	EPA Reg#

Skane M-8	707-100

Kathon 893TP 25	707-205

Sanitized: TB83-35	309-217

Ultra Fresh DM-25	10466-32

Ultra Fresh FT-7	10466-42

Thor: Acticide OTW	67071-31



As a matter of policy, AD has assessed adhesive use as an indirect food
use.  Since it is likely that adhesives may end up in the food packaging
materials, and this may result in the migration of the pesticide into
the food indirectly.  For the indirect food dietary assessment, AD has
adopted Food & Drug Administration (FDA) methodology.  For adhesive use,
FDA has provided guidance for dietary estimation that a maximum of 7 ppb
of a pesticide is likely to migrate from the food packaging materials
into the food. The quantity of 7 ppb can be used to calculate the
Estimated Daily Intake (EDI), Daily Dietary Dose (DDD), and using the
acute and dietary end points from toxicity data, one calculates the
overall risks to general and subgroups of populations ( % aPAD, and %
cPAD).

For the present case: FDA’s assumptions are: 1) Maximum migration of
Octhilinone into food from adhesive use = 7 ppb = 7µg/g; 2) Maximum
adult food intake = 3000 g; 3) Maximum food intake for a child = 1500 g.

In general, % PAD =  DDD/% a PAD or % cPAD.

AD’s End Point Selection Committee did not have enough toxicity data
to select acute or chronic dietary end points. 

					Table 2					

Use	Dietary Conc. (ppb)	Estimated Daily Intake (EDI) µg/p/day	Daily
Dietary Dose (DDD) mg/kg/day

 

	% aPAD	% cPAD

Adhesive	7	Adult: 7µg/g x 3000g = 21 µg/p/day

Child: 7 µg/g x 1500 g = 10.5 µg/p/day	Adult: 21 µg/70 kg/day =
0.0003 mg/kg/day

Child: 10.5 µg/15kg/day = 0.0007 mg/kg/day	Adult: no data. No concerns.

Child: no data. No concerns.	Adult: no data. No concerns.

Child: no data. No concerns

	

Hence the Agency has no dietary concerns, acute or chronic from the use
of Octhilinone in adhesives.

RMBII file room: Octhilinone: Dietary exposure assessment. Najm Shamim

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