Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 2 of 48

TAED Registration Review Team

Human Health & Environmental Effects

Srinivas Gowda

James Breithaupt

William Erickson

Siroos Mostaghimi

Timothy Dole

Zoe Cavinder

Steven Malish

Risk Management

SanYvette Williams

Rose Kyprianou

Karen Leavy

Office of General Counsel

Philip Ross
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 3 of 48

TERMS, ABBREVIATIONS AND SYMBOLS

AD Antimicrobials Division

A.I. or a.i. active ingredient

aPAD acute population adjusted dose 

ASRI activated sludge respiration inhibition

atm-m3

/mole atmospheric pressure-cubic meter per mole

BCF bioconcentration factor 

°C degrees Celsius

CaSO4 calcium sulfate

CaSO3 calcium sulfite

CAS Chemical Abstracts Service 

CCA chromated copper arsenate

CFR Code of Federal Regulations 

CHO Chinese hamster ovary

CMA Chemical Manufacturers Association

CO2 carbon dioxide

COC concentration-of-concern

cPAD chronic population adjusted dose 

CS2 carbon disulfide

DCI data call-in

EC50 median (or 50 percent) effect concentration

EC05 5 percent effect concentration

ECOTOX ECOTOXicology

EDI estimated daily intake

EDSP Endocrine Disruptor Screening Program

EEC Estimated Environmental Concentration

E-FAST Exposure and Fate Assessment Screening Tool

EPI Suite Estimation Program Interface Suite

EPA Environmental Protection Agency 

FDA Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FGD flue-gas desulfurization

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act 

FWP Final Work Plan

g/mol grams per mole

GLN guideline number

HPV high production volume

IDS Incident Data System 

Koc organic carbon normalized soil-water partition coefficient

Kd soil-water partition coefficient

Kow octanol-water partition coefficient

LC50 median (or 50 percent) lethal concentration

LD50 median (or 50 percent) lethal dose

LOAEC lowest-observed-adverse-effect-concentration 

LOEC lowest-observed-effect-concentration

LOAEL lowest-observed-adverse-effect-level

Log Kow logarithm of the octanol-water partition coefficient

μg microgram

ml/g milliliter per gram
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 4 of 48

mg/kg milligram per kilogram

mg/kg/day milligram per kilogram per day 

mg/L milligram per liter

mm Hg millimeter of mercury

MOE margin of exposure 

MRID Master Record Identification Number

MRL maximum residue limit 

N/A not applicable 

nm nanometers

NOAEC no-observed-adverse-effect-concentration

NOAEL no-observed-adverse-effect-level

OCSPP Office of Chemical Safety and Pollution Prevention

OECD Organization for Economic Co-operation and Development

OPP Office of Pesticide Programs

PAD population adjusted dose

PAI pure active ingredient

PDM Probabilistic Dilution Model

% percent

PC Code Pesticide Chemical Code

PCF pounds per cubic foot

pH power of hydrogen or power of the concentration of the hydrogen ion

PHED Pesticide Handler’s Exposure Data

PIS primary irritation score

pKa power of the acid dissociation constant or negative base-10 logarithm of the acid 

dissociation constant of a solution

ppb parts per billion 

ppm parts per million

PWP Preliminary Work Plan

QSAR quantitative structure-activity relationship

RED Reregistration Eligibility Decision

SAR structure activity relationship

SF safety factor

SSTS Section Seven Tracking System

SO2 sulfur dioxide

TAED tetraacetyleneethylenediamine

TEP typical end-use product

TGAI technical grade active ingredient

TMDL total maximum daily loads

UF uncertainty factor

UV/VIS ultraviolet/visible light absorption

% w/w percent weight per weight.

WP wettable powder

WWTPs wastewater treatment plants
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 5 of 48

Table of Contents

1 Introduction............................................................................................................................. 7

1.1 Statutory and Regulatory Authority ................................................................................. 7

1.2 Case Overview ................................................................................................................. 9

1.3 Chemical Identification and Properties............................................................................ 9

1.4 Use/Usage Description................................................................................................... 10

1.4.1 Registrations ........................................................................................................... 10

1.4.2 Summary of Registered Uses.................................................................................. 10

1.4.3 Usage Information .................................................................................................. 11

1.5 Regulatory History ......................................................................................................... 11

1.5.1 Recent/Pending Regulatory Actions....................................................................... 11

1.5.2 Tolerance Information ............................................................................................ 11

1.5.3 Design for the Environment.................................................................................... 11

1.6 Incidents......................................................................................................................... 12

1.6.1 Human Health ......................................................................................................... 12

1.6.2 Ecological ............................................................................................................... 12

2 Anticipated Data Needs ........................................................................................................ 12

3 Human Health Risk Assessment........................................................................................... 14

3.1 Toxicological Endpoints ................................................................................................ 15

3.2 Dietary Exposure............................................................................................................ 15

3.2.1 Food ........................................................................................................................ 15

3.2.2 Drinking Water ....................................................................................................... 15

3.3 Occupational and Residential Exposures....................................................................... 15

3.3.1 Occupational Exposures.......................................................................................... 15

 3.3.2 Residential Exposures.................................................................................................. 16

3.4 Aggregate and Cumulative Exposure............................................................................. 16

3.4.1 Aggregate Exposures.............................................................................................. 16

3.4.2 Cumulative Exposures............................................................................................ 16

4 Environmental Risk Assessment........................................................................................... 17

4.1 Environmental Fate Assessment .................................................................................... 17

4.1.1 Persistence in Water and Sediment......................................................................... 18

4.1.2 Persistence in Soil................................................................................................... 18

4.1.3 Persistence in Air.................................................................................................... 19

4.1.4 Persistence in WWTP ............................................................................................. 19

4.1.5 Water Quality.......................................................................................................... 19

4.2 Environmental Exposure Pathways................................................................................ 19

4.3 Ecological Effects Assessment....................................................................................... 20

4.3.1 Mechanism of Action.............................................................................................. 20

4.3.2 Measures of Effect (Ecotoxicology Endpoints)...................................................... 20

4.4 Exposure Analysis Plan.................................................................................................. 21

4.4.1 Aquatic and Terrestrial Wildlife Exposure Estimates ............................................ 21

4.5 Effects Analysis Plan ..................................................................................................... 21

5 Endocrine Disruptor Screening Program (EDSP)................................................................. 21

6 Optional Label Changes........................................................................................................ 22

7 Guidance for Commenters.................................................................................................... 22

7.1 Preliminary Work Plan................................................................................................... 22
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 6 of 48

7.1.1 Trade Irritants.......................................................................................................... 23

7.1.2 Water Quality.......................................................................................................... 23

7.1.3 Environmental Justice............................................................................................. 23

7.1.4 Structure Activity Relationships............................................................................. 23

7.1.5 Additional Information ........................................................................................... 24

8 Next Steps............................................................................................................................. 24

9 References............................................................................................................................. 25

Appendix A Toxicology Profile............................................................................................... 26

Appendix B Environmental Fate ............................................................................................. 35

Appendix C Ecotoxicology Profile.......................................................................................... 44

Appendix D Product Chemistry............................................................................................... 47

List of Tables

Table 1 – Summary of Anticipated Risk Assessments and Data Needs: TAED............................ 8

Table 2 – Anticipated Registration Review Schedule .................................................................... 8

Table 3 – Chemical Identification of Tetraacetylethylenediamine (TAED) .................................. 9

Table 4 – Physical-Chemical and Environmental Fate Properties for Tetraacetylethylenediamine

....................................................................................................................................................... 10

Table 5 – Summary of TAED Registered Uses............................................................................ 11

Table 6 – Studies Anticipated as Needed for the Registration Review of TAED and DAED ..... 13

Table 7 – Occupational Exposure Scenarios for TAED ............................................................... 16

Table 8 – Residential Exposure Scenarios for TAED .................................................................. 16

Table 9 – Available Ecological Effects Endpoints for TAED..........................................20

List of Figures

None
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 7 of 48

1 Introduction

This document is the United States Environmental Protection Agency’s (USEPA, EPA or “the 

Agency”) Preliminary Work Plan (PWP) for tetraacetyleneethylenediamine (TAED). The PWP 

document explains what EPA's Office of Pesticide Programs (OPP) knows about TAED, 

highlighting anticipated data and assessment needs, identifying the types of information that 

would be especially useful to the Agency in conducting the review, and providing an anticipated 

timeline for completing TAED review.

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about TAED and what types of new data or other 

information would be helpful for the Agency to receive as it moves toward a decision on TAED.

The Agency encourages all interested stakeholders to review the PWP and to provide comments 

and additional information that will help the Agency’s decision-making process for this 

chemical.

1.1 Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the USEPA 

based on scientific data showing that they will not cause unreasonable risks to human health or 

the environment when used as directed on product labeling. The registration review program is 

intended to make sure that, as the ability to assess risk evolves and as policies and practices 

change, all registered pesticides continue to meet the statutory standard of no unreasonable 

adverse effects to human health or the environment. Changes in science, public policy, and 

pesticide use practices will occur over time. Through the registration review program, the 

Agency periodically reevaluates pesticides to make sure that as change occurs, products in the 

marketplace can be used safely. Information on this program is provided at 

http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The Agency 

will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop and commit to a Final Work Plan (FWP) and 

anticipated schedule for the TAED Case. 

Documents associated with this registration review can be viewed at http://www.regulations.gov

in docket EPA-HQ-OPP-2013-0608. Tables 1 and 2 below summarize the issues relevant to this 

registration review case and the anticipated registration review schedule.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 8 of 48

Table 1 – Summary of Anticipated Risk Assessments and Data Needs: TAED

Risk Assessment 

Assessment 

Necessary to

Support 

Registration 

Review

Date of Most 

Recent 

Assessment

Type of 

Assessment 

Required 

(New/Updated)

Data Anticipated as Needed

(See Table 6 for details)

Dietary (food) No None None None

Dietary (drinking water) Yes1 None New

Developmental Toxicity – Rabbit

Reproductive Toxicity

Immuno Toxicity

Occupational Handler Yes1 None New

Indoor Exposure Data – Dermal

Indoor Exposure Data – Inhalation

Developmental Toxicity – Rabbit

Reproductive Toxicity

Immuno Toxicity

Residential Handler No None None None

Residental Post 

Application - Incidental 

Oral and Dermal

Yes1 None New

Textile Leaching Study

Developmental Toxicity – Rabbit

Reproductive Toxicity

Immuno Toxicity

Aggregate Yes1 None New

Developmental Toxicity – Rabbit

Reproductive Toxicity

Immuno Toxicity

Cumulative No None None None

Tolerance Review No None None None

Ecological No None None Green algae toxicity

(for product labeling)

Environmental Fate Yes None New Aquatic exposure 1

. These assessments will be needed if endpoints are selected from the anticipated developmental, reproductive and immunotoxicity studies

Table 2 – Anticipated Registration Review Schedule

Anticipated Activity Target Date Completion Date

Phase 1: Opening the Docket 

Open Docket and 60-Day Comment Period for Preliminary Work Plan 2014-03 2014-03-26

Close Public Comment Period 2014-05

Phase 2: Case Development 

Issue Final Work Plan 2014-09

Issue Data Call-In (DCI) 2015-09

Receive Data to be Considered in Risk Assessment 2017-09

Open 30-Day Public Comment Period for Preliminary Risk Assessment(s) 2019-03

Close Public Comment Period 2019-04

Phase 3: Registration Review Decision and Implementation 

Open 60-Day Public Comment Period for Proposed Decision 2019-09

Close Public Comment Period 2019-11

Issue Final Decision 2020-03

Begin Post-Decision Followup 2020

Total (years) 6
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 9 of 48

*The anticipated schedule will be revised as necessary (e.g., need arising under the Endocrine Disruptor Screening Program with 

respect to the active ingredients in this case).

