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TAED Registration Review Team 

Human Health & Environmental Effects 

James Breithaupt 

William Erickson 

Siroos Mostaghimi 

Timothy Dole 

Zoe Cavinder 

Steven Malish 

Colin Walsh 

Risk Management 

SanYvette Williams 

James Parker 

Karen Leavy 

Eric Miederhoff 

Menyon Adams 

Office of General Counsel 

Philip Ross 
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Table of Contents 

1 Introduction ............................................................................................................................. 5

1.1 Statutory and Regulatory Authority ................................................................................. 5

1.2 Updates to the Work Plan ................................................................................................. 5

1.3 Chemical Identification and Properties ............................................................................ 8

1.4 Use/Usage Description ..................................................................................................... 9

1.4.1 Registrations ............................................................................................................. 9

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

1.4.3 Usage Information .................................................................................................. 10

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

1.5.1 Recent Regulatory Actions ..................................................................................... 11

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

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

1.6 Incidents ......................................................................................................................... 11

1.6.1 Human Health ......................................................................................................... 11

1.6.2 Ecological ............................................................................................................... 11

2 Anticipated Data Needs ........................................................................................................ 11

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

3.1 Toxicological Endpoints ................................................................................................ 14

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

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

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

3.3 Occupational and Residential Exposures ....................................................................... 16

3.3.1 Occupational Exposures.......................................................................................... 16

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

3.4 Aggregate and Cumulative Exposure ............................................................................. 17

3.4.1 Aggregate Exposures .............................................................................................. 17

3.4.2 Cumulative Exposures ............................................................................................ 17

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

4.1 Environmental Fate Assessment .................................................................................... 18

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

4.1.2 Persistence in Soil ................................................................................................... 19

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 ................................................................................ 20

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) ................................................................. 22
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6 Optional Label Changes ........................................................................................................ 23

7 Next Steps ............................................................................................................................. 23

8 References ............................................................................................................................. 23

Appendix A Toxicology Profile .................................................................................................... 24

Appendix B Environmental Fate .................................................................................................. 33

Appendix C Ecotoxicicology Profile ............................................................................................ 43

Appendix D Product Chemistry .................................................................................................... 46

Appendix E Response to Comments............................................................................................. 48

List of Tables 

Table 1 – Summary of Anticipated Risk Assessments and Data Needs: TAED ............................ 7

Table 2 – Anticipated Registration Review Schedule .................................................................... 7

Table 3 – Chemical Identification of Tetraacetylethylenediamine (TAED) .................................. 8

Table 4 – Physical-Chemical and Environmental Fate Properties for TAED ................................ 9

Table 5 – Summary of TAED Registered Uses ............................................................................ 10

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

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

 
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1 Introduction 

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

Agency”) Final Work Plan (PWP) for registration review of the tetraacetyleneethylenediamine 

(TAED) case. The FWP 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’s review. This work plan also addresses 

public comments received concerning the Preliminary Work Plan (PWP) which was posted in 

the TAED registration review docket (EPA-HQ-OPP-2013-0608). Further, this document makes 

final the work plan for the TAED registration review process. 

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. The 

TAED Preliminary Work Plan (PWP) was published on March 26, 2014 and the 60-day 

comment period ended May 26, 2014. Documents associated with this registration review can be 

viewed at http://www.regulations.gov in docket EPA-HQ-OPP-2013-0608. Section 1.2 gives 

updates to the workplan and Tables 1 and 2 summarize the issues relevant to this registration 

review case and the anticipated registration review schedule. 

1.2 Updates to the Work Plan 

Since the publication of the PWP, the agency has made the following updates: 

 Updated signature page, section 1.5, section 3, Table 5, and throughout the 

document to reflect a new biopesticide registration and tolerance exemption for 
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agricultural uses (rice and strawberries) and residential uses on turf and nonbearing food crops, including the addition of toxicological endpoints and points 

of departure. 

 Updated section 1.5.3 to reflect current information regarding Design for the 

Environment (DfE). 

 Updated Table 6 for guideline 850.4500 to reflect the appropriate test substance. 

 Updated Table 6 to remove guideline 835.4300 – Aerobic Aquatic Metabolism 

from the list of anticipated data needs. The HERA documents are expected to 

contain adequate fate data if a drinking water assessment is needed. 

