Aquashade® Human Health Risk Assessment DP No. 0425777 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: September 15, 20 15 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJ ECT: Aquashad e®. Scoping Document and Draft Risk Assessment for Registr ation 

Review 

PC Code: I I 0303, I I 030 I, 11 0302 

Decision No.: 5002 1 I 

DP Barcode: 425777 

Registra tion No.: NA 

Pelilion No.: NA Regulalory Action: Registration Review 

Ris k Assessment Type: Scoping Document Case No.: 4010 

TXR No.: NA CAS No.: 2650-18-2; 1934-2 1-0 

MRID No.: NA 40CFR: 180.1074; 180.910 

FROM: 

THROUGH: 

TO: 

Uma Habiba, Risk Assessor ~ Ii 

Ronnie Bever, Ph.D., Toxicologist /{., /l ~ ~ . Katelynn King, Chemist ~ U 

Risk Assessment Branch 5/7 'I 

Health Effects Division (750 ) 1 ( (~ 

A

Michael 

lexandra 

Met

Gavclck

zger, Chief 

, Bio og 

VJA 

t ";) 

(} 

; 

/() kr· ~ 7

"'-li' L • 

Pete Savoia, Chemist ( ~'--{"" (___ ~--

Risk Assessment Branc 5/7 / 

Health Effects Division (7509P) 

Christina Motilall, CRM 

Risk Management and Implementation Branch (RMIB I) 

Pesticide Re-evaluation Division (PRD) 

Page I of 35 
Aquashade® Human Health Risk Assessment DP No. 0425777 

1.0 Executive Sun1mary .... .... .... .... .... ........ ......... ............................. ... ...................................... 3 

2.0 H ED Recommend ations ................................. ................................................................... 6 

2.1 Data Deficiencies .... .... ... ............................................... ........... ....... ........ .... ....... ....... ...... 7 

2.3.2 Recommendations from Occupational Assessment.. ............................................... 7 

2.3.3 Recommendations from Residential Assessment .. .............................. ....... ........... ... 7 

3.0 Introduction ....................................................................................... ................................. 7 

3.1 Che1nical Identity .. .... ... ........ .... ..................... ......... ... ............ ........ .... ....... .... ... ............... 7 

3.2 Physical/Chemical Char acteristics .......................................................................... ..... 8 

3.3 Pesticide Use Pattern ............ .... .... .... ......... ........ ....................................... ....... ... .... ... ..... 8 

3.4 Anticipated Exposure Pathways ............. ................. ..................................................... 8 

3.5 Consideration of Environmental Justice ..... .... .... ..... ... .... .... ........... ....... ... .... .... ....... ..... 9 

4.0 Hazard Characterization and Dose-Response Assessment ............................................ 9 

4.1 Summary of Toxicological Effects ..... ..... .... ............. ... ........ ............... ........................... 9 

4.2 Safety Factor for Infants and Children (FQPA Safety Factor) ............................... 11 

4.2.1 Completeness of the Toxicology Database ............................ .... .................. ............ 11 

4.2.2 Evidence of Neurotoxicity .................................................................... .................... l l 

4.2.3 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal.. .... .. 11 

4.2.4 Residual Uncertainty in the Exposure Database .................................. ................. 11 

4.3 Toxicity Endpoint and Point of Departure Selections ....... ........ ... ............................ 12 

5.0 Dietary Exposure and Risk Assessment ....... .................................................................. 14 

6.0 Residential (Non-Occupational) Exposure/Risk Char acterization ................... ....... ... 15 

6.1 Residential Handler Exposure ......... ........ ........................ ....... .................................... 15 

6.5 Residential Bystander Post-application Inhalation Exposure .... ........ .... ... ... ........ ... 20 

6.6 Spray Drift ....................................................................................... ............................. 20 

7.0 Aggr egate Exposure/Risk Characterization .. ......... .... .... ....... ....... .... .... ........................ . 20 

8.0 Cumulative Exposure/Risk Characterization ............................................................... 23 

9.0 Occupational Exposure/Risk Characteriza tion .... .......................... .... .... ....... ....... ... ..... 23 

9.1 Short- and Intermediate- Post-Application Risk ....... ............................................... 25 

9.1.1 Dermal Post-application Risk ......... ............. .... .... ............ ...................... .......... ........ 25 

9.1.2 Inhalation Post-application Risk ............................................................................. 25 

10.0 Epidemiology ........................................... ......... .... .... ........ ........ ... ............................. ........ 25 

11.0 References .................................... ............ .................. ....................................................... 25 

Appendix A. Toxicology Profile and Executive Summaries .......... ........ ........... ... .......... ..... 27 

A.l Toxicology Data Requirements ................................................................................... 27 

A.2 Toxicity Profiles ...... ................................................................ .... .... ... ........... .............. .. 28 

Appendix B. Physical/Chemical Properties ........... ................. ........................................ ......... 32 

Appendix C. Summary of Occupational and Residential Non-cancer Algorithms ........... .. 33 

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Aquashade® Human Health Risk Assessment DP No. D425777

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1.0 Executive Summary

The Health Effects Division (HED) of EPA's Office of Pesticide Programs has evaluated the 

toxicity and exposure data bases for the aquatic algaecide/herbicide Aquashade® also known as 

Admiral®, containing the dyes erioglaucine (Acid Blue 9 or FD&C Blue No. 1) and tartrazine 

(Acid Yellow 23 or FD&C Yellow No. 5); and has conducted a human health risk assessment in 

support of the registration review for these active ingredients. 

Erioglaucine and tartrazine have many non-pesticidal uses, including their use as inert 

ingredients (dyes) in other pesticide formulations and as approved food coloring additives in a 

variety of applications. These substances are each Generally Recognized as Safe (GRAS) for 

general use as food, drug, and cosmetic color additives by the Food and Drug Administration 

(FDA). 

This risk assessment considers only the use of erioglaucine and tartrazine as active ingredients in 

Aquashade® and similar products. Human health risk estimates associated with their use as inert 

ingredients were previously assessed by the Office of Pesticide Programs' Registration Division 

(RD) [Reassessment of the Requirement of a Tolerance for the FDA-Certified Color Additives 

FD&C Blue No. 1, FD&C Red No. 40, and FD&C Yellow No. 5 (Tartrazine), K. Liefer, 

December 21, 2004] and by OPP’s HED [Aquashade®: Revised HED Chapter of the 

Reregistration Eligibility Decision Document (RED), W. Britton, September 9, 2005]. HED 

relied heavily on the information presented in RD’s inert ingredient risk assessment and HED’s 

revised HED chapter of the RED in this assessment of the human health risk estimates from the 

pesticidal uses of Aquashade®. 

Use Information

Aquashade® also known as Admiral® is registered for use as an aquatic algaecide/herbicide. 

The two dyes, erioglaucine and tartrazine, work by blocking penetration of the portion of the 

light spectrum required for photosynthesis, thereby limiting the growth of filamentous algae and 

submerged aquatic vegetation. Application is recommended early in the growing season while 

growth is on the bottom of the water body or later in the season after the killing and/or removal 

of any existent growth. Repeated applications are allowed to maintain an effective concentration 

of product in the water body. Aquashade® may be used in natural or manmade ponds, lakes, 

fountains, fish farms and fish hatcheries; and may be applied by both professional applicators 

and homeowners. Water bodies treated with Aquashade® may not be used for human 

consumption. However, treated water may be used for irrigation of crops, livestock watering and 

fishing. Any residues of erioglaucine or tartrazine occurring in foods from the use of 

Aquashade® as an aquatic algaecide/herbicide would be negligible.

Toxicology

The toxicology database is sufficient for characterizing toxicity and hazard. The toxicity profile 

of Aquashade® does not identify a target organ. Systemic toxicity was observed in one study in 

the toxicity database and was limited to a decrease in mean body weight following long-term 

dietary exposure to high doses in rats. No developmental, reproductive, or neurological toxicity 
Aquashade® Human Health Risk Assessment DP No. D425777

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was observed in the database. Immunotoxicity was not tested, but is not required. There was no 

evidence of carcinogenicity or mutagenicity in the database. Aquashade® is not acutely (lethal) 

toxic via the oral, dermal, and inhalation routes (Toxicity Category III or IV), is not an eye or 

dermal irritant, but is a dermal sensitizer. 

Based on the toxicity, duration of exposure, and uses of Aquashade®, the following toxicity 

endpoints were selected: 

Acute Dietary Endpoint (General Population, including Infants and Children; 

Females 13-49 years of age): No appropriate endpoint was identified which could be 

attributed to a single exposure. 

Chronic Dietary Endpoint: chronic population adjusted dose (cPAD) of 5 mg/kg/day 

derived from a no observed adverse effect level (NOAEL) of 500 mg/kg/day tartrazine in 

a chronic oral toxicity study in dog. A lowest observed adverse effect level (LOAEL) was 

not identified. A combined chronic toxicity/carcinogenicity study in rat was considered 

co-critical (NOAEL of 631 mg/kg/day erioglaucine; LOAEL of 1262 mg/kg/day based 

on decreased body weight in females).