1.2 Case Overview

The docket for the TAED case (Case #5105) has been established at http://www.regulations.gov

in docket number EPA-HQ-OPP-2013-0608.

1.3 Chemical Identification and Properties

Table 3 presents the active ingredient to be assessed in case 5105: tetraacetylethylenediamine

(PC Code 004115). When activated using an oxygen activator in the presence of water, TAED 

undergoes rapid perhydrolysis to yield peroxyacetic acid, which will be assessed under it’s own 

case, and hydrogen peroxide and finally degrades to N,N-Diacetylethyenediamine (DAED).

Table 3 – Chemical Identification of Tetraacetylethylenediamine (TAED) 

Chemical Name Tetraacetylethylenediamine (TAED)

Chemical Classification Aliphatic amide

PC Code 004115

CAS Number 10543-57-4

Molecular Formula C10H16N2O4

Molecular Weight 

(grams/mole) 228.25

Purity >99.95%

Molecular Structure

The tetraacetylethylenediamine product chemistry information relative to risk assessment is 

summarized in Table 4 and Appendix D.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 10 of 48

Table 4 – Physical-Chemical and Environmental Fate Properties for Tetraacetylethylenediamine

Guideline No. Parameter Tetraacetylethylenediamine 

 

Physical/Chemical Properties

830.7000 pH 5 (20 o

C, 1g/L)

5 (3% solution)

TAED has a UV/VIS absorption maximum at 214 nm

147°C + 1°C

Not applicable to this product because it is a solid at room temperature

Bulk density at 20°C is 430-520g/L

Not applicable because TAED has no dissociable groups. 

Log Po/w: −0.06

2 g/100 ml at 20°C (20 g/L)

1.48 x 10-8 mm Hg 25 °C (EPI Suite v 4.1)

830.7050 UV/Visible Absorption 

830.7200 Melting point (oC)

830.7220 Boiling point (oC)

830.7300 Density

830.7370 Dissociation constant (pKa)

830.7550 Octanol-water partition coefficient 

at 25 oC (Log Kow)

830.7840 Solubility in water

830.7950 Vapor pressure (mmHg)

atm-m3/mol = atmosphere cubic meter per mole; oC = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury

1.4 Use/Usage Description

1.4.1 Registrations

There are two EPA-registered end use products (EPA Reg. Nos. 1043-125 and 16930-5) that 

contain TAED as an active ingredient (a.i.). EPA Reg. No. 1043-125 contains 61.6% TAED and 

EPA Reg. No. 16930-5 contains 11.9% TAED. 

EPA Reg. No. 1043-125 is Part A of a two part system this is mixed with Part B (EPA Reg. No. 

1043-124 which contains 1.0 percent hydrogen peroxide) to create an end use hard surface 

disinfectant solution which, according to the label, contains approximately 0.085 percent 

peroxyacetic acid and 1.0 percent hydrogen peroxide. 

EPA Reg. No. 16930-5 is a solid formulation that contains TAED and another a.i. (sodium 

percarbonate). It is packaged in a capsule which is loaded into institutional and commercial 

laundry machines. The label states: “When activated in the presence of water, this product will 

generate hydrogen peroxide and peroxyacetic acid to provide disinfectant and bleaching actions.”

Hydrogen peroxide and peroxyacetic acid will be assessed under separate cases.

1.4.2 Summary of Registered Uses 

Table 5 presents a summary of the registered uses of TAED that will be assessed in this 

registration review. 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 11 of 48

Table 5 – Summary of TAED Registered Uses

Use Application Method Application Rate

Commercial Institutional and Industrial Premises and Equipment

Laundry (commercial) Washing Machine 111 ppm aiA

Medical/Dental/Veterinary Premises and Equipment

Hard surface disinfectant on floors, walls, counters, bedrails, 

doorknobs, and bathroom fixtures. Mop, wipe, spongeC 0.085 percent peroxyacetic acidB

Preclean and decontaminate critical or semi-critical medical 

devices prior to high level disinfection or sterilization. Immersion 0.085 percent peroxyacetic acidB

A. Based on the label application rate of 3 oz EPA Reg. No. 16930-5 per 24 gallons wash water.

B. When the TAED product Part A (EPA Reg. No.1043-125) is added to part B (EPA Reg. No. 1043-124). 

C. The label only mentions these methods of application. The label does not mention spray application.

1.4.3 Usage Information

Uses (Not Subject to EPA Registration)

According to the Household Products Database of National Library of Medicine, as of 

1/02/2014, there are 13 non-pesticidal household products that contain TAED. These products 

include dishwashing detergents. According to HERA (2002), 61,000 tons were consumed in the 

household detergents in the European Union in 2000. 

1.5 Regulatory History

Registered products containing TAED date back to 1968. In 2012, a new registration was 

approved, with a variety of uses as outlined in table 5. 

1.5.1 Recent/Pending Regulatory Actions

There is one pending registration action in BPPD (Biopesticides and Pollution Prevention 

Division) that is currently under review.

1.5.2 Tolerance Information

There is no US EPA tolerance or tolerance exemption for TAED or its final degradation product 

DAED because there are no food or feed uses. 

1.5.3 Design for the Environment

TAED has been approved by the EPA’s Design for the Environment (DfE) program in the 

category of “Oxidants and oxidant stabilizers.” The DfE program allows products that have 

undergone rigorous EPA review based on stringent DfE criteria to bear a DfE logo on the label. 

As an approved Safer Chemical Ingredient for use in DfE-labeled products, TAED has been 

“verified to be of low concern based on experimental and modeled data.” The verification 

category is the safest possible for its functional use (green circle) and meets the criteria of the 

DfE Safer Product Labeling Program. The link to access TAED on the DfE list of Oxidants and 

oxidant stabilizers and criteria is: http://www.epa.gov/dfe/saferingredients.htm.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 12 of 48

1.6 Incidents

1.6.1 Human Health 

As of 01/03/2014, there are no TAED human poisoning incidents listed in the OPP’s Incident 

Data System for the time period from 10/24/05 to3/18/14.

1.6.2 Ecological

There are no TAED fish or wildlife poisoning incidents in OPP’s Incident Data System.

2 Anticipated Data Needs

Table 6 presents a summary of the studies anticipated as being needed to support this registration 

review. The Agency is currently evaluating the human health hazard database and whether any 

of the studies listed in Table 6 can be waived, as appropriate. The Agency will also consider any 

additional information or waiver requests from the registrant for the studies anticipated as being 

needed provided that such waivers include a valid rationale of how the registration review could 

be conducted without the studies.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 13 of 48

Table 6 – Studies Anticipated as Needed for the Registration Review of TAED and DAED

GLN Study Name Test Substance

Time Frame (Measured 

in months from DCI 

Receipt)

Risk Assessment(s) Data 

Will Support

Use Site(s) Triggering 

Anticipated Data 

Requirement

Applicable Exposure 

Scenario

Studies Anticipated to be Required through the Registration Review DCI

850.4500 Algal toxicity -

green algae TGAI 24 Precautionary labeling All NA

835.4300 Aerobic aquatic 

metabolism

Parent and DAED 

degradate 24

Drinking water and 

ecological exposure Hard surface disinfectant and 

washing machine use

Oral exposure to 

drinking water and to 

aquatic organisms.

See footnote 4.

870.3700

Prenatal 

Developmental 

Toxicity - Rabbit

TGAI 24

Dietary (Drinking Water)

Occupational Handler

Residential Post Application

Hard surface disinfectant and 

washing machine use See footnotes 1,2,3.

870.3800 Reproduction and 

Fertility Effects TGAI 24

Dietary (Drinking Water)

Occupational Handler

Residential Post Application

Hard surface disinfectant and 

washing machine use See footnotes 1,2,3.

870.7800 Immunotoxicity TGAI 24

Dietary (Drinking Water)

Occupational Handler

Residential Post Application

Hard surface disinfectant and 

washing machine use See footnotes 1,2,3.

875.1200 Indoor Exposure –

Dermal TGAI or surrogate 24 Occupational Handler Hard surface disinfectant See footnote 2.

875.1400 Indoor Exposure -

Inhalation TGAI or surrogate 24 Occupational Handler Hard surface disinfectant See footnote 2.

None Textile Leaching TGAI 24 Residential Post Application Washing Machine See footnote 3.

1

Dietary exposure scenarios include oral exposure to drinking water. 2

Occupational handler scenarios include dermal and inhalation exposure during hard surface disinfection using mops and wipes if toxicological endpoints are 

selected. 3

Residential post application scenarios include dermal and incidental oral exposure to laundered textiles. 4

TAED and its degradates have the potential to reach surface water. TAED and its degradates are water soluble and are likely to be present in surface water in the 

presence of sediment. Aerobic aquatic metabolism represents the dissipation of a compound in the water column of a lake or stream.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 14 of 48

3 Human Health Risk Assessment

The human health database lacks three studies that are required per 40 CFR Section 158 Subpart 

W. These studies include the following:

• 870.3700 - Prenatal Developmental Toxicity (Rabbit)

• 870.3800 - Reproduction and Fertility Effects

• 870.7800 - Immunotoxicity

Based on the existing database which indicates low toxicity via dermal or inhalation exposure, 

EPA did not previously conduct human health risk assessments for dermal or inhalation 

exposures to TAED or the degradate DAED; however, this may change depending upon the 

outcome of the anticipated studies listed above. In addition, it may be necessary to assess 

incidental oral exposures to treated laundry and dietary exposures from drinking water because 

these exposures were not assessed previously.

The toxicological information for TAED was last reviewed in an EPA Memorandum of April 20, 

2005 by the Antimicrobials Division Toxicology Endpoint Selection Committee (ADTC). This 

memo was written to evaluate the proposed new use of TAED as a laundry sanitizer. The ADTC 

recognized that there would be dermal and inhalation exposures from occupational use of TAED, 

as well as incidental oral exposures from post-application exposures in clothing containing 

residues of TAED or DAED. Due to a lack of information on the toxicity of DAED, the ADTC 

concluded that in the absence of data, a metabolism study would be needed in order to determine 

the nature of the chemical exposure to mammalian organisms in vivo. This data is provided in 

summary form within the HERA document (HERA, 2002) and, while not formally reviewed by 

the Antimicrobials Division, indicates that there is significant conversion of TAED to DAED in 

vivo. While the data will need to be formally reviewed, the available data summary suggests that 

the toxic responses observed in the studies conducted with TAED may be the result of exposure 

to TAED and/or DAED, and separate studies with DAED would not be required.

