Page 2 of 47 

Acute oral toxicity studies were performed using C12-ADAA and C16-ADAA. ADAA has 

moderate to low acute toxicity via the oral and dermal routes of exposure. Low acute toxicity is 

generally associated with C16-ADAA while moderate acute toxicity is associated with C12-

ADAA. In acute dermal and eye irritation studies, C12-ADAA was severely irritating to the skin 

and eyes. A mixture of C12-C16 ADAA was used in a local lymph node assay (LLNA) to 

evaluate the potential to cause skin sensitization, C12-C16 ADAA was found to be a sensitizer; 

however, it gave a negative response for skin sensitization in in vivo guinea pigs as determined 

by Magnusson-Kligman test. 

Two developmental studies were available; an oral toxicity study in the rat and a screening level 

developmental dermal toxicity study in the rabbit. In the developmental toxicity study in the rat, 

maternal toxicity was manifested as reduced body weight gain, stained and matted haircoats, 

respiratory rates at 50 mg/kg/day and above. Offspring toxicity was manifested as reduced or 

absent ossification of the skull, sternebrae #5 and/or #6, and other sternebrae at 250 mg/kg/day. 

The no observed adverse effect level (NOAEL) for developmental toxicity in rats was 150 

mg/kg/day. In the screening level developmental dermal toxicity study in rabbits, maternal 

toxicity manifested as skin irritation, inhibition of body weight gain, decreased food 

consumption and resorptions at doses of 100 mg/kg/day and above while offspring toxicity was 

manifested as increased incidence of resorptions and decreased average litter size at ≥ 100 

mg/kg/day. The NOAEL for systemic and development toxicity in rabbits via dermal route was 

40 mg/kg/day. 

A dose range-finding and a main study of Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test according to the OPPTS Harmonized Test 

Guideline 870.3650 study were available in the rat. In the range-finding study, at >100 

mg/kg/day, a reduction was observed in mean food consumption, body weight, and body weight 

gain during the pre-pairing period in all animals. Also, animals pushed their heads through the 

bedding throughout the treatment period at doses >100 mg/kg/day. At 1000 mg/kg/d, mortality 

was observed in all animals within 24 hours. In the main OPPTS Harmonized Test Guideline 

870.3650 study, parental toxicity was manifested as microscopic lesions (squamous hyperplasia, 

hyperkeratosis, submucosal inflammation and edema) in the forestomach at the lowest dose 

tested (50 mg/kg/day). Reproductive and developmental toxicity was manifested as increased 

implantation losses, decreased birth and viability indices, and decreased pup weight at 300 

mg/kg/day (highest dose tested). The NOAEL for reproductive/developmental toxicity was 150 

mg/kg/day. 

Several mutagenicity studies (two Ames assays and chromosome aberration assay) were 

available for review. The results for these studies were negative. No animal carcinogenicity 

studies are available in the database. Based on structure activity relationship (SAR) analysis, no 

structural alerts for carcinogenicity were identified. 

Two in vitro dermal absorption studies were available in hairless mice. The dermal absorption 

factor of C12-ADAA and C16-ADAA was estimated to be <1%. 

There are no residual concerns for susceptibility to the offspring since fetal toxicity was observed 

at doses that were higher than the dose that caused maternal toxicity. In addition, there was a 
Page 3 of 47 

clear NOAEL for reproductive and developmental toxicity seen in the rat offspring, and the point 

of departure is based on these endpoints. Therefore, EPA has determined that the safety of 

infants and children would be adequately protected if the FQPA safety factor was reduced to 1X. 

The Agency notes the surfactants are surface-active materials that can damage the structural 

integrity of cellular membranes at high dose levels. Thus, surfactants are often corrosive and 

irritating in concentrated solutions. It is possible that some of the observed toxicity seen in the 

repeated dose studies, such as microscopic stomach lesions or decreased body weight gain, can 

be attributed to the corrosive and irritating nature of these surfactants. 

There are no published or unpublished ADAA metabolism studies. However, ADAA are 

expected to metabolized via three potential metabolic pathways: 1) omega oxidation followed by 

beta oxidation of the carbon chain, 2) conjugation of ADAA at the carboxylic acid portion of the 

molecule by any of a number of amino acids, or 3) glucuronidation at the same site on ADAA, 

followed by elimination. 

There was no hazard attributable to a single exposure seen in the toxicity database for ADAA. 

Therefore, ADAA is not expected to pose an acute risk. 

A chronic aggregate risk assessment takes into account exposure estimates from chronic dietary 

consumption of food and drinking water. Using the exposure assumptions discussed in this unit 

for chronic exposure and the use limitation of not more than 20% by weight in pesticide 

formulations, the chronic dietary exposure from food and water to ADAA is 19.5% of the cPAD 

for the U.S. population and 62.9% of the cPAD for children 1-2 years old, the most highly 

exposed population subgroup. A more complete list of results can be found in Appendix A. 

Short-term aggregate exposure takes into account short-term residential exposure plus chronic 

exposure to food and water (considered to be a background exposure level). ADAA are used as 

inert ingredients in pesticide products that are currently registered for uses that could result in 

short-term residential exposure and the Agency has determined that it is appropriate to aggregate 

chronic exposure through food and water with short-term residential exposures to ADAA. Using 

the exposure assumptions described in this unit, EPA has concluded that the combined shortterm aggregated food, water, and residential exposures result in aggregate MOEs of 110 for adult 

males and adult females. Adult residential exposure combines high end dermal and inhalation 

handler exposure from indoor hard surface wiping with a high end post application dermal 

exposure from contact with treated lawns. EPA has concluded the combined short-term 

aggregated food, water, and residential exposures result in an aggregate MOE of 130 for 

children. Children’s residential exposure includes total exposures associated with contact with 

treated lawns (dermal and hand-to-mouth exposures). As the level of concern is for MOEs that 

are lower than 100, these MOEs are not of concern.

Intermediate-term aggregate exposure takes into account intermediate-term residential exposure 

plus chronic exposure to food and water (considered to be a background exposure level). ADAA 

are currently registered for uses that could result in intermediate -term residential exposure and 

the Agency has determined that it is appropriate to aggregate chronic exposure through food and 

water with intermediate-term residential exposures to ADAA. Using the exposure assumptions 
Page 4 of 47 

described in this unit, EPA has concluded that the combined intermediate-term aggregated food, 

water, and residential exposures result in aggregate MOEs of 450 for adult males and adult 

females. Adult residential exposure includes high end post application dermal exposure from 

contact with treated lawns. EPA has concluded the combined intermediate-term aggregated 

food, water, and residential exposures result in an aggregate MOE of 150 for children. Children’s 

residential exposure includes total exposures associated with contact with treated lawns (dermal 

and hand-to-mouth exposures). As the level of concern is for MOEs that are lower than 100, this 

MOE is not of concern. 

The EPI SuiteTM estimated values for the physical and chemical properties of ADAA indicate 

that it will have minimal impact on the environment. The results indicate that ADAA is not 

likely to bioconcentrate and is readily biodegradable. It is also not likely to volatilize from 

surface water. ADAA is expected to partition primarily to soil, but the small amounts that enter 

the water will readily degrade. 

The ecotoxicity of ADAA was estimated using ECOSAR, which is a program that estimates a 

chemical’s acute and chronic toxicity to aquatic organisms by using Structure Activity 

Relationships (SARs). The estimated values for ADAA indicate that the ecotoxicity of ADAA 

ranges from practically nontoxic to slightly toxic. 

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.gove/oepa/guidance/justice/eo12898.pdf. This assessment does not rely in 

part on data from studies in which adult human subjects were intentionally exposed to a 

pesticide. 

Taking into consideration all available information on ADAA, EPA concludes that there is a 

reasonable certainty that no harm will result to the general population or to infants and children 

from aggregate exposure to ADAA. Therefore, the establishment of an exemption from the 

requirement of a for residues of ADAA when used as an inert ingredient (surfactant) in pesticide 

formulations at a maximum of 20% in formulation when applied pre-harvest under 40 CFR 

180.920 and when applied to animals under 40 CFR 180.930 can be considered safe under 

section 408 of the FFDCA. 

I. Background

Rhodia, Inc. submitted a petition dated April 9, 2009 proposing to establish specific exemptions 

from the requirement of a tolerance under 40 CFR §180.920 (pre-harvest only) and 40 CFR 

§180.930 (applied to animals) with a limit of up to 20% of pesticide formulations for the 

following descriptor: 

Alkyl (C12-C16) dimethyl ammonio acetate (ADAA) 
Page 5 of 47 

The proposed use of ADAA is as an inert ingredient (surfactant) in pesticide formulations. EPA 

published the Notice of Filing for this petition in the Federal Register of August 19, 2009 (74 FR 

41895, FRL-8429-9). No comments were received in response to this notice. 

This document provides an assessment of ADAA for the requested tolerance exemptions, and is 

based on information and data submitted by the petitioner and information found in the public 

literature. 

II. Use Information 

A. Pesticide Uses 

Currently, two of the CAS Reg. Nos. (CAS Reg. Nos. 2601-33-4 and 693-33-4) for which 

Rhodia is requesting tolerance exemptions, are on the list for Inert Ingredients Permitted for Use 

in Nonfood Use Pesticide Products. 

B. Other Uses 

The components of ADAA are used in personal care products including liquid hand soaps, facial 

cleansers, shampoos and shower gels. These components function as foam boosters and 

typically used in these products at concentrations up to 5%. (Mintel GNPD Database, 2009; 

Wong, 1997) 
Page 6 of 47 

III. Structural Information 

IV. Physical and Chemical Properties 

The physical and chemical properties of ADAA are listed in Table 2. These properties were 

estimated using EPI SuiteTM (EPA Estimation Programs Interface). EPI SuiteTM is a Windows®-

based suite of physical/chemical property and environmental fate estimation programs developed 

by the EPA’s Office of Pollution Prevention and Toxic Substances (OPPTS) and Syracuse 

Research Corporation (SRC). . 

Table 1: Structural Information 

 Structure References 

C12-ADAA 

(CAS Reg. No. 

683-10-3)

C14-ADAA 

(CAS Reg. No. 

2601-33-4)

C16-ADAA 

(CAS Reg. No. 

693-33-4)

ChemIDplus Lite 
Page 7 of 47 

Table 2: Physical and Chemical Properties 

 C12-ADAA C14-ADAA C16-ADAA References 

Molecular 

Formula 

C16H33NO2 C18H37NO2 C20H41NO2 

CAS # 683-10-3 2601-33-4 693-33-4 

Scientific Name 1-Dodecanaminium, N-

(carboxymethyl), N, Ndimethyl, inner salt 

1-Tetradecanaminium, 

N-(carboxymethyl), N, 

N-dimethyl, inner salt 

1-Hexadecanaminium, 

N-(carboxymethyl), N, 

N-dimethyl, inner salt 

ChemIDplus 

Lite 

Molecular 

Weight 

272.5 301.52 329.57 

Log Kow 0.47 3.46 4.44 

Boiling Point 

(oC) 

520 543 566 

Melting Point 

(oC) 

222 233 243 

Vapor Pressure 

(mmHg at 25 oC) 

6.88 E-14 1.3 E-15 2.74 E-15 

Water 

Solubility (mg/L) 

1.73 E+4a 

0.2866b 

33.35a 

0.0267b 

3.301a 

0.00247b 

Henry’s Law 

Constant atmm3/mole at 25 oC 

(Bond) 

1.4 E-14 1.55 E-15 2.74 E-15 

Log Koc 2.804c 

0.329d 

3.325c 

1.982d 

3.846c 

2.524d 

Probability of 

Rapid 

Biodegradation 

(BIOWIN) 

0.7990e 

0.8357f 

3.26 days-weeksg 

0.6677h 

0.7794i 

0.7851e 

0.7710f 

3.1958 weeksg

0.6801h 

0.7828i 

0.7718e 

0.6933f 

3.1338 weeksg 

0.6955h 

0.7910i 

BCF (L/kg wetwt) 70.79 70.79 70.79 

Atmospheric 

Oxidation Half 

Life (hr) 

6.9 E+10j 

7.53 E+11k 

6.55 E+11j 

7.16 E+12k 

3.88 E+11j 

4.23 E+12k 

Fugacity Model 

Compartment/ 

Mass Amount 

(%) 

Air: 6.14 E-5 

Water: 18.5 

Soil: 81.2 

Sediment: 0.321 

Air: 1.64 E-5 

Water: 15.9 

Soil: 83.0 

Sediment: 1.1 

Air: 0.000119 

Water: 15.3 

Soil: 81.4 

Sediment: 3.25 

Fugacity Model 

Compartment/ 

Half Life (hr) 