 Updated Table 10 to include MRID 49184701. 

 Updated Appendix C1 to include an acceptable honeybee study. 

 Deleted “Guidance for Commenters” section and added “Appendix E Response 

to Comments.” 

 Corrected typographical and formatting errors. 

 
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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 2014 None None 

Dietary (drinking water) Yes1 2014 Updated 

Developmental Toxicity – Rabbit 

Reproductive Toxicity 

Immunotoxicity 

Occupational Handler Yes1 None New

Indoor Exposure Data – Dermal 

Indoor Exposure Data – Inhalation 

Developmental Toxicity – Rabbit 

Reproductive Toxicity 

Immunotoxicity 

Residential Handler No None None None

Residental Post 

Application - Incidental 

Oral and Dermal 

Yes1 None New

Textile Leaching Study 

Developmental Toxicity – Rabbit 

Reproductive Toxicity 

Immunotoxicity

Aggregate Yes1 2014 Updated

Developmental Toxicity – Rabbit 

Reproductive Toxicity 

Immunotoxicity

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 new endpoints are selected from the anticipated developmental, reproductive and immunotoxicity studies. 

Table 2 – Anticipated Registration Review Schedule 

Anticipated Activity Target Date 

YYYY-MM-DD 

Completion Date 

YYYY-MM-DD 

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 2014-05-19 

Phase 2: Case Development 

Issue Final Work Plan 2014-09 2014-09 
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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 Follow-up 2020 

Total (years) 6 

*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). 

1.3 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 is being assessed under its 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 
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The tetraacetylethylenediamine product chemistry information relative to risk assessment is 

summarized in Table 4 and Appendix D. 

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

Guideline No. Parameter TAED 

Physical/Chemical Properties

830.7000 pH 5 (3% solution); 5 (20 °C, 1g/l) 

830.7050 UV/Visible Absorption TAED has a UV/VIS absorption maximum at 214 nm. 

830.7200 Melting point (oC) 147°C + 1°C 

830.7300 Density Bulk density at 20°C is 430-520g/L 

830.7370 Dissociation constant (pKa) Not applicable because TAED has no dissociable groups. 

830.7550 Octanol-water partition coefficient 

at 25 o

C (Log Kow) Log Po/w: −0.06 

830.7840 Solubility in water 2 g/100 ml at 20°C (20 g/L) 

830.7840 Vapor pressure (mmHg) 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.

1.4 Use/Usage Description 

1.4.1 Registrations 

There are three EPA-registered end use products (EPA Reg. Nos. 1043-125, 16930-5 and 88306-

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

TAED, EPA Reg. No. 16930-5 contains 11.9% TAED and EPA Reg. No. 88306-3 contains 

19.99% 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 are being assessed under separate cases. 

EPA Reg. No. 88306-3, the end use product, is a granular formulation upon tank mix of the 

initial active ingredients. The product contains 19.99% TAED and two other active ingredients 

that are classified as biochemicals (sodium percarbonate and potassium silicate). It is labeled for 

the early season control of bacterial and fungal pathogens on turf grass, golf courses, 

greenhouses and in nursery or in field-grown rice and strawberries. 
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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. 

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 peroxy acetic acidB

Pre-clean and decontaminate critical or semi-critical medical 

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

Biopesticide Agricultural/Nonagricultural Use Sites 

Early season control of bacterial and fungal pathogens on 1) 

field grown strawberries and rice, 2) seeds, plugs, and 

transplants of fruiting vegetables and crucifers, and 3) 

ornamentals and grasses grown for seed and sod production 

Conventional spray 

application equipment 

(air and ground) and 

irrigation systems 

0.3 lbs DAED/acreD 

Early season control of bacterial and fungal pathogens on 

nonbearing fruit and nut trees 

Conventional spray 

application equipment 

(air and ground) and 

irrigation systems 

0.6 lbs DAED/acreE

Control of bacterial and fungal pathogens on golf course 

turfgrass and turfgrass in parks, sports facilities, and 

landscapes 

Conventional ground 

spray application 

equipment and irrigation 

systems 

0.26 lbs DAED/acreF

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. 