Short- and Intermediate-Term Incidental Oral, Inhalation, and Dermal (residential 

and occupational where applicable): The same endpoints were used as in the chronic 

dietary exposure scenario. An appropriate guideline, dermal toxicity study was not 

available for any exposure scenario. There was a non-guideline, 21-day dermal study in 

rabbits with a NOAEL of 5 mg/kg/day (highest dose tested). However, given that all 

other guideline studies had NOAELs ≥ 500 mg/kg/day and that 5 mg/kg/day was the 

highest dose tested in the dermal study, selection of an endpoint based on this study will

give an extremely conservative endpoint and is unlikely to be near the threshold dose. 

Therefore, the chronic oral toxicity study in dogs was selected, assuming 100% dermal 

absorption (which is expected to be conservative in the absence of a dermal penetration 

study). 

For the occupational and residential risk assessments the level of concern (LOC) is for MOEs

less than 100. The FQPA safety factor has been reduced to 1X. The screening exposure 

assessment for swimmers (SWIMODEL) was developed based upon reliable data and is unlikely 

to underestimate exposure or risk estimates.

Residue Chemistry

Water bodies treated with Aquashade® may not be used as a source of drinking water. 

However, treated water may be used for irrigation of crops, livestock watering and fishing, 

which could result in residues of erioglaucine and/or tartrazine in human foods. In addition, 

Aquashade® may be used in fish farms/hatcheries. In 1982, based on Aquashade's® low 

toxicity profile, EPA waived residue chemistry data requirements and established an exemption 

from the requirement of a tolerance for erioglaucine when used as an aquatic plant control agent 

under 40 CFR 180.1074. Tartrazine, when used as a dye, had previously been exempted from 

the requirement of a tolerance as an inert (or occasionally as an active) ingredient in pesticide 

formulations applied to growing crops or to raw agricultural commodities after harvest under 40 

CFR 180.910 (previously 40 CFR 180.1001). HED has determined that the existing exemption 
Aquashade® Human Health Risk Assessment DP No. D425777

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for tartrazine as an inert ingredient is not sufficient to satisfy reregistration requirements for the 

active ingredient when used as an aquatic plant control agent. Therefore, we are recommending 

that the exemption for erioglaucine at 40 CFR 180.1074 be revised to include both erioglaucine 

and tartrazine.

Residential Exposure

Aquashade® is labeled for consumer use to control aquatic algae and weeds in ponds and lakes. 

The anticipated use patterns and current labeling indicate several residential handler scenarios 

based on the types of equipment and techniques that can potentially be used to make 

Aquashade® applications. Residents or consumers applying Aquashade® products to ponds or 

lakes may be exposed for short-term (1 to 30 days) duration through skin contact or by 

inhalation.

All residential handler scenarios assessed resulted in estimated MOEs greater than 100 and, 

therefore, are not of concern. Residential short-term dermal MOEs range from 16,000 (pouring 

liquid) to 1,400,000 (drop in water soluble packets), and short-term inhalation MOEs range from 

to 92,000 (pouring liquid) to 110,000 (drop in water soluble packets). Combined dermal and 

inhalation MOEs range from 14,000 (pouring liquid) and 110,000 (drop in water soluble 

packets).

Post-application exposures to children and adults that contact Aquashade®-treated swimming 

ponds are anticipated. To address the risk of such exposures, a screening tool from the 2013 

Draft Aquatic SOP, the Swimmer Exposure Assessment Model (SWIMODEL) was applied. The 

SWIMODEL uses well-accepted screening exposure assessment equations to calculate the total 

worst-case exposure for swimmers expressed as a mass-based intake value (mg/ event). Postapplication residential exposure durations are expected to be short-term in duration. All 

residential post-application scenarios assessed (dermal, ingestion, and inhalation routes of 

exposure) resulted in estimated combined MOEs well above 100 and, therefore, are not of 

concern.

Aggregate Risk

In accordance with the FQPA, HED must consider and aggregate pesticide exposures and risk 

estimates from three major sources: drinking water, food and residential exposures. Since 

Aquashade® is applied to contained water bodies with little or no outflow, and none of the 

treated water bodies serves as a source of drinking water, no drinking water exposure is 

expected. Although water treated with Aquashade® may potentially be used for irrigation of 

food crops and livestock watering, and Aquashade® is registered for use in fish farms and 

hatcheries, HED has not quantitatively assessed exposures and risk estimates from food sources 

for several reasons: (1) Aquashade® is used primarily in ornamental and/or recreational lakes 

and ponds with very little treated water expected to be used for agricultural purposes. (2) 

Erioglaucine and tartrazine are highly water soluble compounds and, as such, not likely to 

accumulate in livestock or fish tissues. The results of the rat metabolism study with erioglaucine 

support this determination, since nearly the entire administered dose was excreted unchanged in 

the feces in less than 2 days. (3) Any residues of erioglaucine or tartrazine occurring in foods 
Aquashade® Human Health Risk Assessment DP No. D425777

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from the use of Aquashade® as an aquatic algaecide/herbicide would be negligible compared to 

residues in food from the common use of these dyes as food coloring additives. (4) The most 

significant route of exposure to erioglaucine and tartrazine from the use of Aquashade® is 

residential exposure, including residential handler and post-application (swimming) exposure. 

HED believes that the conservative residential exposure and risk estimates discussed above are 

more than adequate to cover any food exposures that could potentially occur from the use of 

Aquashade® as an aquatic algaecide/herbicide.

Occupational Exposure

Pesticide handler exposure to Aquashade® is likely to occur during its use in a variety of 

occupational environments. The anticipated use patterns and current labeling indicate several 

occupational exposure scenarios based on the types of equipment and techniques that can be 

potentially used for Aquashade® applications. Short-term (1 to 30 days) and intermediate-term 

exposures (1 to 6 months) may occur; however, long-term exposures (greater than 6 months) are 

not expected.

All short-term occupational scenarios assessed (dermal and inhalation) resulted in estimated 

MOEs greater than the LOC of 100 and, therefore, are not of concern.

Public Health and pesticide Epidemiology Data

Based on the low severity of incidents involving Aquashade® (pc code 110303), acid yellow 23 

(pc code 110302), and acid blue 9, diammonium salt (pc code 110301) reported to IDS and the 

fact that no incidents involving Aquashade®, acid yellow 23, and acid blue 9, diammonium salt

were reported to SENSOR-Pesticides, there does not appear to be a concern at this time that 

would warrant further investigation. The Agency will continue to monitor the incident 

information and if a concern is triggered, additional analysis will be included in the risk 

assessment (S. Recore, 2014, D427136).

Conclusions

Aquashade® is a low toxicity algaecide/ herbicide with the potential for occupational, dietary, 

and residential (non-dietary) exposure. The label precludes use of treated water bodies as a 

source of drinking water; and, while treated water may be used to irrigate food crops or for 

livestock watering, resulting food residues are expected to be negligible. Aggregate risk 

estimates (including dietary and non-dietary residential exposure) are well below HED’s level of 

concern. Under the conditions of its current use, human health risk estimates to workers handling 

the pesticide or to the general population are below HED’s level of concern.

2.0 HED Recommendations

The assessment discussed herein constitutes both the registration review scoping document and 

draft risk assessment for Aquashade®. HED concludes that there are no human health risk 

estimates of concern associated with the currently registered uses of Aquashade®. 
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2.1 Data Deficiencies

The toxicity, exposure, and residue chemistry databases are considered complete for the purpose 

of registration review. No additional data is required to support the requested registration of 

Aquashade®.

2.3.2 Recommendations from Occupational Assessment

None.

2.3.3 Recommendations from Residential Assessment

None.

3.0 Introduction

3.1 Chemical Identity

Table 3.1 Aquashade®

Chemical Structure

Empirical Formula C37H34N2Na2 O9 S3 C16H9N4O9S2Na3

Common Name Erioglaucine, Acid Blue 9 Tartrazine, Acid Yellow 23

Company 

experimental name BASF BASF

IUPAC name

disodium;2-[[4-[ethyl-[(3-

sulfonatophenyl)methyl]amino]phenyl

]-[4-[ethyl-[(3-

sulfonatophenyl)methyl]azaniumylide

ne]cyclohexa-2,5-dien-1-

ylidene]methyl]benzenesulfonate

trisodium;5-oxo-1-(4-

sulfonatophenyl)-4-[(4-

sulfonatophenyl)diazenyl]-4Hpyrazole-3-carboxylate

CAS Name

disodium bis[4-(N-ethyl-N-3-

sulfonatophenylmethyl)aminophenyl]phe

nylmethylium

4,5-dihydro-5-oxo-1-(4-

sulophenyl)-4-[(4-

sulfophenyl)azo]-1H-pyrazole-3-

carboxylic acid trisodium salt

CAS Registry Number 2650-18-2 1934-21-0

End-use 

product/EP

33068-1 12.60% ai 1.04% ai

33068-3 30.45% ai 2.45% ai

67064-1 49.72% ai 3.27% ai

67064-2 15.31% ai 1.00% ai

Known Impurities of 

Concern N/A N/A
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3.2 Physical/Chemical Characteristics

Aquashade® is composed of two dyes, erioglaucine and tartrazine. Erioglaucine has a vapor 

pressure of 2.97 x 10-42 mmHg @ 25°Cand tartrazine has a vapor pressure of 7.43 x 10-22 mmHg 

@ 25°C. Both dyes are water soluble and have low octanol/water partition coefficients. 