Air: 7.49 

Water: 208 

Soil: 416 

Sediment: 1.87 E+3 

Air: 6.92 

Water: 360 

Soil: 720 

Sediment: 3.24 E+3 

Air: 6.43 

Water: 360 

Soil: 720 

Sediment: 3.24 E+3 

ADAA EPI 

SuiteTM 

Estimates as 

cited in US EPA 

Petition 

#9E7557 

a WSKOW result; not appropriate for estimation of water f

 Biowin2 (non-linear model) 

solubility of dispersible compounds, including surfactants g

 Biowin3 (Ultimate survey model) 

b

 Fragment Result hBiowin5 (MITI linear model) c MCI method result i

 Biowin (MITI non-linear model) 

d

 Kow method result j Model River e Biowin1 (linear model) k Model Lake 
Page 8 of 47 

V. Human Health Assessment

Toxicological Discussion 

Table 3. Summary of Acute Toxicity Data for ADAA 

Parameter Toxicity Value Reference 

Oral LD50, rat

(C12-ADAA) 71 mg/kg Ridout et al., 1991 

Oral LD50, rat 

(C16-ADAA) 1620 mg/kg Ridout et al., 1991 

Oral LD50, rat

(C12-ADAA) >5000 mg/kg in males Maynard, 1963 

Dermal LD50, rat, 

(C12-ADAA) >1300 mg/kg Ridout et al., 1991 

Dermal LD50, rat 

(C16-ADAA) >16,000 mg/kg Ridout et al., 1991 

Eye Irritation, 

rabbit (C12-

ADAA) 

Severe irritant Maynard, 1963 

Skin Irritation, 

guinea pig(C12-

ADAA) 

Severe irritant (10%) Maynard, 1963 

Skin Sensitizationguinea pig 

(Magnusson -

Kligman) 

Not a sensitizer Pelcot, 2006 

Skin Sensitizationmouse (LLNA) Sensitizer Wang-Fan, 2005 

Developmental Toxicity Study in the rat 

In a developmental toxicity study F1803 (ADAA) was administered by gavage to CD rats at 

doses of 0, 50, 150 or 250 mg/kg/day on days 6-15 of gestation. 

Respiratory rates and stained and matter haircoats were observed at all doses. Also, a dose 

dependent reduction in body weight gain was observed during the overall gestation (days 0-20) 

and treatment intervals in all dose groups. The maternal systemic toxicity LOAEL was 50 

mg/kg/day. 

There was an increased incidence of litters with reduced ossification and unossification of the 

skull, sternabrae #5 and/or 6 and other sternabrae at 250 mg/kg/day. The NOAEL for the 

developmental toxicity was 150 mg/kg/day. 
Page 9 of 47 

Developmental Dermal Toxicity Screening Study in the rabbit 

In a developmental dermal toxicity study in rabbits with B0612-02 (ADAA), the test material in 

vehicle, 5% isopropanol (B0644-01) was administered topically to New Zealand white female 

rabbits (8/dose) at doses of 0, 10, 20, 40,100 or 200 mg/kg/day on days 6-18 of gestation. The 

treatment of the 100 and 200 mg/kg/day dose groups was terminated on days 8 and 6, 

respectively, due to mortality and severe topical effects. Since a no effect level could not be 

established with the tested doses a 2 mg/kg/day and another control group (8/dose) were added to 

the study. These rabbits were not inseminated and were treated for 13 consecutive days. 

The only effects observed at 2 mg/kg/day were erythema and desquamation. Uncoordinated 

movement and partial paralysis were observed on four consecutive days in 1/8 rabbits at 40 

mg/kg/day. The effects were considered secondary to the local skin and stomach irritations 

caused by treatment with ADAA. In addition, these signs were not observed in a new conducted 

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test (MRID 47731301) at a dose of 50 mg/kg/day (oral dosing). A slight reduction 

(3-4%) in body weight gain and food consumption occurred at all doses. Skin irritation 

(erythema, desquamation, atonia, and fissure) were observed at ≥40 mg/kg/day. The effects 

ranged from slight with recovery at 2 mg/kg/day to marked and persistent at 100 and 200 

mg/kg/day. The maternal systemic toxicity NOAEL was 40 mg/kg/day based on mortality seen 

at 100 mg/kg/day and above. 

An increased incidence of resorptions occurred at ≥100 mg/kg/day. A decrease in average litter 

size (live fetuses) was observed at ≥100 mg/kg/day. The developmental toxicity NOAEL is 40 

mg/kg/day. The results of this study may not be used for risk assessment purposes since the 

effect of vehicle used in dermal application of the test material could not be assessed and sever 

skin irritation at all doses was reported. 

Range-finding Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test

In a dose range-finding study for a Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test (MRID 47731302), Ag-RHO FKC 1000 

(Batch # W17C078716) in Milli-Q water was administered by gavage to groups of three male 

and three female Han Wistar rats at doses of 0, 33, 100, 300, or 1000 mg/kg bw/day for 14 days 

before mating. The males remained on treatment throughout mating, and post-mating up to a 

total treatment time of 28 days. Females remained on treatment throughout mating and up to 

post coital day 13. Males and females in the same dose group were paired until evidence of 

mating was observed (copulatory plug or sperm in vaginal smear); the day of mating was 

designated as post coital (gestation day) 0. All animals were observed twice daily for mortality 

and once daily for clinical signs. Food consumption was measured at 3 or 4 day intervals for 

males throughout and for females during the pre-mating period and at weekly intervals during 

gestation. Body weights were measured daily in all animals. Males were sacrificed at the end of 

treatment on day 28, and surviving females were sacrificed on gestation day 14. In males, 

abnormal organs were excised and fixed; in females, the uterus was evaluated for fertility, 
Page 10 of 47 

number and distribution of implantation sites, live or dead embryos, and early and late 

embryonic deaths. The number of corpora lutea was counted; abnormal organs were fixed. 

All animals in the 1000-mg/kg/day group died within 24 hours of receiving the first dose; no 

clinical signs were observed. The remaining animals survived until termination. 

At 300 mg/kg/day, clinical sign included pushing head through the bedding after the daily dosing 

and sedation in males and females and hunched back in females. These clinical signs were 

indicative of local irritation. Food consumption was reduced by 20% in males and 29% in 

females, and weight gain during the pre-mating period was decreased by 45% in males and 63% 

in females. Males gained 38% more weight than controls during mating, and 19% more during 

the post-mating period. No effect was observed on body weight gain of females during 

gestation. The only other abnormality observed was reduced size of testes and epididymides in 

one male rat. 

At 100 mg/kg/day, the only clinical sign observed in male and female rats was pushing the head 

through the bedding after the daily dosing which was considered as secondary effects due to 

local irritation. Food consumption was reduced by 10% in males and was similar to that of 

controls in females. Weight gain was decreased by 27% in males and was unaffected in females 

during the pre-mating period; weight gain was reduced by 14% during mating and was similar to 

that of controls during the post-mating period in males. Gestational weight gain was slightly 

increased in females compared with that of controls. The NOAEL for parental systemic toxicity 

in the range finding study was 33 mg/kg/day. 

At 300 mg/kg/day, no effect was observed on the mating index. One female did not become 

pregnant, thus reducing the fertility and conception indices to 67%. There was a small, but not 

significant reduction in the mean number of corpora lutea and the mean number of live embryos; 

no dead embryos were found. The mean number of implantation sites was not affected by 

treatment. Post-implantation losses were observed (1.5/dam vs 0 in controls). 

At 33 and 100 mg/kg/day, no treatment-related reproductive or developmental effects were 

observed. The mean number of post-implantation losses was 2.0 and 1.3 at 33 and 100 

mg/kg/day, respectively. The lack of a dose-response relationship indicates that this finding is 

not treatment related. The NOAEL for reproductive and developmental toxicity in the range 

finding study was 100 mg/kg/day. 

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test (Main Study) 

In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test (MRID 47731301), Ag-RHO FKC 1000 (Batch # W17C078716) in Milli-Q 

water was administered by gavage to groups of 10 male and 10 female Han Wistar rats at doses 

of 0, 50, 150, or 300 mg/kg bw/day for 14 days before mating. Males remained on treatment 

during mating and after mating for a total of 28 days. Females remained on treatment during 

mating, gestation, and up to post partum day 4. A neurobehavioral assessment (functional 

observational battery (FOB) and locomotor assessment) was conducted prior to sacrifice at study 
Page 11 of 47 

termination. Male rats were sacrificed at the end of treatment on day 28, surviving offspring on 

post partum day 5, and females on post partum day 5 or post coital day 25 if the animals were 

not pregnant. 

No parental animals died during treatment. Treatment-related clinical signs were observed in 

both sexes in the mid-dose (pushing head through the bedding after daily treatments with the test 

material) and high-dose groups (ruffled fur, diarrhea, sedation, and salivation) throughout most 

of the study. General poor condition was noted in males in the high-dose group from pre-mating 

days 5-11. Ruffled fur, diarrhea, and sedation were observed in both sexes and general poor 

condition in males in the high-dose group during the detailed weekly clinical examination. 

These clinical signs were considered due to local irritation at 150 and 300 mg/kg/day. 

During the first 8 days of the pre-mating period, males and females in the high-dose group lost 

weight (-21 g and -11 g, respectively) and controls gained weight (22 g and 

11 g, respectively), and the high-dose group gained 88% (males) and 32% (females) less weight 

than controls overall during the pre-mating period and the males gained 28% less weight than 

controls during the mating period. The weight loss and decreased weight gain resulted in 

significantly decreased absolute body weight in males in the high-dose group throughout the 

study ranging from 8-13% less than that of controls for most of the study. Mid-dose group males 

gained 24% less weight than controls over the entire pre-mating period. Females in the highdose group weighed significantly less (5-10%) than control during pre-mating days 3-11 only. 

Food consumption was reduced in both sexes in the high-dose group during the pre-mating 

period, particularly during the first 8 days. 

No treatment-related hematological changes in either sex or clinical chemistry changes in 

females were observed in this study. The only treatment-related clinical chemistry change in 

male rats was elevated serum urea in the mid- and high-dose groups without collaborating 

histological findings at the mid dose. The post-mortem assessment showed an increase (13%) in 

relative kidney weight in males at the high dose only. There were no changes in organ weights 

considered treatment related and toxicologically significant at the remaining doses. Gross 

findings included thickened stomach in both sexes at the high-dose level and retractions in 

females at the mid- and high-dose levels. Microscopic examination showed that the stomach and 

kidneys and urinary bladder are the primary targets affected by the test substance. Treatmentrelated kidney lesions in males and females in the high-dose group included urothelial 

hyperplasia, collecting duct hyperplasia, tubular basophilia, granular casts, and mononuclear 

infiltrates in the kidneys and urothelial hyperplasia in the urinary. Granular casts were observed 

in one male at the mid-dose level. Treatment-related forestomach lesions were observed at all 

dose levels in females and in the mid- and high-dose level in males. Treatment-related lesions in 

both sexes at the high-dose level included ulcerations/erosion, squamous hyperplasia, 

hyperkeratosis, parakeratosis, pustules, submucosal inflammation, and submucosal edema. The 

same microscopic lesions were observed in the forestomach of male and female rats in the middose group and in female rats in the low-dose group. Submucosal edema was observed in one 

male in the low-dose group. No treatment-related microscopic lesions were observed in the 

glandular stomach of males, but submucosal inflammation and submucosal edema were observed 

in females at the high-dose level and submucosal edema at the mid-dose level. The remaining 

treatment-related microscopic lesions, which were considered secondary to treatment and 
Page 12 of 47 

indicative of the irritative properties of the test substance, included increased granulopoiesis in 

males at the mid- and high-dose levels and in females at all dose levels and extramedullary 

hematopoiesis in the adrenal glands in females at the high-dose level. 

The lowest-observed-adverse-effect level (LOAEL) for Ag RHO FKC 1000 for parental toxicity 

in rats is 50 mg/kg bw/day based on microscopic lesions in the forestomach. The no-observedadverse-effect level (NOAEL) could not be determined. Since the forestomach local irritation 

effects are not considered relevant for risk assessment, the NOAEL for systemic toxicity was 150 

mg/kg/day based on body weight changes, increased in blood urea, increased in kidney/body 

weight ratio, and microscopic changes in the kidneys at 300 mg/kg/day (LOAEL). 