With respect to the need for a TAED dermal and inhalation endpoint to address occupational use 

as well as post-application exposures that might occur (including infants and children), the 

ADTC noted from review of the toxicity data that the dose-response for TAED is shallow and 

the effect levels at which adverse effects are noted are relatively high (in some cases at or above 

limit doses). In addition, there is no evidence of susceptibility following exposure to TAED 

from the available developmental toxicity data. The nature of the response itself (hepatocellular 

hypertrophy) is not considered by the ADTC to be an actual adverse effect, but a biological 

response. Therefore, the ADTC concluded that no endpoints are needed for dermal and 

inhalation exposures to TAED as would occur from the proposed uses of this chemical. The 

Agency will also consider any additional information or waiver requests from the registrant for 

the studies anticipated as being needed provided that such waivers include a valid rationale of 

how the registration review could be conducted without the studies.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 15 of 48

No additional toxicological studies have been submitted to EPA and no additional studies have 

been published in the literature since the ADTC review. A summary of the toxicology studies 

for TAED is included in Appendix A.

EPA does not anticipate the need to conduct human health risk assessments within this case for 

the hydrogen peroxide or peroxyacetic acid generated by TAED because these chemicals are 

being addressed as separate registration review cases.

3.1 Toxicological Endpoints

As discussed above, toxicological endpoints were determined to not be needed for dermal and 

inhalation exposures to TAED based on a 2005 review by the ADTC. This conclusion might 

change; however, if endpoints are selected from the anticipated toxicity studies. In addition, it 

may be necessary to select endpoints to assess incidental oral exposures and drinking water 

exposures because these exposures were not assessed previously. 

3.2 Dietary Exposure

The agency may need to conduct a dietary (drinking water) exposure assessment for TAED 

depending upon the outcome of the anticipated toxicity studies. Additional residue chemistry 

data for TAED are not anticipated to be needed. 

3.2.1 Food

There are no direct or indirect food uses for TAED. Therefore, EPA does not anticipate the need 

to conduct a dietary (food) risk assessment.

3.2.2 Drinking Water

The agency has not conducted a drinking water assessment for TAED in the past. There are no 

direct drinking water uses for TAED, however, approved use as a commercial laundry detergent 

could potentially result in TAED being discharged into waste water and subsequently running off 

into surface water. Both of these exposure routes may potentially lead to indirect contamination 

to human drinking water. Based on the environmental fate assessment, TAED undergoes rapid 

perhydrolysis to yield peroxyacetic acid and hydrogen peroxide and finally degrades to DAED

and is therefore unlikely to result in exposure to TAED. 

If endpoints are selected from the anticipated toxicity studies, the risks to human health from 

exposure to the final degradation product DAED in drinking water will need to be assessed.

3.3 Occupational and Residential Exposures

3.3.1 Occupational Exposures

Occupational exposures are not anticipated for the commercial laundry use because the product 

is packaged as a capsule that is loaded into the washing machines. Occupational handler 

exposures may occur, however, for the hard surface disinfectant use in medical, dental and 

veterinary premises and equipment. If endpoints are selected from the anticipated toxicity 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 16 of 48

studies, these exposures will need to be assessed during registration review. The occupational 

exposure scenario is listed in Table 7.

Table 7 – Occupational Exposure Scenarios for TAED

Handler Scenario Exposure 

Route(s) Duration

Hard surface disinfection using mops or wipes.

Dermal 

Inhalation 

Intermediate 

Term

Occupational post application exposures are not anticipated for the existing uses of TAED

(hydrogen peroxide is being assessed in a separate case).

3.3.2 Residential Exposures

Residential handler exposures are not anticipated for TAED because TAED is used only in 

institutional and industrial laundries and medical/dental/veterinary facilities. 

Although TAED is registered only for use in institutional and industrial laundries, residential 

post application exposures may occur if TAED laundered items are used in a residential 

environment. If endpoints are selected from the anticipated toxicity studies, these exposures will 

need to be assessed during registration review. The residential exposure scenarios are listed in 

Table 8.

Table 8 – Residential Exposure Scenarios for TAED

Scenario Exposure Route(s) Duration

Adults wearing TAED laundered textiles Dermal Intermediate Term

Toddlers wearing or mouthing TAED laundered textiles Dermal 

Incidental Oral Intermediate Term

3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures 

If endpoints are selected from the anticipated toxicity studies, then it will be necessary to assess 

aggregate exposures to TAED.

3.4.2 Cumulative Exposures 

With respect to cumulative exposure, unlike other pesticides for which EPA has followed a 

cumulative risk approach based on a common mechanism of toxicity, EPA has not made a 

common mechanism of toxicity finding as to TAED, and any other substances and TAED does 

not appear to produce a toxic metabolite produced by other substances. For the purposes of this 

registration review, therefore, EPA has not assumed that TAED has a common mechanism of 

toxicity with other substances. For information regarding EPA’s efforts to determine which 

chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such 

chemicals, see http://www.epa.gov/pesticides/cumulative/. 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 17 of 48

4 Environmental Risk Assessment

The Agency has not previously conducted an environmental risk assessment for the antimicrobial 

uses of TAED. Because TAED is transformed into peroxyacetic acid and hydrogen peroxide 

prior to or during application, any material going down the drain into wastewater treatment 

plants will be those moieties and their transformation products. Both peroxyacetic acid and 

hydrogen peroxide are active ingredients in registered antimicrobial products that will be 

addressed separately in Registration Review. The degradate DAED also will be present when 

TAED is transformed. A European risk assessment1 indicates that at least 97% of TAED and 

DAED would be removed during sewage plant treatment. Along with a limited data set 

indicating little if any toxicity to organisms in the water column, minimal risks were predicted 

for either TAED or DAED in the aquatic environment in Europe. Because the amount of TAED 

produced annually in the U.S. is low (about 10,000 kg) and its use (laundries, medical, dental, 

veterinary medical premises) would be widespread geographically and temporally during the 

year, the amount of either TAED or DAED entering the aquatic environment via waste water 

treatment plant discharges is likely to be minimal. 

4.1 Environmental Fate Assessment

The Agency has not previously conducted a risk assessment that supports a complete endangered 

species determination for TAED. The ecological risk assessment planned during registration 

review will allow the agency to determine whether each use of TAED has 'no effect' or 'may 

affect' federally listed threatened or endangered species (listed species) or their designated 

critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species 

or its designated critical habitat, the agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Services (the Services), as appropriate. 

The Agency will conduct an environmental fate assessment for TAED based on the current uses 

in industrial and institutional laundry facilities and hard, non-porous surfaces in healthcare 

facilities, hospitals, medical, and dental offices. It serves as a bleach activator and reacts in 

aqueous solutions in the presence of an oxygen activator, such as sodium percarbonate, to form 

the DAED degradate, hydrogen peroxide and peracetic acid using the perhydrolysis reaction.

2

 

Both peroxyacetic acid and hydrogen peroxide are highly-reactive and degrade rapidly. 

Guideline environmental fate data that address metabolism or transport of TAED in the 

terrestrial or aquatic environment have not been submitted to the Agency for TAED or its 

degradates. Although no data have been submitted, TAED and its degradates, TriAED (transient 

degradate) and DAED (terminal non-volatile degradate), are expected to partition to water in the 

presence of sludge based on a log Kow of -0.06.3 Several studies are present in the literature 

 1 HERA. 2002. Tetraacetylethylenediamine (TAED) (CAS 10543-57-4). Human & Environmental Risk 

Assessment on ingredients of European household cleaning products. December, 2002. 2 Reaction in water to release peroxyacetic acid and hydrogen peroxide

3 MRID 45299701
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 18 of 48

and in the HERA document.4 The studies listed in the HERA document have not been formallyreviewed by the Agency, but they indicate that TAED is readily biodegradable5 and highly 

removed in the activated sludge of a WWTP based on a 97 percent removal rate in a porous pot 

test.6 The appropriate studies in the HERA document will be formally reviewed by the Agency 

before a final risk assessment. The Agency also has not received data on aerobic aquatic 

metabolism of parent TAED or the degradate DAED, which can reach surface water if they pass

through a WWTP. 

Parent TAED is miscible in water (20 g/L)7 and its sequential degradates TriAED and DAED are 

expected to have similar water solubility based on structural similarity. TAED (TGAI) slowly 

degraded by abiotic hydrolysis at pH 7 and 15 o

C with a half-life of 40 days and the DAED 

degradate was shown to be stable and not degrade.8 However, in a washing machine study using 

a formulated product which includes oxygen, TAED appears to degrade rapidly to form the 

degradate DAED at 30, 40, and 60oC9 which represents cold, warm, and hot water temperatures, 

respectively.10 The washing machine study, which is more environmentally-relevant than the 

abiotic hydrolysis study, has not been formally reviewed. It will be reviewed prior to conducting 

the risk assessment. The only detectable residue from the water in the washing machine was the 

DAED degradate. Appendix B contains additional information on the environmental fate of 

TAED and its degradation products. 

4.1.1 Persistence in Water and Sediment

Parent TAED is miscible in water (20 g/L)11 and its degradates, TriAED and DAED, are 

expected to have similar water solubility based on structural similarity. The primary residue to 

which aquatic organisms are likely to be exposed is the DAED molecule12, which is expected to 

partition to water in the presence of sediment based on the log Kow of -0.06 for parent TAED13. 

4.1.2 Persistence in Soil

When used according to the label, TAED is not expected to reach soil because it will not be 

sorbed to biosolids based on the log Kow of -0.06.14 The registrants have not submitted any 

guideline studies on aerobic soil metabolism (OCSPP 835.4100) and anaerobic soil metabolism 

(OCSPP 835.4200) to determine the persistence of parent TAED and formation and decline of 

TriAED and DAED in soil. Because TAED will degrade to release hydrogen peroxide, therefore, 

not expected to reach soil from the current uses, soil metabolism data are not anticipated to be 

required. The Agency also has not received and reviewed any guideline data (OCSPP 835.1230)

 4 Human & Environmental Risk Assessment, http://www.heraproject.com/files/2-F-04-

HERA%20TAED%20full%20web%20wd.pdf

5 OECD 301E data, IUCLID 2000, Proctor & Gamble Internal Data 1976 and 1978

6 Clariant, 2002

7 MRID 45299701

8 MRID 46335801

9 MRID 46335802, study not reviewed

10 http://housekeeping.about.com/od/laundry/a/laundry_h20temp.htm 11 MRID 45299701 12 MRIDs 46335801 (hydrolysis), 46335802 (wash water study) 13 MRID 45299701 14 MRID 45299701
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 19 of 48

on sorption of TAED to soil. However, two unreviewed studies in the HERA document indicate 

that TAED and DAED are expected to have minimal sorption to soil, based on Koc values for 

TAED and the degradate DAED of 15-80 and 25 L/kg, respectively.15 These soil sorption studies 

will be reviewed by the Agency prior to conducting a risk assessment.

4.1.3 Persistence in Air

TAED is miscible in water with a water solubility of 20 g/l and is not expected to volatilize from 

water. Therefore, partitioning from water into air is not likely for TAED. 

4.1.4 Persistence in WWTP

TAED and its degradates, TriAED and DAED, are miscible in water16 and are expected to 

partition to water in the presence of sludge based on a log Kow of -0.06.17 The Agency has not 

received any guideline studies for the biodegradation of TAED, but several studies are present in 

the literature and in the HERA document.18 The studies listed in the HERA document have not 

been formally reviewed by the Agency, but they indicate that TAED and DAED are readily

biodegradable19 and highly removed in the activated sludge of a WWTP based on a 97 % 

removal rate in a porous pot test.20 The Agency will formally review these studies prior to 

conducting a risk assessment. 