D. Based on the label application rate of 3 lbs EPA Reg. No. 88036-3 per acre 

E. Based on the label application rate of 6 lbs EPA Reg. No. 88036-3 per acre 

F. Based on the label application rate of 2.6 lbs EPA Reg. No. 88036-3 per acre 

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. 
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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. In 2014, a new registration was approved 

for agricultural/nonagricultural uses as a biopesticide (see Table 5). 

1.5.1 Recent Regulatory Actions 

The Biopesticide and Pollution Prevention Division (BPPD) registered a product containing the 

active ingredient TAED in August 2014. 

1.5.2 Tolerance Information 

An exemption from the requirement of a tolerance for residues of TAED (and its metabolite 

DAED) in or on rice and strawberries has recently been reviewed and established by the 

Biopesticides & Pollution Prevention Division (BPPD) (Tolerance Petition #3F8148, docket 

EPA-HQ-OPP-2013-0277, August 2014). 

1.5.3 Design for the Environment 

TAED has been evaluated by the EPA’s Design for the Environment (DfE) program and is listed 

on DfE’s Safer Chemical Ingredients List (SCIL) as an Oxidant/Oxidant Stablizer. DfE is a 

voluntary program that recognizes products that are high-performance and use the safest 

chemical ingredients. TAED is currently listed as a “yellow triangle” on SCIL meaning that the 

chemical has met DfE criteria for its functional ingredient-class, but has some hazard profile 

issues. Specifically, a chemical with this code is not associated with a low level of hazard 

concern for all human health and environmental endpoints. While it is a best-in-class chemical 

and among the safest available for a particular function, the function fulfilled by the chemical 

should be considered an area for safer chemistry innovation. The link to access TAED on the 

SCIL is: http://www.epa.gov/dfe/saferingredients.htm. 

1.6 Incidents 

1.6.1 Human Health 

As of 03/18/2014, there are no TAED human poisoning incidents listed in the OPP’s Incident 

Data System for the time period from 10/24/05 to 1/3/14.

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

be conducted without the studies.
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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

Studies Anticipated to be Required through the Registration Review DCI 850.4500 Algal toxicity - green algae DAED degradate 24 Precautionary labeling All 870.3700 

Prenatal Developmental Toxicity - Rabbit 

TGAI 24 Occupational Handler 

Residential Post Application

Hard surface disinfectant and washing machine use 

870.3800 Reproduction and Fertility Effects TGAI 24 Occupational Handler Residential Post Application Hard surface disinfectant and washing machine use 870.7800 Immunotoxicity TGAI 24 Occupational Handler Residential Post Application Hard surface disinfectant and washing machine use 875.1200 Indoor Exposure – Dermal TGAI or surrogate 24 Occupational Handler Hard surface disinfectant 875.1400 Indoor Exposure - Inhalation TGAI or surrogate 24 Occupational Handler Hard surface disinfectant None Textile Leaching TGAI 24 Residential Post Application Washing Machine 

1Occupational handler scenarios include dermal and inhalation exposure during hard surface disinfection using mops and wipes if new toxicological end2Residential post application scenarios include dermal and incidental oral exposure to laundered textiles. 
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3 Human Health Risk Assessment 

The Agency anticipates the need to conduct a human health risk assessment for TAED. The most 

recent risk assessment was conducted in support of a new use in 2014. The Agency expects to 

require additional data for use in conducting the registration review. 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 evaluated by EPA as 

separate registration review cases. 

3.1 Toxicological Endpoints 

Toxicological endpoints and points of departure (POD) were last reviewed and selected for 

TAED to support a new direct food use registration (D410960) in 2014, as shown in Table 7. 

Based on the data anticipated as being required to support this registration review, new endpoints 

and PODs may need to be established. 

Table 7 – Existing Toxicological Endpoints for TAED 

Exposure Scenario Point of Departure

Uncertainty/ 

FQPA Safety Factor 

(SF)

RfD, PAD, Level of 

Concern for Risk 

Assessment

Study and Toxicological 

Effects

Acute Dietary 

(general population, 

including infants 

and children and 

females 13-49 years 

of age) 

An acute endpoint was not selected based on the absence of an appropriate endpoint attributable to 

a single dose. 

Chronic Dietary (all 

population) 

NOAEL = 90 

mg/kg/day 

UFA = 10X 

UFH = 10X 

FQPA = 10X 

cRfD = 0.09 mg/kg/day 

cPAD = 0.09 mg/kg/day

90 day oral study – rat 

LOAEL = 250 

mg/kg/day based on 

significant increase in 

relative liver and testes 

weights in male rats.