Body weight and body weight gain of females in the high-dose group during gestation days 14-

21 was significantly decreased compared with that of controls. The decrease may be due in part 

to the increase in post-implantation losses resulting in decreased number of offspring and to a 

reduction in food consumption. No treatment-related effect was observed on the spermatogenic 

cycle in male rats. No treatment-related effects were observed on the precoital interval, gestation 

interval, or the mating, conception, fertility or gestation indices. The mean numbers of corpora 

lutea and implantation sites were reduced in the high-dose group but not significantly; the total 

(30 vs 2 in controls) and mean number of implantation losses (3.0 vs 0.3 for controls), mean 

number of live pups delivered (9.2 vs 14.5 for controls) were significantly decreased in the highdose group. The number of litters at the high-dose level with implantation losses was also 

increased (8 vs 2 for controls). Treatment-related offspring effects were observed at the highdose level; these included increased number of post-natal deaths (9 vs 0 in controls), decreased 

mean litter size on day 4 (8.3 vs 14.5 for controls), decreased birth index (75.4% vs 98.3% for 

controls), decreased viability index (90.2% vs 100% for controls), and decreased pup body 

weight. No treatment-related reproductive or developmental effects were observed in the low- or 

mid-dose groups. 

The LOAEL for reproductive/developmental toxicity in rats is 300 mg/kg bw/day based on 

increases in implantation losses, decreased birth and viability indices, and decreased pup weight. 

The NOAEL is 150 mg/kg bw/day. 

Mutagenicity studies 

In two Ames assays, S. typhimurium strains TA 98 and TA100 were exposed to ADAA in the 

presence and absence of metabolic activation. There was no increased incidence of revertants. 

No significant increase in chromosomal aberrations was observed in in vitro cytogenetics 

studies. 

Carcinogenicity 

No animal carcinogenicity studies are available in the database. Based on SAR analysis, no 

structural alerts for carcinogenicity were identified. 
Page 13 of 47 

Metabolism 

There are no published or unpublished ADAA metabolism studies. However, ADAA are 

expected to metabolized via three potential metabolic pathways: 1) omega oxidation followed by 

beta oxidation of the carbon chain, 2) conjugation of ADAA at the carboxylic acid portion of the 

molecule by any of a number of amino acids, or 3) glucuronidation at the same site on ADAA, 

followed by elimination. 

For the purpose of this risk assessment, a protective overall NOAEL of 40 mg/kg/day was 

selected for all exposure scenarios based on weight-of-evidence from three studies in which 

systemic toxicity was observed at doses of 100 mg/kg/day or above. The different NOAELs 

observed in these studies are due to the dose selection process. For example, a NOAEL of 33 

mg/kg/day and LOAEL of 100 mg/kg/day (based on pushing head through bedding, decreased 

food consumption and weight gain) were established in a range finding study for a combined 

reproduction/ developmental toxicity screening test. In the main study, Organization for 

Economic Cooperation and Development (OECD) combined repeated dose toxicity study with 

the reproduction/developmental toxicity screening test, the LOAEL was established at 50 

mg/kg/day (lowest dose tested). However, the LOAEL was based on irritation in the 

forestomach of rats due to the physical/chemical properties of ADAA, which was not considered 

relevant for human risk assessments. Also, the NOAEL of 40 mg/kg/day is considered to be 

protective of marginal decreases in body weights seen at the LOAEL of 50 mg/kg/day in the oral 

development toxicity study in rats because body weight effects were not observed in the OECD 

422 study (main study) at a dose level of 150 mg/kg/day. Additionally, this NOAEL is supported 

by the developmental dermal toxicity study in the rabbit. In this study, a NOAEL of 40 was 

established based on the effects (uncoordinated movement, partial paralysis and increased 

incidence of resorptions) observed at 100 mg/kg/day in the presence of sever skin irritation. 
Page 14 of 47 

Table 4:Toxicology Profile for ADAA 

Study Mg/kg/day NOAEL/LOAEL 

870.3650 

Combined Repeated Dose 

Toxicity Study with the 

Reproduction/Developmental 

Toxicity Screening Test 

(Range finding study) 

0, 33, 100, 300, 1000 Parental NOAEL= 33 mg/kg/day 

Parental LOAEL=100 mg/kg/day 

based on decreased body weight 

gains 

Reproductive and Offspring 

NOAEL=100 mg/kg/day 

Reproductive and Offspring =300 

mg/kg/day based on post 

implantation loss 

870.3650 

Combined Repeated Dose 

Toxicity Study with the 

Reproduction/Developmental 

Toxicity Screening Test (Main 

Study) 

0, 50, 150, or 300 mg/kg 

bw/day 

Parental systemic toxicity NOAEL= 

150 mg/kg/day 

Parental LOAEL= 300 mg/kg/day 

based on body weight changes, 

increased in blood urea, increased in 

kidney/body weight ratio, and 

microscopic changes in the kidneys. 

Reproductive and Offspring toxicity 

NOAEL=150 mg/kg/day 

Reproductive and Offspring toxicity 

LOAEL=300 mg/kg/day based on 

increases in implantation losses, 

decreased birth and viability indices, 

and decreased pup weight 

870.3700 

Oral Developmental toxicity 

study- rats 

0, 50, 150 or 250 

mg/kg/day 

Parental systemic toxicity NOAEL = 

not established 

Parental systemic toxicity LOAEL= 

50 mg/kg/day based on body weight 

changes 

Developmental toxicity NOAEL=150 

mg/kg/day 

Developmental toxicity LOAEL=250 

mg/kg/day increased incidence of 

litters with reduced ossification and 

unossification of the skull, sternabrae 

#5 and/or 6 and other sternabrae 

870.3700 

Dermal Developmental 

toxicity study- rabbits 

0, 2, 10, 20, 40,100 or 200 

mg/kg/day 

Parental systemic toxicity NOAEL = 

40 mg/kg/day 

Parental LOAEL= 100 mg/kg/day 

based on mortality 

Developmental toxicity NOAEL=40 

mg/kg/day 

Developmental Toxicity 

LOAEL=100 mg/kg/day based on 

resorption and decrease in litter size 
Page 15 of 47 

Toxicity Endpoint Selection

Table 5: Summary of Toxicological Doses and Endpoints for AADA for Use in Human 

Health Risk Assessment 

Exposure/Scenario Point of Departure and 

Uncertainty/Safety 

Factors 

RfD, PAD, 

LOC for Risk 

Assessment 

Study and Toxicological 

Effects 

Acute dietary 

(General population 

including infants and 

children) 

The Agency notes that surfactants are surface active materials that can 

damage the structural integrity of cellular membranes at high dose 

levels. Moderate acute toxicity is associated with c12-ADAA. 

However, these effects are considered local irritations rather than 

systemic toxicity. Therefore, this endpoint is not appropriate for risk 

assessment. In addition, no endpoint of concern attributed to a single 

dose was identified in the database. 

Chronic dietary 

(All populations) 

NOAEL= [40 ]

mg/kg/day UFA = [10 ]x 

UFH = [10 ]x 

FQPA SF = [11x 

Chronic RfD = 

[0.4 ]

mg/kg/day 

cPAD = [0.4 ]

mg/kg/day 

Overall NOAEL based on 

three studies 

OECD 422 range finding 

and main study 

Developmental toxicity 

study in rabbits via 

dermal route, Oral 

developmental toxicity 

study in rats 

Incidental oral 

short-and 

intermediate term 

(1 to 30 days) 

 (1 to 6 months) 

NOAEL= [40 ]

mg/kg/day UFA = [10 ]x 

UFH = [10 ]x 

FQPA SF = [11x 

LOC for MOE 

= [100 ]

Overall NOAEL based on 

three studies 

OECD 422 range finding 

and main study 

Developmental toxicity 

study in rabbits via 

dermal route, Oral 

developmental toxicity 

study in rats 

Dermal short- and 

intermediate term 

(1 to 30 days) 

 (1 to 6 months) 

NOAEL= [40 ]

mg/kg/day UFA = [10 ]x 

UFH = [10 ]x 

FQPA SF = [11x 

10% dermal absorption 

factor 

LOC for MOE 

= [100 ]

Overall NOAEL based on 

three studies 

OECD 422 range finding 

and main study 

Developmental toxicity 

study in rabbits via 

dermal route, Oral 

developmental toxicity 

study in rats 
Page 16 of 47 

Inhalation shortand intermediate 

term 

(1 to 30 days) 

 (1 to 6 months) 

100% inhalation 

absorption 

LOC for MOE 

= [100]

Overall NOAEL based on 

three studies 

OECD 422 range finding 

and main study 

Developmental toxicity 

study in rabbits via 

dermal route, Oral 

developmental toxicity 

study in rats 

Cancer (Oral, 

dermal, inhalation) 

Not necessary. No cancer concerns were identified.

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 data or other data deficiency. FQPA SF 

= Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = 

reference dose. MOE = margin of exposure. LOC = level of concern.

VI. Special Considerations for Infants and Children 

Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) 

margin of safety for infants and children in the case of threshold effects to account for prenatal 

and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA 

determines, based on reliable data, that a different margin of safety will be safe for infants and 

children. This additional margin of safety is commonly referred to as the Food Quality 

Protection Act (FQPA) safety factor (SF). In applying this provision, EPA either retains the 

default value of 10X, or uses a different additional safety factor when reliable data is available to 

EPA to support the choice of a different factor. EPA concluded that the FQPA safety factor 

should be reduced to 1 X for ADAA. 

There was no evidence of increased susceptibility of infants and children in the available 

developmental toxicity studies via dermal and oral routes of exposure. In these studies, 

developmental toxicity was observed in the presence of maternal toxicity and/or at one dose level 

higher. There was no evidence of increased susceptibility of infants and children in the OPPTS 

870.3650 study (OECD 422) study. In this study, the maternal toxicity was manifested as body 

weight changes and microscopic changes, while the fetal toxicity was manifested as increased 

implantation losses and decreased pup weight. The maternal and developmental NOAEL was 

150 mg/kg/day. 

EPA has determined that reliable data show that the safety of infants and children would be 

adequately protected if the FQPA SF were reduced to 1X. That decision is based on the 

following findings: 

i.The database is considered adequate for FQPA assessment. The following acceptable 

studies are available: 
Page 17 of 47 

Developmental toxicity study in rats (1) 

Developmental dermal toxicity study in rabbits 

Combined development/reproduction repeated dose toxicity study (1) 

ii. Fetal susceptibility was not observed in the oral developmental toxicity study in the rat, 

the developmental dermal toxicity study in the rabbit or in the OPPTS Harmonized Test 

Guideline 870.3650 study. In these studies, fetal toxicity was observed at doses that were 

higher than the dose that caused maternal toxicity. Therefore, there are low concerns or 

residual uncertainties concerning pre- and postnatal toxicity. 

iii. Clinical signs of neurotoxicity (uncoordinated movement, partial paralysis) were 

observed in the developmental dermal study in the rabbit. However, no effects on 

Functional Observation Battery (FOB) parameters were observed at doses up to and 

including 300 mg/kg/day in the OPPTS 870.3650 (OECD 422 study). Therefore, EPA 

concluded that the developmental neurotoxicity study is not required. 

iv. No evidence of immunotoxicity was observed in the database. 

v. No chronic toxicity or carcinogenicity studies are available in the database, however the 

Agency notes that surfactants are surface-active materials that can damage the structural 

integrity of cellular membranes at high dose levels. Thus, surfactants are often corrosive 

and irritating in concentrated solutions. The observed toxicity seen in the repeated dose 

studies, such as microscopic lesions or decreased body weigh gain, are attributed to the 

corrosive and irritating nature of these surfactants. The Agency has considerable toxicity 

information on surfactants, which indicates that the effects do not progressively increase in 

severity over time. In addition, use of the full 10X interspecies factor will actually provide 

an additional margin of safety because it is not expected that humans' response to local 

irritation/corrosiveness effects would be markedly different from animals. The database 

on ADAA indicates that the target organ toxicity is occurring at relatively high doses. 

Based on the above consideration, the Agency concluded that an additional FQPA safety 

factor for the lack of a chronic study is not necessary. 

vi. The dietary food exposure assessment utilizes highly conservative default assumptions 

and would not underestimate the dietary risk to all populations. For the purpose of the 

screening level dietary risk assessment to support this request for an exemption from the 

requirement of a tolerance for ADAA, a value of 100 ppb based on screening level 

modeling was used for the chronic dietary risk assessment. The value of 100 ppb is 

considered to be a high end, conservative assumption that is not likely to underestimate 

drinking water risks. 

Taking into consideration the available information, EPA concludes the additional 10X FQPA 

safety factor can be reduced to 1X. 
Page 18 of 47 

VII. Endocrine Disruption 

EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by 

FQPA, to develop a screening program to determine whether certain substances (including all 

pesticide active and other ingredients) “may have an effect in humans that is similar to an effect 

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

may designate.” Following recommendations of its Endocrine Disruptor and Testing Advisory 

Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of 

the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone 

system. EPA also adopted EDSTAC’s recommendation that the Program include evaluations of 

potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that 

effects in wildlife may help determine whether a substance may have an effect in humans, 

FFDCA authority to require the wildlife evaluations. As the science develops and resources 

allow, screening of additional hormone systems may be added to the Endocrine Disruptor 

Screening Program (EDSP). 