Aquashade® would not partition into fatty tissues. As a result, bioaccumulation would not occur. 

See Appendix B for detailed information.

3.3 Pesticide Use Pattern

Aquashade® is registered for use in a variety of occupational and residential scenarios and thus 

these populations could be exposed while performing Aquashade® applications. Aquashade 

liquids are “ready-to-use” formulations and do not require any mixing/loading for preparation. A 

summary of maximum application rates for registered Aquashade® uses is presented in Table 

3.3.

Table 3.3. Summary of Directions for Use of Aquashade®

Applic. 

Timing, Type, 

and Equip.

Formulation 

[EPA Reg. 

No.]

Applic. 

Rate (lb 

ai/A-ft)

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. Rate 

(lb ai/A)

PHI 

(days)

Use Directions and 

Limitations

Aquatic Areas

Pouring

Aquashade®

Liquid 

(33068-1)

0.75 N/A N/A N/A 80 oz/2.4 L per A-ft

Pouring

Aquashade®

Liquid

(33068-3)

0.79 N/A N/A N/A 32 oz/0.93 L per A-ft

Pouring

Admiral

Liquid

(67064-2)

0.73 N/A N/A N/A 64 oz/1.89 L per A-ft

WSP

Admiral 

WSP

(67064-1)

0.58 N/A N/A N/A 2 WSPs per A-ft

3.4 Anticipated Exposure Pathways

Humans are not exposed to Aquashade® in food and drinking water, since Aquashade® is 

applied directly to aquatic areas application it does not result in Aquashade® leaching and 

infiltrating into ground sources of drinking water. In an occupational setting, applicators may be 

exposed while handling the pesticide during application. There is no potential for postapplication exposure for workers. Residential and occupational handlers may be exposed via 

dermal and inhalation routes. Residential post-application scenarios may results in dermal, 

inhalation, and oral routes of exposure. 

A human health assessment to support a registration eligibility document (RED) (W. Britton, 

2005, D321912) has been previously completed for Aquashade®, but no new toxicity data have 

been received since the previous risk assessment. This risk assessment considers all of the 
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aforementioned exposure pathways of Aquashade® for the dietary and residential risk 

assessments. 

3.5 Consideration of Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

(http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. As a part of every pesticide risk 

assessment, OPP considers a large variety of consumer subgroups according to well-established 

procedures. In line with OPP policy, HED estimates risk estimates to population subgroups from 

pesticide exposures that are based on patterns of that subgroup’s food and water consumption, 

and activities in and around the home that involve pesticide use in a residential setting. 

Extensive data on food consumption patterns are compiled by the USDA under the Continuing 

Survey of Food Intake by Individuals (CSFII) and are used in pesticide risk assessments for all 

registered food uses of a pesticide. These data are analyzed and categorized by subgroups based 

on age, season of the year, ethnic group, and region of the country. Additionally, OPP is able to 

assess dietary exposure to smaller, specialized subgroups and exposure assessments are 

performed when conditions or circumstances warrant. Whenever appropriate, non-dietary 

exposures based on home use of pesticide products and associated risk estimates for adult 

applicators and for toddlers, youths, and adults entering or playing on treated areas postapplication are evaluated. Further considerations are currently in development as OPP has 

committed resources and expertise to the development of specialized software and models that 

consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary 

patterns among specific subgroups.

4.0 Hazard Characterization and Dose-Response Assessment

No new toxicity and/or metabolism data have been received by HED since the last risk 

assessment (W. Britton, 2005, D321912).

4.1 Summary of Toxicological Effects

A combination of erioglaucine (Acid Blue 9 or FD&C Blue No. 1) and tartrazine (Acid Yellow 

23 or FD&C Yellow No. 5) is commonly referred to as Aquashade®. Five currently registered 

pesticide products, which are used as aquatic algaecides/herbicides, contain a combination of 

erioglaucine and tartrazine. These substances are each Generally Recognized as Safe (GRAS) for 

general use as food, drug, and cosmetic color additives by the Food and Drug Administration 

(FDA).

The mode of action for Aquashade® as an aquatic herbicide is through sunlight filtration, 

inhibiting photosynthesis. Tartrazine and erioglaucine each have very low toxicity potentials. 

Erioglaucine and tartrazine are rapidly metabolized, and excreted in rats, rabbits, and dogs. 

Erioglaucine is poorly absorbed; however, this is not the case for tartrazine. The presence of the 

dye was found in the bile. The parent compounds are excreted unchanged mainly in the feces 
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with a small amount excreted by the urine. Erioglaucine was administered orally to rats as a 2% 

aqueous solution at a level of 200 mg/rat. Almost the entire amount was excreted unchanged in 

the feces within 40 h after administration. In a later investigation, the presence of the color in the 

bile was observed in rats, rabbits, and dogs after oral administration. In the case of the dog, the 

amount did not exceed 5% of the dose administered (Hess, 1953; 1954; 1955). Administration of 

an aqueous solution of the color by stomach tube resulted in 89% excretion in the feces; none 

was found in the urine. After subcutaneous injection of 80-100 mg some 79% was excreted; 77% 

appeared in the feces and 2.5% in the urine (Imperial Chemical Industries, 1958). 

An acceptable, guideline dermal absorption study was not submitted. A dermal toxicity study 

was submitted, but the highest dose tested was only 5 mg/kg/day (no adverse effects observed).

A definitive target organ has not been identified, and clinical signs were not observed in any 

study performed using these dyes. Systemic toxicity was observed in one study in the toxicity

database and was limited to a decrease in mean body weight following long-term dietary 

exposure to high doses in rats. There were no adverse effects observed in mice or dogs. All 

NOAELs were reported to be ≥500 mg/kg/day with the exception of a non-guideline 21-day 

dermal study in rats. The NOAEL for this dermal study was 5 mg/kg/day; however, this was the 

highest dose tested.

In both the prenatal developmental toxicity study in rats and the 3-generation reproduction study 

in rats with tartrazine, adverse effects were not observed at any levels below the limit dose. Both 

of the two dyes, tartrazine and erioglaucine, show a similar lack of toxicity, and it is considered 

unlikely that erioglaucine would demonstrate quantitative or qualitative susceptibility. No 

adverse effects have been associated with exposure resulting from the FDA-approved uses of 

either tartrazine or erioglaucine.

There was no evidence of neurotoxicity reported in any study. No evidence of carcinogenicity 

was observed in carcinogenicity studies in mice and rats with erioglaucine, (Borzelleca and 

Hallagan, 1988a, 1988b) and tartrazine (Borzelleca et al, 1990). Aquashade® is classified as not 

likely to be a carcinogen. These substances are not mutagenic in the standard Ames assay with

or without metabolic activation (Brown et al, 1978).

The end-use products each have a different ratio of the dyes. A product containing 68% 

erioglaucine and 4.5% tartrazine was used in the acute studies. It has a low acute toxicity with no 

deaths occurring near the limit dose in oral studies (Category IV). The acute toxicity in dermal 

studies is Category III. Based on the uses, the requirement for the acute inhalation study has 

been historically waived. There were no clinical signs of systemic toxicity in the acute oral and 

dermal studies. No significant differences exist between males and females. The tested product 

caused slight eye irritation (Category III). It was negative for dermal irritation (Category IV); 

however, it is a dermal sensitizer. 
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4.2 Safety Factor for Infants and Children (FQPA Safety Factor)

The Aquashade® risk assessment team has recommended that the FQPA Safety Factor be 

reduced to 1X because there is an adequate toxicity database, and exposure data are complete or 

are estimated based on data that will not underestimate potential exposures. The toxicological 

database for Aquashade® is considered complete with regard to pre- and postnatal toxicity, 

neurotoxicity, and immunotoxicity. The dietary and residential assessments are based on reliable 

data and will not underestimate exposure.