4.1.5 Water Quality

TAED is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act.

21 In addition, Total Maximum Daily Loads (TMDLs)

have not been developed for TAED.

22 More information on impaired water bodies and TMDLs 

can be found at EPA’s website.

23

4.2 Environmental Exposure Pathways

Assuming that any relevant exposure occurs, aquatic organisms potentially at risk include those 

inhabiting water bodies adjacent to or downstream from waste water treatment plants. Water 

bodies might include impounded bodies (e. g., ponds, lakes, reservoirs) or flowing waterways (e. 

g., streams, rivers). For uses in coastal areas, aquatic habitat also includes marine ecosystems,

including estuaries. Aquatic organisms potentially exposed include fish, invertebrates, aquatic 

stages of amphibians, and aquatic and semi-aquatic plants. For aquatic animals, the major route 

of exposure to TAED or DAED is considered to be uptake via the respiratory surface (gills) or 

 15 AISE, 1992 and Shell, 2000 16 MRID 45299701 17 MRID 45299701 18 Human & Environmental Risk Assessment, http://www.heraproject.com/files/2-F-04-

HERA%20TAED%20full%20web%20wd.pdf

19 OECD 301E data, IUCLID 2000, Proctor & Gamble Internal Data 1976 and 1978 20 Clariant, 2002 21 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 22http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES

23 http://www.epa.gov/owow/tmdl/
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 20 of 48

the integument from surface water that has residues. For aquatic plants, the major route of 

exposure is considered to be uptake from surface water.

4.3 Ecological Effects Assessment

Ecological effects data are used as measures of direct and indirect effects to aquatic and 

terrestrial organisms. Acute and chronic toxicity data from registrant-submitted studies 

conducted in accordance with the 850 OCSSP Harmonized Test Guidelines typically are used to 

evaluate the potential direct and indirect effects of a pesticide and its transformation products to

plants and animals. Relevant data from the open literature also may be used to evaluate potential 

direct and indirect effects. As explained below, the agency anticipates calling in data for algal 

toxicity for labeling purposes. No ecological risk assessment is planned for TAED per se, since 

the degradates are hydrogen peroxide and peracetic acid which will be evaluated in their own 

cases.

4.3.1 Mechanism of Action

The main antimicrobial activity occurs after TAED is activated to produce peroxyacetic acid and 

hydrogen peroxide. These transformation products are strong oxidizing agents that disinfect 

with corrosive action.

4.3.2 Measures of Effect (Ecotoxicology Endpoints)

Ecotoxicity endpoints are used as measures of effects to assess acute and chronic hazards and 

risks to aquatic and terrestrial organisms. Because TAED is not expected to occur in the 

environment when used as directed on the product labels, only the basic four ecotoxicity studies 

required for all antimicrobial active ingredients are needed for TAED. Three of the studies have 

been submitted. Only one of studies—algal toxicity, green algae—is anticipated to be required. 

Those studies are used to determine if precautionary label statements are needed and to have a 

basic data set in case of a spill or other unintended environmental accident. The four studies are 

as follows:

• 850.2100 Avian acute Oral Toxicity Test

• 850.1075 Fish Acute Toxicity Test, Freshwater

• 850.1010 Aquatic Invertebrate Acute Toxicity Test, Freshwater

• 850.4500 Algal Toxicity, Green Algae 

The three submitted ecotoxicity studies categorize TAED as being practically nontoxic to birds, 

fish, and aquatic invertebrates. More information on these studies is found in Appendix C. The 

green algae toxicity study is a data gap. The Agency has no ecotoxicity data for DAED but, as 

shown in Table 9, anticipates using available effects data from the open literature.

Table 9. Available Ecological Effects Endpoints for TAED 

Receptor 

Group

Test 

Material

Risk 

Scenario Toxicity Endpoint Reference

Freshwater fish TGAI Acute LC50 >140 mg ai/L 45274308
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 21 of 48

Chronic Not required NA

Freshwater invertebrates TGAI

Acute EC50 >1000 mg ai/L 45712901

Chronic Not required NA

Estuarine/marine fish TGAI

Acute Not required NA

Chronic Not required NA

Estuarine/marine 

invertebrates TGAI

Acute Not required NA

Chronic Not required NA

Sediment-dwelling

Invertebrates

TGAI Acute and 

Chronic Not required NA

Aquatic plants - green 

algae

TGAI EC50

NOAEC Data gap NA

Birds TGAI Acute LD50 >2000 mg ai/kg 45274309

Beneficial insects TGAI Acute Not required NA

4.4 Exposure Analysis Plan

4.4.1 Aquatic and Terrestrial Wildlife Exposure Estimates

Quantitative exposure estimates are not anticipated as being needed. If a risk assessment is 

conducted, available OPP models that estimate exposures from discharges from wastewater 

treatment plants will be used to determine EECs in the aquatic environment. 

4.5 Effects Analysis Plan

Besides the ecotoxicity data submitted by registrants, relevant data from the open literature also

will be used to evaluate potential direct and indirect effects. Information on how the Agency 

obtains and uses the open literature is presented on the Agency’s website 

(http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_species

_reregistration_workgroup/esa_evaluation_open_literature.htm)

5 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 22 of 48

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of registration decision for TAED, EPA reviewed these data and 

selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p), TAED is subject to the 

endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals 

identified for EDSP screening was published on June 14, 201324 and includes some pesticides 

scheduled for registration review and chemicals found in water. Neither of these lists should be 

construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.25

6 Optional Label Changes

The Agency invites comment on any label amendments that could be considered to eliminate the 

anticipated need for EPA to require certain data, reduce the possibility that EPA’s planned risk 

assessments overestimate risk due to reliance on conservative assumptions, and/or improve label 

clarity.

7 Guidance for Commenters

7.1 Preliminary Work Plan

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the TAED registration review case. 

 24 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 25 http://www.epa.gov/endo/
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 23 of 48

7.1.1 Trade Irritants

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Stakeholders are asked to comment on any trade 

irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in 

key export markets, providing as much specificity as possible regarding the nature of the 

concern.

7.1.2 Water Quality

The Agency invites submission of water quality data for this pesticide. To the extent possible, 

data should conform to the quality standards in Appendix A of the OPP Standard Operating 

Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s 

Registration Review Risk Assessment and Management Process26 in order to ensure they can be 

used quantitatively or qualitatively in pesticide risk assessments.

7.1.3 Environmental Justice 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to TAED compared to the general population. Please comment 

if you are aware of any sub-populations that may have atypical, unusually high exposure 

compared to the general population.

7.1.4 Structure Activity Relationships 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the OPP, the evaluation process for a pesticide chemical traditionally begins with 

the applicant’s submission of a set of studies conducted with the specific pesticide chemical of 

interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous 

process that identifies the physical, chemical, and environmental fate properties of the pesticide, 

as well as the dose and endpoints at which an adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, OPP 

has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

 26 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 24 of 48

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this time, 

EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements. 

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

TAED Case, then the Agency invites submission of this information. The submitter would be 

expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged. 

7.1.5 Additional Information 

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining its risk assessments, including human health risk assessments or speciesspecific ecological effects determinations. The Agency is interested in receiving the following 

information: 

1. State or local use restrictions.

2. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency.

3. Monitoring data.

4. Human health toxicology or metabolism studies that could be used to evaluate the need 

for the anticipated to be required toxicity studies (Prenatal Developmental Toxicity, 

Reproduction and Fertility Effects and Immunotoxicity).

8 Next Steps

After the 60-day comment period closes in May 2014, the Agency will review and respond to 

any comments received in a timely manner, and then issue a Final Work Plan for the TAED case. 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 25 of 48

9 References 

HERA, 2002. Human and Environmental Risk Assessment on Ingredients of European 

household cleaning products: Tetraacetylenediamine (TAED), Caffaro , Clariant, Henkel, 

Unilever, P&G and Warwick, December 2002. 

U.S. Environmental Protection Agency (EPA). 2002. ECOTOX User Guide: ECOTOXicology 

Database System. Version 3.0. Available: http://www.epa.gov/ecotox/

U.S. Environmental Protection Agency. High Production Volume Information System (HPVIS). 

http://www.epa.gov/hpvis/
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 26 of 48

Appendix A Toxicology Profile

1.0 Acute Toxicity

The database for acute toxicity for TAED is considered complete. It consists of seven studies 

that have been submitted to EPA and these studies are listed in Table 1. These studies indicate 

that TAED is of low acute toxicity (i.e. Toxicity Categories III and IV) by all routes of exposure 

and that TAED is not a dermal sensitizer.

Table 1 – TAED Acute Toxicity Studies

Guideline 

No.

Data Requirement

/Species

MRID Results [Comments] Toxicity

Category

870.1100 Acute Oral/Rat 452997-02 LD50 = 7940 mg/kg/day 

[Acceptable/Non-Guideline]

IV

870.1200 Acute Dermal/Rabbit 457129-02 LD50 >2000 mg/kg 

[Acceptable/Guideline]

III

870.1300 Acute Inhalation/Rat 462048-01 >2.08 mg/L 

[Acceptable/Guideline]

IV

870.2500 Dermal Irritation/

Rabbit

457129-03 Not a skin irritant

[Acceptable/Guideline]

IV

870.2500 Dermal Irritation/ 

Rabbit

452997-02 Not a skin irritant

[Acceptable/Non-Guideline]

IV

870.2400 Primary Eye 

Irritation/

Rabbit

457129-03 Corrosive

[Acceptable/Guideline]

IV

870.2600 Dermal Sensitization/

Guinea Pig

452997-02 Not a dermal sensitizer

[Acceptable/Non-Guideline]

N/A

2.0 Repeat Dose Toxicity 

The database for repeat dose toxicity includes three studies that have been submitted to EPA as 

well as three studies that are included in the HERA, 2002 document for TAED. These studies 

are listed in Table 2. 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 27 of 48

Table 2 – TAED Repeat Dose Toxicity Studies

Study Type/

Test Substance 

Source/Doses Results

Studies Submitted to EPA

90 Day Oral Toxicity 

Study in Rats

MRID 45299703

0, 25, 500, 1000 

mg/kg/day 

NOAEL = 25 mg/kg/day (F)

LOAEL = 500 mg/kg/day, based on 

centrilobular cytomegaly (hypertrophy) in the 

liver, increased liver weight, and clinical 

chemistry changes. 

90 Day Dermal 

Toxicity Study in Rats

MRID 45274305

0, 20, 200, 2000 

mg/kg/day 

NOAEL = 200 mg/kg/day

LOAEL = 2000 mg/kg/day based on 

centrilobular hypertrophy of the liver

Oral (Gavage) 

Developmental 

Toxicity Study in Rats

MRID 45299704

0, 40, 200, 1000 

mg/kg/day

Maternal NOAEL = 40 mg/kg/day

Maternal LOAEL = 200 mg/kg/day based on

reduced body weight gain and food consumption

Developmental NOAEL = 200 mg/kg/day

Developmental LOAEL = 1000 mg/kg/day 

based on decreased mean fetal weights and 

increased incidence of skeletal variations

Studies from HERA, 2002

28 Day Gavage Study 

in Rats

RCC,1989

0, 40, 200, 1000 

mg/kg/day 

NOAEL = 200 mg/kg/day

LOAEL = 1000 mg/kg/day, based on increased 

liver weight, slight hepatic centrilobular 

parenchymal hypertrophy

90 Day Gavage Study 

in Rats.