Incidental Oral 

Short-Term 

(1-30days) 

NOAEL= 90 

mg/kg/day 

UFA = 10X 

UFH = 10X 

FQPA = 10X 

LOC for MOE = 1000 90 day oral study – rat 

LOAEL = 250 

mg/kg/day based on 

significant increase in 

relative liver and testes 

weights in male rats.

Dermal

Short-Term 

(1-30 days) 

No clinical effect was observed at the highest dose tested (2000 mg/kg/day) in the available dermal 

study; therefore, no dermal risk assessment will be conducted. 

Inhalation

Short-Term 

(1-30 days)

No clinical effect was observed at the highest dose tested (99.7 mg/m3

) in the available inhalation 

study; therefore, no inhalation risk assessment will be conducted. 
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3.2 Dietary Exposure 

A quantitative risk assessment was conducted by EPA for TAED in 2014 to assess potential 

dietary risks to support a new direct food use registration (D410960). The dietary assessment 

focused on its use on rice and strawberries, in accordance with the associated tolerance 

exemption petition. DAED, a degradate of TAED, was identified to be the potential residue for 

dietary assessment. On the basis of conversion of TAED to DAED, EPA concluded that the 

toxicology data on TAED could be used for hazard characterization of DAED and that “there is 

reasonable certainty of no harm to humans when exposed to residues of DAED from pesticidal 

use when label instructions are followed”. 

3.2.1 Food 

In its 2014 assessment, EPA concluded that human exposure to DAED, a degradate of TAED, is 

unlikely to occur via dietary exposure, when used according to label instructions, because TAED 

is used to control early season fungus and bacterial diseases on crops and the timing of its 

applications is well before harvesting occurs. There are no direct or indirect food uses for the 

antimicrobial uses of TAED. Therefore, the agency does not anticipate the need to update the 

dietary (food) risk assessment conducted in 2014. 

3.2.2 Drinking Water 

In its 2014 assessment, EPA concluded that the calculated percent of the chronic Population 

Adjusted Dose (%cPAD) based on drinking water exposure, using DEEM-FCIDTM Version 3.16, 

was well below the agency’s Level of Concern (LOC). Additionally, TAED is not directly 

added to any drinking water sources. Therefore, no risk of concern for drinking water was 

identified when TAED is applied directly on crops according to label instructions. 

There are no direct drinking water uses for the antimicrobial pesticide TAED. However, the 

approved use as a commercial laundry detergent could potentially result in TAED being 

discharged into waste water and subsequently 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 new 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 

evaluated in an updated drinking water assessment. 
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3.3 Occupational and Residential Exposures 

3.3.1 Occupational Exposures 

Antimicrobial Uses 

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. These exposures will need to be assessed during registration 

review if endpoints are identified from the anticipated to be required toxicological studies. The 

occupational exposure scenario is listed in Table 8. 

Table 8 – Occupational Exposure Scenarios for TAED 

Handler Scenario Exposure 

Route(s) Duration 

Hard surface disinfection using mops and wipes. Dermal 

Inhalation 

Intermediate 

Term 

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

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

Biopesticide Agricultural/Nonagricultural Uses 

Occupational exposures were not assessed in the 2014 assessment because endpoints for the 

dermal and inhalation exposure pathways were not identified (see Table 7). 

3.3.2 Residential Exposures 

Antimicrobial Uses 

Residential handler exposures are not anticipated for TAED antimicrobial use because TAED is 

used only in institutional and industrial laundries and medical/dental/veterinary facilities. 

Residential post application exposures; however, may occur if TAED laundered items are used in 

a residential environment. The residential exposure scenarios to be assessed during this 

registration review are listed in Table 9. 

Table 9 – Residential Exposure Scenarios for the Antimicrobial Uses of 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 

Biopesticide Agricultural/Nonagricultural Use Sites 

Residential incidental oral exposures to children can occur from the use of TAED as a 

biopesticide on turf. These exposures occur through the hand to mouth, object to mouth and soil 

ingestion pathways and they were assessed in the 2014 assessment. This assessment used the 
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NOAEL of 90 mg/kg/day from a 90 day oral study in rats as a point of departure (see table 7). 