4.2.1 Completeness of the Toxicology Database

The database of toxicology studies for Aquashade® is complete and considered adequate for risk 

assessment (see Appendix A.1). Developmental toxicity studies in rats and a reproductive 

toxicity study in rats are available for tartrazine. The Hazard and Science Policy Council 

(HASPOC; Schlosser, 2014, TXR # 0053946) recommended waiving all outstanding studies, 

including: 90-day oral in rodent, 90-day oral in non-rodent, 90-day inhalation, prenatal 

developmental study in rat (erioglaucine or Aquashade®), prenatal developmental study in rabbit 

(erioglaucine or Aquashade®), reproduction and fertility effects (erioglaucine or Aquashade®), 

bacterial reverse mutation assay (erioglaucine or Aquashade®), in vitro mammalian cell assay, 

in vivo cytogenetics, acute neurotoxicity, subchronic neurotoxicity, metabolism and 

pharmacokinetics (tartrazine or Aquashade®), dermal penetration, and immunotoxicity

This risk assessment takes a weight of the evidence approach, considering the available data 

from a variety of sources, including studies submitted and reviewed by the agency, the Food and 

Drug Administration (FDA) and the Joint Expert Committee on Food Additives of the Food and 

Agriculture Organization/World Health Organization (JECFA). This information is sufficient to 

evaluate the toxicity of Aquashade® and related compounds. Based on the information available 

from these sources, the toxicity database is complete, and there are no data gaps.

4.2.2 Evidence of Neurotoxicity

Neurotoxicity studies have not been conducted on either erioglaucine or tartrazine. However, 

no evidence of neurotoxicity was observed in any study. No clinical signs indicative of 

neurotoxicity were noted in subchronic and chronic studies in dogs or rats. 

4.2.3 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal

There was no evidence of increased sensitivity in the developing animal. Two developmental 

studies in rats were conducted using tartrazine and no adverse effect was observed at the limit 

dose in dams and fetuses. In the reproduction study in rats, no adverse finding was noted at the 

highest dose tested (750 mg/kg/day tartrazine) in parents, offspring, or reproductive parameters.

4.2.4 Residual Uncertainty in the Exposure Database

There are no residual uncertainties in the exposure database for Aquashade® based on the 

following considerations: (1) adequate exposure data are available to assess the residential and 
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occupational exposures resulting from these uses and (2) exposures are not expected to be 

underestimated.

4.3 Toxicity Endpoint and Point of Departure Selections

Since the last risk assessment, no new guideline toxicity study has been submitted to HED. The 

endpoints and points of departures have not changed from the previous risk assessment. There is 

no change in the prior recommendations for combining routes of exposure nor for the cancer 

classification. Endpoints and points of departure are provided in Table 4.3.1 below. 

Table 4.3.1. Summary of Toxicological Doses and Endpoints for Aquashade® for Use in Dietary and NonOccupational Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty/ 

FQPA Safety 

Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

- - - No appropriate endpoint for the general 

population attributable to a single 

exposure

Acute Dietary 

(Females 13-

49 years of 

age)

- - - No appropriate endpoint for females age 

13-49 attributable to a single exposure

Chronic 

Dietary

NOAEL = 500 

mg/kg/day 

(Tartrazine)

Co-critical: 

NOAEL = 631 

mg/kg/day 

(Erioglaucine)

UFA=10x

UFH=10x

FQPA SF=1x

Chronic RfD 

= cPAD =

5 mg/kg/day

Chronic oral toxicity in dogs (Tartrazine)

LOAEL was not identified 

Combined chronic toxicity/ 

carcinogenicity study in rats 

(Erioglaucine)

LOAEL = 1262 mg/kg/day based on 

decreased body weight in females

Incidental 

Oral Shortand 

Intermediate 

Term (1-30 

days and 1-6 

months)

NOAEL = 500 

mg/kg/day 

(Tartrazine)

Co-critical: 

NOAEL = 631 

mg/kg/day 

(Erioglaucine)

UFA=10x

UFH=10x

FQPA SF=1x

Residential 

LOC for 

MOE = 100

Chronic oral toxicity in dogs (Tartrazine)

LOAEL was not identified 

Combined chronic toxicity/ 

carcinogenicity study in rats 

(Erioglaucine)

LOAEL = 1262 mg/kg/day based on 

decreased body weight in females
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Table 4.3.1. Summary of Toxicological Doses and Endpoints for Aquashade® for Use in Dietary and NonOccupational Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty/ 

FQPA Safety 

Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment Study and Toxicological Effects

Dermal Shortand 

IntermediateTerm (1-30 

days and 1-6 

months)

NOAEL = 500 

mg/kg/day 

(Tartrazine)

Co-critical: 

NOAEL = 631 

mg/kg/day 

(Erioglaucine)

Dermal 

absorption rate 

= 100%

UFA=10x

UFH=10x

FQPA SF=1x

Residential 

LOC for 

MOE = 100

Chronic oral toxicity in dogs (Tartrazine)

LOAEL was not identified 

Combined chronic toxicity/ 

carcinogenicity study in rats 

(Erioglaucine)

LOAEL = 1262 mg/kg/day based on 

decreased body weight in females

Inhalation 

Short-and 

IntermediateTerm (1-30 

days and 1-6 

months)

NOAEL = 500 

mg/kg/day 

(Tartrazine)

Co-critical: 

NOAEL = 631 

mg/kg/day 

(Erioglaucine)

Inhalation 

absorption rate 

= 100%

UFA=10x

UFH=10x

FQPA SF=1x

Residential 

LOC for 

MOE = 100

Chronic oral toxicity in dogs (Tartrazine)

LOAEL was not identified 

Combined chronic toxicity/ 

carcinogenicity study in rats 

(Erioglaucine)

LOAEL = 1262 mg/kg/day based on 

decreased body weight in females

Cancer (oral, 

dermal, 

inhalation)

Not likely to be carcinogenic to humans.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk estimates associated with lower environmentally 

relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect 

level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation 

in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a 

NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of key 

data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c 

= chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

DAF = dermal absorption factor.
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Table 4.3.2. Summary of Toxicological Doses and Endpoints for Aquashade® for Use in Occupational 

Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of 

Concern for 

Risk 

Assessment Study and Toxicological Effects

Dermal Shortand 

IntermediateTerm (1-30 

days and 1-6 

months)

NOAEL = 500 

mg/kg/day 

(Tartrazine)

Co-critical: 

NOAEL = 631 

mg/kg/day 

(Erioglaucine)

Dermal 

absorption rate 

= 100%

UFA=10x

UFH=10x

Occupational 

LOC for 

MOE = 100

Chronic oral toxicity in dogs (Tartrazine)

LOAEL was not identified 

Combined chronic toxicity/ 

carcinogenicity study in rats 

(Erioglaucine)

LOAEL = 1262 mg/kg/day based on 

decreased body weight in females

Inhalation 

Short-and 

IntermediateTerm (1-30 

days and 1-6 

months)

NOAEL = 500 

mg/kg/day 

(Tartrazine)

Co-critical: 

NOAEL = 631 

mg/kg/day 

(Erioglaucine)

Inhalation 

absorption rate 

= 100%

UFA=10x

UFH=10x

Occupational 

LOC for 

MOE = 100

Chronic oral toxicity in dogs (Tartrazine)

LOAEL was not identified 

Combined chronic toxicity/ 

carcinogenicity study in rats 

(Erioglaucine)

LOAEL = 1262 mg/kg/day based on 

decreased body weight in females

Cancer (oral, 

dermal, 

inhalation)

Not likely to be carcinogenic to humans. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk estimates associated with lower environmentally 

relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect 

level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation 

in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a 

NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of key 

data (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

5.0 Dietary Exposure and Risk Assessment 

Since Aquashade® is applied to contained water bodies with little or no outflow, and labels 

preclude us in treated water bodies that serve as a source of drinking water, no drinking water 

exposure is expected. Although water treated with Aquashade® may potentially be used for 

irrigation of food crops and livestock watering, and Aquashade® is registered for use in fish 

farms and hatcheries, HED has not quantitatively assessed exposures and risk estimates from 

food sources for several reasons: (1) Aquashade® is used primarily in ornamental and/or 

recreational lakes and ponds with very little treated water expected to be used for agricultural 

purposes. (2) Erioglaucine and tartrazine are highly water soluble compounds and, as such, not 

likely to accumulate in livestock or fish tissues. The results of the rat metabolism study with 

erioglaucine support this determination, since nearly the entire administered dose was excreted 
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unchanged in the feces in less than 2 days. (3) Any residues of erioglaucine or tartrazine 

occurring in foods from the use of Aquashade® as an aquatic algaecide/herbicide would be 

negligible compared to residues in food from the common use of these dyes as food coloring 

additives.

6.0 Residential (Non-Occupational) Exposure/Risk Characterization

Aquashade® is labeled for consumer use to control aquatic algae and weeds in ponds and lakes. 

The anticipated use patterns and current labeling indicate several residential handler scenarios 

based on the types of equipment and techniques that can potentially be used to make tartrazine 

and erioglaucine applications. Residents or consumers applying tartrazine and erioglaucine 

products to ponds or lakes may be exposed for short-term (1 to 30 days) duration through dermal 

contact or by the inhalation route.