When additional appropriate screening and/or testing protocols being considered under the 

Agency’s EDSP have been developed, ADAA may be subjected to further screening and/or 

testing to better characterize effects related to endocrine disruption. 

VIII. Exposure Assessment 

A. Dietary Exposure 

In evaluating dietary exposure to ADAA, EPA considered exposure under the petitioned for 

exemptions from the requirement of a tolerance. EPA assessed dietary exposure from ADAA in 

food as follows: 

*Residues of Concern 

Sufficient data were provided on the chemical identity of ADAA, however, limited data are 

available on the metabolism and environmental degradation of these compounds. The Agency 

relied collectively on information provided on the representative chemical structures, the 

submitted physicochemical EPI SuiteTMdata, structure activity relationship information, as well 

as information on other surfactants and chemicals of similar size and functionality to determine 

the residues of concern for these inert ingredients. The residues of concern for risk assessment 

purposes are the parent compounds only.

*Quantification of Dietary Risk 

* Acute 

The Agency notes the surfactants are surface-active materials that can damage the structural 

integrity of cellular membranes at high dose levels. Moderate acute toxicity is associated with 

C12-ADAA. However, these effects are considered local irritations rather than systemic 

toxicity. Therefore, this endpoint is not appropriate for risk assessment. In addition, no endpoint 

of concern attributed to a single dose was identified in the database.
Page 19 of 47 

* Chronic 

In conducting the chronic dietary exposure assessment, EPA used food consumption information 

from the United States Department of Agriculture (USDA) [1994–1996 and 1998] Nationwide 

Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no 

residue data were submitted for ADAA. In the absence of specific residue data, EPA has 

developed an approach, which uses surrogate information to derive upper bound exposure 

estimates for the subject inert ingredient. Upper bound exposure estimates are based on the 

highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and 

fungicides. A complete description of the general approach taken to assess inert ingredient risks 

in the absence of residue data is contained in the memorandum entitled “Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary 

Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738. 

In the dietary exposure assessment, the Agency assumed that the residue level of the inert 

ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this 

assumption is that there would be similar rates of degradation (if any) between the active and 

inert ingredient and that the concentration of inert ingredient in the scenarios leading to these 

highest of tolerances would be no higher than the concentration of the active ingredient. 

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely 

conservative assessment of dietary risk due to a series of compounded conservatisms. First, 

assuming that the level of residue for an inert ingredient is equal to the level of residue for the 

active ingredient will overstate exposure. The concentrations of active ingredient in agricultural 

products is generally at least 50 percent of the product and often can be much higher. Further, 

pesticide products rarely have a single inert ingredient; rather there is generally a combination of 

different inert ingredients used which additionally reduces the concentration of any single inert 

ingredient in the pesticide product in relation to that of the active ingredient. In the case of 

ADAA, EPA made a specific adjustment to the dietary exposure assessment to account for the 

use limitations of the amount of ADAA that may be in formulations (no more than 20% by 

weight in pesticide formulations) and assumed that ADAA are present at the maximum 

limitation rather than at equal quantities with the active ingredient. This remains a very 

conservative assumption because surfactants are generally used at levels far below this 

percentage. 

Second, the conservatism of this methodology is compounded by EPA’s decision to assume that, 

for each commodity, the active ingredient which will serve as a guide to the potential level of 

inert ingredient residues is the active ingredient with the highest tolerance level. This 

assumption overstates residue values because it would be highly unlikely, given the high number 

of inert ingredients, that a single inert ingredient or class of ingredients would be present at the 

level of the active ingredient in the highest tolerance for every commodity. Finally, a third 

compounding conservatism is EPA’s assumption that all foods contain the inert ingredient at the 

highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with 

the inert ingredient at the rate and manner necessary to produce the highest residue legally 

possible for an active ingredient. In summary, EPA chose a very conservative method for 
Page 20 of 47 

estimating what level of inert residue could be on food, then used this methodology to choose the 

highest possible residue that could be found on food and assumed that all food contained this 

residue. No consideration was given to potential degradation between harvest and consumption 

even though monitoring data shows that tolerance level residues are typically one to two orders 

of magnitude higher than actual residues in food when distributed in commerce. 

Accordingly, although sufficient information to quantify actual residue levels in food is not 

available, the compounding of these conservative assumptions will lead to a significant 

exaggeration of actual exposures. EPA does not believe that this approach underestimates 

exposure in the absence of residue data. 

* Cancer 

ADAA is not expected to be carcinogenic since there was no evidence of carcinogenicity in the 

available studies. Since the Agency has not identified any concerns for carcinogenicity relating 

to ADAA, a cancer dietary exposure assessment was not conducted. 

*Drinking Water Residue Profile 

For the purpose of the screening level dietary risk assessment to support this request for an 

exemption from the requirement of a tolerance for ADAA, a conservative drinking water 

concentration value of 100 ppb, based on screening level modeling, was used to assess the 

contribution to drinking water for the chronic dietary risk assessments for parent compound. 

These values were directly entered into the dietary exposure model. 

B. Non-Dietary Exposure 

The term “residential exposure” is used in this document to refer to non-occupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and 

flea and tick control on pets). ADAA may be used as inert ingredients in pesticide products that 

are registered for specific uses that may result in both indoor and outdoor residential exposures. 

A screening level residential exposure and risk assessment was completed for products 

containing ADAA as inert ingredients. The ADAA inerts are used in pesticide formulations that 

may be used around the home in pesticide formulations used on lawn, turf, or gardens. In 

addition, these inerts may be present in personal care products. The Agency selected 

representative scenarios and conducted an assessment to represent worst-case residential 

exposure by assessing ADAA in pesticide formulations (outdoor scenarios) and ADAA in 

disinfectant-type uses (indoor scenarios). Based on information contained in the petition, ADAA 

can be present in personal care products (maximum concentration 5%). Therefore, the Agency 

assessed the personal care products containing ADAA using exposure scenarios used by OPP’s 

Antimicrobials Division to represent worst-case residential handler exposure. The Agency 

conducted an assessment to represent worst-case residential exposure by assessing post 

application exposures and risks from ADAA in pesticide formulations (Outdoor Scenarios) and 

ADAA in disinfectant-type uses (Indoor Scenarios). All estimated MOEs were below the level 

of concern for RD. Further details of this residential exposure and risk analysis can be found at 

http://www.regulations.gov in the memorandum entitled JITF Inert Ingredients. Residential 

and Occupational Exposure Assessment Algorithms and Assumptions Appendix for the Human 

Health Risk Assessments to Support Proposed Exemption from the Requirement of a Tolerance 
Page 21 of 47 

When Used as Inert Ingredients in Pesticide Formulations” (D364751, 5/7/09, Lloyd/LaMay in 

docket ID number EPA-HQ-OPP-2008-0710.

IX. Cumulative Exposure 

Section 408(b)(2)(D)(v) of FFFDCA requires that, when considering whether to establish, 

modify, or revoke a tolerance, the Agency consider “available information” concerning the 

cumulative effects of a particular pesticide’s residues and “other substances that have a common 

mechanism of toxicity.” 

Unlike other pesticide ingredients for which EPA has followed as cumulative risk approach 

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

finding as to ADAA acetate and any other substances and, ADAA 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 ADAA 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/. 

X. Occupational Exposure 

Occupational handler risks are not of concern for all scenarios except for workers using a low 

pressure hand wand to apply pesticides containing ADAA to ornamentals in greenhouse settings. 

Since MOEs for workers applying pesticides to ornamentals in greenhouses do not exceed an 

MOE of 100, the Agency has provided additional exposure and risk estimates reflecting reduced 

amounts of ADAA in all pesticide formulations. The Agency does not believe that it is routine 

for workers to wear gloves for these scenarios. MOEs exceed 100 at a concentration of 20% 

ADAA as an inert ingredient is pesticide formulations. A more complete list of results can be 

found in Appendix C. 

The Agency notes that that the occupational handler assessment assumes that 

mixer/loader/applicators who are handling pesticides containing ADAA for aerial and ground 

application on high acreage crops or turf will wear chemical resistant gloves. The Agency 

believes this is a reasonable assumption given the volume of pesticide handled for these 

applications. 

Occupational post application handler risks exceed and MOE of 100 on the day of application for 

all scenarios except for postapplication activities involving herbicides, insecticide and fungicides 

on corn, specifically the hand-harvesting/detassling scenario. Those scenarios results an MOE of 

44, 46 and 92 respectively on the day of application (Day 0). The Agency notes that it is not 

expected to be typical agricultural practice to apply herbicides, insecticides or fungicides on the 

same day workers would be conducting hand harvesting and detassling activities. 
Page 22 of 47 

XI. Environmental Justice Statement 

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.. 

XII. Environmental Fate and Drinking Water Consideration 

The estimated physical and chemical properties for ADAA listed in Table 2 provide the basis for 

the environmental fate consideration of this chemical in regards to its use as an inert ingredient in 

pesticide products. All the values in the table were estimated using EPI SuiteTM. 

The octanol-water partition coefficient (log Kow) indicates whether a chemical is hydrophilic or 

lipophilic in an aquatic environment. The estimated log Kow values range from 0.47 to 4.44, 

indicating that ADAA has a similar affinity for water and lipids to a slightly higher affinity for 

lipids than water and is not likely to bioconcentrate. Water solubility was estimated at 0.29 -

0.0025 mg/l, indicating that the subject chemical is slightly soluble. However, due to model 

constraints it is believed that EPI SuiteTM underestimates the water solubility of this chemical. 

The estimated values for melting point (222-243oC) and boiling point (520-566 oC) are high. 

These two factors, in combination with the predicted vapor pressure (6.88E-11-2.42E-12 mmHg 

at 25 oC) indicate that the subject chemical exists primarily as a solid. The low Henry’s Law 

Constant (1.4E-14-2.74-E-15 atm-m3/mole at 25 oC) also indicates that ADAA is not likely to 

volatilize from surface water. 

The Organic Carbon Absorption Coefficient (Log Koc) values demonstrate the likelihood of a 

chemical to partition to soil or sediment from water. The estimated log Koc values (2.8 to 3.8) 

of ADAA suggest sorption to soils and sediments may occur and are not likely to enter 

groundwater. 

The probability of rapid biodegradation was estimated using methods and modules within EPI 

SuiteTM. In general, values greater than 0.5 indicate rapid biodegradation or that the test material 

is readily degradable, while values less than 0.5 indicate “not rapid biodegradation” or that the 

test material is not readily biodegradable. (EPA, 2005) The estimated values for probability of 

rapid biodegradation are listed in Table 2 and all indicate that ADAA is likely to undergo rapid 

biodegradation and that it is readily degradable. 

The potential for ADAA to bioconcentrate in aquatic organisms was determined by EPI SuiteTM. 

The bioconcentration factor (BCF) is the ratio (in L/kg) of a chemical’s concentration in the 

tissue of an aquatic organism to it concentration in ambient water, when exposure of the 

organism is to waterborne chemicals only, not including dietary intake. (EPA, 2005) Measured 

values that are greater than or equal to 5000 are considered to have high bioconcentration 

potential, 1000-5000 are moderate, and less than 1000 are considered low. Since the estimated 

value for ADAA is 70.78, this indicates that ADAA is not expected to bioconcentrate in aquatic 

organisms. 
Page 23 of 47 

The fugacity model within EPI SuiteTM provides screening level predictions of environmental 

partitioning (percent in each media) of chemicals between air, soil, sediment, and water under 

steady state conditions for a default model “environment”. This information is useful in 

determining where a chemical is most likely to reside once it has been released to the 

environment. (EPA, 2005) The estimated values for ADAA indicate that once the chemical is 

released to the environment, 81.2-83.0% would reside in soil, 0.321-3.25% would reside in 

sediment and 1.64 E-5 to .0000119% would be in the air. 

The EPI SuiteTM estimated values for the physical and chemical properties of ADAA indicate 

that it will have minimal impact on the environment. The results indicate that ADAA is not 

likely to bioconcentrate and is readily biodegradable. It is also not likely to volatilize from 

surface water. ADAA is expected to partition primarily to soil, but the small amounts that enter 

the water will readily degrade. 

XIII. Ecological Assessment 

The ecotoxicity of ADAA was estimated using Ecological Structure Activity Relationships 

(ECOSAR). ECOSAR is a computerized predictive system that estimates the aquatic toxicity of 

industrial chemicals. The program estimates a chemical's acute (short-term) toxicity and chronic 

(long-term or delayed) toxicity to aquatic organisms such as fish, aquatic invertebrates, and 

aquatic plants by using Structure Activity Relationships (SARs). 