The individual MOEs range from 23,000 to 10,000,000 depending upon the exposure pathway. 

These MOEs are all greater than the target MOE of 1000 which means that the risks are not of 

concern.

3.4 Aggregate and Cumulative Exposure 

3.4.1 Aggregate Exposures 

In its 2014 assessment, EPA concluded that aggregate risk from TAED was below the agency’s 

LOC. If new endpoints are selected from the anticipated toxicity studies, EPA will update the 

aggregate assessment. 

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/. 

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 for pesticidal uses 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. 

 

1

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

Assessment on ingredients of European household cleaning products. December, 2002.
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4.1 Environmental Fate Assessment 

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 

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 

for a final fate (exposure) assessment. 

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 15o 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 study9 using 

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

degradate DAED at 30, 40, and 60o C 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 

 

2

 Reaction in water to release peroxyacetic acid and hydrogen peroxide 

3

 MRID 45299701 

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 
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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) 

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) 

 

12 MRIDs 46335801 (hydrolysis), 46335802 (wash water study) 

13 MRID 45299701 

14 MRID 45299701 

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
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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 

As explained above under Environmental Risk Assessment, exposure to TAED is not anticipated 

due to its rapid dissociation into peroxyacetic acid and hydrogen peroxide. Exposure pathways 

for those active ingredients will be addressed in their registration review cases. As also 

discussed above, any degradates formed are likely to be removed during sewage plant treatment. 

Therefore, the Agency does not expect TAED or it’s degradates to have any relevant 

environmental pathways leading to exposure of terrestrial or aquatic nontarget organisms. 

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 are being 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 

 

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/
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 • 850.4500 Algal Toxicity, Green Algae 

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

fish, and aquatic invertebrates and beneficial insects. 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 10, anticipates using available effects data from the open 

literature. 

Table 10. 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 

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 LD50>25 ug a.i./bee 49184701 

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 
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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 

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

 

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/ 
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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 Next Steps 

After the FWP is issued, the agency will continue it registration review by issuing a data call in 

designated in the TAED case. 

8 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/. 
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Appendix A Toxicology Profile 

A1 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 

452997-02 Minimally Corrosive 

[Acceptable/Guideline] 

IV 

870.2600 Dermal Sensitization/ 

Guinea Pig 

452997-02 Not a dermal sensitizer 

[Acceptable/Non-Guideline] 

N/A 

A2 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. 
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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. 

A3 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 
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 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). 
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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 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 
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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). 

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. 
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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. 

A4 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. 

A5 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. 

A6 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 

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. 
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A7 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. 

A8 Chronic Toxicity and Carcinogenicity 

There are no chronic toxicity or carcinogenicity 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. 

A9 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. 

A10 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 

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. 
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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, TriAED and DAED, indicate that deacetylation was 

the main metabolic route for TAED in the rat. 

A11 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. 

A12 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) 
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A13 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).

 
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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 reaction26. 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 -0.06.27 Several studies are present in the 

literature and in the HERA document.28 The studies listed in the HERA document have not been 

formally-reviewed by the agency, but they indicate that TAED is readily biodegradable29 and 

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

porous pot test.30 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)31 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 oC with a half-life of 40 days and the 

DAED degradate was shown to be stable and not degrade.32 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

C33 which represents cold, warm, and hot water 

temperatures, respectively.34 The washing machine study, which is more environmentally-

 

26 Reaction in water to release peroxyacetic acid and hydrogen peroxide 

27 MRID 45299701 

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

HERA%20TAED%20full%20web%20wd.pdf 29 OECD 301E data, IUCLID 2000, Proctor & Gamble Internal Data 1976 and 1978 

30 Clariant, 2002 

31 MRID 45299701 

32 MRID 46335801 

33 MRID 46335802, study not reviewed 

34 http://housekeeping.about.com/od/laundry/a/laundry_h20temp.htm 
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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)35 which indicates relative stability of parent TAED with a half-life of 40 days at pH 7 

and 15 o

C. 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)36. 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.37 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 light38, these data are not required because the study would not provide any 

meaningful results. 

 

35 MRID 46335801, find review date 

36 MRID 46335802 not formally-reviewed 

37 http://housekeeping.about.com/od/laundry/a/laundry_h20temp.htm 

38 MRID 45299701 
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Octanol-Water Partition Coefficient 

The octanol water coefficient (Log Kow or Log P) is -0.0639, 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 

 

39 MRID 45299701 
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because of limited sorption to activated sludge or to be sorbed to soil based on the AISE (1992) 

and Shell (2000) studies cited above. 