Post-application exposures to children and adults that contact tartrazine and erioglaucine treated 

swimming ponds are anticipated. To address the risk estimates of such exposures, a screening 

tool called the Swimmer Exposure Assessment Model (SWIMODEL) from the 2013 Draft 

Aquatic Use SOP was used to estimate risks. Post-application residential exposure durations are 

expected to be short-term (1 to 30 days) in duration. 

The previous residential exposure assessment was conducted in 2005. The current assessment 

updates the previous assessment using the 2012 Residential SOPs and the 2013 Draft Aquatic 

Use SOP to recalculate risk estimates. 

6.1 Residential Handler Exposure

HED uses the term “handlers” to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct tasks related to applications and that 

exposures can vary depending on the specifics of each task. Residential handlers are addressed 

somewhat differently by HED as homeowners are assumed to complete all elements of an 

application without use of any protective equipment.

Aquashade® is labeled for consumer use to control aquatic algae and weeds in ponds and lakes; 

therefore, pesticide handler exposure to Aquashade® is likely to occur during its use. The 

anticipated use patterns and current labeling indicate several residential handler exposure 

scenarios based on the types of equipment and techniques that can be potentially used for 

consumer Aquashade® applications. The quantitative exposure/risk assessment developed for 

residential handlers is based on the following scenarios. 

Mixer/ Loader/ Applicators:

(1) Liquids for Pouring Applications (using PHED mixer/ loader data)

(2) Water Soluble Packets (using PHED mixer/ loader data)

Non-cancer risk estimates were calculated using the Margin of Exposure (MOE). The overall 

uncertainty factor applied to Aquashade® handler risk assessments is an MOE of 100, which is 

based on 10X for inter-species extrapolation and 10X for intra-species variation. No surrogate 
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data was available to assess the open pour scenario in the Residential SOP, therefore, 

occupational unit exposures from mixer/loader/applicators data were modified to be 

representative of residential handlers to better represent the scenario. 16.85 acre-ft was used as 

the volume treated, which is representative of an acreage of 2.5 acres and a depth of 2 m (6.74 ft) 

based on the 2013 Draft Aquatic Use SOP. 

Risk Summary: A summary of the short-term risk estimates (dermal and inhalation) for each 

exposure scenario is presented below in Table 6.1. All residential handler scenarios assessed 

resulted in estimated MOEs greater than 100 and, therefore, are not of concern. Residential 

short-term dermal MOEs range from 16,000 (pouring liquid) to 1,400,000 (drop-in water soluble 

packets), and short-term inhalation MOEs range from to 92,000 (pouring liquid) to 110,000 

(drop-in water soluble packets). Combined dermal and inhalation MOEs range from 14,000 

(pouring liquid) to 110,000 (drop-in water soluble packets).
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Table 6.1: Short-Term Residential Handler Exposure and Risk Estimates for Aquashade®

Exposure Scenario Level of 

Concern

Dermal Unit 

Exposure (mg/ 

lb ai)

Inhalation Unit 

Exposure

(mg/lb ai)

Application 

Rate 1

Amount Treated or 

Handled Daily 

Dermal Inhalation Total

Dose

(mg/kg/day)

2

MOE 3 Dose

(mg/kg/day) 4 MOE 5 MOE 6

Mixer/Loader/Applicator

Liquids for pouring 

applications 100 0.187 0.219 0.79 lb ai/A-ft

16.85 A-ft 

(2.5 A 6.74 ft deep) 0.031 16,000 0.0054 92,000 14,000

Water Soluble Packet 100 0.02 0.24 0.58 lb 

ai/A-ft

16.85 A-ft

(2.5 A 6.74 ft deep)

0.0036 1,400,000 0.0044 110,000 110,000

1 Based on registered or proposed label (Reg. No. 33068-1 and 67064-1)

2 Dermal Dose = Dermal Unit Exposure (mg/kg) x Application Rate (lb ai/acre or gal) x Amount Treated or Handled (A or gallons/day) x DAF (%)/BW (80 kg)

3 Dermal MOE = Dermal NOAEL (mg/kg/day)/Dermal Dose (mg/kg/day)

4 Inhalation Dose = Dermal Unit Exposure (mg/kg) x Application Rate (lb ai/acre or gal) x Amount Treated or Handled (A or gallons/day) /BW (kg)

5 Inhalation MOE = Inhalation NOAEL (mg/kg/day)/ Inhalation Dose (mg/kg/day)

6 Total MOE = NOAEL (mg/kg/day)/(Dermal Dose + Inhalation Dose) OR Total MOE = 1/[(1/Dermal MOE) + (1/Inhalation MOE)
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6.2 Post-Application Exposure

There is the potential for post-application exposure for individuals as a result of being in an 

environment that has been previously treated with Aquashade® products. In order to assess 

short-term post-application risk estimates for children and adults exposed to Aquashade®-treated 

residential swimming ponds, the 2013 Draft Aquatic Use SOP was applied. 

The lifestages selected for each post-application scenario are based on an analysis provided as an 

Appendix in the 2012 Residential SOPs1and in the 2013 Draft Aquatic Use SOP. While not the 

only lifestage potentially exposed for these post-application scenarios, the lifestage that is 

included in the quantitative assessment is health protective for the exposures and risk estimates 

for any other potentially exposed lifestage.

Risk estimates were calculated for residential handler and post-application exposures using the 

MOE approach. All short-term residential post-application scenarios assessed (dermal, 

ingestion, and inhalation) resulted in estimated combined MOEs greater than 100 and, therefore, 

are not of concern. A summary of these MOEs are presented in Table 6.2.

 

1 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
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Post-Application Non-cancer Risk Estimates

Table 6.2: Short-Term Residential Post-Application Exposure and Risk Estimates for Aquashade®

Life stage Post-application Exposure 

Scenario

Water 

Concentration1

(mg/L)

Dose2 MOEs3

Combined Routes

(X indicates included in 

Combined MOE)

Combined MOEs4

Adult

Aquatic

Dermal 0.291 3.4 x 10-5 1.5 x 107 X

9.52 x 106

Inhalation 0.291 9.7 x 10-14 5.2 x 1015 X

Ingestion 0.291 1.8 x 10-5 2.7 x 107 X

Child

(3 to <6 

years old)

Dermal 0.291 1.0 x 10-5 3.5 x 107 X

1.50 x 107

Inhalation 0.291 6.7 x 10-15 7.5 x 1016 X

Ingestion 0.291 1.9 x 10-5 2.6 x 107 X

1 Based on registered or proposed label (Reg. No. 33068-1 and 67064-1).

2 DOSE (mg/kg/day) : equations provided in appendix 

3 MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day).

4 Combined MOE = 1 ÷ (1/dermal MOE) + (1/inhalation MOE) + (1/incidental oral MOE), where applicable
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6.5 Residential Bystander Post-application Inhalation Exposure

Volatilization of pesticides may be a source of post-application inhalation exposure to 

individuals nearby pesticide applications. The agency sought expert advice and input on issues 

related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act 

Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on 

March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The 

agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a 

subsequent Volatilization Screening Analysis 

(http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2014-0219). During Registration 

Review, the agency will utilize this analysis to determine if data (i.e., flux studies, route-specific 

inhalation toxicological studies) or further analysis is required.

6.6 Spray Drift

Spray drift is a potential source of exposure to those nearby pesticide applications. This is 

particularly the case with aerial application, but, to a lesser extent, spray drift can also be a 

potential source of exposure from the ground application methods (e.g., groundboom and 

airblast) which are not employed for Aquashade®. The agency has been working with the Spray 

Drift Task Force (a task force composed of various registrants which was developed as a result 

of a Data Call-In issued by EPA), EPA Regional Offices and State Lead Agencies for pesticide 

regulation and other parties to develop the best spray drift management practices (see the 

agency’s Spray Drift website for more information). The agency has also developed a policy on 

how to appropriately consider spray drift as a potential source of exposure in risk assessments for 

pesticides. The potential for spray drift is qualitatively evaluated for each pesticide during the 

Registration Review process which ensures that all uses for that pesticide will be considered 

concurrently. The approach is outlined in the revised (2012) Standard Operating Procedures For 

Residential Risk Assessment (SOPs) - Residential Exposure Assessment Standard Operating 

Procedures Addenda 1: Consideration of Spray Drift.

There is no potential for spray drift exposure for Aquashade® as liquids are poured in directly 

and water soluble packets are dropped in directly in to water bodies.