(http://www.epa.gov/oppt/newchems/tools/21ecosar.htm) 

The estimated ecotoxicity values for C12-ADAA, C14-ADAA and C16-ADAA are listed in 

Tables 6, 7, and 8. The results indicate that the ecotoxicity of ADAA ranges from practically 

nontoxic to slightly toxic. 

Table 6: ECOSAR Predicted Calculations for C12-ADAA (CAS Reg. No. 683-10-3) 

Organism Duration End Point Predicted mg/L 

(ppm) 

Fish 96-hr LC50 805.746* 

Fish 14-day LC50 820.957* 

Daphnid 48-hr LC50 487.380* 

Green Algae 96-hr EC50 284.300 

Fish 30-day ChV 86.658* 

Daphnid ChV 60.914 

Green Algae ChV 117.581 

Fish (SW) 96-hr LC50 1080.529* 

Mysid Shrimp 96-hr LC50 572.753* 

Fish (SW) ChV 154.155 

Mysid Shrimp (SW) ChV 43.012 

Earthworm 14-day LC50 4245.049* 

* Asterisk designates: Chemical may not be soluble enough to measure this predicted effect 
Page 24 of 47 

Table 7: ECOSAR Predicted Calculations for C14-ADAA (CAS Reg. No. 2601-33-4) 

Organism Duration End Point Predicted mg/L 

(ppm) 

Fish 96-hr LC50 

121.443* 

Fish 14-day LC50 125.710* 

Daphnid 48-hr LC50 84.938* 

Green Algae 96-hr EC50 75.902* 

Fish 30-day ChV 13.950 

Daphnid ChV 12.403 

Green Algae ChV 39.976* 

Fish (SW) 96-hr LC50 151.147* 

Mysid Shrimp 96-hr LC50 42.841* 

Fish (SW) ChV 40.859* 

Mysid Shrimp (SW) ChV 2.405 

Earthworm 14-day LC50 3702.048* 

* Asterisk designates: Chemical may not be soluble enough to measure this predicted effect 

Table 8: ECOSAR Predicted Calculations for C16-ADAA (CAS Reg. No. 693-33-4) 

Organism Duration End Point Predicted mg/L 

(ppm) 

Fish 96-hr LC50 

18.146* 

Fish 14-day LC50 19.083* 

Daphnid 48-hr LC50 14.674* 

Green Algae 96-hr EC50 20.089* 

Fish 30-day ChV 2.226 

Daphnid ChV 2.504 

Green Algae ChV 11.528* 

Fish (SW) 96-hr LC50 20.960* 

Mysid Shrimp 96-hr LC50 3.177 

Fish (SW) ChV 10.736* 

Mysid Shrimp (SW) ChV 0.133 

Earthworm 14-day LC50 3200.555* 

* Asterisk designates: Chemical may not be soluble enough to measure this predicted effect 

XIV. Risk Characterization 

Rhodia Inc. submitted a petition (#9E7557) proposing to establish an exemption from the 

requirement of a tolerance under 40 CFR 180.920 (pre-harvest) and 40 CFR 180.930 (animal 

application) for residues of ADAA when used as a pesticide inert ingredient, with a limit of up to 

20% in pesticide formulations. 
Page 25 of 47 

Currently, two of the CAS Reg. Nos. (CAS Reg. Nos. 2601-33-4 and 693-33-4) for which 

Rhodia is requesting tolerance exemptions, are on the list for Inert Ingredients Permitted for Use 

in Nonfood Use Pesticide Products. The components of ADAA are used in personal care 

products including liquid hand soaps, facial cleansers, shampoos and shower gels. These 

components function as foam boosters and typically used in these products at concentrations up 

to 5%. (Mintel GNPD Database, 2009; Wong, 1997) 

Acute oral toxicity studies were performed using C12-ADAA and C16-ADAA. ADAA has 

moderate to low acute toxicity via the oral and dermal routes of exposure. Low acute toxicity is 

generally associated with C16-ADAA while moderate acute toxicity is associated with C12-

ADAA. In acute dermal and eye irritation studies, C12-ADAA was severely irritating to the skin 

and eyes. A mixture of C12-C16 ADAA was used in a local lymph node assay (LLNA) to 

evaluate the potential to cause skin sensitization, C12-C16 ADAA was found to be a sensitizer; 

however, it gave a negative response for skin sensitization in in vivo guinea pigs as determined 

by Magnusson-Kligman test. 

Two developmental studies were available; an oral toxicity study in the rat and a screening level 

developmental dermal toxicity study in the rabbit. In the developmental toxicity study in the rat, 

maternal toxicity was manifested as reduced body weight gain, stained and matted haircoats, 

respiratory rates at 50 mg/kg/day and above. Offspring toxicity was manifested as reduced or 

absent ossification of the skull, sternebrae #5 and/or #6, and other sternebrae at 250 mg/kg/day. 

The NOAEL for developmental toxicity was 150 mg/kg/day. In the screening level 

developmental dermal toxicity study in rabbits, maternal toxicity manifested as skin irritation, 

inhibition of body weight gain and decreased food consumption at doses of 100 mg/kg/day and 

above while offspring toxicity was manifested as increased incidence of resorptions and 

decreased average litter size at ≥ 100 mg/kg/day. 

A dose range-finding and a main study of Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test according to the OPPTS Harmonized Test 

Guideline 870.3650 study were available in the rat. In the range-finding study, at >100 

mg/kg/day , a reduction was observed in mean food consumption, body weight, and body weight 

gain during the pre-pairing period in all animals. Also, animals pushed their heads through the 

bedding throughout the treatment period at doses >100 mg/kg/day. At 1000 mg/kg/d, mortality 

was observed in all animals within 24 hours. In the main OPPTS Harmonized Test Guideline 

870.3650 study, parental toxicity was manifested as microscopic lesions (squamous hyperplasia, 

hyperkeratosis, submucosal inflammation and edema) in the forestomach at the lowest dose 

tested (50 mg/kg/day). Reproductive and developmental toxicity was manifested as increased 

implantation losses, decreased birth and viability indices, and decreased pup weight at 300 

mg/kg/day (highest dose tested). The NOAEL for reproductive/developmental toxicity was 150 

mg/kg/day. 

Several mutagenicity studies (two Ames assays and chromosome aberration assay) were 

available for review. The results for these studies were negative. No animal carcinogenicity 

studies are available in the database. Based on SAR analysis, no structural alerts for 

carcinogenicity were identified. 
Page 26 of 47 

Two in vitro dermal absorption studies were available in hairless mice. The dermal absorption 

factor of C12-ADAA and C16-ADAA was estimated to be <1%. 

There are no published or unpublished ADAA metabolism studies. However, ADAA are 

expected to metabolized via three potential metabolic pathways: 1) omega oxidation followed by 

beta oxidation of the carbon chain, 2) conjugation of ADAA at the carboxylic acid portion of the 

molecule by any of a number of amino acids, or 3) glucuronidation at the same site on ADAA, 

followed by elimination. 

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate 

exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe 

exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by 

dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability 

of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and 

chronic-term risks are evaluated by comparing the estimated aggregate food, water, and 

residential exposure to the POD to ensure that the MOE called for by the product of all 

applicable UFs is not exceeded. 

There was no hazard attributable to a single exposure seen in the toxicity database for ADAA. 

Therefore ADAA is not expected to pose an acute risk. 

A chronic aggregate risk assessment takes into account exposure estimates from chronic dietary 

consumption of food and drinking water. Using the exposure assumptions discussed in this unit 

for chronic exposure and the use limitation of not more than 20% by weight in pesticide 

formulations, the chronic dietary exposure from food and water to ADAA is 19.5% of the cPAD 

for the U.S. population and 62.9% of the cPAD for children 1-2 years old, the most highly 

exposed population subgroup. A more complete list of results can be found in Appendix A. 

The Agency has not identified any concerns for carcinogenicity relating to ADAA.

Short-term aggregate exposure takes into account short-term residential exposure plus chronic 

exposure to food and water (considered to be a background exposure level). ADAA are used as 

inert ingredients in pesticide products that are currently registered for uses that could result in 

short-term residential exposure and the Agency has determined that it is appropriate to aggregate 

chronic exposure through food and water with short-term residential exposures to ADAA. Using 

the exposure assumptions described in this unit, EPA has concluded that the combined shortterm aggregated food, water, and residential exposures result in aggregate MOEs of 110 for adult 

males and adult females. Adult residential exposure combines high end dermal and inhalation 

handler exposure from indoor hard surface wiping with a high end post application dermal 

exposure from contact with treated lawns. EPA has concluded the combined short-term 

aggregated food, water, and residential exposures result in an aggregate MOE of 130 for 

children. Children’s residential exposure includes total exposures associated with contact with 

treated lawns (dermal and hand-to-mouth exposures). As the level of concern is for MOEs that 

are lower than 100, these MOEs are not of concern.
Page 27 of 47 

Intermediate-term aggregate exposure takes into account intermediate-term residential exposure 

plus chronic exposure to food and water (considered to be a background exposure level). ADAA 

are currently registered for uses that could result in intermediate -term residential exposure and 

the Agency has determined that it is appropriate to aggregate chronic exposure through food and 

water with intermediate-term residential exposures to ADAA. Using the exposure assumptions 

described in this unit, EPA has concluded that the combined intermediate-term aggregated food, 

water, and residential exposures result in aggregate MOEs of 450 for adult males and adult 

females. Adult residential exposure includes high end post application dermal exposure from 

contact with treated lawns. EPA has concluded the combined intermediate-term aggregated 

food, water, and residential exposures result in an aggregate MOE of 150 for children. Children’s 

residential exposure includes total exposures associated with contact with treated lawns (dermal 

and hand-to-mouth exposures). As the level of concern is for MOEs that are lower than 100, this 

MOE is not of concern. 

A more complete list of results for aggregate exposure to ADAA can be found in Appendix B. 

Taking into consideration all available information on ADAA, EPA concludes that there is a 

reasonable certainty that no harm will result to the general population or to infants and children 

from aggregate exposure to ADAA. Therefore, the establishment of an exemption from the 

requirement of a for residues of ADAA when used as an inert ingredient (surfactant) in pesticide 

formulations at a maximum of 20% in formulation when applied pre-harvest under 40 CFR 

180.920 and when applied to animals under 40 CFR 180.930 can be considered safe under 

section 408 of the FFDCA. 
Page 28 of 47 

References 

ChemIDplus Lite. Search date: August 10, 2009. 

http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

Maynard, C.W. 1963. Haskell Laboratory. Report 3385. Sponsored by E.I. DuPont de Nemours 

& Co. June 13, 1963. EPA TSCA No. 8EHQ-1092-12353. 

Mintel GNPD Database Search, 2009. http://www.gnpd.com/

Subscription service database contains personal car product names, brands and ingredients. 

Search date: April 2, 2009. (As cited in PP#9E7557) 

Pelcot, C. 2006. CIT Safety and Health Research Laboratories. July 26, 2006. Lab study no. 

31597 TSG. 

Ridout, G., Hinz, R.S., Hostynek, JJ., Reddy, A.K., Wiersema, R.J., Hodson, C.D., Lorence, C.R. 

Guy, R.H. 1991. Fundam.Appl. Toxicol. 16:41-50. 

Simon, G. (2009) Copies of Studies Cited in "Petition Proposing an Exemption from the 

Requirement of a Tolerance for Residues of (Inert Ingredient) under 40 CFR 180.920 and 

180.930. Project Number: 040809. Unpublished study prepared by Rhodia, Inc. 480 p. (MRID 

47731303) 

Technology Sciences Group, Inc. (on behalf of Rhodia, Inc.) 2009. Petition Proposing an 

Exemption from the Requirement of a Tolerance for Residues of “Alkyl (C12-C16) Dimethyl 

Ammonio Acetate (ADAA)” under 40 CFR 180.920 and 180.930. (US EPA Petition #9E7557) 

US EPA. 2009. Estimation Programs Interface SuiteTM for Microsoft Windows, v 4.00. United 

States Environmental Protection Agency, Washington, DC, USA. 

http://www.epa.gov/oppt/exposure/pubs/episuite.htm

US EPA. 2009. Ecological Structure Activity Relationships (ECOSAR) Class Program

http://www.epa.gov/oppt/newchems/tools/21ecosar.htm

US EPA. 2009. Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products Last 

Updated January 27, 2009. http://www.epa.gov/opprd001/inerts/inert_nonfooduse.pdf

US EPA. 2005. OPPTS Pollution Prevention P2 Framework, 748-B-04-001-2005. 

http://www.epa.gov/oppt/sf/pubs/p2frame-june05a2.pdf

Wang-Fan, W. 2005. RCC Ltd., Study no. 859355. August 30, 2005. 