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 water40 and are expected to 

partition to water in the presence of sludge based on a log Kow of -0.06.41 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.42 The studies listed in the HERA 

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

biodegradable43 and highly removed in the activated sludge of a WWTP based on a 97 % 

removal rate in a porous pot test.44 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 

 

40 MRID 45299701 

41 MRID 45299701 

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

HERA%20TAED%20full%20web%20wd.pdf 43 OECD 301E data, IUCLID 2000, Proctor & Gamble Internal Data 1976 and 1978 

44 Clariant, 2002 
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(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. 

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 organism’s information were found for peroxyacetic 

acid. 
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Table B1. Chemical, Physical, and Environmental Fate Properties of TAED and its degradates/metaboliteDAED 

 TAED TriAED DAED Guideline Guidelin

e (OCSPP number unless specified) 

Unit 

CAS No. None None 10543-57-4 None None Molecular formula 

None None C10 H16 N2 O4 C8 H14 N2 O3 C7 H14 N2 O2 

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 

Molecular weight 

None g/mol 228.25 186.21 158.20 

Melting point 830.7200 oC 147 + 1 No data, but expected to be similar 

based on structural similarity 

No data, but expected to 

based on structural sim

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 

based on structural sim

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 

based on structural sim

Vapor Pressure (mm Hg) 

830.7950 mm 

Hg 

No data No data No data 

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 

based on structural sim
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 TAED TriAED DAED Guideline Guidelin

e (OCSPP number unless specified) 

Unit 

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 bbased on structural similar

Hydrolysis 835.2120 Days 40 120 Stable Perhydrolysis in Washing Process 

None Min 3 <5 Stable 

Photodegradation 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 bbased on structural similar

Leachingadsorptiondesorption to soil 

835.1230 ml/g Koc values 15-80 L/kg No data Koc value of 25 L

Aerobic aquatic metabolism 

835.4300 Days No data No data No data 

45 Gilbert (1992) and Buecking (1990) have not been reviewed by the Agency 46 Koc values from AISE (1992) and Shell (2000) have not been validated through Agency Review 
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 TAED TriAED DAED Guideline Guidelin

e (OCSPP number unless specified) 

Unit 

Anaerobic aquatic metabolism 

835.4400 Days No data No data No data 

Activated sludge sorption 

835.1110 %, 

L/kg 

No data No data No data 

Ready biodegradability 

835.3110 OECD 301D 

% 52-56 % degradation in 28 days No data 60 % degradation in 2

Activated sludge respiration inhibition 

850.3300 mg/l No data No data No data 

Bioconcentration in fish48

850.1730 Unitl

ess 

No data No data No data 

47 Henkel (1972) has not been formally reviewed 48 BCF predictions should increase as the water solubility decreases and log Kow increases. 
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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. 
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Appendix C Ecotoxicicology Profile 

C1 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 

One acceptable nontarget insect (LD50) study categorizes TAED as being practically nontoxic to 

adult honeybees via direct acute contact. The guideline (880.4350) is satisfied. No additional 

nontarget insect toxicity data are anticipated to be needed. 

Nontarget Insect Toxicity

Test Species 

Test Material 

(% ai)

Toxicity 

Toxicity 

Category

EPA Study 

ID

Adult honeybee 

(Apis mellifera L.) 

99 Direct Acute Contact LD50 

>25 ug ai/bee 

Practically 

nontoxic 

49184701 

Acceptable 

C2 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. 
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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 acceptable 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. 
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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}. 

 
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Appendix D Product Chemistry 

Tetraacetylethylenediamine (TAED) product chemistry information is summarized in Table D1 

(source: MRID No. 45299701). 

Table D1 – Product Chemistry of TAED

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. 
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Guideline 

No.

Physical and Chemical 

Properties Tetraacetylethylenediamine 

830.6314 Oxidation/Reduction The product has no oxidizing or reducing potential because 

there are no reactive oxidizable/reducible groups in the 

compound. 

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

 
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Page 48 of 48

Appendix E Response to Comments 

There were no comments posted in the docket for TAED.