Henkel, 1987

0, 90, 250, 800

mg/kg/day 

NOAEL = 90 mg/kg/day

LOAEL = 250 mg/kg/day based on increased 

liver and testes weights in male rats.

90 Day Whole Body 

Inhalation Study in 

Rats TAED, (<3.5 um).

Unilever, 1981

12.2, 60.3, 99.7 mg/m3 6 

hours/day, 5 days/week

NOAEL = 99.7 mg/m3 (HDT)

Microscopic observation showed no treatment 

induced effects on the lungs. 

2.1 Subchronic Toxicity 

The database for subchronic toxicity is considered complete. This database includes three oral 

toxicity studies, one dermal toxicity study and one inhalation toxicity study
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 28 of 48

2.1.1 Subchronic Oral Toxicity

MRID 45299703 - In a 90-day oral toxicity study TAED was administered to 10 rats/sex/dose 

by gavage in 1% carboxymethylcellulose (CMC) at nominal dose levels of 0, 25, 500, or 1000 

mg/kg/day.

There were no treatment-related findings regarding mortality, clinical signs of toxicity, 

ophthalmology, and hematology. Significant dose-related decreases in body weight and body 

weight gain were observed in treated males at all dose levels and ≥500-mg/kg/day in treated 

females. Food consumption was decreased in treated rats but the decreases reached statistical 

significance only in the 1000-mg/kg/day males. Significant increases occurred in total protein 

(1000-mg/kg/day males and females), albumin (1000-mg/kg/day males), and globulin values 

(1000-mg/kg/day females). Liver weights (absolute, relative to body and brain weights) were 

significantly increased in the 1000-mg/kg/day males and ≥500-mg/kg/day females that correlated 

with incidences of grossly enlarged liver in 1000-mg/kg/day males and incidences of 

centrilobular cytomegaly of the liver (1000 mg/kg/day males) in all 500- and 1000-mg/kg/day 

treated rats. Bilateral, mild degeneration of the seminiferous tubules was noted in 2/10 high-dose 

males.

Based on weight loss and decrease in the rate of weight gain, microscopic lesions observed in the 

liver (centrilobular cytomegaly), increased liver weights, and clinical chemistry changes, the 

LOAEL is 500 mg/kg/day in females and 25 mg/kg/day in males. The NOAEL is 25 mg/kg/day 

in females, but could not be determined in males (<25 mg/kg/day).

This 90-day oral toxicity study is Acceptable/Guideline and it satisfies the guideline requirement 

for a 90-day subchronic oral toxicity study [OPPTS 870.3100 [§82-1]; OECD 408] in rats. 

RCC, 1989. Subacute oral toxicity was evaluated in groups of 10 rats (5 males, 5 females) 

receiving TAED by once daily gavage at dose levels of 0, 40, 200 and 1000 mg/kg/day for 28 

days. Mortality, clinical abnormalities, ophthalmoscopic findings and toxicologically relevant 

changes of hematological, biochemical and urinalysis parameters were not observed throughout 

the study. Food consumption in male rats of the high dose group and female rats of the high and 

mid dose group was significantly less than the controls during treatment days 1 to 8. The same 

occurred in female rats of the high dose group during treatment days 15 to 28. The body weights 

and body weight gains of the high dose female rats were significantly lower than control from 

day 15 until the end of the 28 day treatment period. A significant increase of absolute and 

relative liver weights was found in male and female rats of the 1000 mg/kg/day group. Male rats 

of this group showed also significantly reduced absolute and relative spleen weights. 

Histopathological examination revealed slight hepatic centrilobular parenchymal hypertrophy, 

consistent with enzyme induction, in male and female rats of the high dose group. The lower 

dose levels produced no pathological evidence of toxicity. 

Based upon the results a NOAEL of 200 mg/kg/day was determined. The study was performed 

according to GLP standards and OECD guideline 407 and is therefore reliable without 

restrictions (data quality score 1). This study is also acceptable under the analogous EPA 

guideline (OCSPP 870.3050). 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 29 of 48

Henkel, 1987. Groups of 10 male and 10 female rats received TAED by gavage at daily doses of 

0, 90, 250 and 800 mg/kg/day for 90 days. A recovery control and high dose group consisting of 

5 male and 5 female rats was terminated 28 days after the 90 day treatment period. 

Mortality did not occur. Salivation observed in the animals of the high dose group was the only 

clinical finding. Water consumption was increased in males of the 250 and 800 mg/kg/day group 

and in all female test groups, whereas food consumption was not affected. Total body weight 

gain was decreased in male and female rats of all high dose groups.

Slightly decreased haematocrit values in all male test groups and an increase in leukocytes in 

females of the high dose were observed. Changes in biochemical parameters considered to be 

compound-related comprised increased protein values in male and female rats of the high dose 

group and increased cholesterol values in female animals treated with 800 mg/kg/day. Eye 

examination revealed no compound related findings. At the dose level of 250 mg/kg/day relative 

liver and testes weights were significantly increased in male rats. At 800 mg/kg/day absolute and 

relative liver weights of both sexes and relative adrenal and testes weights in male rats were 

statistically significantly increased. No compound related macroscopically visible findings were 

present at necropsy. Histopathological examination revealed centrilobular hypertrophy of 

hepatocytes in all high dose animals. This effect reversed completely within the 28 day recovery 

period. In the animals of the low and mid dose group centrilobular hypertrophy was borderline in 

some rats and not considered a clear substance related effect, since this finding was also present 

in some control animals of the recovery group. 

Definitive treatment-related adverse effects occurred at the dose level of 800 mg/kg/day. 

Changes in organ weights were present at 250 mg/kg/day. No adverse effects were observed at 

90 mg/kg/day. Hence, a “no-adverse-effect-level” of 90 mg/kg/day can be deduced. The study 

was performed according to OECD guideline 408 and GLP and is therefore reliable without 

restrictions (data quality score 1). This study is also acceptable under the analogous EPA 

guideline (OCSPP 870.3100).

2.2.2 Subchronic Inhalation Toxicity 

Unilever, 1981. Three groups of 12 male rats were exposed in inhalation chambers to mean 

concentrations of TAED dust (< 3.5 μm) of 12.2, 60.3 and 99.7 mg/m3 for 6 hours a day, 5 days 

a week, for 13 weeks. A control group of 12 male rats was sham-exposed. Male rats were used, 

as they were more sensitive than females in the acute inhalation study. Following exposure, 6 

rats from each group were killed and examined by whole body necropsy. The remaining rats 

were maintained without further treatment for 13 weeks to investigate the reversibility of any 

treatment-related effects. 

Mortality did not occur. There were statistically significant increases in absolute and relative 

liver and kidney weights. All organ weights returned to normal values following the recovery 

period, apart from a small increase in liver weight at the high dose. There was a statistically 

significant reduction in hemoglobin and an increase in platelet numbers in the rats exposed to the 

high level of TAED, and an increase in the number of monocytes in the high and mid level 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 30 of 48

exposure groups. These values were within normal limits following the 13-week recovery period. 

Levels of glucose and aspartate transaminase activity were reduced in all TAED exposure 

groups. Increased Ca2+ , serum total protein and albumin and reduced alanine transaminase 

activity were found in the high and mid-exposure groups, and increases in total cholesterol and 

pseudo-cholinesterase activity and reduced alkaline phosphatase activity in the high level group. 

The values had returned to normal after the recovery period. At post-mortem, one rat exposed to 

the high level of TAED had a slight enlargement of the liver, otherwise no abnormal features 

were observed in any of the rats. 

Microscopic examination showed no treatment-induced effects in the lungs. There was a 

systemic response as evidenced by significant increases in kidney weights in the high and mid 

exposure groups, and in liver weights in all exposure groups. This was reflected in changes in 

hepatic and renal morphology. The morphological change seen in the liver was hypertrophy of 

centrilobular hepatocytes. This was considered to be due to induction of hepatic microsomal drug 

metabolizing enzymes, based on further ultrastructural studies that demonstrated proliferation of 

smooth endoplasmatic reticulum in these hepatocytes. The morphological changes found in the 

kidneys were eosinophilic droplets in the tubular epithelial cells, usually referred to as hyaline 

droplets composed principally of the normal male rat urinary protein α2μ-globulin. The fact that 

in another Unilever study female rats fed TAED did not develop this pathology, but males did, 

confirms this to be the case (Carthew, 2001). The kidney findings are therefore specific to the 

male rat and not relevant to humans. Examination of recovery rats showed that these effects 

reversed completely during a 13-week recovery period. 

The NOAEL for systemic effects cannot be derived from this study as the whole body of the 

animals was exposed to TAED dust and the oral ingestion of unquantifiable amounts of 

substance would have occurred due to grooming. Under the conditions of this study, repeated 

exposure by inhalation to TAED dust at doses up to 99.7 mg/m3 did not cause any adverse 

effects in the rat lung, respiratory tract or nasal mucosa. 

The study was conducted according to GLP standards and while the report does not state whether 

it was conducted according to a recognized guideline, the study does meet the requirements of 

OECD Test Guideline No. 413. However, small group sizes were used. The study is therefore 

valid with restrictions (data quality score 2, assigned by Unilever (Moran, 2002). Because of the 

small group sizes, this study is also rated as supplemental under the analogous EPA guideline 

(OCSPP 870.3465).

2.3.3 Subchronic Dermal Toxicity

MRID 452743-05 TAED as a paste in 1% CMC was applied daily to the shaved skin of ten 

rats/sex/dose at doses of 0 (vehicle control), 20, 200, or 2000 mg/kg/day, for 6 hours/day during 

a 90-day period.

Exposure to the test article did not result in increased mortality, clinical signs, or significant 

changes in body weight or body weight gain, food consumption, hematology, clinical chemistry, 

ophthalmology, organ weights, or gross necropsy findings. Exposure at the highest dose resulted 

in an increase in centrilobular hypertrophy of the liver, which was not observed at lower doses. 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 31 of 48

The LOAEL for systemic toxicity is >2000 mg/kg/day. The NOAEL for systemic toxicity is 200 

mg/kg/day.

This study is Acceptable/Guideline and satisfies the guideline requirement for a 90-day dermal 

toxicity study (OPPTS 870.3250 [§82-3]; OECD 411) in the rat.

2.3 Developmental Toxicity

This database for developmental toxicity consists of one study (MRID 45299704) and this study 

was done on the rat. The database for developmental toxicity is considered incomplete because 

only one species has been tested. 

MRID 45299704. TAED was administered to 25 mated female rats/dose by gavage at dose 

levels of 0, 40, 200, or 1000 mg/kg/day from days 6 through 15 of gestation. 