Whitlow, S.; Flade, D.; Thio, T. (2009) Ag-RHO FKC 1000: Combined Repeated Dose Toxicity 

Study with the Reproduction / Developmental Toxicity Screening Test in the Han Wistar Rat: 

Final Report. Project Number: B62774. Unpublished study prepared by Harlan Laboratories, 

Ltd. 579 p. (MRID 47731301) 
Page 29 of 47 

Whitlow, S.; Flade, D. (2008) Ag-RHO FKC 1000: Dose Range-Finding Study for a Combined 

Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in 

the Han Wistar Rat. Project Number: B62763. Unpublished study prepared by RCC, Ltd. 212 p. 

(MRID 47731302) 

Wong, M. 1997. “Cleansing of Hair.” In Hair and Hair Care. E. Dale H. Johnson. Marcel 

Dekker, Inc.: 1997. PP. 48. 49, 52-54. 

“Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and 

can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738. 

JITF Inert Ingredients. Residential and Occupational Exposure Assessment Algorithms and 

Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption 

from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” 

(D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710. 
Page 30 of 47 

Appendices
Page 31 of 47 

Appendix A: 

U.S. Environmental Protection Agency 

Ver. 2.00 

DEEM-FCID Chronic analysis for ADAA DEEM 

(1994-98 data) 

Residue file name: C:\DEEMFCID\ADAA (20 percent limit) DEEM.R98 

 

Adjustment factor #2 used. 

Analysis Date 09-14-2009/14:07:00 

Residue file dated: 09-14-2009/13:55:06/8 

Reference dose (RfD, Chronic) = .4 mg/kg bw/day 

NOEL (Chronic) = 40 mg/kg bw/day 

COMMENT 1: Inert 57 active ingredients + drinking water (100ppb) for ADAA (limit 20% in 

formulation) 

=============================================================================== 

 Total exposure by population subgroup 

------------------------------------------------------------------------------- 

 Total Exposure 

 ----------------------------------- 

 Population mg/kg Margin of Percent 

 Subgroup body wt/day Exposure 1/ of RfD 

-------------------------------------- ------------- ---------- --------- 

U.S. Population (total) 0.077868 514 19.5% 

U.S. Population (spring season) 0.079459 503 19.9% 

U.S. Population (summer season) 0.078852 507 19.7% 

U.S. Population (autumn season) 0.076480 523 19.1% 

U.S. Population (winter season) 0.076718 521 19.2% 

Northeast region 0.084453 474 21.1% 

Midwest region 0.077463 516 19.4% 

Southern region 0.069793 573 17.4% 

Western region 0.085214 469 21.3% 

Hispanics 0.082115 487 20.5% 

Non-hispanic whites 0.076323 524 19.1% 

Non-hispanic blacks 0.075316 531 18.8% 

Non-hisp/non-white/non-black 0.100337 399 25.1% 

All infants (< 1 year) 0.162979 245 40.7% 

Nursing infants 0.086622 462 21.7% 

Non-nursing infants 0.191967 208 48.0% 

Children 1-6 yrs 0.200100 200 50.0% 

Children 7-12 yrs 0.097084 412 24.3% 

Females 13-19 (not preg or nursing) 0.056466 708 14.1% 

Females 20+ (not preg or nursing) 0.060979 656 15.2% 

Females 13-50 yrs 0.063033 635 15.8% 

Females 13+ (preg/not nursing) 0.066766 599 16.7% 

Females 13+ (nursing) 0.078789 508 19.7% 

Males 13-19 yrs 0.060208 664 15.1% 

Males 20+ yrs 0.058790 680 14.7% 

Seniors 55+ 0.062214 643 15.6% 

Children 1-2 yrs 0.251480 159 62.9% 

Children 3-5 yrs 0.186542 214 46.6% 

Children 6-12 yrs 0.103337 387 25.8% 

Youth 13-19 yrs 0.058563 683 14.6% 

Adults 20-49 yrs 0.058941 679 14.7% 

Adults 50+ yrs 0.062073 644 15.5% 

Females 13-49 yrs 0.059332 674 14.8% 

---------------------------------------------------------------------- 
Page 32 of 47 

Appendix B: 

Table 1. Short-term Exposure and Risks for ADAA Residential Handlers 

Exposure 

Scenario 

(Formulation/ 

Application)

Application 

Rate1 (lb 

inert/ 

gallon) 

Quantity 

Handled/ 

Treated 

per day2

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(mg/ lb 

inert)3

Dermal 

Dose 

(mg/kg 

/day)4

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Outdoor Products 

Liquids/ Low 

Pressure 

Handwand (ST) 

(ORETF data) 

0.18 lb/gal 5 

gallons 38 0.003 0.049 3.86E-5 820 1000000 820 

Liquids/ Hose End 

Sprayer, Lawn 

(ST) 

(ORETF data) 

0.18 lb/gal 5 

gallons 11 0.017 0.014 0.00022 2800 180000 2800 

Liquids/ Trigger 

Sprayer/ Home 

Garden (ST) 

(ORETF data) 

0.18 lb/gal 5 

gallons 54 0.0019 0.069 2.44E-5 580 1600000 580 

Indoor Products 

Indoor hard 

surface, Mopping 

(ST) 

(CMA data) 

0.0065 

lb/gal 1 gallon 71.6 2.38 0.00067 0.00022 60,000 180,000 45,000 

Indoor hard 

surface, Wiping 

(ST) 

(CMA data) 

0.417 

lb/gal 

0.13 

gallons 2870 67.3 0.2223 0.05212 180 770 150 

Indoor hard 

surface, Aerosol 

spray (ST) 

(PHED data) 

0.417 

lb/gal 

0.094 

gallons 

(12 oz) 

220 2.4 0.0123 0.0013 3,200 30,000 2,900 

1

Application rates are based on maximum application rates of products containing ADAA inerts multiplied by 20% for outdoor 

products and 5% for indoor products to convert from product application rate to inert application rate. 2

Quantity treated daily values for indoor products are assumed to be used at 1 gallon of solution for the mopping scenario, 0.5 L 

of solution for the wiping scenario, and a 12 oz can of spray for the aerosol spray/air deodorization scenario. 3

Unit Exposure data sources are identified in the exposure scenario column. All exposure scenarios assess exposure reflecting 

applicators wearing short-sleeved shirts and shorts and no respiratory protection. 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb /gal) * Quantity handled (gallons/day))/ 

Body Weight (70 kg) *Dermal Absorption factor (10%) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (mg inert / lb inert) * Application Rate (lb /gal) * Quantity handled 

(gallons/day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

 Total MOE = 1/ [(1/ Dermal MOE) + (1/ inhalation MOE)] 
Page 33 of 47 

Table 2. Residential Postapplication Short- and Intermediate-term Exposures and Risks 

for ADAAs

Exposure Scenario Application Rate1 Exposed 

Population & 

Exposure 

Duration2

Daily Dose 

(mg/kg/day)3

MOE4

Outdoor Products 

Adult ST 0.021 1900 

Adult IT 0.011 3800 

Child ST 0.035 1100 

Dermal Exposure to 

Treated Lawns 

Child IT 0.0175 2300 

Hand-to-Mouth from Child ST 0.013 3000 

Treated Lawn Child IT 0.0064 6300 

Object-to-Mouth Child ST 12000 

from Treated Lawn Child IT 0.0034 

Child ST Soil Ingestion Child IT 4.51E-5 890,000 

Total Lawn Child ST 0.048 830 

Combined 

Exposures* 

0.9 lb/day 

Child IT 0.024 1700 

Indoor Cleaning Product 

Dermal Exposure to Child ST 

Treated Indoor 

Surface 

Child IT 0.00349 11000 

Hand-to-Mouth from Child ST 0.00425 9400 

Treated Indoor 

Surface 

Child IT 0.00202 20000 

Total Surface Child ST 0.00774 5200 

Combined 

Exposures*

6.5E-6 lb/ft2

Child IT 0.00551 7300 

1 Application rates for outdoor products assume 5 gallons used her day, with 1/10 dilution. Application rates indoor products are 

determined by assuming 0.5 gallons of solution used per day, 1 gallon used to treat 1,000 ft2

 of hard surface (0.5 gallons used 

treats 500 ft2

), a dilution rate of 2 ounces product per gallon of water in solution, solution is assumed to have a density of 8.34 lbs 

per gallon (density of water), and 5% inert is assumed to be in product. 2 ST and IT indicate short- or intermediate-term exposure durations 3 Daily Dose = Daily Dose algorithms for various residential postapplication scenarios outlined in “JITF Inert Ingredients. 

Residential and Occupational Exposure Assessment Algorithms and Assumptions Appendix for the Human Health Risk 

Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 

Formulations”, D364751, 5/7/09. 

4

 MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dose (mg/kg/day) 

5

 Combined exposures reflect the aggregation of dermal exposure to treated areas and HTM exposure from treated areas (for 

children). Total Combined Exposures = 1/ [(1/ Dermal MOE) + (1/ HTM MOE)] 
Page 34 of 47 

Table 3. Short- and Intermediate-Term Residential Exposures for the ADAA Aggregate 

Risk Calculations 

Population Handler Exposure 

(mg/kg/day)1

Postapplication 

Exposure 

(mg/kg/day)2

Residential 

Exposure 

(mg/kg/day)3

Short-Term 

Adult Male 0.27442 

Indoor hard surface, Wiping (ST) 

0.021 

Dermal Lawn Exposure 

0.29542 

Adult Female 0.27442 

Indoor hard surface, Wiping (ST)

0.021 

Dermal Lawn Exposure 

0.29542 

Child N/A 0.048 

Dermal + HTM Lawn Exposure 

0.048 

Intermediate-Term 

Adult Male N/A 0.011 

Dermal Lawn Exposure 

0.011 

Adult Female N/A 0.011 

Dermal Lawn Exposure 

0.011 

Child N/A 0.024 

Dermal + HTM Lawn Exposure

0.024 

1 – Handler exposure represents high end inhalation handler exposure, where the exposure duration is appropriate to assess. 

2 – Postapplication exposure combines high end dermal and incidental oral exposure to outdoor or indoor products for the 

relevant exposure duration. 

3 - Residential exposure represents handler exposure for short-term with combined post-application dermal and incidental oral 

exposure. 

Short- and intermediate-term aggregate risks are summarized in the table below. 

Table 4. Short- and Intermediate-Term Aggregate Risk Calculations for ADAAs 

Population 

PoD 

mg/kg/day LOC1

Max 

Allowable 

Exposure2

mg/kg/day

Average 

Food & 

Water 

Exposure 

mg/kg/day

Residential 

Exposure3

mg/kg/day

Aggregate 

dose 

(food and 

residential)4

Aggregate 

MOE5

Short-Term 

Adult Male 40 100 0.4 0.077868 0.29542 0.373288 110 

Adult 

Female 40 100 0.4 0.077868 

0.29542 

0.373288 110 

Child 40 100 0.4 0.25148 0.048 0.29948 130 

Intermediate-Term 

Adult Male 40 100 0.4 0.077868 0.011 0.088868 450 

Adult 

Female 40 100 0.4 0.077868 

0.011 

0.088868 450 

Child 40 100 0.4 0.25148 0.024 0.27548 150 

1

 The LOC (Level of Concern) is based on the standard inter- and intra-species uncertainty factors totaling 100. 2

 Maximum Allowable Exposure (mg/kg/day) = PoD (Point of Departure)/LOC 3

 Residential Exposure = [Oral exposure + Dermal exposure + Inhalation Exposure]. Sources identified above in Table XX 4

 Aggregate dose = Avg Food & Water Exposure + Residential Exposure 

5 Aggregate MOE = [PoD/ (Avg Food & Water Exposure + Residential Exposure)]
Page 35 of 47 

Appendix C. 