7.0 Aggregate Exposure/Risk Characterization

In accordance with the FQPA, HED must consider and aggregate (add) pesticide exposures and 

risk estimates from three major sources: food, drinking water, and residential exposures. In an 

aggregate assessment, exposures from relevant sources are added together and compared to 

quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risk estimates themselves can 

be aggregated. When aggregating exposures and risk estimates from various sources, HED 

considers both the route and duration of exposure. HED has not quantitatively assessed 

exposures and risk estimates from food sources for several reasons: (1) Aquashade® is used 

primarily in ornamental and/or recreational lakes and ponds with very little treated water 

expected to be used for agricultural purposes. (2) tartrazine and erioglaucine are highly water 

soluble compounds and, as such, not likely to accumulate in livestock or fish tissues. The results 

of the rat metabolism study with erioglaucine support this determination, since nearly the entire
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administered dose was excreted unchanged in the feces in less than 2 days. (3) Any residues of 

erioglaucine or tartrazine occurring in foods from the use of Aquashade® as an aquatic 

algaecide/herbicide would be negligible compared to residues in food from the common use of 

these dyes as food coloring additives. (4) The most significant route of exposure to erioglaucine

and tartrazine is residential exposure, including residential handler and post-application

(swimming) exposure. HED believes that the conservative residential exposure and risk 

estimates discussed above are more than adequate to cover any food exposures that could 

potentially occur from the use of Aquashade® as an aquatic algaecide/herbicide. Therefore, the 

aggregate risks are equivalent to the short-term residential risks described in Section 6 of this 

document, which are also protective for intermediate-term exposure since the same toxicological 

endpoint and point of departure are used for both durations of exposure. These aggregate risks 

are not of concern. Acute and chronic aggregate assessments are not required since there are no 

significant dietary exposures. 
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Table 7.0. Recommendations for the Short-Term Residential Exposures for the Aquashade® Aggregate Assessment 1

Lifestage

Handler Exposure 

(mg/kg/day) 2 Residential

Handler Total 

Exposure 

(mg/kg/day) 3

Residential 

Handler 

Total MOE 4

Post-application Exposure (mg/kg/day)

5

Residential 

Postapplication 

Total Exposure 

(mg/kg/day)

Residential Postapplication MOE 6

Dermal Inhalation Dermal Inhalation Oral

Short-Term

Adult 0.031 0.0054 0.0364 14,000 3.43 x 10-5 9.70 x 10-14 1.82 x 10-5 5.25 x 10-5 9.52 x 106

Child (3 to <6 

years old) N/A N/A N/A N/A 1.00 x 10-5 6.70 x 10-15 1.91 x 10-5 3.32 x 10-5 1.50 x 107

1 Bolded risk estimates should contribute to the residential exposure portion of the aggregate assessment. 

2 Handler exposure represents high-end handler exposure from WSP, where the exposure duration is appropriate to assess.

3 For adults, residential handler total exposure combines the highest dermal and inhalation exposures, where applicable. For young children, total residential exposure combines 

high-end post-application incidental oral AND dermal exposure, where applicable.

4 Residential Handler Total MOE = 1 / (1/Dermal MOE) + (1/Inhalation MOE). Dermal NOAEL = 500 mg/kg/day; Inhalation NOAEL = 500 mg/kg/day

5 Post-application exposure represents high-end dermal, inhalation and/or incidental oral exposure for the relevant exposure duration

6 Total MOE = 1/ (1/Dermal MOE) + (1/Inhalation MOE) + (1/Incidental oral MOE). Dermal NOAEL = 500 mg/kg/day, Inhalation NOAEL = 500 mg/kg/day; Incidental oral 

NOAEL = 500 mg/kg/day. 
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8.0 Cumulative Exposure/Risk Characterization

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 Aquashade® and any other substances and Aquashade® does not appear to produce a toxic 

metabolite produced by other substances. For the purposes of this tolerance action, therefore, 

EPA has not assumed that Aquashade® 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 the 

policy statements released by EPA’s Office of Pesticide Programs concerning common 

mechanism determinations and procedures for cumulating effects from substances found to have 

a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.

9.0 Occupational Exposure/Risk Characterization

HED uses the term handlers to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct job functions or tasks related to 

applications and exposures can vary depending on the specifics of each task. Job requirements 

(amount of chemical used in each application), the kinds of equipment used, the target being 

treated, and the level of protection used by a handler can cause exposure levels to differ in a 

manner specific to each application event. Occupational application methods assessed include 

pour-in liquids and drop-in water soluble packets. 

Pesticide handler exposure to Aquashade® is likely to occur during its use in a variety of 

occupational environments. The anticipated use patterns and current labeling indicate several 

occupational exposure scenarios based on the types of equipment and techniques that can be 

potentially used for Aquashade® applications. Short-term (1 to 30 days) and intermediate-term 

exposures (1 to 6 months) may occur; however, long-term exposures (greater than 6 months) are 

not expected.

The previous occupational exposure assessment was conducted in 2005. The current assessment 

updates the previous assessment recalculating risk estimates. A water body size of 30 acres by 

5ft (6.74 ft) deep, a total of 150 A-ft was used to conduct the occupational assessment based on 

information from the Army Corp of Engineers (Endothall RED, D319373, 8/12/05; 2,4-D RED, 

D316596, 5/4/05). 

All short- and intermediate-term occupational scenarios assessed (dermal and inhalation) resulted 

in estimated MOEs greater than 100 and, therefore, are not of concern. Short- and intermediateterm dermal MOEs range from 1500 (liquids for pouring applications) to 47,000 (water soluble 

packets), and short- and intermediate-term inhalation MOEs range from 1,500,000 (liquids for 

pouring applications) to 1,900,000 (drop-in water soluble packets). The combined MOEs range 

from 1500 (liquids for pouring applications) to 46,000 (drop-in water soluble packets).
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Table 9.0 Occupational Handler Non-Cancer Exposure and Risk Estimates for Aquashade® 

Exposure Scenario Crop or 

Target

Level of 

Concern

Dermal Unit 

Exposure 

(μg/lb ai)1

Inhalation Unit 

Exposure 

(μg/lb ai)1

Maximum 

Application 

Rate2

Area 

Treated or 

Amount 

Handled 

Daily

Dermal Inhalation Total

Mitigation 

Level

Mitigation 

Level

Dose 

(mg/kg/day)3 MOE4 Dose (mg/kg/day)5 MOE6 MOE8

Mixer/loader/Applicator

Liquid 

(pour on)

Aquatic 

areas (lakes, 

ponds, etc.)

100

220 

(baseline)*

0.219 

(baseline)

0.79 lb 

ai/Acre-ft

150 Acre-ft 

(30 A and 5 

ft deep)

0.326

(baseline)

1500

(baseline)

0.000325

(baseline)

1,500,000

(baseline)

1500

(baseline)

Water Soluble Packets 

(drop in)

Aquatic 

areas (lakes, 

ponds, etc.)

100 9.8 (EC)* 0.24 (EC) 0.58 lb 

ai/Acre-ft

150Acre-ft

(30 A and 5 

ft deep)

0.0107

(EC)

47,000

(EC)

0.000261

(EC)

1,900,000

(EC)

46,000 

(EC)

1 Level of mitigation: Baseline, PPE, Eng. Controls.

2 Based on registered or proposed label (Reg. No. 36068-3, 67064-1).

3 Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A or gal/day) × DAF (%) ÷ BW (80 

kg).

4 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day).

5 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A or gal/day) ÷ BW (80 kg).

6 Inhalation MOE = Inhalation NOAEL (500 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

7 Total MOE = NOAEL (500 mg/kg/day) ÷ Dermal Dose + Inhalation Dose OR Total MOE = 1 ÷ (1/Dermal MOE + 1/Inhalation MOE)

*Baseline includes long pants, long-sleeve shirt, socks, and shoes

*Engineering Controls includes packaging of the chemical i.e. WSP
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9.1 Short- and Intermediate- Post-Application Risk

9.1.1 Dermal Post-application Risk

Since Aquashade® is an algaecide/ herbicide, HED is not aware of any occupational postapplication activities which may result in exposure. No harvesting is required, and while 

scouting may include identifying any algae or aquatic weed regrowth, these activities should not 

require contact with the treated water body. For these reasons, occupational post-application 

exposure of workers to previously treated water bodies is expected to be negligible and was not 

assessed quantitatively.

9.1.2 Inhalation Post-application Risk

Based on the Agency's current practices, a quantitative non-cancer occupational post-application 

inhalation exposure assessment was not performed for Aquashade® at this time. If new policies 

or procedures are put into place, the Agency may revisit the need for a quantitative occupational 

post-application inhalation exposure assessment for Aquashade®. 

10.0 Epidemiology

Based on the low severity of incidents involving Aquashade® (pc code 110303), acid yellow 23 

(pc code 110302), and acid blue 9, diammonium salt (pc code 110301) reported to IDS and the 

fact that no incidents involving Aquashade®, acid yellow 23, or acid blue 9, diammonium salt

were reported to SENSOR-Pesticides, there does not appear to be a concern at this time that 

would warrant further investigation. The Agency will continue to monitor the incident 

information and if a concern is triggered, additional analysis will be included in the risk 

assessment (S. Recore, 2014, D427136).