Maternal toxicity was observed at 1000 and 200 mg/kg/day. Treatment-related effects at 1000 

mg/kg/day included decreased body weight, body weight gain, corrected body weight, corrected 

body weight gain, and food consumption. Treatment-related effects at 200 mg/kg/day were 

similar to those observed at the high dose and included decreased body weight gain, corrected 

body weight gain, and food consumption. The maternal LOAEL is 200 mg/kg/day, based on a 

reduction in body weight gain, corrected body weight gain, and food consumption. The maternal 

NOAEL is 40 mg/kg/day.

Fetal toxicity was observed at 1000 mg/kg/day, with treatment-related effects including 

decreased mean fetal weights (male, female, and combined) and an increased incidence of 

skeletal variations. There were no treatment-related effects observed at 200 or 40 mg/kg/day. 

The developmental LOAEL is 1000 mg/kg/day, based on decreased mean fetal weights and 

increased incidence of skeletal variations. The developmental NOAEL is 200 mg/kg/day.

This study is classified as Acceptable/Guideline and satisfies the guideline requirements for a 

developmental toxicity study (OPPTS 870.3700 [§83-3a]; OECD 414) in rats. 

2.4 Reproductive Toxicity

There are no reproductive toxicity studies available for TAED; however, a significant increase in 

testes weights was observed in one of the two 90 day oral toxicity studies (Henkel, 1987).

Because of this finding and because a reproductive effect toxicity study is required by 40 CFR 

Part 158W, a reproductive toxicity study is anticipated to be needed for TAED. 

2.5 Neurotoxicity

There are no neurotoxicity studies available for TAED. The study is conditionally required per 

40 CFR Part 158W if the neurotoxicity screen in the 90 day oral rodent study or other data 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 32 of 48

indicates neurotoxicity. Neurotoxicity has not been observed in the TAED toxicity studies and 

therefore the neurotoxicity study is not anticipated to be required for TAED.

2.6 Mutagenicity

Three mutagenicity studies have been submitted for TAED and the results are summarized in 

Table 3. TAED was negative for mutagenic effects in all three studies. 

Table 3 – TAED Mutagenicity Studies

Study Type MRID 

Number

Results

Ames assay 45274306 No evidence of mutagenicity in strains TA98, TA100, 

TA1535, TA1537, and TA1538 (with or without S9)

In vivo micronucleus 

assay

45547202 No significant increase in frequency of micron

nucleated PCEs at any dose level tested

Human lymphocyte 

chromosome aberrations

45547201 No repeatable significant increases in either 

frequency of structural aberrations or frequency of 

polyploidy cells at any dose level tested. 

2.7 Chronic Toxicity and Carcinogeneticity

There are no chronic toxicity or carcinogeneticity studies available for TAED; however, these 

studies are not needed for TAED because the use pattern does not involve food exposure or long 

term occupational and residential exposure.

2.8 Immunotoxicity

There are no Immunotoxicity studies for TAED. According to subpart 40 CFR Part 158W and 

based on the existing toxicity database and use pattern, this study is anticipated to be required for 

TAED registration review.

3.0 Biotransformation

A biotransformation study for TAED (Unilever, 1978a) is included in the HERA, 2002 

document. The fates of tetra acetyl [14C]ethylene diamine (TA[14C]ED) and [1-

14C]tetra acetyl 

ethylene diamine ([14C]TAED) were followed in groups of 3 male and 3 female Wistar rats after 

oral intubation with 0.5 ml dietary slurry containing 5 mg TA[14C]ED or 4.6 mg [14C]TAED 

(Unilever, 1978a). The nature of the radio-labelled compounds in urine and feces was studied 

and 14C levels were monitored in tissues, carcass remains, urine and feces. A further group of 

rats was intubated with [14C]TAED and killed at 1, 2, 4, 7 and 24 hours to monitor the rate of 

absorption from the intestine and uptake by the liver, adrenal and kidney tissues. Monitored 14C 

levels showed no gender differences in the absorption, metabolism and excretion of TA[14C]ED

and [14C]. At one hour post-dosing, more than 50% of the administered 14C had been absorbed 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 33 of 48

from the intestine. Tissue levels of 14C were at their highest at 2 hours post-dosing. 

Subsequently, levels fell rapidly except in the adrenal gland where 14C levels rose during the 7 

hours post-dosing. More than 90% of the urinary 14C was excreted within 24 hours of dosing. 

Chromatographic analysis showed only traces of TAED in the urine. Most of the 14C was 

excreted as triacetyl ethylene diamine (TriAED) and diacetyl ethylene diamine (DAED). Mono 

acetyl ethylene diamine (MAED) and ethylene diamine were not found. 

The results show that TAED was rapidly absorbed from the rat intestine and was largely 

metabolized and excreted in the urine within 24 hours. Differences in the levels of 14C recovered 

as expired CO2 reflect the different metabolic fates of the acetyl and ethylene diamine moieties. 

The 14C compounds identified in the urine, TirAED and DAED, indicate that deacetylation was 

the main metabolic route for TAED in the rat. 

4.0 Dermal Penetration

A dermal penetration study for TAED (Unilever, 1978b) is included in the HERA, 2002 

document. Skin penetration studies using TA[14C]ED in detergent solutions and in chloroform 

were conducted in rats. One group of Wistar rats was treated with 0.2 ml of a 1% w/v detergent 

A base containing 400 μg TA[14C]ED applied over 10 cm2 of clipped dorsal skin. A second 

group was treated with 200 μl of a solution containing 6% powder detergent B base, 1% 

perborate and 0.5% TA[14C]ED (1348 μg TA[14C]ED) and a third group was treated with 50 μl 

chloroform containing 1124±40μg TA[14C]ED. The amounts of TA[14C]ED penetrating the skin 

measured. Of the TA[14C]ED which penetrated the skin, most was recovered in the urine while 

less than 3% was recovered in the feces. The results indicate that TAED can penetrate rat skin 

depending on contact time, with increased contact time leading to increased skin penetration. 

5.0. Data Gaps: 

According to subpart 40 CFR Part 158W and based on the existing toxicity database and use 

pattern, the following data requirements apply to TAED.

1) Immunotoxicity 

2) Reproduction toxicity 

3) Developmental toxicity (non-rodent)
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 34 of 48

6.0 Open Literature References for Appendix A.

Henkel, 1987. Henkel KGaA – Institut für Toxikologie. Tetra-acetyl-ethylen-diamin – 90-Tage-Test 

mit wiederholter oraler Verabreichung an Ratten. Unpublished data. Archive No. 860114. (Cited in 

HERA, 2002)

HERA, 2002. Human and Environmental Risk Assessment on Ingredients of European 

household cleaning products: Tetraacetylenediamine (TAED), Caffaro , Clariant, Henkel, 

Unilever, P&G and Warwick, December 2002. 

RCC,1989. RCC AG on behalf of Hoechst AG – Pharma Forschung Toxikologie and 

Pathologiue (1989) . Subacute 28-day oral toxicity (gavage) study with TAED in the Rat. 

Unpublished data. Project No. 233820 (Cited in HERA, 2002)

Unilever, 1978a. Unilever’s Toxicology Lab. Tetra acetyl ethylene diamine (TAED): Oral 

absorption, metabolism and excretion study in rats – summary of study no. AM77.01 (report no. P 

CE 78 1147). In: SEAC Toxicology Group - Unilever Research Colworth (2001). Tetra acetyl 

ethylene diamine (TAED): Toxicity and ADME summary data. Unpublished data. Document 

reference D01-023. (Cited in HERA, 2002)

Unilever, 1978b. Unilever’s Toxicology Lab. Tetra acetyl ethylene diamine (TAED): Skin 

penetration study in rats – summary of study no. AM77.01 (report no. PCW 78 1147). In: SEAC 

Toxicology Group - Unilever Research Colworth (2001). Tetra acetyl ethylene diamine (TAED): 

Toxicity and ADME summary data. Unpublished data. Document reference D01-023. (Cited in 

HERA, 2002)

Unilever, 1981. Unilever’s Toxicology Lab. Tetra acetyl ethylene diamine (TAED): 13-week 

inhalation toxicity study in rats – summary of study no. R1234 (IT80.004). In: SEAC Toxicology 

Group - Unilever Research Colworth (2001). Tetra acetyl ethylene diamine (TAED): Toxicity and 

ADME summary data. Unpublished data. Document reference D01-023. (Cited in HERA, 2002)
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 35 of 48

Appendix B Environmental Fate

Environmental Fate and Transport Properties of TAED and its Degradates 

TriAED and DAED and Perhydrolysis Products Peroxyacetic Acid and 

Hydrogen Peroxide

The Agency will conduct an environmental fate assessment for TAED based on the current uses 

in industrial and institutional laundry facilities and hard, non-porous surfaces in healthcare 

facilities, hospitals, medical, and dental offices. It serves as a bleach activator and reacts in 

aqueous solutions in the presence of an oxygen activator to form the DAED degradate, hydrogen 

peroxide and peracetic acid using the perhydrolysis reaction27. Both peroxyacetic acid and 

hydrogen peroxide are highly-reactive and degrade rapidly. 

Guideline environmental fate data that address metabolism or transport of TAED in the 

terrestrial or aquatic environment have not been submitted to the Agency for TAED or it’s 

degradates. Although no data have been submitted, TAED and the degradates, TriAED 

(transient degradate) and DAED (terminal non-volatile degradate), are expected to partition to 

water in the presence of sludge based on a log Kow of -0.06.28 Several studies are present in the 

literature and in the HERA document.29 The studies listed in the HERA document have not been 

formally-reviewed by the Agency, but they indicate that TAED is readily biodegradable30 and 

highly removed in the activated sludge of a WWTP based on a 97 percent removal rate in a 

porous pot test.31 The appropriate studies in the HERA document will be formally-reviewed by 

the Agency before a final risk assessment. The Agency also has not received data on aerobic 

aquatic metabolism of parent TAED or the degradate DAED, which can reach surface water if 

they pas through a WWTP. 

Parent TAED is miscible in water (20 g/L)32 and its sequential degradates TriAED and DAED 

are expected to have similar water solubility based on structural similarity. TAED (TGAI) 

slowly degraded by abiotic hydrolysis at pH 7 and 15 o

C with a half-life of 40 days and the 

DAED degradate was shown to be stable and not degrade.33 However, in a washing machine 

study using a formulated product which includes oxygen, TAED appears to degrade rapidly to 

form the degradate DAED at 30, 40, and 60 o

C34 which represents cold, warm, and hot water 

temperatures, respectively.35 The washing machine study, which is more environmentally-

 27 Reaction in water to release peroxyacetic acid and hydrogen peroxide 28 MRID 45299701

29 Human & Environmental Risk Assessment, http://www.heraproject.com/files/2-F-04-

HERA%20TAED%20full%20web%20wd.pdf

30 OECD 301E data, IUCLID 2000, Proctor & Gamble Internal Data 1976 and 1978 31 Clariant, 2002 32 MRID 45299701 33 MRID 46335801 34 MRID 46335802, study not reviewed 35 http://housekeeping.about.com/od/laundry/a/laundry_h20temp.htm
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 36 of 48

relevant than the abiotic hydrolysis study, has not been formally-reviewed. It will be reviewed 

prior to conducting the risk assessment. The only detectable residue from the water in the 

washing machine was the DAED degradate. 