Table 5. Exposure and Risks for Occupational Handlers of ADAA in Herbicide Products (All 

Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST) 

2.08 10.34 0.043 4 930 4 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT) 

0.4 

1200 

1.99 0.0082 20 4,900 20 

Liquids/ Airblast/ Nut 

Tree (ST) 1.44 0.239 0.00099 170 41,000 170 

Liquids/ Airblast/ Nut 

Tree (IT) 0.64 

40 

0.106 0.00044 380 91,000 380 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 2.08 1.723 0.00713 23 5,600 23 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.4 

200 

0.331 0.0014 120 29,000 120 

Liquids/ Groundboom/ 

Turf (ST) 2.08 0.345 0.0014 120 28,000 120 

Liquids/ Groundboom/ 

Turf (IT) 0.4 

40 

0.0663 0.00027 600 150,000 600 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 1.44 0.0298 0.00012 1,300 320,000 1,300 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 1.44 

5 

2.9 1.2 

0.0298 0.00012 1,300 320,000 1,300 

Wettable Powder/ 

Airblast/ Nut Tree (ST) 0.32 0.068 0.0079 590 5,100 530 

Wettable Powder/ 

Airblast/ Nut Tree (IT) 0.32 

40 

0.068 0.0079 590 5,100 530 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.32 0.338 0.039 120 1,000 110 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.2 

200 

0.2114 0.0246 190 1,600 170 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.32 0.0677 0.0079 590 5,100 530 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.2 

40 

0.0423 0.0049 950 8,100 850 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

1.44 0.038 0.0044 1,100 9,000 940 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

1.44 

5 

3.7 43 

0.038 0.0044 1,100 9,000 940 

Applicator Scenarios 

Liquid/ Aerial 

Application/ High Acreage 

Crops (ST)9 2.08 0.0196 0.0024 2,000 16,000 1,800 

Liquid/ Aerial 

Application/ High Acreage 

Crops (IT)9 0.4 

1200 

Eng 

control 

only: 

0.0055 

Eng 

control 

only: 

0.068 0.0038 0.0005 11,000 86,000 9,400 

Airblast/ Nut Tree (ST) 0.32 0.0066 0.00082 6,100 49,000 5,400 

Airblast/ Nut Tree (IT) 0.32 40 0.36 4.5 0.0066 0.00082 6,100 49,000 5,400 

Groundboom/ High 

Acreage Crops (ST) 2.08 0.0083 0.0044 4,800 9,100 3,100 

Groundboom/ High 

Acreage Crops (IT) 0.4 

200 

0.0016 0.00085 25,000 47,000 16,000 

Groundboom/ Turf (ST) 2.08 0.00166 0.00088 24,000 45,000 16,000 

Groundboom/ Turf (IT) 0.4 40 

0.014 0.74 

0.00032 0.00017 130,000 240,000 82,000 

Mixer/Loader/Applicator Scenario 

Low Pressure Handwand/ 1.44 5 No 6.6 NA 0.00068 NA 59,000 NA 
Page 36 of 47 

Table 5. Exposure and Risks for Occupational Handlers of ADAA in Herbicide Products (All 

Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Turf (ORETF data) (ST)10

Low Pressure Handwand/ 

Turf (ORETF data) (IT)10 1.44 Data NA 0.00068 NA 59,000 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (ST)10 1.44 NA 0.1131 NA 350 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (IT)10 1.44 NA 0.1131 NA 350 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (LT)10 1.44 

5 No 

Data 1100 

NA 0.1131 NA 350 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(ST) 

1.44 1.029 0.0031 39 13,000 39 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

1.44 1.029 0.0031 39 13,000 39 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(LT) 

1.44 

5 100 30 

1.029 0.0031 39 13,000 39 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 2.08 0.039 0.0125 1,000 3,200 770 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.4 

1200 0.011 0.35 

0.0075 0.0024 5,300 17,000 4,000 1

Application rates are based on maximum application rates of products containing inerts in ADAAs multiplied by 20% to convert 

to application rate of just inert in a product (Pesticide products assumed to contain a maximum of 20% inert ADAA). 

Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for 

Intermediate-term (IT) and long-term (LT) exposures are based on average application rates. Baseline Dermal PPE is single 

layer clothing, no gloves. 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor (10%) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7

ST Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = 1/ [(1/ Dermal MOE) + (1/ inhalation MOE)] 9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. All other exposure 

scenarios assess baseline dermal (no gloves) plus baseline inhalation exposure. 10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed 

has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves dermal 

exposure. 
Page 37 of 47 

1

Application rates are based on maximum application rates of products containing inerts in ADAA multiplied by 20% to convert 

to application rate of just inert in a product (Pesticide products contain a maximum of 20% inert ADAA). Application rates for

Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for Intermediate-term (IT) 

and long-term (LT) exposures are based on average application rates. Scenarios shown are with Baseline Dermal PPE (single 

layer clothing) plus gloves and Baseline Inhalation PPE (no respirator). 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess minimum dermal PPE (plus gloves) plus baseline inhalation exposure. 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 10% (0.10) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Daily dose dermal + Daily dose inhalation (mg/kg/day)] 9

 Exposure scenarios assess minimum dermal PPE (baseline PPE plus gloves) plus baseline inhalation exposure. 

Table 6. Exposure and Risks for Occupational Handlers of ADAA in Herbicide Products (All Exposure 

Durations) with Baseline Dermal PPE (single layer clothing) plus Gloves and Baseline Inhalation PPE 

(No respirator) for High Acreage Mixer/ Loader Scenarios 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Min PPE 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Min PPE 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST)9 2.08 0.082 0.0428 490 930 320 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT)9 0.4 

1200 

0.0158 0.00823 2,500 4,900 1,700 

Liquids/ Groundboom/ 

High Acreage Crops (ST)9 2.08 0.01367 0.00713 2,900 5,600 1,900 

Liquids/ Groundboom/ 

High Acreage Crops (IT)9 0.4 

200 

0.023 1.2 

0.00263 0.00137 15,000 29,000 10,000 

Table 7: Exposure and Risks for Occupational Handlers of ADAA in Herbicide Products Used in Low 

Pressure Handwand Applications to Ornamentals in Greenhouses (All Exposure Durations) at Baseline 

Dermal PPE (single layer clothing, no gloves) and Baseline Inhalation PPE (no respirator) 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader/Applicator for Herbicide Products with 15% ADAA in formulation 

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

1.08 5 100 30 0.7714 0.0023 52 17,000 52 

Mixer/Loader/Applicator for Herbicide Products with 10% ADAA in formulation

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

0.72 5 100 30 0.5143 0.00154 78 26,000 78 

Mixer/Loader/Applicator for Herbicide Products with 7% ADAA in formulation

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 0.504 5 100 30 0.36 0.00108 110 37,000 110 
Page 38 of 47 

1

Application rates are based on maximum application rates of products containing inerts in the ADAA cluster multiplied by 

variable % ADAA in formulation to convert to application rate of just inert in an herbicide product. 2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE (single layer no gloves) plus baseline inhalation exposure 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 10% (0.10) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Daily dose dermal + Daily dose inhalation (mg/kg/day)] 

Table 8. Exposure and Risks for Occupational Handlers of ADAA in Insecticide Products (All 

Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High 

Acreage Crops (ST) 

0.4 1.989 0.0082 20 4,900 20 

Liquids/ Aerial 

Application/ High 

Acreage Crops (IT) 

0.14 

1200 

0.696 0.00288 57 14,000 57 

Liquids/ Airblast/ Nut 

Tree (ST) 1.8 0.298 0.00123 130 32,000 130 

Liquids/ Airblast/ Nut 

Tree (IT) 0.5 

40 

0.083 0.00034 480 120,000 480 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 0.4 0.331 0.0014 120 29,000 120 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.14 

200 

0.116 0.00048 340 83,000 340 

Liquids/ Groundboom/ 

Turf (ST) 0.4 0.066 0.00027 600 150,000 600 

Liquids/ Groundboom/ 

Turf (IT) 0.14 

40 

0.023 0.0001 1,700 420,000 1,700 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 1.44 0.0298 0.00012 1,300 320,000 1,300 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 1.44 

5 

2.9 1.2 

0.0298 0.00012 1,300 320,000 1,300 

Wettable Powder/ 

Airblast/ Nut Tree (ST) 1.2 0.254 0.029 160 1,400 140 

Wettable Powder/ 

Airblast/ Nut Tree (IT) 0.6 

40 

0.127 0.0147 320 2,700 280 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.32 0.338 0.039 120 1,000 110 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.14 

200 

0.148 0.0172 270 2,300 240 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.32 0.0677 0.0079 590 5,100 530 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.14 

40 

0.0296 0.00344 1,400 12,000 1,200 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

1.44 0.038 0.0044 1,100 9,000 940 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

1.44 

5 

3.7 43 

0.038 0.0044 1,100 9,000 940 

Applicator Scenarios 

Liquid/ Aerial 

Application/ High 

0.4 1200 Eng 

control 

Eng 

control 0.0038 0.0005 11,000 86,000 9,400 
Page 39 of 47 

Table 8. Exposure and Risks for Occupational Handlers of ADAA in Insecticide Products (All 

Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Acreage Crops (ST)9

Liquid/ Aerial 

Application/ High 

Acreage Crops (IT)9 0.14 

only: 

0.0055 

only: 

0.068 0.0013 0.0002 30,000 250,000 27,000 

Airblast/ Nut Tree (ST) 1.8 0.037 0.0046 1,100 8,600 960 

Airblast/ Nut Tree (IT) 0.5 40 0.36 4.5 0.0103 0.0013 3,900 31,000 3,500 

Groundboom/ High 

Acreage Crops (ST) 0.4 0.0016 0.00085 25,000 47,000 16,000 

Groundboom/ High 

Acreage Crops (IT) 0.14 

200 

0.00056 0.0003 71,000 140,000 47,000 

Groundboom/ Turf (ST) 0.4 0.00032 0.00017 130,000 240,000 82,000 

Groundboom/ Turf (IT) 0.14 40 

0.014 0.74 

0.00011 0.00006 360,000 680,000 230,000 

Mixer/Loader/Applicator Scenarios 

Low Pressure Handwand/ 

Turf (ORETF data) (ST)10 1.44 NA 0.00068 NA 59,000 NA 

Low Pressure Handwand/ 

Turf (ORETF data) (IT)10 1.44 

5 No 

Data 6.6 

NA 0.00068 NA 59,000 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (ST)10 1.44 NA 0.1131 NA 350 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (IT)10 1.44 NA 0.1131 NA 350 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (LT)10 1.44 

5 No 

Data 1100 

NA 0.1131 NA 350 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(ST) 

1.44 1.029 0.0031 39 13,000 39 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

1.44 1.029 0.0031 39 13,000 39 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(LT) 

1.44 

5 100 30 

1.029 0.0031 39 13,000 39 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 0.4 0.0075 0.0024 5,300 17,000 4,000 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.14 

1200 0.011 0.35 

0.0026 0.00084 15,000 48,000 11,000 1

Application rates are based on maximum application rates of products containing inerts in ADAA multiplied by 20% to convert 

to application rate of just inert in a product (Pesticide products assumed to contain a maximum of 20% inert ADAA). 

Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for 

Intermediate-term (IT) and long-term (LT) exposures are based on average application rates. Baseline Dermal PPE is single 

layer clothing, no gloves. 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor (10%) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7

ST Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = 1/ [(1/ Dermal MOE) + (1/ inhalation MOE)] 9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. All other exposure 

scenarios assess baseline dermal (no gloves) plus baseline inhalation exposure.
Page 40 of 47 

10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed 

has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves dermal 

exposure. 

1

Application rates are based on maximum application rates of products containing inerts in the ADAA multiplied by 20% to 

convert to application rate of just inert in an insecticide product (Insecticide products contain maximum of 20% inert ADAA). 

Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for 

Intermediate-term (IT) and long-term (LT) exposures are based on average application rates. 2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess minimum dermal PPE (plus gloves) plus baseline inhalation exposure. 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 10% (0.10) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Daily dose dermal + Daily dose inhalation (mg/kg/day)] 9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. All other exposure 

scenarios assess baseline dermal (no gloves) plus baseline inhalation exposure. 