11.0 References

Review of Aquashade® Incident Reports, Chemicals #110303, #110301, and #110302, DP 

Barcode: D302184, Jerome Blondell, 08/22/05.

Aquashade®: Occupational and Residential Exposure Assessment and Recommendations for the 

Reregistration Eligibility Decision Document; DP Barcode: 302180, Wade Britton, 09/13/05.

Aquashade®: Revised Occupational and Residential Exposure Assessment and 

Recommendations for the Reregistration Eligibility Decision Document; DP Barcode: D321915; 

W. Britton; 09/27/05.

BIBRA. 1999. BIBRA International Ltd. Toxicity profile: Brilliant Blue FCF, 3rd ed. 

Carshalton, Surrey: BIBRA International Ltd., 11 pp.

Borzelleca, J.F. and J.B. Hallagan. 1988a. Chronic toxicity/carcinogenicity studies of FD&C 

Yellow No. 5 (tartrazine) in rats. Fd. Chem. Toxicol. 26(3):179-187.
Aquashade® Human Health Risk Assessment DP No. 425777

Page 26 of 35

Borzelleca, J.F. and J.B. Hallagan. 1988b. A chronic toxicity/carcinogenicity study of FD&C 

Yellow No. 5 (tartrazine) in mice. Fd. Chem. Toxicol. 26(3):189-194.

Borzelleca, J.F., K. Depukat, and J.B. Hallagan. 1990. Lifetime toxicity/carcinogenicity studies 

of FD&C Blue No. 1 (Brilliant Blue FCF) in rats and mice. Fd. Chem. Toxicol. 28:221-234.

Brown, J.P., G.W. Roehm, and R.J. Brown. 1978. Mutagenicity testing of certified food colors 

and related azo, xanthene and triphenylmethane dyes with the Salmonella/microsome system. 

Mutat. Res. 56:249-271.

Collins, T.F.X., T.N. Black, L.H. Brown, et al. 1990. Study of the teratogenic potential of 

FD&C Yellow No. 5 when given by gavage to rats. Fd. Chem. Toxic. 28(12):821-827.

Collins, T.F.X., T.N. Black, M.W. O'Connell, Jr., et al. 1992. Study of the teratogenic potential 

of FD&C Yellow No. 5 when given in drinking water. Fd. Chem. Toxic. 30(4):263-268.

FDA. 1982. FD&C Blue No. 1.; Final Rule. 47 FR 42563; September 28, 1982

FDA. 1985. FD&C Yellow No. 5.; Final Rule; Removal of Stay. 40 FR 35774; 

September 4, 1985.

IACM. 2004. International Association of Color Manufacturers. Test Plan and Robust 

Summaries for C.I. Acid Yellow 23 (FD&C Yellow 5). 

http://www.epa.gov/chemrtk/ciacdylo/c15133tp.pdf

JECFA. 1964. Joint FAO/WHO Expert Committee on Food Additives. Tartrazine. WHO Food 

Additive Series. 66.25/NMRS 38B-JECFA 8/88. 

http://www.inchem.org/documents/jecfa/jeceval/jec_1936.htm

JECFA. 1969. Joint FAO/WHO Expert Committee on Food Additives. Toxicological 

Evaluation of Some Food Colours, Emulsifiers, Stabilizers, Anti-caking Agents and Certain 

Other Substances. FAO Nutrition Meetings Report Series No. 46A . World Health 

Organization, Geneva. http://www.inchem.org/documents/jecfa/jecmono/v46aje08.htm

Leifer, Kerry. 2004. United States Environmental Protection Agency. Reassessment of 

Exemptions from the requirement of a tolerance for the FDA-certified color additives FD&C 

Blue No. 1, FD&C Red No. 40, and FD&C Yellow No. 5. 

Sasaki, Y.F., S. Kawaguchi, A. Kamaya, et al. 2002. The comet assay with 8 mouse organs: 

results with 39 currently used food additives. Mutat. Res. 519:103-119.

SRC. 2004. Syracuse Research Corporation. Interactive Physical Properties (PHYSPROP) 

Database Demo. Search terms: FD&C Blue. No. 1, FD&C Red No. 40, FD&C Yellow No. 5. 

(November 28, 2004) http://www.syrres.com/esc/physdemo.htm
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Appendix A. Toxicology Profile and Executive Summaries

A.1 Toxicology Data Requirements

The requirements (40 CFR 158.500) for food-use for Aquashade® are in Table 1. Use of the new guideline numbers 

does not imply that the new (1998) guideline protocols were used.

Study

Technical

Required Satisfied

870.1100 Acute Oral Toxicity.......................................................

870.1200 Acute Dermal Toxicity..................................................

870.1300 Acute Inhalation Toxicity..............................................

870.2400 Primary Eye Irritation....................................................

870.2500 Primary Dermal Irritation..............................................

870.2600 Dermal Sensitization .....................................................

yes

yes

yes

yes

yes

yes

yes a

yes a

yes a

yes a

yes a

yes a

870.3100 Oral Subchronic (rodent)...............................................

870.3150 Oral Subchronic (nonrodent).........................................

870.3200 21-Day Dermal..............................................................

870.3250 90-Day Dermal..............................................................

870.3465 90-Day Inhalation..........................................................

yes

yes

yes

no

yes

yes b

yes b

yes c

-

yes b

870.3700a Developmental Toxicity (rodent) ..................................

870.3700b Developmental Toxicity (nonrodent) ............................

870.3800 Reproduction .................................................................

yes

yes

yes

yes d

yes b

yes d

870.4100a Chronic Toxicity (rodent)..............................................

870.4100b Chronic Toxicity (nonrodent)........................................

870.4200a Oncogenicity (rat)..........................................................

870.4200b Oncogenicity (mouse) ...................................................

yes

no

yes

yes

yes d

-

yes e

yes e

870.5100 Mutagenicity—Bacterial reverse mutation assay ....................

870.5300 Mutagenicity—In vitro mammalian cell gene mutation test.......

870.5375 Mutagenicity—In vitro mammalian chromosome aberration test

870.5395 Mutagenicity—Mammalian erythrocyte micronucleus test........

yes

yes

yes

yes

yes d

yes b

yes b

yes b

870.6100a Acute Delayed Neurotoxicity (hen)...............................

870.6100b 90-Day Neurotoxicity (hen) ..........................................

870.6200a Acute Neurotoxicity Screening Battery (rat).................

870.6200b 90-Day Neurotoxicity Screening Battery (rat) ..............

870.6300 Developmental Neurotoxicity .......................................

no

no

yes

yes

no

-

-

yes b

yes b

-

870.7485 General Metabolism ......................................................

870.7600 Dermal Penetration........................................................

870.7800 Immunotoxicity .............................................................

yes

yes

yes

yesf

yes b

yes b

a Tested Admiral WSP (Erioglaucine : Tartrazine, 68.13% : 4.51%).

b This study was not submitted, but is not required (Schlosser, 2014, TXR # 0053946), The requirement for outstanding 

studies for Aquashade® were waived including: 90-day oral in rodent, 90-day oral in non-rodent, 90-day inhalation, prenatal 

developmental study in rat (erioglaucine or Aquashade®), prenatal developmental study in rabbit (erioglaucine, tartrazine,

or Aquashade®), reproduction and fertility effects (erioglaucine or Aquashade®), bacterial reverse mutation assay 

(erioglaucine or Aquashade®), in vitro mammalian cell assay, in vivo cytogenetics, acute neurotoxicity, subchronic 

neurotoxicity, metabolism and pharmacokinetics (tartrazine or Aquashade®), dermal penetration, and immunotoxicity.

c An acceptable, non-guideline study was submitted. No additional data are required at this time. Erioglaucine was tested

d A study was submitted evaluating tartrazine.

e Guidelines 870.4100 and 870.4200 were satisfied by Guideline 870.4300 where tartrazine and erioglaucine were tested 

separately, both in rat and mice.

f A study was submitted evaluating erioglaucine.
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A.2 Toxicity Profiles

Table A.2.1 Acute Toxicity Profile – Admiral WSP a

Guideline No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute oral - Rat 45281101 LD50 > 5000 

mg/kg

IV

870.1200 Acute dermal - Rabbit 45144401 LD50 > 2000 

mg/kg

III

870.1300 Acute inhalation None Data requirement 

waived

-

870.2400 Acute eye irritation - Rabbit 44902902 No eye irritation III

870.2500 Acute dermal irritation - Rabbit 45086102 Negative IV

870.2600 Skin sensitization - Guinea Pig 44902904 Positive NA

a 68.13% Erioglaucine and 4.51% Tartrazine

Table A.2.2 Subchronic, Chronic, and Other Toxicity Profile - Aquashade®

Guideline 

No. Study Type

MRID No. (year)/ 

Classification /Doses Results

870.3100 90-Day oral 

toxicity (rodent)