Water and Sediment

Hydrolysis

The only submitted guideline environmental fate study on TAED is hydrolysis (MRID 

46335801)36 which indicates relative stability of parent TAED with a half-life of 40 days at pH 7 

and 15 oC. The major hydrolytic degradate TriAED (once-deacetylated TAED) reached 40 % of 

parent compound by 60 days and had a half-life of 120 days. The terminal degradate DAED 

(twice-deacetylated TAED) reached 50 % of parent compound by 180 days and did not degrade 

in the study. 

The Agency also had access to a washwater study that used TAED (MRID 46335802)37. At 30 o

C (86 oF), 40 oC (104 oF), and 60 oC (140 oF), parent TAED dissipated by the end of the wash 

cycle and the only residue remaining was the degradate DAED. These temperatures 

approximate the cold (60-80 oF), warm (90-110 oF), and hot (>130 oF) water temperatures for a 

washer.38 The lack of degradation of the DAED degradate was consistent with the results of the 

hydrolysis study, and DAED is the residue to which the microorganisms in a WWTP would be 

exposed.

The abiotic hydrolysis study and the washing machine study show apparently contradictory 

results because the tested materials were different. However, the abiotic hydrolysis study used 

parent TAED without an oxygen activator and the washing machine study used a formulated 

product with an oxygen activator which promotes the perhydrolysis of parent TAED to form 

DAED and peroxyacetic acid.

Aqueous Photolysis

The registrant has not submitted any photodegradation in water (835.2240) or photodegradation 

on soil (OCSPP 835.2410) data for TAED or its degradates. However, based on the limited 

sorption of UV light39, these data are not required because the study would not provide any 

meaningful results.

 36 MRID 46335801, find review date 37 MRID 46335802 not formally-reviewed 38 http://housekeeping.about.com/od/laundry/a/laundry_h20temp.htm

39 MRID 45299701
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 37 of 48

Octanol-Water Partition Coefficient

The octanol water coefficient (Log Kow or Log P) is -0.0640, which indicates limited potential 

for bioconcentration in fish (OCSPP 850.1730) or for sorption to activated sludge (OCSPP 

835.1110) or to soil and sediment (OCSPP 835.1230). 

Aerobic Aquatic Metabolism

The registrant has not submitted any guideline studies for aerobic aquatic metabolism (OCSPP 

835.4300) and the Agency anticipates requiring data for this test guideline. If TAED or its 

degradate DAED reach surface water, they will likely be associated with the water column in the 

presence of sediment. 

Anaerobic Aquatic Metabolism

The registrant has not submitted any guideline studies for anaerobic aquatic metabolism (OCSPP 

835.4400) but the Agency does not anticipate requiring data for this test guideline for TAED and 

DAED because of the lack of sorption would indicate little/no TAED in the anaerobic (sediment) 

phase of the aquatic system. 

Soil Leaching/Adsorption/Desorption Batch Equilibrium

The registrant has not submitted any guideline studies on sorption to soil and sediment (OCSPP 

835.1230). However, there are two unreviewed studies (AISE, 1992, Shell, 2000) for TAED and 

AISE, 1992 for DAED. These studies indicate that sorption to soil is limited for both 

compounds with Koc values of 15-80 L/kg for TAED and 25 L/kg for DAED. The apparent lack 

of sorption to soil is consistent with the high water solubility of 20 g/L and the low log Kow of -

0.06. Studies will be reviewed prior to conduct of risk assessment but do not impact data 

requirements at this time.

Aerobic Soil Metabolism

No data on aerobic soil metabolism (OCSPP 835.4100) have been submitted, and none are 

anticipated to be required. Based on the current uses, TAED is not likely to be reach soil 

because of limited sorption to activated sludge or to be sorbed to soil based on the AISE (1992),

and Shell (2000) studies cited above.

Anaerobic Soil Metabolism

No data on anaerobic soil metabolism (OCSPP 835.4200) have been submitted, and none are 

anticipated to be required. Based on the current uses, TAED is not likely to be reach soil 

because of limited sorption to activated sludge or to be sorbed to soil based on the AISE (1992) 

and Shell (2000) studies cited above.

 40 MRID 45299701
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 38 of 48

Fate and Transport in WWTP

Activated Sludge Sorption Isotherm

Data on sorption to activated sludge are not anticipated to be required because the log Kow (Log 

P) is -0.06 (<3 and indicates no sorption.

Activated Sludge Biodegradation

TAED and its degradates TriAED and DAED are miscible in water41 and are expected to 

partition to water in the presence of sludge based on a log Kow of -0.06.42 The Agency has not 

received any submitted guideline studies for the biodegradation of TAED, but several studies are 

present in the literature and in the HERA document.43 The studies listed in the HERA 

document have not been formally reviewed by the Agency, but they indicate that TAED is 

readily biodegradable44 and highly removed in the activated sludge of a WWTP based on a 97 % 

removal rate in a porous pot test.45 The Agency has not formally reviewed these studies but will 

review them before conducting the final risk assessment.

Hydrogen Peroxide

Based on information from the open literature and the peroxy compounds, RED and registration 

review, under abiotic conditions, hydrogen peroxide does not appear to be hydrolytically or 

photolytically stable. The half-life in water under abiotic conditions has not been determined 

absolutely, but it varies with concentration. In seawater, the DT20 of hydrogen peroxide was 25-

35 minutes. The half-life of hydrogen peroxide (90% purity) was 8.3 days in the presence of 

sunlight in the UV range. Hydrogen peroxide is not expected to pose any concerns for surface 

water runoff. 

Under aerobic aquatic metabolism conditions, hydrogen peroxide degrades with half-lives of 1.1-

5.3 hours in non-sterile conditions, and ca. 80 hours in sterile conditions. Under anaerobic soil 

metabolism conditions, hydrogen peroxide degrades with a half-life of ca. 4 hours in samples of 

nine petroleum-contaminated surface soils from five different states. The texture and pH of the 

soil, as well as the experimental temperature, did not affect the degradation process; however, 

the organic carbon content of the soil did affect the degradation. Under aerobic soil metabolism 

conditions, hydrogen peroxide degrades with a half-life of ca. 1.4 hours in diluted test solutions. 

This half-life value was extrapolated to ca. 7 hours for concentrated test solutions.

There are no data on the mobility of hydrogen peroxide in regards to either adsorption/desorption 

(to determine Kd) with various soils or soil column leaching. However, it is assumed that, since 

hydrogen peroxide has physical properties that are similar to water, hydrogen peroxide will not 

bind to soils. 

 41 MRID 45299701 42 MRID 45299701 43 Human & Environmental Risk Assessment, http://www.heraproject.com/files/2-F-04-

HERA%20TAED%20full%20web%20wd.pdf

44 OECD 301E data, IUCLID 2000, Proctor & Gamble Internal Data 1976 and 1978 45 Clariant, 2002
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 39 of 48

The Agency does not have data on hydrogen peroxide bioaccumulation in aquatic organisms. 

However, hydrogen peroxide is not expected to bioaccumulate due to its low octanol-water 

partition coefficients (0.40). 

The average degradation half-life for hydrogen peroxide in the atmosphere is 24 hours. 

Peroxyacetic Acid

Peroxyacetic acid is expected to easily degraded in air, water and soil and does not persist or 

accumulate in the environment. The half-lives/DT50s for peroxyacetic acid are 48 hours at pH 4 

and 7, and 3.6 hours at pH 9. In water containing 0.01 mol/L, the half-lives were 107, 109, and 

112 hours for pH values of 4, 7,and 9, respectively. For solutions containing 0.001 mol/L, the 

half-lives were 3.5, 3.5, and 0.3 hours, respectively. In seawater, the DT50 of peroxyacetic acid 

was 7-20 minutes. Only a minor portion (<1%) of peroxyacetic acid, which is released into the 

environment, will remain in the atmosphere, where it is rapidly degraded (half-life of 22 

minutes). Peroxyacetic acid will not partition into sediment, suspended matter, or biota. In the 

OECD Closed Bottle Test with adapted bacteria, peroxyacetic acid (initial concentration of 2-5 

mg/L) was highly biodegradable (>79%). 

The hydrolysis products of peroxyacetic acid (acetic acid and hydrogen peroxide) are readily 

biodegradable. The biodegradation/DT50 of peroxyacetic acid is rapid (not defined). The ready 

biodegradation of peroxyacetic acid is >70%. In soil, diluted peroxyacetic acid is rapidly and 

easily degraded via hydrolysis and instantaneously degraded via transition metal decomposition. 

At low concentrations, biodegradation could contribute to the degradation in soils. After ca. 20 

minutes, 99.2% of the peroxyacetic acid (1.1% solution) had degraded in dried soil (not 

specified) following extraction with demineralized water.

The soil column leaching of peroxyacetic acid was studied in an unspecified soil. At 5 minutes 

post-treatment, 21.5% of the peroxyacetic acid was recovered, along with 42% of hydrogen 

peroxide, at a soil depth of 25 mm. The recovery of peroxyacetic acid decreased to 3.2% at 50 

mm, 0.3% at 100 mm, and <0.2% at 150 mm. At 150 mm, 10% of hydrogen peroxide was 

present. At 10 minutes post-treatment, the column washing yielded only 8.7% recovered 

peroxyacetic acid at the 25-mm depth. Peroxyacetic acid is not expected to bioaccumulate due to 

its low octanol-water partition coefficients (0.30). Peroxyacetic acid and its transformation 

products, hydrogen peroxide and acetic acid, are of low molecular weight, high water solubility, 

low fat solubility, and have no tendency to bioaccumulate.

No photodegradation in water, photodegradation in air, anaerobic soil metabolism or 

accumulation studies in aquatic non-target organisms information were found for peroxyacetic 

acid.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 40 of 48

Table 1. Chemical, Physical, and Environmental Fate Properties of TAED and its degradates TriAED and DAED

TAED TriAED DAED

Guideline Guidelin

e 

(OCSPP 

number 

unless 

specified)

Unit Source/Comme

nt (MRID 

Number)

CAS No. None None 10543-57-4 None None None

Molecular 

formula

None None C10 H16 N2 O4 C8 H14 N2 O3 C7 H14 N2 O2 None

Smiles code None None O=C(N(C(=O)C)CCN(C(=O)C)C(=

O)C)C

O=C(NCCN(C(=O)C)C(=O)C)C O=C(NCCN(CC(=O)C))C None

Molecular 

weight

None g/mol 228.25 186.21 158.20 None

Melting point 830.7200 oC 147 + 1 No data, but expected to be similar 

based on structural similarity 

No data, but expected to be similar 

based on structural similarity

45299701

Boiling point 830.7220 oC Not applicable because it is a solid at 

room temperature

No data, but expected to be similar 

based on structural similarity

No data, but expected to be similar 

based on structural similarity

45299701

Water 

solubility

830.7840 g/l 2 (20 oC) 

Miscible in water

No data, but expected to be similar 

based on structural similarity

No data, but expected to be similar 

based on structural similarity

45299701

Vapor 

Pressure (mm 

Hg)

830.7950 mm 

Hg

No data No data No data Not applicable

Henry’s Law None atm 

m3

mol-1

Not expected to be volatile from 

water into air based on miscibility in 

water

No data, but expected to be similar 

based on structural similarity

No data, but expected to be similar 

based on structural similarity

Not applicable
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 41 of 48

TAED TriAED DAED

Guideline Guidelin

e 

(OCSPP 

number 

unless 

specified)