Table 9. Exposure and Risks for Occupational Handlers of ADAA in Insecticide Products (All Exposure 

Durations) with Baseline Dermal PPE (single layer clothing) plus Gloves and Baseline Inhalation PPE 

(No respirator) for High Acreage Mixer/ Loader Scenarios 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Min PPE 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Min PPE 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST) 0.4 0.01577 0.00823 2,500 4,900 1,700 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT) 

0.14 

1200 0.023 1.2 

0.00552 0.00288 7,200 14,000 4,800 

Table 10: Exposure and Risks for Occupational Handlers of ADAA in Insecticide Products Used in Low 

Pressure Handwand Applications to Ornamentals in Greenhouses (All Exposure Durations) at Baseline 

Dermal PPE (single layer clothing, no gloves) and Baseline Inhalation PPE (no respirator) 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader/Applicator for Insecticide Products with 15% ADAA in formulation 

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

1.08 5 100 30 0.7714 0.0023 52 17,000 52 

Mixer/Loader/Applicator for Insecticide Products with 10% ADAA in formulation

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

0.72 5 100 30 0.5143 0.00154 78 26,000 78 

Mixer/Loader/Applicator for Insecticide Products with 7% ADAA in formulation

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 0.504 5 100 30 0.36 0.00108 110 37,000 110 
Page 41 of 47 

1

Application rates are based on maximum application rates of products containing inerts in the ADAA multiplied by variable % 

ADAA in formulation to convert to application rate of just inert in an insecticide product. 2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE (single layer no gloves) plus baseline inhalation exposure 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 10% (0.10) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Daily dose dermal + Daily dose inhalation (mg/kg/day)]

Table 11. Exposure and Risks for Occupational Handlers of ADAA in Fungicide Products (All 

Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High 

Acreage Crops (ST) 

1 4.97 0.0206 8 1900 8 

Liquids/ Aerial 

Application/ High 

Acreage Crops (IT) 

0.14 

1200 

0.696 0.00288 57 14000 57 

Liquids/ Airblast/ Nut 

Tree (ST) 2.2 0.365 0.0015 110 27,000 110 

Liquids/ Airblast/ Nut 

Tree (IT) 0.6 

40 

0.0994 0.0004 400 97,000 400 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 1 0.829 0.0034 48 12,000 48 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.14 

200 

0.116 0.00048 340 83,000 340 

Liquids/ Groundboom/ 

Turf (ST) 1 0.166 0.00069 240 58,000 240 

Liquids/ Groundboom/ 

Turf (IT) 0.14 

40 

0.023 0.0001 1,700 420,000 1,700 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 1.44 0.0298 0.00012 1,300 320,000 1,300 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 1.44 

5 

2.9 1.2 

0.0298 0.00012 1,300 320,000 1,300 

Wettable Powder/ 

Airblast/ Nut Tree (ST) 1.4 0.296 0.0344 140 1,200 120 

Wettable Powder/ 

Airblast/ Nut Tree (IT) 0.4 

40 

0.085 0.0098 470 4,100 420 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.2 0.211 0.025 190 1,600 170 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.12 

200 

0.127 0.0147 320 2,700 280 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.2 0.0423 0.005 950 8,100 850 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.12 

40 

0.0254 0.00295 1,600 14,000 1,400 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

1.44 0.038 0.0044 1,100 9,000 940 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

1.44 

5 

3.7 43 

0.038 0.0044 1,100 9,000 940 

Applicator Scenarios 

Liquid/ Aerial 

Application/ High 

1 1200 Eng 

control 

Eng 

control 0.0094 0.0012 4,200 34,000 3,800 
Page 42 of 47 

Table 11. Exposure and Risks for Occupational Handlers of ADAA in Fungicide Products (All 

Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Acreage Crops (ST)9

Liquid/ Aerial 

Application/ High 

Acreage Crops (IT)9 0.14 

only: 

0.0055 

only: 

0.068 0.0013 0.00016 30,000 250,000 27,000 

Airblast/ Nut Tree (ST) 1.4 0.0289 0.0036 1,400 11,000 1,200 

Airblast/ Nut Tree (IT) 0.6 40 0.36 4.5 0.0123 0.0015 3,200 26,000 2,900 

Groundboom/ High 

Acreage Crops (ST) 1 0.004 0.002 10,000 19,000 6,500 

Groundboom/ High 

Acreage Crops (IT) 0.14 

200 

0.00056 0.0003 71,000 140,000 47,000 

Groundboom/ Turf (ST) 1 0.0008 0.00042 50,000 95,000 33,000 

Groundboom/ Turf (IT) 0.14 40 

0.014 0.74 

0.00011 0.00006 360,000 680,000 230,000 

Mixer/Loader/Applicator Scenarios 

Low Pressure Handwand/ 

Turf (ORETF data) (ST)10 1.44 NA 0.00068 NA 5,900 NA 

Low Pressure Handwand/ 

Turf (ORETF data) (IT)10 1.44 

5 No Data 6.6 

NA 0.00068 NA 5,900 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (ST)10 1.44 NA 0.113 NA 350 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (IT)10 1.44 NA 0.113 NA 350 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (LT)10 1.44 

5 No Data 1100 

NA 0.113 NA 350 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(ST) 

1.44 1.029 0.0031 39 13,000 39 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

1.44 1.029 0.0031 39 13,000 39 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(LT) 

1.44 

5 100 30 

1.029 0.0031 39 13,000 39 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 1 0.0189 0.006 2,100 6,700 1,600 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.14 

1200 0.011 0.35 

0.0026 0.0008 15,000 48,000 11,000 1

Application rates are based on maximum application rates of products containing inerts in ADAA multiplied by 20% to convert 

to application rate of just inert in a product (Pesticide products assumed to contain a maximum of 20% inert ADAA). 

Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for 

Intermediate-term (IT) and long-term (LT) exposures are based on average application rates. Baseline Dermal PPE is single 

layer clothing, no gloves. 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor (10%) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7

ST Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = 1/ [(1/ Dermal MOE) + (1/ inhalation MOE)] 9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. All other exposure 

scenarios assess baseline dermal (no gloves) plus baseline inhalation exposure.
Page 43 of 47 

10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed 

has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves dermal 

exposure. 

Table 12. Exposure and Risks for Occupational Handlers of ADAA in Fungicide Products (All Exposure 

Durations) with Baseline Dermal PPE (single layer clothing) plus Gloves and Baseline Inhalation PPE 

(No respirator) for High Acreage Mixer/ Loader Scenarios 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Min PPE 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Min PPE 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST) 1 0.0394 0.02057 1,000 1,900 670 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT) 

0.14 

1200 0.023 1.2 

0.00552 0.00288 7,200 14,000 4,800 

1

Application rates are based on maximum application rates of products containing inerts in the ADAA multiplied by 20% to 

convert to application rate of just inert in an fungicide product (Fungicide products contain maximum of 20% inert ADAA). 

Application rates for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for 

Intermediate-term (IT) exposures are based on average application rates. 2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess minimum dermal PPE (plus gloves) plus baseline inhalation exposure . 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 10% (0.10) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Daily dose dermal + Daily dose inhalation (mg/kg/day)] 

1

Application rates are based on maximum application rates of products containing inerts in the ADAA multiplied by variable % 

ADAA in formulation to convert to application rate of just inert in a fungicides product. 

Table 13: Exposure and Risks for Occupational Handlers of ADAA in Fungicide Products Used in Low 

Pressure Handwand Applications to Ornamentals in Greenhouses (All Exposure Durations) at Baseline 

Dermal PPE (single layer clothing, no gloves) and Baseline Inhalation PPE (no respirator) 

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader/Applicator for Fungicide Products with 15% ADAA in formulation 

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

1.08 5 100 30 0.7714 0.0023 52 17,000 52 

Mixer/Loader/Applicator for Fungicide Products with 10% ADAA in formulation

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

0.72 5 100 30 0.5143 0.00154 78 26,000 78 

Mixer/Loader/Applicator for Fungicide Products with 7% ADAA in formulation

Liquids/ Low Pressure 

Handwand/ Ornamentals 

(IT) 0.504 5 100 30 0.36 0.00108 110 37,000 110 
Page 44 of 47 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE (single layer no gloves) plus baseline inhalation exposure 4

Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body 

Weight (70 kg) * Dermal Absorption Factor of 10% (0.10) 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dermal dose (mg/kg/day) 7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Daily dose dermal + Daily dose inhalation (mg/kg/day)]

Table 14. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures and 

Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

Herbicide Products 

Scout, weed low 

foliage 100 0 0.0053 7,500 

Scout, weed 

high foliage 400 0 0.0213 1,900 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0533 750 

Corn (ST) 2.08 

Harvesting/ 

detassling 17,000 0 

4.667 

0.9067 44 

Days after Treatment when MOE > LOC of 100 8 

Scout, weed low 

foliage 100 0 0.0006 65,000 

Scout, weed 

high foliage 400 0 0.0025 16,000 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0062 6,500 

Corn (IT) 0.24 

Harvesting/ 

detassling 17,000 0 

0.539 

0.1046 380 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 0.0123 3,200 

Scout, train, tie 1,000 0 0.0246 1,600 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.1231 320 

Grapes 

(Table) (ST) 0.96 

Cane turning, 

girdle 10,000 0 

2.154 

0.2462 160 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 0.0072 5,600 

Scout, train, tie 1,000 0 0.0144 2,800 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.0718 560 

Grapes 

(Table) 

(IT) 

0.56 

Cane turning, 10,000 0 

1.257 

0.1436 280 
Page 45 of 47 

Table 14. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures and 

Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

girdle 

Mowing 500 0 0.007 6,000 Turf/ sod 

(ST) 2.08 Transplant, 

weed, harvest 6,800 0 1.167 0.091 440 

Mowing 500 0 0.001 52,000 Turf/ Sod 

(IT) 0.24 Transplant, 

weed, harvest 6,800 0 0.135 0.01 3,800 

Insecticide Products 

Scout, weed low 

foliage 100 0 0.0051 7,800 

Scout, weed 

high foliage 400 0 0.0205 1,900 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0513 780 

Corn (ST) 2 

Harvesting/ 

detassling 17,000 0 

4.488 

0.8719 46 

Days after Treatment when MOE > LOC of 100 8 

Scout, weed low 

foliage 100 0 0.0005 78,000 

Scout, weed 

high foliage 400 0 0.0021 19,000 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0051 7,800 

Corn (IT) 0.2 

Harvesting/ 

detassling 17,000 0 

0.449 

0.0872 460 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 0.018 2,200 

Scout, train, tie 1,000 0 0.0359 1,100 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.1795 220 

Grapes 

(Table) (ST) 1.4 

Cane turning, 

girdle 10,000 0 

3.141 

0.359 110 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 0.0077 5,200 

Scout, train, tie 1,000 0 0.0154 2,600 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.0769 520 

Grapes 

(Table) 

(IT) 

0.6 

Cane turning, 

girdle 10,000 0 

1.356 

0.1539 260 

Mowing 500 0 0.006 6,200 Turf/ sod 

(ST) 2 Transplant, 

weed, harvest 6,800 0 

1.122 

0.087 460 
Page 46 of 47 

Table 14. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures and 

Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

Mowing 500 0 0.001 62,000 Turf/ Sod 

(IT) 0.2 Transplant, 

weed, harvest 6,800 0 

0.112 

0.009 4,600 

Fungicide Products 

Scout, weed low 

foliage 100 0 0.0026 16,000 

Scout, weed 

high foliage 400 0 0.0103 3,900 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0256 1,600 

Corn (ST) 1 

Harvesting/ 

detassling 17,000 0 

2.244 

0.4359 92 

Day after Treatment when MOE > LOC of 100 1 

Scout, weed low 

foliage 100 0 0.0005 78,000 

Scout, weed 

high foliage 400 0 0.0021 19,000 

Scout, irrigate, 

weed high 

foliage 

1,000 0 0.0051 7,800 

Corn (IT) 0.2 

Harvesting/ 

detassling 17,000 0 

0.449 

0.0872 460 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 0.0128 3,100 

Scout, train, tie 1,000 0 0.0256 1,600 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.1282 310 

Grapes 

(Table) (ST) 1 

Cane turning, 

girdle 10,000 0 

2.244 

0.2564 160 

Hedge, irrigate, 

weed, scout, 

train, tie 

500 0 0.0051 7,800 

Scout, train, tie 1,000 0 0.0103 3,900 

Harvest, pull, 

thin, prune, 

train, tie 

5,000 0 0.0513 780 

Grapes 

(Table) 

(IT) 

0.4 

Cane turning, 

girdle 10,000 0 

0.898 

0.1026 390 

Mowing 500 0 0.003 12,000 Turf/ sod 

(ST) 1 Transplant, 

weed, harvest 6,800 0 

0.561 

0.044 920 

Mowing Turf/ Sod 500 0 0.001 62,000 

(IT) 0.2 

Transplant, 6,800 0 

0.112 

0.009 4,600 
Page 47 of 47 

Table 14. Short- and Intermediate-Term Occupational Postapplication Dermal Exposures and 

Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & 

Exposure 

Duration 

Application 

Rate 

(lb inert /A) Work Activity 

Transfer 

Coefficient1

(cm2/hr) 

Day after 

Treatment2

DFRt

(μg/cm2)

3

Daily Dose 

(mg/kg/day)4 MOE5

weed, harvest 1

 Transfer coefficient from Science Advisory Council for Exposure: Policy Memo #003 “Agricultural Transfer 

Coefficients” 05/07/98. 

2 DAT = Day After Treatment 

3

 DFR = Application rate (lbs inert/acre) * fraction of active ingredient that remains on foliage (0.2 for crop, 0.05 for 

turf)* (1-D(10% dissipation))(t= 0) * 4.54 μg/lb * 24.7 x10-9 acre/cm2 

4 Daily Dose = DFR (μg/cm2

) * Tc (cm2/hr) * (1 mg/1000 μg) * ET (8 hrs/day) / body weight (70 kg) * Dermal 

Absorption Factor (10%) 

5

 MOE = Dermal PoD (NOAEL of 40 mg/kg/day) / Daily Dose (mg/kg/day)