None Not required

870.3150 90-Day oral 

toxicity (nonrodent)

None Not required

870.3200 21-Day dermal 

toxicity (rabbit)

43410101 (1962)

Acceptable, non-guideline

♀: 0, 0.5, 5.0 mg/kg/day

Erioglaucine

NOAEL = 5 mg/kg/day

LOAEL was not observed 

870.3250 90-Day dermal 

toxicity (species)

None Not required

870.3465 90-Day inhalation 

toxicity (species)

None Not required

870.3700a Prenatal 

developmental 

(rat)

43408101 

Acceptable, guideline

0, 100, 300, 1000 

mg/kg/day 

Tartrazine

Maternal NOAEL = 1000 mg/kg/day

LOAEL was not observed

Developmental NOAEL = 1000 mg/kg/day

LOAEL was not observed

870.3700a Prenatal 

developmental 

(rat)

No MRID; Collins, et al., 

1990

0, 60, 100, 200, 400, 600, 

1000 mg/kg/day 

Tartrazine

Maternal NOAEL = 1000 mg/kg/day

LOAEL was not observed

Developmental NOAEL = 1000 mg/kg/day

LOAEL was not observed
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Table A.2.2 Subchronic, Chronic, and Other Toxicity Profile - Aquashade®

Guideline 

No. Study Type

MRID No. (year)/ 

Classification /Doses Results

870.3700b Prenatal 

developmental 

(non-rodent)

None Not required

870.3800 Reproduction and 

fertility effects

(rat)

43410901 

Acceptable, guideline

0, 7.5, 75, 225, 750

mg/kg/day 

Tartrazine

Parental/Systemic NOAEL = 750 mg/kg/day

LOAEL was not observed

Reproductive NOAEL = 750 mg/kg/day

LOAEL was not observed

Offspring NOAEL = 750 mg/kg/day

LOAEL was not observed

870.4100a Chronic toxicity

(rat)

Not submitted. See 

870.4300.

-

870.4100a Chronic toxicity

(mouse)

Not submitted. See 

870.4300.

-

870.4100b Chronic toxicity 

(dog)

No MRID; FDA, 1985

Tartrazine

NOAEL = 500 mg/kg/day

LOAEL was not observed

870.4200a Carcinogenicity

(rat)

Not submitted. See 

870.4300.

-

870.4200b Carcinogenicity

(mouse)

Not submitted. See 

870.4300.

-

870.4300 Combined 

Chronic Toxicity/ 

Carcinogenicity

(rat)

No MRID; Borzelleca, 

et al., 1990

♂: 0, 54, 536, 1072 

mg/kg/day

♀: 0, 63, 631, 1262 

mg/kg/day

Erioglaucine

NOAEL = 631 mg/kg/day

LOAEL = 1262 mg/kg/day based on decreased 

body weight in females 

No evidence of carcinogenicity

870.4300 Combined 

Chronic Toxicity/ 

Carcinogenicity

(rat)

No MRID; Borzelleca, 

et al., 1988a

♂: 0, 67, 1339, 3348 

mg/kg/day

♀: 0, 53, 1056, 2641 

mg/kg/day

Tartrazine

NOAEL = 2641 mg/kg/day

LOAEL was not observed 

No evidence of carcinogenicity

870.4300 Combined 

Chronic Toxicity/ 

Carcinogenicity

(mouse)

No MRID; FDA, 1982

Erioglaucine

NOAEL = 1200 mg/kg/day

LOAEL was not identified 

No evidence of carcinogenicity
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Table A.2.2 Subchronic, Chronic, and Other Toxicity Profile - Aquashade®

Guideline 

No. Study Type

MRID No. (year)/ 

Classification /Doses Results

870.4300 Combined 

Chronic Toxicity/ 

Carcinogenicity

(mouse)

No MRID; Borzelleca, 

et al., 1990

♂: 0, 735, 2206, 7354 

mg/kg/day

♀: 0, 897, 2690, 8966 

mg/kg/day

Erioglaucine

NOAEL = 7354 mg/kg/day

LOAEL was not identified 

No evidence of carcinogenicity

870.4300 Combined 

Chronic Toxicity/ 

Carcinogenicity

(mouse)

No MRID; Borzelleca, 

et al., 1988b

♂: 0, 41, 2431, 8103 

mg/kg/day

♀: 0, 974, 2912, 9735 

mg/kg/day

Tartrazine

NOAEL = 8103 mg/kg/day

LOAEL was not observed 

No evidence of carcinogenicity

870.5100 Genotoxicity

Bacterial reverse 

mutation test

No MRID; Hansen, et al., 

1964, as cited in JEFCA, 

1969

Tartrazine

Negative

870.5300 Genotoxicity

In vitro 

mammalian cell 

gene mutation test

None Not required

870.5375 Genotoxicity

In vitro 

mammalian 

chromosome 

aberration test

None Not required

870.5395 Genotoxicity

Mammalian 

erythrocyte 

micronucleus test

None Not required

870.6200a Acute 

neurotoxicity 

screening battery

None Not required

870.6200b Subchronic 

neurotoxicity 

screening battery

None Not required

870.6300 Developmental 

neurotoxicity

None Not required
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Table A.2.2 Subchronic, Chronic, and Other Toxicity Profile - Aquashade®

Guideline 

No. Study Type

MRID No. (year)/ 

Classification /Doses Results

870.7485 Metabolism and 

pharmacokinetics

(rat)

No MRID; Imperial 

Chemical Industries, 1958

200 mg/rat

Erioglaucine

Erioglaucine was administered orally to rats as 

a 2% aqueous solution at a level of 200 mg/rat. 

Almost the entire amount was excreted 

unchanged in the feces within 40 h after 

administration.

870.7600 Dermal 

penetration (rat)

None Not required

870.7800 Immunotoxicity

(rat)

None Not required

All studies that were noted in this table as “Not required” were considered so because the studies were conditionally 

required and did not meet the conditions for requirement, were considered not required in the previous risk 

assessment, or were specified as not required by HASPOC (Schlosser, 2014, TXR # 0053946).
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Appendix B. Physical/Chemical Properties

Table C1. Physico-Chemical Properties

Parameter Value Reference

Chemical Tartrazine Erioglaucine

Molecular Weight 534.37 792.86 SRC 2004

Water solubility (20°C) 1.0 x 106 mg/L @ 

25°C

1.45 mg/L @ 25°C BASF, 2003

Vapor pressure (25°C) 7.43 x 10-22 mmHg 

@ 25°C

2.97 x 10-42 mmHg 

at 25°C EPI Suite, 2004

Dissociation constant, pKa -10.7 -1.50 EPI Suite, 2004

Octanol/water partition coefficient, 

log KOW (25°C) Kow = 6.3 x 10-11 Kow = 0.032 SRC, 2004

Soil Half-life (or other relevant 

information from EFED Drinking 

water assessment)

N/A N/A N/A
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Appendix C. Summary of Occupational and Residential Non-cancer Algorithms

Occupational Non-cancer Handler Algorithms

Potential daily exposures for occupational handlers are calculated using the following formulas:

E=UE * AR * A * 0.001 mg/ug

where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

AR = maximum application rate according to proposed label (lb ai A or lb ai/gal), and

A = area treated or amount handled (e.g., A/day, gal/day).

The daily doses are calculated using the following formula:

ADD= 

E * AF

BW

where:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day),

E = exposure (mg ai/day),

AF = absorption factor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each application handler scenario are 

calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to 

the daily dose of concern. The daily dermal and inhalation dose received by occupational 

handlers are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational 

handlers for each exposure route. All MOE values are calculated using the following formula:

MOE= 

POD

ADD

where:

MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).

Occupational Non-cancer Post-application Algorithms
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Potential daily exposures for occupational post-application workers are calculated using the 

following formulas:

DFRt=AR * F* (1-D)t* (4.54E8

ug

lb) * (2.47E-8

A

cm2

)

where:

DFRt = dislodgeable foliage residue on day "t" (μg/cm2),

AR = application rate (lb ai/acre),

F = fraction of ai retained on foliage or 25% (unitless),

D = fraction of residue that dissipates daily or 10% (unitless), and

t = number of days after application day (days).

E=TC * DFR t * ET * 0.001

mg

ug

where:

E = exposure (mg ai/day),

TC = transfer coefficient (cm2/hr),

DFRt = dislodgeable foliar residue on day “t” (μg/cm2), and

ET = exposure time (hours/day).

The daily doses are calculated using the following formula:

ADD= 

E * AF

BW

where:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day),

E = exposure (mg ai/day),

AF = absorption factor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each scenario are calculated using a Margin 

of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. 

The daily dermal dose received by occupational post-application workers is compared to the 

appropriate POD (i.e., NOAEL) to assess the risk to occupational post-application workers. All 

MOE values are calculated using the following formula:

MOE= 

POD

ADD

where:
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MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).