Unit Source/Comme

nt (MRID 

Number)

Log P (log 

Kow)

830.7550 Unitl

ess

-0.06 No data, but expected to be similar 

based on structural similarity

No data, but expected to be similar 

based on structural similarity

45299701

Hydrolysis 835.2120 Days 40 120 Stable 45299701

pH 7, 15 oC

Perhydrolysis

in Washing 

Process

None Min 3 <5 Stable Gilbert, 1992, 

Buecking, 

199046

23 oC, pH 10.1

Photodegradati

on in water

835.2240 Days Not expected to photodegrade based 

on limited UV light sorption from 

290-800 nm

No data, but expected to be similar 

based on structural similarity

No data, but expected to be similar 

based on structural similarity

45299701

Leachingadsorptiondesorption to 

soil

835.1230 ml/g Koc values 15-80 L/kg No data Koc value of 25 L/kg AISE, 1992, 

Shell, 2000 (for 

TAED)

AISE, 1992 for 

DAED47

Aerobic 

aquatic 

metabolism

835.4300 Days No data No data No data Not applicable

 46 Gilbert (1992) and Buecking (1990) have not been reviewed by the Agency 47 Koc values from AISE (1992) and Shell (2000) have not been validated through Agency Review
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 42 of 48

TAED TriAED DAED

Guideline Guidelin

e 

(OCSPP 

number 

unless 

specified)

Unit Source/Comme

nt (MRID 

Number)

Anaerobic 

aquatic 

metabolism

835.4400 Days No data No data No data Not applicable

Activated 

sludge 

sorption

835.1110 %, 

L/kg

No data No data No data Not applicable

Ready 

biodegradabilit

y

835.3110

OECD 

301D

% 52-56 % degradation in 28 days No data 60 % degradation in 28 days Henkel, 197248

Activated 

sludge 

respiration 

inhibition

850.3300 mg/l No data No data No data Not applicable

Bioconcentrati

on in fish49

850.1730 Unitl

ess

No data No data No data Not applicable

Bioconcentration 

in aquatic 

organisms is not 

likely because of 

the low log Kow 

of -0.06 (<3)

 48 Henkel (1972) has not been formally reviewed

49 BCF predictions should increase as the water solubility decreases and log Kow increases.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 43 of 48

References

About.com. January 15, 2014. Laundry and Water Temperature: What Temperature 

Should You Use for Your Laundry? 

http://housekeeping.about.com/od/laundry/a/laundry_h20temp.htm

AISE. October, 1992. Principles for Environmental Risk Assessment of Detergent Chemicals 

in Europe; Outcome of 2nd AISE Workshop, Limelette.

 

Buecking, H.W., Reinhardt, D., Lotsch, R., Ziemer, M., Pleschke, H. 1990. Environmental 

behavior and testing of the biodegradation of bleach systems, Commun. Jorn. Com. Esp. 

Deterg. 21: 167-182, ISSN 0212-7466.

Clariant (2002), GmbH, Division FUN, Tetracetylethylenediamine – Water Solubility 

according to OECD 105, Report No H575, 2002-05-21

Gilbert PA (1992). TAED – Tetraethylenediamine. In: Hutzinger O (ed). The handbook of 

environmental chemistry. Springer-Verlag Berlin Heidelberg, Volume 3 Part F p. 319-328.

Henkel (1972a). Henkel KGaA, TAED – Closed Bottle Test, OECD 301D, Report No.

0000749

Henkel (1972b). Henkel KGaA, DAED – Closed Bottle Test, OECD 301D, Report No. 1491

HERA, 2002. Human and Environmental Risk Assessment on Ingredients of European 

household cleaning products: Tetraacetylenediamine (TAED), Caffaro , Clariant, Henkel, 

Unilever, P&G and Warwick, December 2002. 

Hoechst (1983). OECD 302B, Zahn-Wellens-Test, Report No. W 83-016, 1983

Hoechst (1995a). OECD 301B, Sturm CO2 Evolution Test, Test report No. B 812b

IUCLID (2000) CD-ROM. Public data on high volume chemicals. Joint Research Centre, 

European Chemicals Bureau. Ispra, Italy

Shell. 2000. TAED: Determination of soil Sorption Coefficient (Koc), Report No. CSC 00349

Shell (2002) TAED: Determination of soil sorption coefficient (Koc). Report CSC 00349

Unilever (1981a). TAED – Ready biodegradability, Sturm Test, Study Report D87038
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 44 of 48

Appendix C Ecotoxicology Profile

Toxicity to Terrestrial Organisms

Birds

One acceptable acute-oral (LD50) study categorizes TAED as being practically nontoxic to 

birds. The guideline (850.2100) is satisfied. No additional avian toxicity data are anticipated to 

be needed.

Avian Acute-oral Toxicity

Test Species

Test Material

(% ai)

Toxicity

Toxicity

Category

EPA Study

ID

Northern bobwhite

(Colinus virginianus)

99 LD50 >2000 mg ai/kg bw Practically 

nontoxic

45274309

Acceptable

Nontarget Insects 

Toxicity data for beneficial insects (850.3020, 850.3030) are not needed to support the current 

use patterns of TAED. 

Toxicity to Aquatic Organisms

Freshwater Fish 

One available acute toxicity study (850.1075) categorizes technical-grade TAED as being 

practically nontoxic to freshwater fish. The guideline (850.1075) for acute toxicity testing is 

satisfied. No additional fish toxicity data are anticipated to be needed.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 45 of 48

Acute Toxicity to Freshwater Fish

Test Species

Test Material

(% ai)

Toxicity Endpoint

(mg ai/L)

Toxicity

Category

EPA Study

ID

Rainbow Trout

(Oncorhynchus 

mykiss)

99 96-h LC50 >140 Practically 

nontoxic

45274308

Acceptable

Freshwater Invertebrates

One available acute toxicity study for the waterflea categorizes technical-grade TAED as being 

practically nontoxic to freshwater invertebrates. The guideline (850.1010) for acute toxicity 

testing is satisfied. No additional aquatic invertebrate toxicity data are anticipated to be needed.

Acute Toxicity to Freshwater Invertebrates

Test Species

Test Material

(% ai)

Toxicity Endpoint

(mg ai/L)

Toxicity

Category

EPA Study

ID

Waterflea

(Daphnia magna)

99 48-h EC50 >1000 Practically 

nontoxic

45712901

Acceptable

Estuarine/Marine Fish and Invertebrates

No data (850.1075, 850.1025, 850.1035) are available. Because TAED is not expected to occur 

in the estuarine/marine environment, data for estuarine marine organisms are not anticipated to 

be needed.

Aquatic Plants

No data are available. A Tier II study (850.4500) is needed for green algae (Selenastrum 

capricornutum) for a hazards assessment. No additional data (850.4400, 850.4500, 850.4550) 

are anticipated to be needed.

Sediment toxicity

Sediment toxicity data are not anticipated to be needed based on the environmental fate 

properties of TAED.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 46 of 48

Appendix C References

45274309 Pedersen, C. (2000) Avian Acute Oral Toxicity Test With Tetraacetylethylenediamine in Bobwhite Quail: Lab Project Number: 168-001-03. Unpublished study 

prepared by Bio-Life Associates, Ltd. 36 p. {OPPTS 850.2100} 

45274308 Sousa, J. (2000) Tetra Acetyl Ethylene Diamine (TAED)-Acute Toxicity to Rainbow 

Trout (Oncorhynchus mykiss) Under Flow-Through Conditions: Lab Project 

Number: 13727.6103: WI/SLI/001. Unpublished study prepared by Springborn 

Laboratories, Inc. 50 p. {OPPTS 850.1075} 

45712901 Mattock, S. (2002) Tetraacetyl Ethylene Diamine: Acute Toxicity to Daphnia magna: 

Final Report: Lab Project Number: 1434/11: 1434/11-D2149. Unpublished study 

prepared by Covance Laboratories, Ltd. 27 p. {OPPTS 850.1010} 
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 47 of 48

Appendix D Product Chemistry

Tetraacetylethylenediamine product chemistry information is summarized in Table D1 (source: 

MRID No. 45299701).

Table D1 – Product Chemistry of Tetraacetylethylenediamine

Guideline 

No.

Physical and Chemical 

Properties Tetraacetylethylenediamine 

830.1550 Product identity and composition Refer to Table 3 

830.1600 Description of materials used to 

produce the product

Confidential Business Information (CBI)

830.1620 Description of production process CBI

830.1650 Description of Formulation Process CBI

830.1670 Discussion of Formation of Impurities CBI

830.1700 Preliminary analysis CBI

830.1750 Certified limits CBI

830.1800 Enforcement analytical method GLC and F.I.D. Detection

830.1900 Submittal of samples CBI

830.6302 Color Off-white (white/cream colored) Material

830.6303 Physical State Solid at room temperature (25°C)

830.6304 Odor No discernible odor

Weak acetic acid odor

830.6313 Stability to normal and elevated 

temperature, metals/metal ions 

TAED was stable under the conditions tested (room 

temperature and 54°C).

TAED was stable to metals and metal ions under the 

conditions tested (room temperature and 54°C).

The TAED technical is expected to be stable for at least one 

year stored away from sunlight and at ambient temperature 

storage conditions. This is based on the absence of reactive or 

unstable groups in the product and on the result from an 

accelerated storage study at elevated temperature.

This material was considered stable under accelerated storage 

stability conditions (i.e., at 54°C)

Stable at normal storage and handling conditions.

Conditions to Avoid: Acids; strong alkalies; strong oxidizing 

agents. Reacts with acids, alkalies, and strong oxidizing 

agents.

TAED is stable when dry at room temperatures. 

830.6314 Oxidation/Reduction The product has no oxidizing or reducing potential because 

there are no reactive oxidizable/reducible groups in the 

compound.
Docket Number EPA-HQ-OPP-2013-0608

www.regulations.gov

Page 48 of 48

Guideline 

No.

Physical and Chemical 

Properties Tetraacetylethylenediamine 

830.6315 Flammability Not applicable because the product contains no combustible 

liquids.

830.6316 Explodability Not applicable because the product is not potentially 

explosive.

830.6320 Corrosion Characteristic

Stable with respect to metals (i.e., non-corrosive) and did not 

exhibit corrosion/degradation of LDPE and PP plastics under 

the conditions tested.

830.7000 pH 5 (20 °C, 1g/l)

5 (3% solution)

830.7050 UV/Visible Absorption TAED has a UV/VIS absorption maximum at 214 nm

830.7200 Melting point 147°C + 1°C

830.7220 Boiling point Not applicable to this product because it is a solid at room 

temperature.

830.7300 Density Bulk density at 20°C is 430-520g/L

830.7100 Viscosity Not applicable because this product is a solid at room 

temperature and other typical environmental conditions.

830.7370 Dissociation Constant Not applicable because TAED has no dissociable groups. 

830.7550 Partition coefficient (n-octanol/water) Log Po/w of −0.06

830.7840 Solubility in water 2 g/100 ml at 20°C

830.7860 Solubility in organic solvents Dimethyl sulfoxide: 5g/100 ml

830.7950 Vapor pressure 1.48 x 10-8 mm Hg 25 °C (EPI Suite v 4.1)

atm-m3/mol = atmosphere cubic meter per mole; oC = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury